CEFDINIR capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

EPM Packaging, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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

Product summary:

Cefdinir Capsules USP are available as follows: 300 mg - hard gelatin capsules with a light green-opaque body and a lavender-opaque cap, imprinted with “93” over “3160” on both body and cap, in bottles of 60 (NDC 0093-3160-06). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFDINIR- CEFDINIR CAPSULE
EPM PACKAGING, INC.
----------
CEFDINIR 300MG CAPSULES
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 USP contain the active ingredient cefdinir, USP an
extended-spectrum,
semisynthetic cephalosporin, for oral administration. Chemically,
cefdinir is (6 _R_,7 _R_)-7-
[[(2Z)-(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 light yellow
crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7.0
phosphate buffer.
Cefdinir has the structural formula shown below:
C
H
N
O
S
M.W. 395.41
Cefdinir Capsules USP contain 300 mg cefdinir, USP and the following
inactive
ingredients: carboxymethylcellulose calcium, colloidal silicon
dioxide, croscarmellose
sodium, D&C red #28, D&C yellow #10, D&C yellow #10 aluminum lake,
FD&C blue #1,
FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C green #3,
FD&C red
#40, FD&C red #40 aluminum lake, gelatin, iron oxide black, magnesium
stearate,
polyoxyl 40 stearate, propylene glycol, shellac glaze, sodium lauryl
sulfate, and titanium
dioxide.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS AND DRUG METABOLISM
14
13
5
5
2
Absorption
_Oral Bioavailability_
Maximal plasma cefdinir concentrations occur 2 to 4 hours postdose
following capsule
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.
_Effect of Food_
The C
and AUC of cefdinir fr