Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
CEFDINIR (UNII: CI0FAO63WC) (CEFDINIR - UNII:CI0FAO63WC)
Physicians Total Care, Inc.
CEFDINIR
CEFDINIR 300 mg
ORAL
PRESCRIPTION DRUG
Cefdinir capsules contain 300 mg cefdinir and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide and magnesium stearate. The empty hard gelatin capsule shells contain FD&C Blue #1, D&C Red #28, titanium dioxide, gelatin and sodium lauryl sulphate. The capsules are printed with edible ink containing black iron oxide and shellac.
Abbreviated New Drug Application
CEFDINIR - CEFDINIR CAPSULE PHYSICIANS TOTAL CARE, INC. ---------- CEFDINIR CAPSULES 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 contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α, 7β (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 phosphate buffer. The molecular formula is C H N O S and the molecular weight is 395.42. Cefdinir has the structural formula shown below: Cefdinir capsules contain 300 mg cefdinir and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide and magnesium stearate. The empty hard gelatin capsule shells contain FD&C Blue #1, D&C Red #28, titanium dioxide, gelatin and sodium lauryl sulphate. The capsules are printed with edible ink containing black iron oxide and shellac. 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 streng Olvassa el a teljes dokumentumot