CEPHALEXIN capsule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

Cephalexin (UNII: OBN7UDS42Y) (Cephalexin Anhydrous - UNII:5SFF1W6677)

थमां उपलब्ध:

Pharma-C, Inc.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Cephalexin capsules, USP are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. Cephalexin capsule, USP 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 capsule, USP 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 capsule, USP are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. Cephalexin capsule, USP 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 devel

उत्पाद समीक्षा:

Cephalexin capsules, USP, are supplied as follows: Cephalexin capsules, USP 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.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

CEPHALEXIN- CEPHALEXIN CAPSULE
PHARMA-C, 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 USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Cephalexin capsules, USP is a cephalosporin antibacterial drug
indicated for the treatment of the following infections
caused by susceptible isolates of designated bacteria:
•
•
•
•
•
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cephalexin capsules, USP and
other antibacterial drugs, Cephalexin capsules, USP 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 )
•
•
•
•
•
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
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions associated with cephalexin include
diarrhea, nausea, vomiting, dyspepsia and
abdominal pain. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PHARMA-C, INC. AT
1-866-562-4708 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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)
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