Linked Life Data

OMNICEF (Capsule)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3226

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dailymed-drugs:3226rdfs:labelOMNICEF (Capsule)lld:dailymed
dailymed-drugs:3226dailymed-instance:dosage(see INDICATIONS AND USAGE for Indicated Pathogens)<br/>Capsules: The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, OMNICEF Capsules should be administeredtwice daily in these infections. OMNICEF Capsules may be taken without regard to meals.<br/>Powder for Oral Suspension: The recommended dosage and duration of treatment for infections in pediatric patients are described in the following chart; the total daily dose for all infections is 14 mg/kg, up to a maximum dose of 600 mg per day. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in skin infections; therefore, OMNICEF for Oral Suspension should be administered twice daily in this infection. OMNICEF for Oral Suspension may be administered without regard to meals.<br/>Patients With Renal Insufficiency: For adult patients with creatinine clearance<30 mL/min, the dose of cefdinir should be 300 mg given once daily. Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CL) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function. where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL. The following formula may be used to estimate creatinine clearance in pediatric patients: where K = 0.55 for pediatric patients older than 1 yearand 0.45 for infants (up to 1 year). In the above equation, creatinine clearance is in mL/min/1.73 m, body length or height is in centimeters, and serum creatinine is in mg/dL. For pediatric patients with a creatinine clearance of<30 mL/min/1.73 m, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.<br/>Patients on Hemodialysis: Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300-mg or 7-mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day. After mixing, the suspension can be stored at room temperature (25��C/77��F). The container should be kept tightly closed, and the suspension should be shaken well before each administration. The suspension may be used for 10 days, after which any unused portion must be discarded.lld:dailymed
dailymed-drugs:3226dailymed-instance:descripti...OMNICEF (cefdinir) capsules and OMNICEF (cefdinir) for oral suspension contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6��, 7��(Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The empirical formula is CHNOSand the molecular weight is 395.42. Cefdinir has the structural formula shown below: OMNICEF Capsules contain 300 mg cefdinir and the following inactive ingredients: carboxymethylcellulose calcium, NF; polyoxyl 40 stearate, NF; and magnesium stearate, NF. The capsule shells contain FD&C Blue #1; FD&C Red #40; D&C Red #28; titanium dioxide, NF; gelatin, NF; silicon dioxide, NF; and sodium lauryl sulfate, NF. OMNICEF for Oral Suspension, after reconstitution, contains 125 mg cefdinir per 5 mL or 250 mg cefdinir per 5 mL and the following inactive ingredients: sucrose, NF; citric acid, USP; sodium citrate, USP; sodium benzoate, NF; xanthan gum, NF; guar gum, NF; artificial strawberry and cream flavors; silicon dioxide, NF; and magnesium stearate, NF.lld:dailymed
dailymed-drugs:3226dailymed-instance:clinicalP...Pharmacokinetics and Drug Metabolism:<br/>Absorption:<br/>Distribution: The mean volume of distribution (Vd) of cefdinir in adult subjects is 0.35 L/kg (��0.29); in pediatric subjects (age 6 months-12 years), cefdinir Vdis 0.67 L/kg (��0.38). Cefdinir is 60% to 70% bound to plasma proteins in both adult and pediatric subjects; binding is independent of concentration.<br/>Metabolism and Excretion: Cefdinir is not appreciably metabolized. Activity is primarily due to parent drug. Cefdinir is eliminated principally via renal excretion with a mean plasma elimination half-life (t) of 1.7 (��0.6) hours. In healthy subjects with normal renal function, renal clearance is 2.0 (��1.0) mL/min/kg, and apparent oral clearance is 11.6 (��6.0) and 15.5 (��5.4) mL/min/kg following doses of 300- and 600-mg, respectively. Mean percent of dose recovered unchanged in the urine following 300- and 600-mg doses is 18.4% (��6.4) and 11.6% (��4.6), respectively. Cefdinir clearance is reduced in patients with renal dysfunction (see Special Populations - Patients with Renal Insufficiency). Because renal excretion is the predominant pathway of elimination, dosage should be adjusted in patients with markedly compromised renal function or who are undergoing hemodialysis (see DOSAGE AND ADMINISTRATION).<br/>Special Populations:<br/>Microbiology: As with other cephalosporins, bactericidal activity of cefdinir results from inhibition of cell wall synthesis. Cefdinir is stable in the presence of some, but not all,��-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins are susceptible to cefdinir. Cefdinir has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in INDICATIONS AND USAGE.