CEPHALEXIN capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Unit Dose Services

DCI (Dénomination commune internationale):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 250 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:   Respiratory tract infections caused by and (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.   Cephalexin capsules, USP are 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 , , , and   Skin and skin structure infections caused by and/or   Bone infections caused by and/or   Genitourinary tract infections, including acute prostatitis, caused by , , and   — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.   To reduce the development of drug-resistant bacteria and maint

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CEPHALEXIN - CEPHALEXIN CAPSULE
UNIT DOSE SERVICES
----------
CEPHALEXIN CAPSULES, USP TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT
BACTERIA AND MAINTAIN
THE EFFECTIVENESS OF CEPHALEXIN CAPSULES, USP AND OTHER ANTIBACTERIAL
DRUGS, CEPHALEXIN CAPSULE,
USP SHOULD BE USED ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN
OR STRONGLY SUSPECTED TO
BE CAUSED BY BACTERIA.
DESCRIPTION
Cephalexin Capsules, USP is a semisynthetic cephalosporin antibiotic
intended for oral administration.
It is 7-(D-a-Amino-a-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, USP 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
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 magnesium stearate, capsule
shell contains D & C Yellow
No. 10, FD & C Yellow No. 6, FD & C green 3, sodium lauryl sulfate,
gelatin, titanium dioxide. In
addition, the 500 mg capsule also contains FD & C Blue No. 1.
Imprinting ink contains shellac,
dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene
glycol, strong ammonia solution, black
iron oxide, potassium hydroxide, purified water.
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