Statements in which the resource exists as a predicate.
SubjectObject
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Cefizox (ceftizoxime for injection, USP) is a sterile, semisynthetic, broad���spectrum, beta���lactamase resistant cephalosporin antibiotic for parenteral (IV, IM) administration. It is the sodium salt of [6R��[6a,7��(Z)]]���7���[[(2,3���dihydro���2���imino���4���thiazolyl) (methoxyimino) acetyl] amino]���8���oxo���5���thia���1���azabicyclo [4.2.0] oct���2���ene���2���carboxylic acid. Its sodium content is approximately 60 mg (2.6 mEq) per gram of ceftizoxime activity. It has the following structural formula: CHNNaOS 405.38 Ceftizoxime for injection, USP is a white to pale yellow crystalline powder. Cefizox is supplied in ADD-vantage vials as ceftizoxime sodium equivalent to 1 gram or 2 grams ceftizoxime.
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The active component of FLOVENT DISKUS is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6��,9-difluoro-11��,17-dihydroxy-16��-methyl-3-oxoandrosta-1,4-diene-17��-carbothioate, 17-propionate and the following chemical structure: Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is CHFOS. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. FLOVENT DISKUS is a specially designed plastic inhalation delivery system containing a double-foil blister strip of a powder formulation of fluticasone propionate intended for oral inhalation only. The DISKUS inhalation unit, which is the delivery component, is an integral part of the drug product. Each blister on the double-foil strip within the unit contains 50 mcg of microfine fluticasone propionate in 12.5 mg of formulation containing lactose (which contains milk proteins). After a blister containing medication is opened by activating the DISKUS, the medication is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, FLOVENT DISKUS 50 mcg delivers 46 mcg of fluticasone propionate when tested at a flow rate of 60 L/min for 2 seconds. In adult patients with obstructive lung disease and severely compromised lung function (mean forced expiratory volume in 1 second [FEV] 20% to 30% of predicted), mean peak inspiratory flow (PIF) through a DISKUS was 82.4 L/min (range, 46.1 to 115.3 L/min). In children with asthma 4 and 8 years old, mean PIF through FLOVENT DISKUS was 70 and 104 L/min, respectively (range, 48 to 123 L/min). The actual amount of drug delivered to the lung may depend on patient factors, such as inspiratory flow profile.
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Nadolol USP is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1-naphthyl)oxy]-2-propanol. The structural formula is: Nadolol USP is a white to off-white, practically odorless, crystalline powder. It is freely soluble in water, in alcohol, and in methanol and slightly soluble in chloroform. Nadolol USP is available for oral administration as 20 mg, 40 mg, 80 mg, 120 mg, and 160 mg tablets and contains the following inactive ingredients: citric acid, corn starch, magnesium stearate, microcrystalline cellulose and povidone. In addition, the 80 mg, 120 mg and 160 mg tablets contain sodium starch glycolate.
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Kepivance (palifermin) is a human keratinocyte growth factor (KGF) produced by recombinant DNA technology in Escherichia coli (E coli). Kepivance is a water-soluble, 140 amino acid protein with a molecular weight of 16.3 kilodaltons. It differs from endogenous human KGF in that the first 23 N-terminal amino acids have been deleted to improve protein stability. Kepivance is supplied as a sterile, white, preservative-free, lyophilized powder for IV injection after reconstitution with 1.2 mL of Sterile Water for Injection, USP. Reconstitution yields a clear, colorless solution of Kepivance (5 mg/mL) with a pH of 6.5. Each single-use vial of Kepivance contains 6.25 mg palifermin, 50 mg mannitol, 25 mg sucrose, 1.94 mg L-histidine, and 0.13 mg polysorbate 20 (0.01% w/v).
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Mepivacaine hydrochloride is 2-Piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-methyl-, monohydrochloride and has the following structural formula: The molecular formula is CHNO HCl. It is a white, crystalline odorless powder, soluble in water, but very resistant to both acid and alkaline hydrolysis. Mepivacaine hydrochloride is a local anesthetic available as sterile isotonic solutions (clear, colorless) in concentrations of 1%, 1.5% and 2% for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Mepivacaine hydrochloride is related chemically and pharmacologically to the amide-type local anesthetics. It contains an amide linkage between the aromatic nucleus and the amino group. The pH of the solution is adjusted between 4.5 and 6.8 with sodium hydroxide or hydrochloric acid.
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MUSTARGEN, an antineoplastic nitrogen mustard also known as HN2 hydrochloride, is a nitrogen analog of sulfur mustard. It is a light yellow brown, crystalline, hygroscopic powder that is very soluble in water and also soluble in alcohol.Mechlorethamine hydrochloride is designated chemically as 2-chloro-N-(2-chloroethyl)-N-methylethanamine hydrochloride. The molecular weight is 192.52 and the melting point is 108 - 111��C. The empirical formula is CHClN���HCl, and the structural formula is: CHN(CHCHCl)���HCl.Trituration of MUSTARGEN is a sterile, light yellow brown crystalline powder for injection by the intravenous or intracavitary routes after dissolution. Each vial of MUSTARGEN contains 10 mg of mechlorethamine hydrochloride triturated with sodium chloride q.s. 100 mg. When dissolved with 10 mL Sterile Water for Injection or 0.9% Sodium Chloride Injection, the resulting solution has a pH of 3-5 at a concentration of 1 mg mechlorethamine HCl per mL.
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Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass vials. Fluconazole is designated chemically as 2,4-difluoro-��,��-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of CHFNO and molecular weight 306.27. The structural formula is: Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole injection is an iso-osmotic, sterile, nonpyrogenic solution of fluconazole in a sodium chloride diluent. Each mL contains 2 mg of fluconazole and 9 mg of sodium chloride. The pH ranges from 4.0 to 8.0 in the sodium chloride solution. Injection volumes of 100 mL and 200 mL are packaged in glass vials.
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PRED FORTE (prednisolone acetate ophthalmic suspension, USP) 1% is a topical anti-inflammatory agent for ophthalmic use.<br/>Structural Formula::<br/>Chemical Name:: 11��,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate Contains: Active: prednisolone acetate (microfine suspension) 1.0% Preservative: benzalkonium chloride. Inactives: boric acid; edetate disodium; hypromellose; polysorbate 80; purified water; sodium bisulfite; sodium chloride; and sodium citrate. The pH during its shelf life ranges from 5.0 - 6.0.
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Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula: LUPRON DEPOT is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 3.75 mg prefilled dual-chamber syringe contains leuprolide acetate (3.75 mg), purified gelatin (0.65 mg), DL-lactic and glycolic acids copolymer (33.1 mg), and D-mannitol (6.6 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. During the manufacture of LUPRON DEPOT 3.75 mg, acetic acid is lost, leaving the peptide.
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Betimol (timolol ophthalmic solution), 0.25% and 0.5%, is a non-selective beta-adrenergic antagonist for ophthalmic use. The chemical name of the active ingredient is (S)-1-[(1,1-dimethylethyl)amino]-3-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-2-propanol. Timolol hemihydrate is the levo isomer. Specific rotation is [��]=-16��(C=10% as the hemihydrate form in 1N HCl). The molecular formula of timolol is Formula CHNOS and its structural formula is: Timolol (as the hemihydrate) is a white, odorless, crystalline powder which is slightly soluble in water and freely soluble in ethanol. Timolol hemihydrate is stable at room temperature. Betimol is a clear, colorless, isotonic, sterile, microbiologically preserved phosphate buffered aqueous solution.It is supplied in two dosage strengths, 0.25% and 0.5%. Each mL of Betimol 0.25% contains 2.56 mg of timolol hemihydrate equivalent to 2.5 mg timolol. Each mL of Betimol 0.5% contains 5.12 mg of timolol hemihydrate equivalent to 5.0 mg timolol. Inactive ingredients: monosodium and disodium phosphate dihydrate to adjust pH (6.5 - 7.5) and water for injection, benzalkonium chloride 0.01% added as preservative. The osmolality of Betimol is 260 to 320 mOsmol/kg.
