CEPHALEXIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Blenheim Pharmacal, Inc.

INN (International Name):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by S. pneumoniae and S. pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci, and M. catarrhalis Skin and skin structure infections caused by staphylococci and/or streptococci Bone infections caused by staphylococci and/or P. mirabilis Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae Note - Culture and susceptibility tests should be initiated prior to and during

Product summary:

Cephalexin capsules, USP are available in: The 250 mg capsules are white opaque body imprinted with “KLX” in black ink and green opaque cap imprinted with “140” in black ink. They are available as follows: Bottles of 100             NDC 42043-140-01 Bottles of 500             NDC 42043-140-05 The 500 mg capsules are light green opaque body imprinted with “KLX” in black ink and green opaque cap imprinted with “141” in black ink. They are available as follows: Bottles of 100             NDC 42043-141-01 Bottles of 500             NDC 42043-141-05 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN - CEPHALEXIN CAPSULE
BLENHEIM PHARMACAL, INC.
----------
CEPHALEXIN CAPSULES, USP
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
CEPHALEXIN CAPSULES, USP AND OTHER ANTIBACTERIAL DRUGS, CEPHALEXIN
CAPSULES, USP 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 monohydrate equivalent to 250 mg (720
μmol) or 500 mg (1439 μmol)
of cephalexin. The capsules also contain the following inactive
ingredients: Croscarmellose Sodium, D
& C Yellow No. 10, F D & C Blue No.1, F D & C Yellow No. 6, Gelatin,
Magnesium Stearate,
Microcrystalline Cellulose, Titanium Dioxide. Ink constituents are:
Black Iron Oxide, Butyl Alcohol,
Dehydrated Alcohol, Isopropyl Alcohol, Potassium Hydroxide, Propylene
Glycol, Shellac and Strong
Ammonia Solution.
CLINICAL PHARMACOLOGY
HUMAN PHARMACOLOGY
Cephalexin is acid stable and may be give