CEPHALEXIN- cephalexin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK 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 infections, inc

Product summary:

Cephalexin Capsules, USP are available in: The 250 mg capsules are a white to off-white powder filled into size 2 capsules (white opaque and dark green opaque) that are imprinted with identity code “J1” on the dark green opaque cap, and “J1” on the white opaque body in edible black ink. The 500 mg capsules are a white to off-white powder filled into size 0 capsules (light green opaque and dark green opaque) that are imprinted with identity code "J2” on the dark green opaque cap, and “J2” on the light green opaque body in edible black ink. They are supplied by Altura Pharmaceuticals, Inc. 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 with a child resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN- CEPHALEXIN CAPSULE
REMEDYREPACK INC.
----------
CEPHALEXIN CAPSULES, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cephalexin and
other antibacterial drugs, Cephalexin 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-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; ie, 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 (1,439
μmol) of cephalexin. The capsules also contain colloidal silicon
dioxide, D & C Yellow No. 10, FD &
C Blue No. 2, gelatin, magnesium stearate, sodium starch glycolate,
and titanium dioxide.
CLINICAL PHARMACOLOGY
HUMAN PHARMACOLOGY
Cephalexin Capsules, USP 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, and 32 mcg/mL respectively were
obtained at 1 hour. Measura