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CHEMET (Succimer) is an orally active, heavy metal chelating agent. The chemical name for succimer is meso 2, 3-dimercaptosuccinic acid (DMSA). Its empirical formula is CHOSand molecular weight is 182.2.The meso-structural formula is: Succimer is a white crystalline powder with an unpleasant, characteristic mercaptan odor and taste. Each CHEMET opaque white capsule for oral administration, contains beads coated with 100 mg of succimer and is imprinted black with CHEMET 100. Inactive ingredients in medicated beads are: povidone, sodium starch glycolate, starch and sucrose. Inactive ingredients in capsule are: gelatin, iron oxide, titanium dioxide and other ingredients.
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REMERON (mirtazapine) Tablets are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c] benzazepine and has the empirical formula of CHN. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture: Mirtazapine is a white to creamy white crystalline powder which is slightly soluble in water. REMERON' is supplied for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet also contains corn starch, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide, lactose, and other inactive ingredients.
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BenzaClin Topical Gel contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (CHClNOPS). The structural formula for clindamycin is represented below: Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate). BenzaClin Topical Gel also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (CHO). It has the following structural formula: Benzoyl peroxide has a molecular weight of 242.23. Each gram of BenzaClin Topical Gel contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer, sodium hydroxide, dioctyl sodium sulfosuccinate, and purified water.
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Bicillin L-A (penicillin G benzathine injectable suspension) is available for deep intramuscular injection. Penicilin G benzathine is prepared by the reaction of dibenzylethylene diamine with two molecules of penicillin G. It is chemically designated as (2S, 5R, 6R )-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with N,N' -dibenzylethylenediamine (2:1), tetrahydrate. It occurs as a white, crystalline powder and is very slightly soluble inwater and sparingly soluble in alcohol. Its chemical structure is as follows: Bicillin L-A contains penicillin G benzathine in aqueous suspension with sodium citrate buffer and, as w/v, approximately 0.5% lecithin, 0.6% carboxymethylcellulose, 0.6% povidone, 0.1% methylparaben, and 0.01% propylparaben. Bicillin L-A suspension in the disposable-syringe formulation is viscous and opaque. It is available in a 1 mL, 2 mL, and 4 mL sizes containing the equivalent of 600,000, 1,200,000 and 2,400,000 units respectively of penicillin G as the benzathine salt. Read CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections prior to use.
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Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentrationand caloric content are shown in Table 1. The flexible container is made with non-latex plastic materials specially designed for a wide range of parenteral drugs including those requiring delivery in containers made of polyolefins or polypropylene. For example, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of paclitaxel. In addition, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of all drugs deemed compatible with existing polyvinyl chloride container systems. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The suitability of the container materials has been established through biological evaluations, which have shown the container passes Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container system. The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration. The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication (See Directions for Use). The primary function of the overwrap is to protect the container from the physical environment.
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Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine Hydrochloride Oral Solution USP for oral administration contains 50 mg of amantadine hydrochloride per 5 mL and has the following inactive ingredients: citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, purified water, sorbitol solution, and natural and artificial flavoring.
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Dipyridamole USP is a platelet inhibitor chemically described as 2,2',2",2"'-[(4,8-Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula: Dipyridamole is an odorless yellow crystalline powder, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and practically insoluble in water. Dipyridamole USP tablets for oral administration contain: Active Ingredient TABLETS 25 mg, 50 mg, and 75 mg: dipyridamole USP 25 mg, 50 mg and 75 mg, respectively. Inactive Ingredients TABLETS 25 mg, 50 mg, and 75 mg: corn starch, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.
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This product is designed to provide a stable aqueous suspension of penicillin G procaine, ready for immediate use. This eliminates the necessity for addition of any diluent, required for the usual dry formulation of injectable penicillin. Penicillin G procaine is chemically designated as (2S, 5R, 6R)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with 2-(diethylamino)ethyl p-aminobenzoate (1:1) monohydrate. Its molecular formula is CHNOS���CHNO���HO with a molecular weight of 588.72. Its structural formula is as follows: Each TUBEX; Sterile Cartridge-Needle Unit, 1,200,000 units (2 mL size) or 600,000 units (1 mL size), contains penicillin G procaine in a stabilized aqueous suspension with sodium citrate buffer; and as w/v, approximately 0.5% lecithin, 0.5% carboxymethylcellulose, 0.5% povidone, 0.1% methylparaben, and 0.01% propylparaben. Penicillin G Procaine Injectable Suspension in the TUBEX formulation is viscous and opaque. Read CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections prior to use.
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Quinapril hydrochloride, USP is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is CHNO���HCl and its structural formula is: M.W. = 474.98 Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. Quinapril hydrochloride tablets contain 5 mg, 10 mg, 20 mg, or 40 mg of quinapril for oral administration. Each tablet also contains crospovidone, hypromellose, iron oxide black, iron oxide yellow, lactose monohydrate, magnesium oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80 and titanium dioxide.
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Dipivefrin Hydrochloride Ophthalmic Solution USP, 0.1% is a sterile, isotonic solution. Dipivefrin hydrochloride is a white, crystalline powder, freely soluble in water. It is classified as a sympathomimetic agent and has the following structural formula: Chemical Name: (��) -3, 4-Dihydroxy-a- [(methylamino) methyl] benzyl alcohol 3, 4-dipivalate hydrochloride. Contains: Active: Dipivefrin hydrochloride, 0.1% (1 mg/mL). Preservative: Benzalkonium chloride 0.005%. Inactive Ingredients: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH to 2.5 to 3.5), Purified Water. DM-00
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Each 100 mL of Ringer's Injection USP contains: Sodium Chloride USP 0.86 g; Calcium Chloride Dihydrate USP 0.033 g Potassium Chloride USP 0.03 g; Water for Injection USP qs pH: 5.8 (5.0���7.5) Calculated Osmolarity: 310 mOsmol/liter Concentration of Electrolytes (mEq/liter): Sodium 147; Potassium 4 Calcium 4.5; Chloride 156 Ringer's Injection USP is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration in a single dose container. The formulas of the active ingredients are: The EXCEL Container is Latex-free, PVC-free, and DEHP-free. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.
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NuvaRing' (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17��-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17��-pregna-1,3,5(10)-trien-20-yne-3, 17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. NuvaRing' is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. NuvaRing' is latex-free. NuvaRing' has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows:
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Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a polyethylene and mineral oil base. The structural formula is as follows:
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Surmontil (trimipramine maleate) is 5-(3-dimethylamino-2-methylpropyl)-10,11-dihydro-5H-dibenz (b,f) azepine acid maleate (racemic form). Surmontil capsules contain trimipramine maleate equivalent to 25 mg, 50 mg, or 100 mg of trimipramine as the base. The inactive ingredients present are black ink, FD&C Blue 1, gelatin, lactose, magnesium stearate, and titanium dioxide. The 25 mg dosage strength also contains benzyl alcohol, D&C Yellow 10, edetate calcium disodium, FD&C Yellow 6, parabens (butyl, propyl and methyl), sodium lauryl sulfate, and sodium propionate; the 50 mg dosage strength also contains benzyl alcohol, D&C Red 28, edetate calcium disodium, FD&C Red 40, FD&C Yellow 6, parabens (butyl, propyl and methyl), sodium lauryl sulfate, and sodium propionate. Trimipramine maleate is prepared as a racemic mixture which can be resolved into levorotatory and dextrorotatory isomers. The asymmetric center responsible for optical isomerism is marked in the formula by an asterisk. Trimipramine maleate is an almost odorless, white or slightly cream-colored, crystalline substance, melting at 140��-144��C. It is very slightly soluble in ether and water, is slightly soluble in ethyl alcohol and acetone, and freely soluble in chloroform and methanol at 20��C.
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LACRISERT(hydroxypropyl cellulose ophthalmic insert) is a sterile, translucent, rod-shaped, water soluble, ophthalmic insert made of hydroxypropyl cellulose, for administration into the inferior cul-de-sac of the eye. The chemical name for hydroxypropyl cellulose is cellulose, 2-hydroxypropyl ether. It is an ether of cellulose in which hydroxypropyl groups (-CHCHOHCH) are attached to the hydroxyls present in the anhydroglucose rings of cellulose by ether linkages. A representative structure of the monomer is: The molecular weight is typically 1��10. Hydroxypropyl cellulose is an off-white, odorless, tasteless powder. It is soluble in water below 38��C, and in many polar organic solvents such as ethanol, propylene glycol, dioxane, methanol, isopropyl alcohol (95%), dimethyl sulfoxide, and dimethyl formamide. Each LACRISERT is 5 mg of hydroxypropyl cellulose. LACRISERT contains no preservatives or other ingredients. It is about 1.27 mm in diameter by about 3.5 mm long. LACRISERT is supplied in packages of 60 units, together with illustrated instructions and a special applicator for removing LACRISERT from the unit dose blister and inserting it into the eye. A spare applicator is included in each package.