<br/>Aerobic Gram-Positive Microorganisms: Staphylococcus aureus (including��-lactamase producing strains) NOTE: Cefdinir is inactive against methicillin-resistant staphylococci. Streptococcus pneumoniae (penicillin-susceptible strains only) Streptococcus pyogenes<br/>Aerobic Gram-Negative Microorganisms: Haemophilus influenzae (including��-lactamase producing strains) Haemophilus parainfluenzae (including��-lactamase producing strains) Moraxella catarrhalis (including��-lactamase producing strains) The following in vitro data are available, but their clinical significance is unknown. Cefdinir exhibits in vitro minimum inhibitory concentrations (MICs) of 1��g/mL or less against (���90%) strains of the following microorganisms; however, the safety and effectiveness of cefdinir in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.<br/>Aerobic Gram-Positive Microorganisms: Staphylococcus epidermidis (methicillin-susceptible strains only) Streptococcus agalactiae Viridans groupstreptococci NOTE: Cefdinir is inactive against Enterococcus and methicillin-resistant Staphylococcus species.<br/>Aerobic Gram-Negative Microorganisms: Citrobacter diversus Escherichia coli Klebsiella pneumoniae Proteus mirabilis NOTE: Cefdinir is inactive against Pseudomonas and Enterobacter species.<br/>Susceptibility Tests:lld:dailymed
dailymed-drugs:3226dailymed-instance:activeIng...dailymed-ingredient:cefdini...lld:dailymed
dailymed-drugs:3226dailymed-instance:contraind...OMNICEF (cefdinir) is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.lld:dailymed
dailymed-drugs:3226dailymed-instance:supplyOMNICEF Capsules, containing 300 mg cefdinir, as lavender and turquoise capsules imprinted with the product name, are available as follows: 60 Capsules/Bottle NDC 0074-3769-60 OMNI-PACcarton of 3 unit-of-use, 5-day, 10-capsule blister cards NDC 0074-3769-30 OMNICEF for Oral Suspension is a cream-colored powder formulation that, when reconstituted as directed, contains 125 mg cefdinir/5 mL or 250 mg cefdinir/5 mL. The reconstituted suspensions have a cream color and strawberry flavor. The powder is available as follows: 125 mg/5 mL 60-mL bottles NDC 0074-3771-60 100-mL bottles NDC 0074-3771-13 250 mg/5 mL 60-mL bottles NDC 0074-6151-60 100-mL bottles NDC 0074-6151-13 Store the capsules and unsuspended powder at 25��C (77��F); excursions permitted to 15��-30��C (59��-86��F) [see USP Controlled Room Temperature]. Once reconstituted, the oral suspension can be stored at controlled room temperature for 10 days.lld:dailymed
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dailymed-drugs:3226dailymed-instance:overdosag...Information on cefdinir overdosage in humans is not available. In acute rodent toxicity studies, a single oral 5600-mg/kg dose produced no adverse effects. Toxic signs and symptoms following overdosage with other��-lactam antibiotics have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis removes cefdinir from the body. This may be useful in the event of a serious toxic reaction from overdosage, particularly if renal function is compromised.lld:dailymed
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dailymed-drugs:3226dailymed-instance:warningBEFORE THERAPY WITH OMNICEF (CEFDINIR) IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFDINIR, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF CEFDINIR IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG��-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEFDINIR OCCURS, THE DRUG SHOULD BE DISCONTINUED. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including OMNICEF, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.lld:dailymed
dailymed-drugs:3226dailymed-instance:indicatio...To reduce the development of drug-resistant bacteria and maintain the effectiveness of OMNICEF and other antibacterial drugs, OMNICEF should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. OMNICEF (cefdinir) capsules and OMNICEF (cefdinir) for oral suspension are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.<br/>Adults and Adolescents:<br/>Community-Acquired Pneumonia: caused by Haemophilus influenzae (including��-lactamase producing strains), Haemophilus parainfluenzae (including��-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including��-lactamase producing strains) (see CLINICAL STUDIES).<br/>Acute Exacerbations of Chronic Bronchitis: caused by Haemophilus influenzae (including��-lactamase producing strains), Haemophilus parainfluenzae (including��-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including��-lactamase producing strains).<br/>Acute Maxillary Sinusitis: caused by Haemophilus influenzae (including��-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including��-lactamase producing strains). NOTE: For information on use in pediatric patients, see Pediatric Use and DOSAGE AND ADMINISTRATION.<br/>Pharyngitis/Tonsillitis: caused by Streptococcus pyogenes (see CLINICAL STUDIES). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.<br/>Uncomplicated Skin and Skin Structure Infections: caused by Staphylococcus aureus (including��-lactamase producing strains) and Streptococcus pyogenes.<br/>Pediatric Patients: Acute Bacterial Otitis Media caused by Haemophilus influenzae (including��-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including��-lactamase producing strains).<br/>Pharyngitis/Tonsillitis: caused by Streptococcus pyogenes (see CLINICAL STUDIES). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.<br/>Uncomplicated Skin and Skin Structure Infections: caused by Staphylococcus aureus (including��-lactamase producing strains) and Streptococcus pyogenes.lld:dailymed
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