CEPHALEXIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 pneum

Product summary:

Cephalexin capsules, USP, are supplied as follows: The 250 mg capsules are a white to off white powder filled into size 2 capsules (dark green cap and dark green body) that are imprinted with “220” on the both cap and body in edible black ink. They are available as follows: Bottles of 4 NDC 43063-497-04 Bottles of 6 NDC 43063-497-06 Bottles of 8 NDC 43063-497-08 Bottles of 9 NDC 43063-497-09 Bottles of 10 NDC 43063-497-10 Bottles of 15 NDC 43063-497-15 Bottles of 20 NDC 43063-497-20 Bottles of 28 NDC 43063-497-28 Bottles of 30 NDC 43063-497-30 Bottles of 40 NDC 43063-497-40 Store at 20°C to 25°C (68°F to77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN- CEPHALEXIN CAPSULE
PD-RX PHARMACEUTICALS, INC.
----------
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 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 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, 333 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 s