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14.6% Sodium Chloride Injection, USP Additive Solution is a sterile, nonpyrogenic, concentrated solution for intravenous administration ONLY AFTER DILUTION to replenish electrolytes. The preparations contain either 2.92 or 5.84 g of sodium chloride (50 or 100 mEq each of Naand Cl) in Water for Injection, USP. The solution contains no bacteriostat, antimicrobial agent or added buffer; pH 4.8 (4.5 to 7.0). May contain hydrochloric acid for pH adjustment. The osmolar concentration is 5 mOsmol/mL (calc.); specific gravity is 1.10. Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The semi-rigid material used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.
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Darvon (Propoxyphene Hydrochloride, USP) is an odorless, white crystalline powder with a bitter taste. It is freely soluble in water. Chemically, it is (2S,3R)-(+)-4-(Dimethylamino)-3-methyl-1,2-diphenyl-2-butanol propionate (ester) hydrochloride, which can be represented by the accompanying structural formula. Its molecular weight is 375.94. Each Pulvule contains 65 mg (172.9��mol) propoxyphene hydrochloride. It also contains D&C Red No. 33, F D&C Yellow No. 6, gelatin, magnesium stearate, silicone, starch, titanium dioxide, and other inactive ingredients.
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PLAVIX (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex. Chemically it is methyl (+)-(S)-��-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is CHClNOS���HSOand its molecular weight is 419.9. The structural formula is as follows: Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56��. PLAVIX for oral administration is provided as pink, round, biconvex, debossed film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains hydrogenated castor oil, hydroxypropylcellulose, mannitol, microcrystalline cellulose and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains ferric oxide, hypromellose 2910, lactose monohydrate, titanium dioxide and triacetin. The tablets are polished with Carnauba wax.
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Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula: Nystatin Nyamyc���(Nystatin Topical Powder, USP) is for dermatologic use. Nyamyc���(Nystatin Topical Powder, USP) contains 100,000 USP nystatin units per gram dispersed in talc.
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Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula: Nystatin Oral Suspension, for oral administration, is cherry/mint flavored, containing 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (���1% v/v), 49.8% (w/v) sucrose, purified water, glycerin, sodium citrate, magnesium aluminum silicate, flavors, saccharin sodium, xanthan gum, benzaldehyde, edetate calcium disodium, methylparaben and propylparaben.
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Etodolac is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (��) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n- octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is CHNO, and it has the following structural formula: Each capsule, for oral administration, contains 200 mg or 300 mg of etodolac. In addition, each capsule contains the following inactive ingredients: black iron oxide, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 10 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, synthetic black iron oxide, and titanium dioxide. Each tablet, for oral administration, contains 400 mg or 500 mg of etodolac. In addition to the active ingredient, the 400 mg tablet contains the following inactive ingredients: D&C yellow no.10 aluminum lake, FD&C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, titanium dioxide and triacetin. And the 500 mg tablet contains the following inactive ingredients: FD&C blue no. 2 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone, sodium starch glycolate, titanium dioxide and triacetin.
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Geocillin, a semisynthetic penicillin, is the sodium salt of the indanyl ester of Geopen' (carbenicillin disodium). The chemical name is: 1-(5-Indanyl)-N-(2-carboxy-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] hept-6-yl)-2-phenylmalonamate monosodium salt. The structural formula is: The empirical formula iis: CHNNaOS and mol. wt. is 516.55. Geocillin tablets are yellow, capsule-shaped and film-coated, made of a white crystalline solid. Carbenicillin is freely soluble in water. Each Geocillin tablet contains 382 mg of carbenicillin, 118 mg of indanyl sodium ester. Each Geocillin tablet contains 23 mg of sodium. Inert ingredients are: glycine; magnesium stearate and sodium lauryl sulfate. May also include the following: hydroxypropyl cellulose; hypromellose; opaspray (which may include Blue 2 Lake, Yellow 6 Lake, Yellow 10 Lake, and other inert ingredients); opadry light yellow (which may contain D&C Yellow 10 Lake, FD&C Yellow 6 Lake and other inert ingredients); opadry clear (which may contain other inert ingredients).
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Mirtazapine tablets are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazinoazepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c] benzazepine and has the molecular formula of CHN. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture: STRUCTURAL FORMULA Mirtazapine is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are supplied for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored tablets containing 45 mg of mirtazapine. Each tablet also contains colloidal silicon dioxide, crospovidone, hypromellose 2910 3cP, hypromellose 2910 6cP hypromellose 2910 50cP, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, polyethylene glycol 400, polyethylene glycol 8000, pregelatinized starch, titanium dioxide, and triacetin. The 15 mg tablet also contains iron oxide yellow and the 30 mg tablet contains iron oxide yellow and iron oxide red.
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Irinotecan Hydrochloride Injection is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride was clinically investigated as CPT-11. Irinotecan Hydrochloride Injection is supplied as a sterile, yellow, clear, aqueous solution. It is available in two single-dose sizes: 2 mL-fill vials contain 40 mg irinotecan hydrochloride and 5 mL-fill vials contain 100 mg irinotecan hydrochloride. Each milliliter of solution contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of sorbitol NF powder, and 0.9 mg of lactic acid, USP. The pH of the solution has been adjusted to 3.0 to 3.8 with sodium hydroxide or hydrochloric acid. Irinotecan Hydrochloride Injection is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP. Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Mappia foetida. The chemical name is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3',4':6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4'bipiperidine]-1'-carboxylate, monohydrochloride, trihydrate. Its structural formula is as follows: Irinotecan hydrochloride is a pale yellow to yellow crystalline powder, with the empirical formula CHNO���HCl���3HO and a molecular weight of 677.20. It is slightly soluble in water and organic solvents.
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PROMETRIUM' (progesterone, USP) Capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of CHO. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126��and 131��C. The structural formula is: Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. PROMETRIUM Capsules are available in multiple strengths to afford dosage flexibility for optimum management. PROMETRIUM Capsules contain 100 mg or 200 mg micronized progesterone. The inactive ingredients for PROMETRIUM Capsules 100 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Red No. 40. The inactive ingredients for PROMETRIUM Capsules 200 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Yellow No. 6.
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TIKOSYN (dofetilide) is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is CHNOSand it has a molecular weight of 441.6. The structural formula is The chemical name for dofetilide is N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan-2-ol and is soluble in 0.1M aqueous sodium hydroxide, acetone and aqueous 0.1M hydrochloric acid. TIKOSYN capsules contain the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide and magnesium stearate. TIKOSYN is supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.
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Aminosyn, Sulfite-Free, (a crystalline amino acid solution) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn is oxygen sensitive. Five different formulations are available: The formulas for the individual amino acids present in Aminosyn are as follows: The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25��C/77��F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
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Dexamethasone sodium phosphate, a synthetic adrenocortical steroid, is a white or slightly yellow crystalline powder. It is freely soluble in water and is exceedingly hygroscopic. The molecular weight is 516.41. It is designated chemically as 9-fluoro-11��,17-dihydroxy-16��-methyl-21-(phosphonooxy)pregna-1,4-diene-3, 20-dione disodium salt. The molecular formula is: CHFNaOP and the structural formula is: Dexamethasone Sodium Phosphate Injection is a sterile solution of dexamethasone sodium phosphate for intravenous and intramuscular use. The 4 mg/mL strength may also be used for intra-articular, intralesional and soft tissue administration. Each mL of Dexamethasone Sodium Phosphate Injection 4 mg/mL contains dexamethasone sodium phosphate, equivalent to 4 mg dexamethasone phosphate or 3.33 mg dexamethasone. Inactive ingredients per mL: 1 mg sodium sulfite anhydrous, 19.4 mg sodium citrate anhydrous and 10.42 mg (0.01 mL) benzyl alcohol (preservative) in Water for Injection. Each mL of Dexamethasone Sodium Phosphate Injection 10 mg/mL contains dexamethasone sodium phosphate, equivalent to 10 mg dexamethasone phosphate or 8.33 mg dexamethasone. Inactive ingredients per mL: 1.5 mg sodium sulfite anhydrous, 16.5 mg sodium citrate anhydrous and 10.42 mg (0.01 mL) benzyl alcohol (preservative) in Water for Injection. The pH of both concentrations is 7.0-8.5; sodium hydroxide and/or citric acid used, if needed, for pH adjustment. Sealed under nitrogen.
