Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
ceftibuten dihydrate (UNII: 62F4443RWP) (CEFTIBUTEN - UNII:IW71N46B4Y)
Macoven Pharmaceuticals
ceftibuten dihydrate
CEFTIBUTEN 400 mg
PRESCRIPTION DRUG
New Drug Application Authorized Generic
CEFTIBUTEN- CEFTIBUTEN DIHYDRATE CAPSULE CEFTIBUTEN- CEFTIBUTEN DIHYDRATE SUSPENSION MACOVEN PHARMACEUTICALS ---------- CEFTIBUTEN CAPSULES CEFTIBUTEN ORAL SUSPENSION FOR ORAL USE ONLY PRODUCT INFORMATION DESCRIPTION Ceftibuten Capsules and Ceftibuten Oral Suspension contain the active ingredient ceftibuten as ceftibuten dihydrate. Ceftibuten dihydrate is a semisynthetic cephalosporin antibiotic for oral administration. Chemically, it is (+)-(6R,7R)-7-[(Z)-2-(2-Amino-4-thiazolyl)-4-carboxycrotonamido]-8- oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, dihydrate. Its molecular formula is C H N O S •2H O. Its molecular weight is 446.43 as the dihydrate. Ceftibuten dihydrate has the following structural formula: Ceftibuten Capsules contain ceftibuten dihydrate equivalent to 400 mg of ceftibuten. Inactive ingredients contained in the capsule formulation include: magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shell and/or band contains gelatin, sodium lauryl sulfate, titanium dioxide, and polysorbate 80. The capsule shell may also contain benzyl alcohol, sodium propionate, edetate calcium disodium, butylparaben, propylparaben, and methylparaben. Ceftibuten Oral Suspension after reconstitution contains ceftibuten dihydrate equivalent to 90 mg of ceftibuten per 5 mL or 180 mg of ceftibuten per 5 mL. Ceftibuten Oral Suspension is cherry flavored and contains the inactive ingredients: cherry flavoring, polysorbate 80, silicon dioxide, simethicone, sodium benzoate, sucrose (approximately 1 g/5 mL), titanium dioxide, and xanthan gum. CLINICAL PHARMACOLOGY PHARMACOKINETICS Absorption _CEFTIBUTEN CAPSULES_ Ceftibuten is rapidly absorbed after oral administration of Ceftibuten Capsules. The plasma concentrations and pharmacokinetic parameters of ceftibuten after a single 400-mg dose of Ceftibuten 15 14 4 6 2 2 Capsules to 12 healthy adult male volunteers (20 to 39 years of age) are displayed in the table below. When Ceftibuten Capsules were administered once daily for 7 da Lire le document complet