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:

Pragma Pharmaceuticals, LLC

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 antibac

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
PRAGMA PHARMACEUTICALS, LLC
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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 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, 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 su