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Bupivacaine Hydrochloride is 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula: Epinephrine is (-)-3,4-Dihydroxy-��-[(methylamino)methyl] benzyl alcohol. It has the following structural formula: Bupivacaine Hydrochloride is available in sterile isotonic solutions with and without epinephrine (as bitartrate) 1:200,000 for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Solutions of Bupivacaine Hydrochloride may be autoclaved if they do not contain epinephrine. Solutions are clear and colorless. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Bupivacaine Hydrochloride Injection, USP is available in sterile, isotonic solutions containing bupivacaine hydrochloride in water for injection with characteristics as follows: May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. (See HOW SUPPLIED section for pH information.) Multiple-dose vials contain methylparaben 1 mg/mL added as a preservative. Bupivacaine and Epinephrine Injection, USP is available in sterile, isotonic solutions containing bupivacaine hydrochloride and epinephrine 1:200,000 with characteristics as follows: Sodium metabisulfite 0.1 mg/mL added as antioxidant and edetate calcium disodium, anhydrous 0.1 mg/mL added as stabilizer. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. (See HOW SUPPLIED section for pH information.) Multiple-dose vials contain methylparaben 1 mg/mL added as a preservative. Single-dose solutions contain no added bacteriostat or anti-microbial agent and unused portions should be discarded after use.
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Fluoxetine hydrochloride is a psychotropic drug for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem, fluoxetine hydrochloride). It is designated (��)-N-methyl-3-phenyl-3-[(��,��,��-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of CHFNO���HCl. Its molecular weight is 345.79. The structural formula is: Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains colloidal silicon dioxide, magnesium stearate, pregelatinized starch, sodium lauryl sulfate. In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, and titanium dioxide and the following colorant agents: 10 mg���FD&C Red No. 40; the 20 mg���FD&C Blue No. 1 and FD&C Red No. 40; and the 40 mg���FD&C Blue No. 1 and FD&C Red No. 3. The imprinting ink contains the following: black iron oxide, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, propylene glycol, and shellac glaze.
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Granisetron hydrochloride tablets contain granisetron hydrochloride, an antinauseant and antiemetic agent. Chemically it is endo-N-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride. CHNO���HCl M.W. 348.9 (312.4 free base) Granisetron hydrochloride is a white to off-white crystalline powder that is freely soluble in water and slightly soluble in methanol.<br/>Tablets for Oral Administration: Each white to off-white, film-coated, capsule-shaped, granisetron hydrochloride tablet contains 1.12 mg granisetron hydrochloride equivalent to granisetron, 1 mg. Inactive ingredients are: hypromellose, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, polysorbate 80, sodium starch glycolate, and titanium dioxide.
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HYPAQUE sodium, brand of diatrizoate sodium, is a radiopaque diagnostic agent, water-soluble organic iodide contrast medium. In pure form, it contains 59.87 percent organically bound iodine. The 50 percent (w/v) solution contains 300 mg iodine per mL and 0.8 mEq (18.1 mg) sodium per mL. It has an osmolality of 1515 mosm/kg (determined by VPO), and is hypertonic to blood. As a point of information only, a 10 percent solution (w/v) is isotonic. The viscosity (cp) is about 3.25 at 25��C and 2.34 at 37��C. Sodium carbonate and hydrochloric acid have been added to adjust pH between 6.5 and 7.7.The pKa is 3.4 for diatrizoic acid. If a solution of this medium is chilled, crystals may form but readily dissolve if the vial is placed in moderately hot water before use; cool to body temperature before injecting. The sterile aqueous solution is clear and nearly colorless. It is relatively thermostable and may be autoclaved without harmful effects, although it should be protected from strong light. The 50 percent solution contains edetate calcium disodium 1:10,000 as a sequestering stabilizing agent. Diatrizoate sodium is a triiodinated benzoic acid derivative, the sodium salt of 3,5-diacetamido-2,4,6-triiodobenzoate with a molecular weight of 635.90, and has the following structural formula:
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Axid(Nizatidine, USP) is a histamine H-receptor antagonist. Chemically, it is N-[2-[[[2-[(dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine. The structural formula is as follows: Nizatidine has the empirical formula CHNOSrepresenting a molecular weight of 331.47. It is an off-white to buff crystalline solid that is soluble in water. Nizatidine has a bitter taste and mild sulfur-like odor. Each Pulvule(capsule) contains for oral administration gelatin, pregelatinized starch, dimethicone, starch, titanium dioxide, yellow iron oxide, 150 mg (0.45 mmol) or 300 mg (0.91 mmol) of nizatidine, and other inactive ingredients. The 150-mg Pulvule also contains magnesium stearate, and the 300-mg pulvule also contains croscarmellose sodium, povidone, red iron oxide, and talc.
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Dextrose Injections, USP are sterile, nonpyrogenic hypertonic solutions for fluid replenishment and caloric supply in Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. They contain no antimicrobial agents. Composition, osmolarity, pH, and caloric content are shown below. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl choloride (PL 146 Plastic). Exposure to temperatures above 25��C/77��F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as tissue culture toxicity studies.
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Minoxidil tablets contain minoxidil, an antihypertensive peripheral vasodilator. Minoxidil occurs as a white to off-white, odorless crystalline powder that is soluble in alcohol and propylene glycol; sparingly soluble in methanol; slightly soluble in water; practically insoluble in chloroform, acetone and ethyl acetate. The chemical name for minoxidil is 2,4-pyrimidinediamine, 6-(1-piperidinyl)-,3-oxide. The structural formula is represented below: Minoxidil tablets for oral administration contain either 2.5 mg or 10 mg of minoxidil. Inactive ingredients: colloidal silicon dioxide, anhydrous lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.
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Phenytoin Sodium Injection, USP is a sterile solution for intravenous (no infusion) or intramuscular use, containing in each mL phenytoin sodium 50 mg, propylene glycol 0.4 mL and alcohol 0.1 mL in Water for Injection. pH 10.0-12.3; sodium hydroxide added, if needed, for pH adjustment. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2,4-imidazolidinedione. The structural formula is as follows: CHNNaOMW 274.25
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CASODEX' (bicalutamide) Tablets for oral administration contain 50 mg of bicalutamide, a non-steroidal antiandrogen with no other known endocrine activity. The chemical name is propanamide, N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methyl-,(+-). The structural and empirical formulas are: Bicalutamide has a molecular weight of 430.37. The pKa' is approximately 12. Bicalutamide is a fine white to off-white powder which is practically insoluble in water at 37��C (5 mg per 1000 mL), slightly soluble in chloroform and absolute ethanol, sparingly soluble in methanol, and soluble in acetone and tetrahydrofuran. CASODEX is a racemate with its antiandrogenic activity being almost exclusively exhibited by the R-enantiomer of bicalutamide; the S-enantiomer is essentially inactive. The inactive ingredients of CASODEX Tablets are lactose, magnesium stearate, hypromellose, polyethylene glycol, polyvidone, sodium starch glycollate, and titanium dioxide.
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RIFADIN (rifampin capsules USP) for oral administration contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. RIFADIN IV (rifampin for injection USP) contains rifampin 600 mg, sodium formaldehyde sulfoxylate 10 mg, and sodium hydroxide to adjust pH. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is CHNO. The chemical name for rifampin is either: 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22���heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is:
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Cephalexin Capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-��-Amino-��-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula CHNOS���HO and the molecular weight is 365.41. Cephalexin has the following structural formula: The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; ie, the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg (720��mol) or 500 mg (1,439��mol) of cephalexin. The capsules also contain colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No. 2, gelatin, magnesium stearate, sodium starch glycolate, and titanium dioxide.
