CEPHALEXIN capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

AvKARE

INN (International Name):

CEPHALEXIN

Sammensætning:

CEPHALEXIN ANHYDROUS 250 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae , Haemophilus influenzae , Staphylococcus aureus , Streptococcus pyogenes , and Moraxella catarrhalis. Cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes . Cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli , Proteus mirabilis , and Klebsiella pneumoniae . 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 infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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 is contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs. Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Reproduction studies have been performed on mice and rats using oral doses of cephalexin monohydrate 0.6 and 1.5 times the maximum daily human dose (66 mg/kg/day) based upon body surface area basis, and have revealed no evidence of impaired fertility or harm to the fetus. Cephalexin is excreted in human milk. Caution should be exercised when Cephalexin is administered to a nursing woman. The safety and effectiveness of Cephalexin in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section [ see Dosage and Administration ( 2.2) ] . Of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [ see Warnings and Precautions ( 5.4) ]. Cephalexin should be administered with caution in the presence of impaired renal function (creatinine clearance < 30 mL/min, with or without dialysis). Under such conditions, careful clinical observation and laboratory studies renal function monitoring should be conducted because safe dosage may be lower than that usually recommended [see Dosage and Administration ( 2.3)] .

Produkt oversigt:

Cephalexin capsules, USP is supplied as follows: 250 mg Capsules, bottles of 500 NDC 42291-208-50 500 mg Capsules, bottles of 500 NDC 42291-209-50 Cephalexin should be stored at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CEPHALEXIN- CEPHALEXIN CAPSULE
AVKARE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
CEPHALEXIN - CEPHALEXIN CAPSULE
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEPHALEXIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEPHALEXIN.
CEPHALEXIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Cephalexin is a cephalosporin antibacterial drug indicated for the
treatment of the following infections
caused by susceptible isolates of designated bacteria:
Respiratory tract infection ( 1.1)
Otitis media ( 1.2)
Skin and skin structure infections ( 1.3)
Bone infections ( 1.4)
Genitourinary tract infections ( 1.5)
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
infections that are proven or strongly
suspected to be caused by bacteria. ( 1.6)
DOSAGE AND ADMINISTRATION
Adults and patients
at
least 15 years of
age
The usual dose is 250 mg every 6 hours, but a dose of 500 mg every 12
hours may
be administered ( 2.1)
Pediatric patients
(over 1 year of age)
Otitis media: 75 to 100 mg/kg in equally divided doses every 6 hours (
2.2)
All other indications: 25 to 50 mg/kg given in equally divided doses (
2.2)
In severe infections: 50 to 100 mg/kg may be administered in equally
divided
doses ( 2.2)
Duration of therapy ranges from 7 to 14 days depending on the
infection type and severity. ( 2)
Dosage adjustment is required in patients with severe and end stage
renal disease (ESRD) defined as
creatinine clearance below 30 mL/min. ( 2.3)
DOSAGE FORMS AND STRENGTHS
Capsules: 250 mg and 500 mg ( 3)
CONTRAINDICATIONS
Patients with known hypersensitivity to cephalexin or other members of
the cephalosporin class of
antibacterial drugs. ( 4)
WARNINGS AND PRECAUTIONS
Serious hypersensitivity (anaphylactic) reactions: Prior to use,
inquire regarding history of
hypersensitivity to beta-lactam antibacterial drugs. Discontinue the
drug if signs or symptoms of an
allergi