CLARITHROMYCIN EXTENDED-RELEASE- clarithromycin tablet, extended release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)

から入手可能:

Estreno Pharmaceuticals, LLC

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Clarithromycin tablets, clarithromycin for oral suspension and clarithromycin extended-release tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae , Haemophilus parainfluenzae , Moraxella catarrhalis , or Streptococcus pneumoniae [see Indications and Usage (1.9)] . Clarithromycin tablets, clarithromycin for oral suspension and clarithromycin extended-release tablets (in adults) are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae , Moraxella catarrhalis , or Streptococcus pneumoniae [see Indications and Usage (1.9)] . Clarithromycin tablets, clarithromycin for oral suspension and clarithromycin extended-release tablets are indicated [see Indications and Usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to: - Haemophilus influenzae (in adults) - Haemophilus parainfluenzae (clarithromycin extended-rele

製品概要:

Clarithromycin Extended-Release tablets, USP are supplied as white to off-white, film-coated, oval–shaped tablets, debossed with "EP" on one side and "070" on the other side. 500 mg tablets: Bottles of 60 (72763-0100-06) Store Clarithromycin extended-release tablets at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

認証ステータス:

Abbreviated New Drug Application

製品の特徴

CLARITHROMYCIN EXTENDED-RELEASE- CLARITHROMYCIN TABLET, EXTENDED
RELEASE
ESTRENO PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLARITHROMYCIN EXTENDED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CLARITHROMYCIN EXTENDED-
RELEASE TABLETS.
CLARITHROMYCIN EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Serious Adverse Reactions with Concomitant
Use with Other Drugs (5.4)
10/2015
INDICATIONS AND USAGE
Clarithromycin is a macrolide antimicrobial indicated for mild to
moderate infections caused by designated, susceptible
bacteria in the following:
Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1)
Acute Maxillary Sinusitis (1.2)
Community-Acquired Pneumonia (1.3)
Pharyngitis/Tonsillitis (1.4)
Uncomplicated Skin and Skin Structure Infections (1.5)
Acute Otitis Media in Pediatric Patients (1.6)
Treatment and Prophylaxis of Disseminated Mycobacterial Infections
(1.7)
_Helicobacter pylori_ Infection and Duodenal Ulcer Disease in Adults
(1.8)
Limitations of Use
Clarithromycin extended-release tablets are indicated only for acute
bacterial exacerbation of chronic bronchitis, acute
maxillary sinusitis, and community-acquired pneumonia in adults. (1.9)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clarithromycin and other
antibacterial drugs, clarithromycin should be used only to treat or
prevent infections that are proven or strongly suspected
to be caused by bacteria. (1.9)
DOSAGE AND ADMINISTRATION
Adults: clarithromycin 250 mg or 500 mg every 12 hours for 7 to 14
days; clarithromycin extended-release tablets 1
gram every 24 hours for 7 to 14 days (2.2)
_H. pylori_ eradication (in combination with lansoprazole/amoxicillin,
omeprazole/amoxicillin, or omeprazole):
clarithromycin 500 mg every 8 or 12 hours for 10 to 14 days. See full
prescribing information (FPI) for additional
informat