KEFLEX- cephalexin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Shionogi Inc.

INN (International Name):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

KEFLEX is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. KEFLEX is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae , Haemophilus influenzae , Staphylococcus aureus , Streptococcus pyogenes , and Moraxella catarrhalis. KEFLEX 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 . KEFLEX is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. KEFLEX 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 KEFLEX and other antiba

Product summary:

KEFLEX (cephalexin) Capsules, USP, is supplied as follows: KEFLEX 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.

Authorization status:

New Drug Application

Summary of Product characteristics

KEFLEX- CEPHALEXIN CAPSULE
SHIONOGI INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KEFLEX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR KEFLEX
KEFLEX (CEPHALEXIN) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
KEFLEX 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 KEFLEX and other antibacterial
drugs, KEFLEX 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 to14 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, 500 mg and 750 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 allergic reaction occur and institute
supportive meas