CEPHALEXIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 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 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 an

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.    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 supplied by State of Florida DOH Central Pharmacy as follows: 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
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
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,
purifi