CEFDINIR capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

CEFDINIR (UNII: CI0FAO63WC) (CEFDINIR - UNII:CI0FAO63WC)

Verfügbar ab:

Physicians Total Care, Inc.

INN (Internationale Bezeichnung):

CEFDINIR

Zusammensetzung:

CEFDINIR 300 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

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