CEFDINIR- cefdinir monohydrate capsule
OrchidPharma Inc
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Cefdinir capsules USP contain the active ingredient cefdinir monohydrate, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir USP 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 monohydrate is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1M pH 7 phosphate buffer. The empirical formula is C14 H13 N5 O5 S2 .H2 O and the molecular weight is 413.47. Cefdinir monohydrate has the structural formula shown below:
strcture
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Cefdinir Capsules USP contain cefdinir USP equivalent to anhydrous cefdinir 300 mg and the following inactive ingredients: carboxymethylcellulose calcium; croscarmellose sodium; polyoxyl 40 stearate; colloidal silicon dioxide and magnesium stearate. The capsule shells contain FD&C Blue #1, FD&C Green #3, FD&C Red #40, D&C Red #28, D&C Red #33, titanium dioxide and gelatin. Ink constituents are: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide.
CLINICAL PHARMACOLOGY
Pharmacokinetics and Drug Metabolism
Absorption
Oral Bioavailability:
Maximal plasma cefdinir concentrations occur 2 to 4 hours postdose following capsule or suspension administration. Plasma cefdinir concentrations increase with dose, but the increases are less than dose-proportional from 300 mg (7 mg/kg) to 600 mg (14 mg/kg). Following administration of suspension to healthy adults, cefdinir bioavailability is 120% relative to capsules. Estimated bioavailability of cefdinir capsules is 21% following administration of a 300 mg capsule dose, and 16% following administration of a 600 mg capsule dose. Estimated absolute bioavailability of cefdinir suspension is 25%. Cefdinir oral suspension of 250 mg/5 mL strength was shown to be bioequivalent to the 125 mg/5 mL strength in healthy adults under fasting conditions.
Effect of Food:
The Cmax and AUC of cefdinir from the capsules are reduced by 16% and 10%, respectively, when given with a high-fat meal. In adults given the 250 mg/5 mL oral suspension with a high-fat meal, the Cmax and AUC of cefdinir are reduced by 44% and 33%, respectively. The magnitude of these reductions is not likely to be clinically significant because the safety and efficacy studies of oral suspension in pediatric patients were conducted without regard to food intake. Therefore, cefdinir may be taken without regard to food.