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Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, CHNO, and has the structural formula: Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets are formulated in Nifedipine GITS. Nifedipine GITS (Gastrointestinal Therapeutic System) Tablet is formulated as a once-a-day controlled-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the formulations are: cellulose acetate; hydroxypropyl cellulose; hypromellose; magnesium stearate; polyethylene glycol; polyethylene oxide; red ferric oxide; sodium chloride; titanium dioxide. Meets USP Drug Release Test 1.<br/>System Components and Performance: Nifedipine extended-release tablet is similar in appearance to a conventional tablet. It consists, however, of a semipermeable membrane surrounding an osmotically active drug core. The core itself is divided into two layers: an "active" layer containing the drug, and a"push" layer containing pharmacologically inert (but osmotically active) components. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and "pushes" against the drug layer, releasing drug through the precision laser-drilled tablet orifice in the active layer. Nifedipine extended-release tablet is designed to provide nifedipine at an approximately constant rate over 24 hours. This controlled rate of drug delivery into the gastrointestinal lumen is independent of pH or gastrointestinal motility. Nifedipine extended-release tablet depends for its action on the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the GI tract. Drug delivery is essentially constant as long as the osmotic gradient remains constant, and then gradually falls to zero. Upon swallowing, the biologically inert components of the tablet remain intact during GI transit and are eliminated in the feces asan insoluble shell.
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Glipizide and metformin hydrochloride tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes, glipizide and metformin hydrochloride. Glipizide is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. The structural formula is represented below. CHNOS M.W. 445.55 Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or��-glucosidase inhibitors. It is a white to off-white crystalline compound. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown: CHClNM.W. 165.63 Glipizide and metformin hydrochloride is available for oral administration in tablets containing 2.5 mg glipizide with 250 mg metformin hydrochloride, 2.5 mg glipizide with 500 mg metformin hydrochloride, and 5 mg glipizide with 500 mg metformin hydrochloride. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, povidone, starch, talc, and titanium dioxide. Additionally, 2.5 mg/250 mg and 5 mg/500 mg tablets contain iron oxide black, iron oxide red, and iron oxide yellow. The tablets are film coated, which provides color differentiation.
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Busulfan is a bifunctional alkylating agent known chemically as 1,4- butanediol, dimethanesulfonate. BUSULFEX (busulfan) Injection is intended for intravenous administration. It is supplied as a clear, colorless, sterile, solution in 10 mL single use vials. Each vial of BUSULFEX contains 60 mg (6 mg/mL) of busulfan, the active ingredient, a white crystalline powder with a molecular formula of CHSOO(CH)OSOCHand a molecular weight of 246 g/mole. Busulfan is dissolved in N,N-dimethylacetamide (DMA) 33% vol/vol and Polyethylene Glycol 400, 67% vol/vol. The solubility of busulfan in water is 0.1 g/L and the pH of BUSULFEX diluted to approximately 0.5 mg/mL busulfan in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP as recommended for infusion reflects the pH of the diluent used and ranges from 3.4 to 3.9. BUSULFEX is intended for dilution with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP prior to intravenous infusion.
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Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water for injection. Each 100 mL contains 1 or 2 g magnesium sulfate heptahydrate and dextrose, hydrous 5 g in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 1% and 2% concentrations. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes. Magnesium Sulfate, USP heptahydrate is chemically designated MgSO���7HO, colorless crystals or white powder freely soluble in water. Dextrose, USP is chemically designated D-glucose, monohydrate (CHO���HO), a hexose sugar freely soluble in water. It has the following structural formula: Molecular weight 198.17. Water for Injection, USP is chemically designated HO. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperaturesabove 25��C/77��F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
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Paroxetine hydrochloride is an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate. The structural formula is: CHFNO���HCl�����HO M.W. 374.8 (329.4 as free base) Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 141��to 145��C and a solubility range of 1 to 10 mg/mL in water. Each film-coated tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mg���yellow (scored); 20 mg���pink (scored); 30 mg���blue; 40 mg���green. Inactive ingredients consist of calcium phosphate dibasic anhydrous, hypromellose (2910, 3 cP +6 cP), magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, and titanium dioxide. In addition, the 10 mg and 40 mg strengths contain FD&C yellow #5 lake, the 10 mg strength contains FD&C yellow #6 lake, the 20 mg strength contains FD&C red #40 lake and carmine, the 30 mg and 40 mg strengths contain FD&C blue #2 lake, and the 40 mg strength contains FD&C blue #1 lake.
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Each tablet, for oral administration, contains: Diphenxylate Hydrochloride������������������������������������������������2.5 mg (Warning-May be habit forming) Atropine Sulfate ..................................................................................... 0.025 mg Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride and has the following structural formula: Molecular formula CHNO���HCl M.W. 489.05 Atropine sulfate, an anticholinergic, is endo-(��)-��-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1) (salt) monohydrate and has the following structural formula: Molecular formula (CHNO)���HSO���HO M.W. 694.83 A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, acacia, calcium stearate, methylcellulose, and corn starch.
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Paroxetine Hydrochloride Oral Suspension is an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride anhydrous and has the molecular formula of CHFNO���HCl. The molecular weight is 365.83 (329.4 as free base). The structural formula of paroxetine hydrochloride is: Paroxetine hydrochloride is a white to off-white crystalline powder, with a melting range of 116��to 120��C and a solubility at 5.4 mg/mL in water. Each 5 mL of orange-colored suspension with an orange aroma contains paroxetine hydrochloride equivalent to paroxetine, 10 mg. Inactive ingredients consist of bitter blocker type flavor, FD&C Yellow No. 6, glycerin, methylparaben, microcrystalline cellulose and carboxymethylcellulose sodium, natural orange blood sicilian flavor, propylene glycol, propylparaben, purified water, saccharin sodium, 30% simethicone emulsion and sorbitol solution.
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Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. They contain no bacteriostat or antimicrobial agent or added buffer. Edetate disodium, anhydrous is added as a stabilizer. The solution may contain sodium hydroxide and/or hydrochloric acid for pH adjustment. See Table for summary of contents and characteristics of these solutions. Heparin Sodium, USP is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1)��- L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-��-D-glucose 6-sulfate, (3)��-D-glucuronic acid, (4) 2-acetamido-2-deoxy-��-D-glucose, and (5)��-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)>(1)>(4)>(3)>(5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits): Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. Water for Injection, USP is chemically designated HO. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.
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Levocarnitine is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane. Levocarnitine Injection USP is a sterile aqueous solution containing 1 g of levocarnitine per 5 mL vial. The pH is adjusted to 6.0 to 6.5 with hydrochloric acid. Chemically, levocarnitine is (R)-(3-Carboxy-2-hydroxypropyl)trimethyl-ammonium hydroxide, inner salt. It is a white powder with a melting point of 196��to 197��C and is readily soluble in water, hot alcohol, and insoluble in acetone. The pH of a solution (1 in 20) is between 6 to 8 and its pKa value is 3.8. Its structural formula is: Molecular Formula: CHNOMolecular Weight: 161.20
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Aminosyn-HF 8% (amino acid injection 8%) is a sterile, nonpyrogenic, hypertonic solution for intravenous infusion. The formulation is described below: The formulas for the individual amino acids present in Aminosyn���HF 8% are as follows: The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthlate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Exposure to temperatures above 25��C/77��F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
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TEMODAR Capsules for oral administration contain temozolomide, an imidazotetrazine derivative. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula is: The material is a white to light tan/light pink powder with a molecular formula of CHNOand a molecular weight of 194.15. The molecule is stable at acidic pH (<5), and labile at pH>7, hence TEMODAR can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl)imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Each capsule contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for TEMODAR Capsules are lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid. The 5 mg, 20 mg, 100 mg, and 250 mg gelatin capsule shells contain titanium dioxide. The capsules are white and imprinted with pharmaceutical ink. The body of the capsules for the 140 mg and 180 mg strengths is made of gelatin, and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. TEMODAR 5 mg: green imprint contains pharmaceutical grade shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, titanium dioxide, yellow iron oxide, and FD&C Blue #2 aluminum lake. TEMODAR 20 mg: brown imprint contains pharmaceutical grade shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, purified water, ammonium hydroxide, potassium hydroxide, titanium dioxide, black iron oxide, yellow iron oxide, brown iron oxide, and red iron oxide. TEMODAR 100 mg: blue imprint contains pharmaceutical glaze (modified) in an ethanol/shellac mixture, isopropyl alcohol, n-butyl alcohol, propylene glycol, titanium dioxide, and FD&C Blue #2 aluminum lake. TEMODAR 140 mg: The blue cap contains gelatin, sodium lauryl sulfate, FD&C Blue #2, and titanium dioxide. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. TEMODAR 180 mg: The orange cap contains gelatin, sodium lauryl sulfate, titanium dioxide, iron oxide red and iron oxide yellow. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. TEMODAR 250 mg: black imprint contains pharmaceutical grade shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, purified water, ammonium hydroxide, potassium hydroxide, and black iron oxide.
