CEFIXIME capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

CEFIXIME (UNII: 97I1C92E55) (CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX)

Доступна с:

Ascend Laboratories, LLC

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Cefixime is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis . Cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Cefixime capsules are generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime capsules in the subsequent prevention of rheumatic fever is not available.) Cefixime capsules is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of Streptococcus pneumoniae and Haemophilus influenzae. Cefixime capsules is

Обзор продуктов:

Cefixime Capsules are available for oral administration in following strengths and packages listed in the table below:

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

CEFIXIME - CEFIXIME CAPSULE
ASCEND LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFIXIME
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CEFIXIME CAPSULES.
CEFIXIME CAPSULES, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1986
INDICATIONS AND USAGE
Cefixime is a cephalosporin antibacterial drug indicated in the
treatment of adults and pediatric six months
and older with the following infections:
Uncomplicated Urinary Tract Infections (1.1)
Pharyngitis and Tonsillitis (1.3)
Acute Exacerbations of Chronic Bronchitis (1.4)
Uncomplicated Gonorrhea (cervical/urethral) (1.5)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefixime and
other antibacterial drugs, cefixime should be used only to treat
infections that are proven or strongly
suspected to be caused by bacteria.
DOSAGE AND ADMINISTRATION
· Adults: 400 mg daily (2.1)
DOSAGE FORMS AND STRENGTHS
· Capsules: 400 mg (3)
CONTRAINDICATIONS
· Contraindicated in patients with known allergy to cefixime or other
cephalosporins. (4)
WARNINGS AND PRECAUTIONS
· Hypersensitivity reactions including shock and fatalities have been
reported with cefixime. Discontinue
use if a reaction occurs. (5.1)
· _Clostridium difficile associated_ diarrhea: Evaluate if diarrhea
occurs. (5.2)
ADVERSE REACTIONS
Most common adverse reactions are gastrointestinal such as diarrhea
(16%), nausea (7%), loose stools
(6%), abdominal pain (3%), dyspepsia (3%), and vomiting. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASCEND LABORATORIES,
LLC AT 1-877-ASC-
RX01 (877-272-7901) OR FDA AT 1-800-FDA-1088 OR
_WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
· Elevated carbamazepine levels have been reported in postmarketing
experience when cefixime is
administered concomitantly. (7.1)
· Increased prothrombin time, with or without clinical bleeding, has
been reported when cefixime is
administered concomitantly with warfarin and anticoagulants. (7.2)
USE IN SPECIFI