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:

Preferred Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cephalexin capsules 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 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 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 and/or Proteus mirabilis Genitourinary tract infections, including acute prostatitis, caused by Escherich

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 cap and white opaque body) that are imprinted with 801 on the cap in black. They are available as follows: Bottles of 20 Bottles of 21 NDC 68788-8994-7 Bottles of 28 Bottles of 30 Bottles of 40 Bottles of 60 NDC 68788-8994-8 NDC 68788-8994-3 NDC 68788-8994-4 NDC 68788-8994-6 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
PREFERRED PHARMACEUTICALS INC.
----------
CEPHALEXIN CAPSULES, USP
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; 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 or
500 mg of cephalexin. The
capsules also contain anhydrous lactose, gelatin, magnesium stearate,
talc and titanium dioxide. The
capsules are imprinted with edible ink containing black iron oxide.
CLINICAL PHARMACOLOGY
HUMAN PHARMACOLOGY
Cephalexin 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 µg/mL respectively were obtained at 1
hour. Measurable levels were
present 6 hou