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Coly-Mycin M Parenteral (Colistimethate for Injection, USP) is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution), is suitable for intramuscular or intravenous administration. Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity). Colistimethate sodium is a polypeptide antibiotic with an approximate molecular weight of 1750. The empirical formula is CHNNaOSand the structural formula is represented below:
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Citalopram HBr is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (��)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula: The molecular formula is CHBrFNO and its molecular weight is 405.35. Citalopram HBr occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available as tablets. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or40 mg citalopram base. The tablets also contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch, croscarmellose sodium, copovidone, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red, ferric oxide yellow, glycerin, and polyethylene glycol.
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Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, silicon dioxide, white wax, and cocoa butter. Promethazine hydrochloride suppositories are for rectal administration only. Promethazine HCl is a racemic compound; the empirical formula is CHNS���HCl and its molecular weight is 320.88. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,��-trimethyl-,monohydrochloride, (��)- with the following structural formula: Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.
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CARBASTAT (Carbachol Intraocular Solution, USP) 0.01% is a sterile balanced salt solution of carbachol for intraocular injection. The active ingredient is represented by the structural formula: Established name: Carbachol Chemical name: Ethanaminium, 2-[(aminocarbonyl)oxy]-N,N,N -trimethyl-, chloride. Each mL contains: Active: Carbachol 0.01%. Inactive: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dihydrate 0.048%, magnesium chloride hexahydrate 0.03%, sodium acetate trihydrate 0.39%, sodium citrate dihydrate 0.17%, sodium hydroxide and/or hydrochloric acid to adjust pH (5.0-7.5) and water for injection USP.
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Verapamil hydrochloride extended-release is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). Verapamil hydrochloride extended-release is available for oral administration as a 120 mg hard gelatin capsule, a 180 mg hard gelatin capsule and a 240 mg hard gelatin capsule. These bead filled capsules provide an extended-release of the drug in the gastrointestinal tract. The structural formula of verapamil hydrochloride is given below: CHNO���HCl M.W. 491.07 Chemical name: (��)-5-[(3,4-Dimethoxyphenethyl) methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil hydrochloride is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not structurally related to other cardioactive drugs. In addition to verapamil hydrochloride, verapamil hydrochloride extended-release capsules contain the following inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, dibutyl sebacate, diethyl phthalate, ethylcellulose, FD&C blue no. 2 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C green #3, FD&C red no. 40 aluminum lake, gelatin, hypromellose, isopropyl alcohol, maltodextrin, methacrylic acid copolymer, n-butyl alcohol, oleic acid, pharmaceutical glaze, polyethylene glycol, povidone, propylene glycol, SDA-3A alcohol, silicon dioxide, sodium lauryl sulfate, sugar spheres, synthetic black iron oxide, talc, and titanium dioxide.In addition the 180 mg capsule contains D&C yellow #10.
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Trecator (ethionamide tablets, USP) is used in the treatment of tuberculosis. The chemical name for ethionamide is 2-ethylthioisonicotinamide with the following structural formula: Ethionamide is a yellow crystalline, nonhygroscopic compound with a faint to moderate sulfide odor and a melting point of 162��C. It is practically insoluble in water and ether, but soluble in methanol and ethanol. It has a partition coefficient (octanol/water) Log P value of 0.3699. Trecator tablets contain 250 mg of ethionamide. The inactive ingredients present are croscarmellose sodium, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, and titanium dioxide.
dailymed-drugs:76
ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of ZOVIRAX Cream 5% contains 50 mg of acyclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water, and white petrolatum. Acyclovir is a white, crystalline powder with the molecular formula CHNOand a molecular weight of 225. The maximum solubility in water at 37��C is 2.5 mg/mL. The pKa's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula:
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Desoximetasone Gel USP, 0.05% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Each gram of Desoximetasone Gel USP, 0.05% contains 0.5 mg desoximetasone in a gel consisting of purified water USP, docusate sodium USP, edetate disodium USP, isopropyl myristate NF, carbomer 940, trolamine NF, SD alcohol 40 (20% w/w). The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-, (11��, 16��)-. Desoximetasone has the empirical formula CHFOand a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The chemical structure is:
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Fluticasone propionate ointment, 0.005% contains fluticasone propionate [(6��,11��,16��,17��)-6,9,-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy) androsta-1,4-diene-17-carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is CHFOS. It has the following structural formula: Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of fluticasone propionate ointment contains fluticasone propionate 0.05 mg in a base of propylene glycol, sorbitan sesquioleate, microcrystalline wax, and liquid paraffin.
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REBETOL REBETOL is Schering Corporation's brand name for ribavirin, a nucleoside analog. The chemical name of ribavirin is 1-��-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula: Ribavirin is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The empirical formula is CHNOand the molecular weight is 244.21. REBETOL Capsules consist of a white powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The capsule shell consists of gelatin, sodium lauryl sulfate, silicon dioxide, and titanium dioxide. The capsule is printed with edible blue pharmaceutical ink which is made of shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, and FD&C Blue #2 aluminum lake. REBETOL Oral Solution is a clear, colorless to pale or light yellow bubble gum-flavored liquid. Each milliliter of the solution contains 40 mg of ribavirin and the inactive ingredients sucrose, glycerin, sorbitol, propylene glycol, sodium citrate, citric acid, sodium benzoate, natural and artificial flavor for bubble gum #15864, and water.<br/>Mechanism of Action: The mechanism of inhibition of hepatitis C virus (HCV) RNA by combination therapy with ribavirin and interferon products has not been established.
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Oxcarbazepine is an antiepileptic drug available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is: CHNOM.W. 252.27 Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol, very slightly soluble in ethanol, and insoluble in ether and water. Oxcarbazepine film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.
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HYDREA (hydroxyurea capsules, USP) is an antineoplastic agent available for oral use as capsules providing 500 mg hydroxyurea. Inactive ingredients: citric acid, colorants (D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red 40, and D&C Red 28), gelatin, lactose, magnesium stearate, sodium phosphate, and titanium dioxide. Hydroxyurea occurs as an essentially tasteless, white crystalline powder. Its structural formula is:
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Dilantin (phenytoin) is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula: Each 5 ml of suspension contains 125 mg of phenytoin, USP; alcohol, USP (maximum content not greater than 0.6 percent); banana flavor; carboxymethylcellulose sodium, USP; citric acid, anhydrous, USP; glycerin, USP; magnesium aluminum silicate, NF; orange oil concentrate; polysorbate 40, NF; purified water, USP; sodium benzoate, NF; sucrose, NF; vanillin, NF; and FD&C yellow No. 6.
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Cromolyn sodium ophthalmic solution, USP 4% is a clear, colorless, sterile solution intended for topical ophthalmic use. Cromolyn sodium is represented by the following structural formula:<br/>Chemical Name:: disodium 5-5' - [(2-hydroxytrimethylene) dioxy] bis [4-oxo-4H-1-benzopyran-2-carboxylate]. Pharmacologic Category: Mast cell stabilizer Each mL contains: Active: Cromolyn sodium 40 mg (4%); Preservative: Benzalkonium chloride 0.01%; Inactives: Edetate disodium 0.1% and purified water. It has a pH of 4.0 to 7.0.
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Permapen' (Penicillin G Benzathine) Injectable Suspension, a sterile antibacterial agent, is a repository penicillin compound which provides blood levels for long periods following its intramuscular injection. This property is the result of its extremely low solubility in water. Each milliliter contains 600,000 units of penicillin G benzathine; 0.006 grams sodium citrate; 0.003 grams polyvinylpyrrolidone; 0.010 grams lecithin, and 0.003 grams sodium carboxymethylcellulose in an aqueous suspension. Permapen also contains methylparaben 0.09% and propylparaben 0.01% as preservatives. Chemically, Permapen is 3,3-dimethyl-7-oxo-6-(2-phenylacetamido)-4 thia-l azabicyclo [3.2.0] heptane-2-carboxylic acid compound with N,N'-dibenzylethylenediamine (2:1) tetrahydrate. It is prepared by the reaction of dibenzyl-tetrahydrate-ethylenediamine with 2 molecules of penicillin G. It has a molecular weight of 981.19 and the following chemical structure: Formula CHN���2CHNOS���4HO Penicillin G benzathine occurs as a white crystalline powder and is very slightly soluble in water. The pH of the injectable suspension is between 5.0���7.5.
