CEFDINIR capsule

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

NuCare Pharmaceuticals,Inc.

INN:

CEFDINIR

composition:

CEFDINIR 300 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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, USP 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. Community-Acquired Pneumonia 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 ). Acute Exacerbations of Chronic Bronchitis 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). Acute Maxillary Sinusitis caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). NOTE: For information on use in pediatric patients, see Pediatric Use   and DOSAGE AND ADMINISTRATION . Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes . Acute Bacterial Otitis Media caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes . Cefdinir capsules are contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

leaflet_short:

Cefdinir Capsules USP, 300 mg are lavender opaque/turquoise opaque size 0 hard gelatin capsule filled with off-white to yellow powder and imprinted with E99 on turquoise opaque body with black ink. NDC 68071-4007-7 Bottles of 14 NDC 68071-4007-2 Bottles of 20 NDC 68071-4007-3 Bottles of 30 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

authorization_status:

Abbreviated New Drug Application

SPC

CEFDINIR- CEFDINIR CAPSULE
NUCARE PHARMACEUTICALS,INC.
----------
CEFDINIR CAPSULES, USP
RX ONLY
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, 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 USP 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 molecular formula is C
H
N
O
S
and the molecular
weight is 395.42. Cefdinir has the structural formula shown below:
Cefdinir capsules, USP contain 300 mg cefdinir USP 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_
14
13
5
5
2
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%. Cef