CEPHALEXIN capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Blenheim Pharmacal, Inc.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 byStreptococcus pneumoniae andStreptococcus 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 toStreptococcus pneumoniae ,Haemophilus influenzae ,Staphylococcus aureus ,Streptococcus pyogenes , andMoraxella catarrhalis . Skin and skin structure infections caused byStaphylococcus aureus and/orStreptococcus pyogenes . Bone infections caused byStaphylococcus aureus and/orProteus mirabilis . Genitourinary tract infections, including acute prostatitis, caused byEscherichia c

Produktsammanfattning:

Cephalexin capsules USP 250 mg, 500 mg (or cephalexin, USP), are available in: 250 mg The 250 mg capsules are a white to yellowish-white granular powder filled into size "2" capsules (white and dark green) that are imprinted with "250" on dark green cap, and "LUPIN" on the white body in edible black ink. They are available as follows: Bottles of 100 NDC 68180-121-01 Bottles of 500 NDC 68180-121-02 500 mg The 500 mg capsules are a white to yellowish-white granular powder filled into size "0" capsules (light green and dark green) that are imprinted with "500" on the dark green cap, and "LUPIN" on the light green body in edible black ink. They are available as follows: Bottles of 100 NDC 68180-122-01 Bottles of 500 NDC 68180-122-02 Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature].

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CEPHALEXIN- CEPHALEXIN CAPSULE
BLENHEIM PHARMACAL, INC.
----------
CEPHALEXIN CAPSULES USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cephalexin
capsules and other antibacterial drugs, cephalexin capsules should be
used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Cephalexin, 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 USP equivalent to 250 mg or 500 mg of
anhydrous cephalexin. The
capsules also contain the following inactive ingredients D&C Yellow
10, FD&C Blue 1, FD&C Green
3, FD&C Yellow 6, ferric oxide black, gelatin, magnesium stearate,
microcrystalline cellulose,
potassium hydroxide, propylene glycol, shellac and titanium dioxide.
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
ap