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ClomiPRAMINE hydrochloride capsules USP are an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. ClomiPRAMINE hydrochloride is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is: CHClN���HCl M.W. 351.3 ClomiPRAMINE hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Each capsule, for oral administration, contains 25 mg, 50 mg, or 75 mg of ClomiPRAMINE hydrochloride. In addition, each capsule contains the following inactive ingredients: pregelatinized starch, colloidal silicon dioxide, magnesium stearate, titanium dioxide, shellac, black iron oxide, and gelatin. Each 25 mg capsule contains D&C Red No. 28, FD&C Red No. 40, D&C Yellow No. 10, and FD&C Blue No. 1. Each 50 mg capsule contains FD&C Blue No. 1. Each 75 mg capsule contains red iron oxide and yellow iron oxide. The imprinting ink may contain antifoam DC 1510, propylene glycol, and soya lecithin.
dailymed-drugs:88
Sterile INDOCINI.V. (Indomethacin for Injection) for intravenous administration is lyophilized indomethacin for injection. Each vial contains indomethacin for injection equivalent to 1 mg indomethacin as a white to yellow lyophilized powder or plug. Variations in the size of the lyophilized plug and the intensity of color have no relationship to the quality or amount of indomethacin present in the vial. Indomethacin for injection is designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid, sodium salt, trihydrate. Its molecular weight is 433.82. Its empirical formula is CHClNNaO���3HO and its structural formula is:
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Chemically, trimethobenzamide HCl is N-[p -[2-(dimethylamino)ethoxy]benzyl]-3,4,5- trimethoxybenzamide monohydrochloride. It has a molecular weight of 424.93 and the following structural formula: Capsules: Each 300-mg Tigan capsule for oral use contains trimethobenzamide hydrochloride equivalent to 300 mg. The capsule has an opaque purple cap marked���Tigan���and an opaque purple body marked���M079���. Inactive Ingredients: D&C Red No. 28, FD&C Blue No.1, lactose, magnesium stearate, starch and titanium dioxide. Single-Dose Vials: Each 2-mL single-dose vial contains 200 mg trimethobenzamide hydrochloride compounded with 1 mg sodium citrate and 0.4 mg citric acid as buffers and pH adjusted to approximately 5.0 with sodium hydroxide. Multi-Dose Vials: Each mL contains 100 mg trimethobenzamide hydrochloride compounded with 0.45% phenol as preservative, 0.5 mg sodium citrate and 0.2 mg citric acid as buffers and pH adjusted to approximately 5.0 with sodium hydroxide.
dailymed-drugs:90
SEROQUEL (quetiapine fumarate) is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is CHNOS���CHOand it has a molecular weight of 883.11 (fumarate salt). The structural formula is: Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide.
dailymed-drugs:91
Cystadane (betaine anhydrous for oral solution) is an agent for the treatment of homocystinuria. Cystadane is a white, granular, hygroscopic powder. It contains no ingredients other than anhydrous betaine. Betaine anhydrous powder is very soluble in water, soluble in methanol and ethanol, and sparingly soluble in ether. The chemical name of betaine anhydrous powder is trimethylglycine. It has a molecular weight of 117.15. The structural formula is:
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CLEOCIN PHOSPHATE Sterile Solution in vials contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name of clindamycin phosphate is L-threo-��-D-galacto- Octopyranoside, methyl 7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2- pyrrolidinyl) carbonyl] amino]-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-. The molecular formula is CHCINPS and the molecular weight is 504.96. The structural formula is represented below: CLEOCIN PHOSPHATE in the ADD-Vantage Vial is intended for intravenous use only after further dilution with appropriate volume of ADD-Vantage diluent base solution. CLEOCIN PHOSPHATE IV Solution in the Galaxy plastic container for intravenous use is composed of clindamycin phosphate equivalent to 300, 600 and 900 mg of clindamycin premixed with 5% dextrose as a sterile solution. Disodium edetate has been added at a concentration of 0.04 mg/mL. The pH has been adjusted with sodium hydroxide and/or hydrochloric acid. The plastic container is fabricated from a specially designed multilayer plastic, PL 2501. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.
dailymed-drugs:93
Mefloquine hydrochloride is an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral administration. Mefloquine hydrochloride is a 4-quinolinemethanol derivative with the specific chemical name of (R, S)-(��)-��-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. Mefloquine hydrochloride has a calculated molecular weight of 414.78 and the following structural formula: The inactive ingredients are crospovidone, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc.
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ARIXTRA (fondaparinux sodium) Injection is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa). Fondaparinux sodium is methyl O-2-deoxy-6-O-sulfo-2-(sulfoamino)-��-D-glucopyranosyl-(1���4)-O-��-D-glucopyra-nuronosyl-(1���4)-O-2-deoxy-3,6-di-O-sulfo-2-(sulfoamino)-��-D-glucopyranosyl-(1���4)-O-2-O-sulfo-��-L-idopyranuronosyl-(1���4)-2-deoxy-6-O-sulfo-2-(sulfoamino)-��-D-glucopyranoside, decasodium salt. The molecular formula of fondaparinux sodium is CHNNaOSand its molecular weight is 1728. The structural formula is provided below: ARIXTRA is supplied as a sterile, preservative-free injectable solution for subcutaneous use. Each single dose, prefilled syringe of ARIXTRA, affixed with an automatic needle protection system, contains 2.5 mg of fondaparinux sodium in 0.5 mL, 5.0 mg of fondaparinux sodium in 0.4 mL, 7.5 mg of fondaparinux sodium in 0.6 mL, or 10.0 mg of fondaparinux sodium in 0.8 mL of an isotonic solution of sodium chloride and water for injection. The final drug product is a clear and colorless to slightly yellow liquid with a pH between 5.0 and 8.0.
dailymed-drugs:95
Ridaura (auranofin) is available in oral form as capsules containing 3 mg auranofin. Auranofin is (2,3,4,6-tetra-O-acetyl-1-thio-��-D-glucopyranosato-S-) (triethyl���phosphine) gold. Auranofin contains 29% gold and has the following chemical structure: Each Ridaura capsule, with opaque brown cap and opaque tan body, contains auranofin, 3 mg, and is imprinted with the product name RIDAURA. Inactive ingredients consist of benzyl alcohol, cellulose, cetylpyridinium chloride, D&C Red No. 33, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, povidone, sodium lauryl sulfate, sodium starch glycolate, starch, titanium dioxide and trace amounts of other inactive ingredients.
dailymed-drugs:96
The active ingredient in Ipratropium Bromide Nasal Spray is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo (3.2.1) octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (��)- :a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is: Ipratropium bromide is a white to off-white, crystalline substance. It is freely soluble in lower alcohols and water, existing in an ionized state in aqueous solutions, and relatively insoluble in non-polar media. Ipratropium Bromide Nasal Spray 0.03% is a metered-dose, manual pump spray unit which delivers 21 mcg (70mcL) ipratropium bromide per spray on an anhydrous basis in an isotonic, aqueous solution with pH adjusted to 4.7. It also contains benzalkonium chloride, edetate disodium, sodium chloride, sodium hydroxide, hydrochloric acid, and purified water. Each bottle contains 345 sprays.
dailymed-drugs:97
Bumetanide is a loop diuretic, available as scored tablets. Each tablet for oral administration contains 0.5 mg, 1 mg or 2 mg of bumetanide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, with the following dye systems: 0.5 mg- D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake; 1 mg- D&C Yellow No. 10 Aluminum Lake; 2 mg- synthetic black iron oxide, synthetic red iron oxide nd synthetic yellow iron oxide. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula: CHNOS
dailymed-drugs:98
Hydralazine hydrochloride USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: Hydralazine hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275��C, with decomposition, and has a molecular weight of 196.64. Hydralazine HCl Tablets are available in 10, 25, 50 and 100 mg strengths. Each tablet contains the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid. In addition, the 10 mg tablet contains FD&C Red #40. The 25 mg, 50 mg and 100 mg tablets contain FD&C Yellow #6.
