Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/645
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Oracea (Capsule, Delayed Release Pellets)
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| dailymed-instance:dosage |
THE DOSAGE OF ORACEA DIFFERS FROM THAT OF DOXYCYCLINE USED TO TREAT INFECTIONS. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS INCLUDING THE DEVELOPMENT OF RESISTANT MICROORGANISMS. One ORACEA Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals. Efficacy beyond 16 weeks and safety beyond 9 months have not been established. Administration of adequate amounts of fluid along with the capsules is recommended to wash down the capsule to reduce the risk of esophageal irritation and ulceration. .
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| dailymed-instance:descripti... |
ORACEA (doxycycline, USP) capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (CHNO). The structural formula of doxycycline, USP is: with an empirical formula of CHNO���HO and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4a��, 4a��, 5��, 5a��, 6a,12a��)]-, monohydrate. It is very slightly soluble in water. Inert ingredients in the formulation are: hypromellose, iron oxide red, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate. Active ingredients: Each capsule contains doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline.
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| dailymed-instance:clinicalP... |
Pharmacokinetics: ORACEA capsules are not bioequivalent to other doxycycline products. The pharmacokinetics of doxycycline following oral administration of ORACEA was investigated in 2 volunteer studies involving 61 adults. Pharmacokinetic parameters for ORACEA following single oral doses and at steady-state in healthy subjects are presented in Table 1.<br/>Absorption: In a single-dose food-effect study involving administration of ORACEA to healthy volunteers, concomitant administration with a 1000 calorie, high-fat, high-protein meal that included dairy products, resulted in a decrease in the rate and extent of absorption (Cmax and AUC) by about 45% and 22%, respectively, compared to dosing under fasted conditions. This decrease in systemic exposure can be clinically significant, and therefore if ORACEA is taken close to meal times, it is recommended that it be taken at least one hour prior to or two hours after meals.<br/>Distribution: Doxycycline is greater than 90% bound to plasma proteins.<br/>Metabolism: Major metabolites of doxycycline have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.<br/>Excretion: Doxycycline is excreted in the urine and feces as unchanged drug. It is reported that between 29% and 55.4% of an administered dose can be accounted for in the urine by 72 hours. Terminal half-life averaged 21.2 hours in subjects receiving a single dose of ORACEA.<br/>Special Populations:<br/>MICROBIOLOGY: Doxycycline is a member of the tetracycline class of antibacterial drugs. The plasma concentrations of doxycycline achieved with ORACEA during administration are less than the concentration required to treat bacterial diseases. In vivo microbiological studies utilizing a similar drug exposure for up to 18 months demonstrated no detectable long-term effects on bacterial flora of the oral cavity, skin, intestinal tract, and vagina. ORACEA should not be used for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease.
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| dailymed-instance:contraind... |
This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.
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| dailymed-instance:supply |
ORACEA (beige opaque capsule printed with CGPI 40) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline. Bottle of 30 (NDC 64682-009-01).<br/>Storage: All products are to be stored at controlled room temperatures of l5��C-30��C (59��F-86��F) and dispensed in tight, light-resistant containers (USP). Keep out of reach of children. Patent Information: U.S. Patents 5,789,395; 5,919,775 and patents pending. Manufactured by:CardinalHealthWinchester, KY 40391 Marketed by:CollaGenex Pharmaceuticals, Inc.Newtown, PA 18940 May 26, 2006
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| dailymed-instance:genericDr... | |
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... |
dailymed-ingredient:Polysorbate_80,
dailymed-ingredient:hypromellose,
dailymed-ingredient:iron_oxide_red,
dailymed-ingredient:iron_oxide_yellow,
dailymed-ingredient:methacrylic_acid_copolymer,
dailymed-ingredient:polyethylene_glycol,
dailymed-ingredient:sugar_spheres,
dailymed-ingredient:talc,
dailymed-ingredient:titanium_dioxide,
dailymed-ingredient:triethyl_citrate
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| dailymed-instance:overdosag... |
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdose.
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| dailymed-instance:genericMe... |
Doxycycline
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| dailymed-instance:fullName |
Oracea (Capsule, Delayed Release Pellets)
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| dailymed-instance:adverseRe... |
Adverse Reactions in Clinical Trials of ORACEA: In controlled clinical trials of adult patients with mild to moderate rosacea, 537 patients received ORACEA or placebo over a 16-week period. The most frequent adverse reactions occurring in these studies are listed in Table 3.<br/>Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity has been reported rarely. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline class. Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down. . Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. . Renal toxicity: Rise in BUN has been reported and is apparently dose-related. . Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus. Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.
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| dailymed-instance:indicatio... |
ORACEA is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea. ORACEA has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. Efficacy of ORACEA beyond 16 weeks and safety beyond 9 months have not been established. This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. ORACEA should not be used for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ORACEA should be used only as indicated.
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Oracea
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