CEFDINIR capsule

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

REMEDYREPACK INC.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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 ).  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).  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.  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.  Caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes .  Caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).  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.  Caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes .  Cefdinir is contraindicated in patients with known allergy to the cephalosporin class of antibiotics. 

Product samenvatting:

Cefdinir capsules USP, 300 mg, size '0' capsules having blue cap imprinted twice with "LUPIN" (in black ink) and purple body imprinted twice with "CEFDINIR" (in white ink) containing off white to creamish granular slug, are available as follows: NDC: 70518-3577-00 PACKAGING: 20 in 1 BOTTLE PLASTIC Store the capsules at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

CEFDINIR- CEFDINIR CAPSULE
REMEDYREPACK INC.
----------
CEFDINIR CAPSULES USP
300 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
cefdinir capsules and other antibacterial drugs, cefdinir capsules
should be used only to
treat or prevent infections that are proven or strongly suspected to
be caused by
bacteria.
DESCRIPTION
Cefdinir capsules contains 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 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 of cefdinir and the following
inactive ingredients:
carboxymethylcellulose calcium; colloidal silicon dioxide; and
magnesium stearate. The
capsule shells contain D&C Red #28; FD&C Blue #1; FD&C Red #40;
gelatin and titanium
dioxide.
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%.
_EFFECT OF FOOD: _The C
and AUC of cefdinir from the capsules are reduced by 16%
and 10%, respectively, when given with a