dailymed-drugs:99
Prednisolone Acetate Ophthalmic Suspension USP, 1% is an adrenocortical steroid product prepared as a sterile ophthalmic suspension. The active ingredient is represented by the chemical structure: Each mL contains: Active: Prednisolone Acetate 1.0%. Preservative: Benzalkonium Chloride 0.01%. Vehicle: Hypromellose 2910. Inactives: Dibasic Sodium Phosphate, Polysorbate 80, Edetate Disodium, Glycerin, Citric Acid and/or Sodium Hydroxide (to adjust pH), and Purified Water.
dailymed-drugs:100
RIOMET (metformin hydrochloride oral solution) is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N- dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown: Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of CHN���HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. RIOMET contains 500 mg of metformin hydrochloride per 5 mL and the following inactive ingredients: Saccharin Calcium, Potassium Bicarbonate, Xylitol, Hydrochloric Acid, Purified Water and Cherry Flavor.
dailymed-drugs:101
DDAVP' Nasal Spray (desmopressin acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows: Mol. wt. 1183.34 Empirical formula: CHNOS���CHO���3HO 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. DDAVP Nasal Spray is provided as an aqueous solution for intranasal use. The DDAVP Nasal Spray compression pump delivers 0.1 mL (10 mcg) of DDAVP (desmopressin acetate) per spray.
dailymed-drugs:102
Potassium Chloride in Lactated Ringer's and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown below: The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2- ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
dailymed-drugs:104
Cefazolin for Injection, USP is a semi-synthetic cephalosporin for intravenous administration, that has the following chemical name: Sodium (6R,-7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[2-1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo-[4.2.0]oct-2-ene-2-carboxylate. Cefazolin Sodium has the following structural formula: The sodium content is 48 mg (2 mEq) per gram of cefazolin sodium. Cefazolin for Injection, USP is supplied as a lyophilized form in Pharmacy Bulk Packages containing cefazolin sodium equivalent to 10 grams of cefazolin. FURTHER DILUTION IS REQUIRED BEFORE USE. A Pharmacy Bulk Package is a container of a sterile preparation tor intravenous use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion .
dailymed-drugs:105
Diclofenac sodium ophthalmic solution, 0.1% is a sterile, topical, nonsteroidal, anti-inflammatory product for ophthalmic use. Diclofenac sodium is designated chemically as Benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino] monosodium salt, with a molecular formula of CHClNNaO. The structural formula of diclofenac sodium is: Diclofenac sodium ophthalmic solution is available as a sterile solution which contains diclofenac sodium 0.1% (1 mg/mL). Inactive Ingredients: Boric acid, edetate disodium, polyoxyl 35 castor oil, sorbic acid, tromethamine, and water for injection. Diclofenac sodium is a white or slightly yellow crystalline powder. It is freely soluble in methanol, soluble in alcohol, sparingly soluble in water, and slightly soluble in acetone. Its molecular weight is 318.1. Diclofenac sodium ophthalmic solution, 0.1% is an iso-osmotic solution with an osmolality between 270 mOsmols/kg and 310 mOsmols/kg, buffered at a pH between 6.0 to 8.0. Diclofenac sodium ophthalmic solution has a faint characteristic odor of castor oil.
dailymed-drugs:106
Erythromycin Ophthalmic Ointment USP belongs to the macrolide group of antibiotics. The sterile ophthalmic ointment flows freely over the conjunctiva. Erythromycin base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin is an antibiotic produced from a strain of Streptomyces erythraeus. It is basic and readily forms asalt when combined with an acid. It has the following structural formula: CHNO Mol. Wt. 733.94 Chemical Name: (3R���, 4S���, 5S���, 6R���, 7R���, 9R���, 11R���, 12R���, 13S���, 14R���)-4-[(2,6-Dideoxy-3-C-methyl-3-0-methyl-��-L-ribo-hexopyranosyl)oxy]-14-ethyl-7, 12, 13-trihydroxy-3, 5, 7, 9, 11, 13 hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-��-D-xylo-opyranosyl]oxy]oxacyclotetradecane-2, 10-dione Each Gram Contains: ACTIVE: Erythromycin, USP 5 mg (0.5%); INACTIVES: White Petrolatum, Mineral Oil.
dailymed-drugs:107
NOLVADEX' (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are for oral administration. NOLVADEX Tablets are available as:<br/>10 mg Tablets:: Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10 mg of tamoxifen.<br/>20 mg Tablets:: Each tablet contains 30.4 mg of tamoxifen citrate which is equivalent to 20 mg of tamoxifen. Inactive Ingredients: carboxymethylcellulose calcium, magnesium stearate, mannitol and starch. Chemically, NOLVADEX is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine 2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and empirical formulas are: Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium solubility in water at 37��C is 0.5 mg/mL and in 0.02 N HCl at 37��C, it is 0.2 mg/mL.
dailymed-drugs:108
Carvedilol phosphate is a nonselective��-adrenergic blocking agent with��-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure: Carvedilol phosphate is a white to almost-white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of CHNO���HPO���1/2 HO. COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone.
dailymed-drugs:109
YAZ' provides an oral contraceptive regimen consisting of 24 active film coated tablets each containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol stabilized by betadex as a clathrate (molecular inclusion complex) and 4 inert film coated tablets. Other ingredients are lactose monohydrate NF, corn starch NF, magnesium stearate NF, hypromellose USP, talc USP, titanium dioxide USP, ferric oxide pigment, red NF. The inert film coated tablets contain lactose monohydrate NF, corn starch NF, povidone25000 USP, magnesium stearate NF, hypromellose USP, talc USP, titanium dioxide USP. Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol (19-nor-17��-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows:
dailymed-drugs:110
TYZEKAis the trade name for telbivudine, a synthetic thymidine nucleoside analogue with activity against hepatitis B virus (HBV). The chemical name for telbivudine is 1-((2S,4R,5S)-4-hydroxy-5-hydroxymethyltetrahydrofuran-2-yl)-5-methyl-1H-pyrimidine-2,4-dione, or 1-(2-deoxy-��-L-ribofuranosyl)-5-methyluracil. Telbivudine is the unmodified��-L enantiomer of the naturally occurring nucleoside, thymidine. Its molecular formula is CHNO, which corresponds to a molecular weight of 242.23. Telbivudine has the following structural formula: Telbivudine is a white to slightly yellowish powder. Telbivudine is sparingly soluble in water (>20 mg/mL), and very slightly soluble in absolute ethanol (0.7 mg/mL) and n-octanol (0.1 mg/mL). TYZEKA(telbivudine) film-coated tablets are available for oral administration in 600 mg strength. TYZEKA 600 mg film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. The tablet coating contains titanium dioxide, polyethylene glycol, talc and hypromellose.
dailymed-drugs:111
Cevimeline is cis-2'-methylspiro {1-azabicyclo [2.2.2] octane-3, 5' -[1,3] oxathiolane} hydrochloride, hydrate (2:1). Its empirical formula is CHNOS.HCl.1/2 HO, and its structural formula is: Cevimeline has a molecular weight of 244.79. It is a white to off white crystalline powder with a melting point range of 201 to 203��C. It is freely soluble in alcohol and chloroform, very soluble in water, and virtually insoluble in ether. The pH of a 1% solution ranges from 4.6 to 5.6. Inactive ingredients include lactose monohydrate, hydroxypropyl cellulose, and magnesium stearate.
dailymed-drugs:112
IQUIX (levofloxacin ophthalmic solution) 1.5% is a sterile topical ophthalmic solution. Levofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens. Levofloxacin is a fluorinated 4-quinolone containing a six-member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure. Levofloxacin is the pure(-)-(S)-enantiomer of the racemic drug substance, ofloxacin. It is more soluble in water at neutral pH than ofloxacin. Chemical Name: (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate. Levofloxacin (hemihydrate) is a yellowish-white crystalline powder.Each mL of IQUIX contains 15.36 mg of levofloxacin hemihydrate equivalent to 15 mg levofloxacin. Contains:Active: Levofloxacin 1.5% (15 mg/mL); Inactives: glycerin and water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH to approximately 6.5. IQUIX solution is isotonic with an osmolality of approximately 290 mOsm/kg.
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