CEPHALEXIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)

Available from:

RedPharm Drug Inc.

INN (International Name):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cephalexin Capsules, USP 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. Cephalexin Capsules, USP is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Cephalexin Capsules, USP in the subsequent prevention of rheumatic fever are not available at present.) -  Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae , Staphyloccus 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 in

Product summary:

Cephalexin capsules USP 250 mg, 500 mg (or cephalexin, USP), are available in: 500 mg The 500 mg capsules are a white to yellowish-white granular powder filled into size "0" capsules (light green and dark green) that are imprinted with "500" on the dark green cap, and "LUPIN" on the light green body in edible black ink. They are available as follows: Bottles of 100 NDC 67296-0320-7 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN - CEPHALEXIN CAPSULE
REDPHARM DRUG INC.
----------
CEPHALEXIN CAPSULE
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cephalexin
capsules and other antibacterial drugs, cephalexin capsules should be
used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
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 USP equivalent to 250 mg or 500 mg of
anhydrous cephalexin. The
capsules also contain the following inactive ingredients D and C
Yellow 10, edible printing ink with
black iron oxide, FD and C Blue 1, FD and C Green 3, FD and C Yellow
6, gelatin, magnesium stearate,
microcrystalline cellulose and titanium dioxide.
CLINICAL PHARMACOLOGY
Human Pharmacology:
Cephalexin 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
peak serum levels of
approximately 9, 18,