CEPHALEXIN capsule

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

MedVantx, Inc.

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Note –Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cephalexin capsules, USP are contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Sommarju tal-prodott:

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. They are available as follows: 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 available 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.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

CEPHALEXIN- CEPHALEXIN CAPSULE
MEDVANTX, INC.
----------
CEPHALEXIN CAPSULES, USP
Rev. 11/10
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 are 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:
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 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