CEFDINIR- cefdinir capsule

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

PD-Rx Pharmaceuticals, Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 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. Cefdinir capsules 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. caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES ).

Přehled produktů:

Cefdinir capsules, containing 300 mg cefdinir, are blue, opaque hard gelatin capsules imprinted with “Sandoz 663” and are supplied as follows: NDC 43063-853-20 in bottles of 20 capsules Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CEFDINIR- CEFDINIR CAPSULE
PD-RX PHARMACEUTICALS, 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 7.0 phosphate
buffer. The empirical 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 silicone dioxide, magnesium
stearate, and polyoxyl 40
stearate. The capsule shells contain FD&C Blue #2; gelatin, titanium
dioxide, shellac, propylene glycol,
black iron oxide, ammonia hydroxide, and potassium hydroxide.
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
bioequiva