CEPHALEXIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

CEPHALEXIN ANHYDROUS

Composition:

CEPHALEXIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Product summary:

Cephalexin capsules, USP, are available in:   The 250 mg cephalexin capsules, USP are a white to off white powder filled into size 2 capsules (opaque dark green cap and opaque white body) that are imprinted with “293” in edible black ink on cap and body. They are available as follows:   Bottle of 20’s NDC 33261-149-20 Bottle of 28’s NDC 33261-149-28 Bottle of 30’s NDC 33261-149-30 Bottle of 40’s NDC 33261-149-40 Bottle of 100’s NDC 33261-149-00   The 500 mg cephalexin capsules, USP are a white to off white powder filled into size 0 capsules (opaque dark green cap and opaque light green body) that are imprinted with “294” in edible black ink on cap and body.  They are available as follows:   Bottle of 20’s NDC 33261-020-20 Bottle of 28’s NDC 33261-020-28 Bottle of 30’s NDC 33261-020-30 Bottle of 40’s NDC 33261-020-40 Bottle of 100’s NDC 33261-020-00 Store at 25°C (77°F); excursions permitted to 15‑30°C (59‑86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN- CEPHALEXIN CAPSULE
AIDAREX PHARMACEUTICALS LLC
----------
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
_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 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.
C