CEPHALEXIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fera Pharmaceuticals, LLC

INN (International Name):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 750 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cephalexin capsules are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes . Cephalexin capsules are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes , and Moraxella catarrhalis . Cephalexin capsules are 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 capsules are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis . Cephalexin capsules are 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-resista

Product summary:

Cephalexin Capsules, USP, is supplied as follows: Cephalexin capsules 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

CEPHALEXIN- CEPHALEXIN CAPSULE
FERA PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEPHALEXIN CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CEPHALEXIN CAPSULES.
CEPHALEXIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Cephalexin capsules are 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
capsules and other antibacterial drugs, cephalexin capsules 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 sign