keflex- cephalexin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

cephalexin (UNII: OBN7UDS42Y) (cephalexin - UNII:OBN7UDS42Y)

Available from:

ADVANCIS PHARMACEUTICAL CORPORATION

INN (International Name):

cephalexin

Pharmaceutical form:

CAPSULE

Composition:

250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Keflex is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Keflex is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Keflex in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes , and Moraxella catarrhalis Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabili

Product summary:

Keflex® Capsules (Cephalexin, USP), are available in: The 250 mg capsules are a white powder filled into size 2 capsules (opaque white and opaque dark green) that are imprinted with Keflex 250 mg on the white body in edible black ink. They are available as follows: The 333 mg capsules are a white powder filled into size 1 capsules (opaque light green and opaque light green) that are imprinted Keflex 333 mg on the light green body in edible black ink. They are available as follows: The 500 mg capsules are a white powder filled into size 0 capsules (opaque light green and opaque dark green) that are imprinted with Keflex 500 mg on the light green body in edible black ink. They are available as follows: The 750 mg capsules are a white powder filled into elongated size 00 capsules (opaque dark green and opaque dark green) that are imprinted Keflex 750 mg on the dark green body in edible white ink. They are available as follows: Store at 25˚C (77˚F); excursions permitted to 15-30˚C (59-86˚F) [see USP Controlled Room Temperature].

Summary of Product characteristics

KEFLEX- CEPHALEXIN CAPSULE
ADVANCIS PHARMACEUTICAL CORPORATION
----------
KEFLEX CAPSULES
CEPHALEXIN, USP
Keflex PIL Insert (Conversion to Word Doc) MOVA (Feb. 20, 2007)
Revision Date: 11/06
6311501
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Keflex and other
antibacterial drugs, Keflex should be used only to treat or prevent
infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Keflex
Capsules (Cephalexin, USP) is a semisynthetic cephalosporin antibiotic
intended for oral
administration. It is
7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid
monohydrate. Cephalexin has the molecular formula C
H N O S•H O and the molecular weight is
365.41.
Cephalexin has the following structural formula:
The nucleus of cephalexin is related to that of other cephalosporin
antibiotics. The compound is a
zwitterion; i.e., the molecule contains both a basic and an acidic
group. The isoelectric point of
cephalexin in water is approximately 4.5 to 5.
The crystalline form of cephalexin which is available is a
monohydrate. It is a white crystalline solid
having a bitter taste. Solubility in water is low at room temperature;
1 or 2 mg/mL may be dissolved
readily, but higher concentrations are obtained with increasing
difficulty.
The cephalosporins differ from penicillins in the structure of the
bicyclic ring system. Cephalexin has a
_D_-phenylglycyl group as substituent at the 7-amino position and an
unsubstituted methyl group at the 3-
position.
Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333
mg, 500 mg or 750 mg of
cephalexin. The capsules also contain cellulose, D & C Yellow No. 10,
F D & C Blue No. 1, F D & C
Yellow No. 6, gelatin, magnesium stearate, silicone, titanium dioxide,
and other inactive ingredients.
CLINICAL PHARMACOLOGY
HUMAN PHARMACOLOGY
Keflex is acid stable and may be given without regard to meals. It is
rapidly absorbed after oral
administration. Following doses of 250 mg, 500 mg, and 1 g, average