CEPHALEXIN capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Preferred Pharmaceuticals, Inc.

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

Cephalexin capsules USP, are supplied as follows:             Cephalexin capsules USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

CEPHALEXIN- CEPHALEXIN CAPSULE
PREFERRED PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEPHALEXIN CAPSULES
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CEPHALEXIN CAPSULES USP
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)
• 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)
•
•
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 LUPIN PHARMACEUTICALS,
INC. AT 1-800-
399-2561 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2023
Respiratory tract infection (1.1)
Otitis media (1.2)
Skin and skin structure