CLARITHROMYCIN tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

REMEDYREPACK INC.

INN (Международно Name):

CLARITHROMYCIN

Композиция:

CLARITHROMYCIN 500 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Clarithromycin tablets, USP 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, USP are indicated for the treatment of mild to moderate infections c

Каталог на резюме:

Clarithromycin Tablets, USP are supplied as white to off-white oval film-coated tablets in the following packaging sizes: 500 mg tablets: (debossed with the “S4” on one side) NDC: 70518-1136-00 PACKAGING: 30 in 1 BLISTER PACK Store clarithromycin tablets, USP at controlled room temperature 20° to 25°C (68° to 77°F) in a well-closed container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLARITHROMYCIN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLARITHROMYCIN
TABLETS.
CLARITHROMYCIN TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Contraindications, Lomitapide, Lovastatin, and Simvastatin (4.5)
9/2019
Warnings and Precautions, QT Prolongation (5.2)
11/2018
Warnings and Precautions, Serious Adverse Reactions Due to Concomitant
Use with Other Drugs (5.4)
9/2019
Warnings and Precautions, Embryo-fetal Toxicity (5.7)
12/2018
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
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 7–14 days
(2.2)Adults:Adults: clarithromycin 250 mg or
500 mg every 12 hours for 7–14 days (2.2)Adults:Adults:
clarithromycin 250 mg or 500 mg every 12 hours for 7–14
days (2.2)Adults:Adults: clarithromycin 250 mg or 500 mg every 12
hours for 7–14 days (2.2)Adults:
_H. pylori_ eradication (in combination with lansoprazole/amoxicillin,
omeprazole/amoxicillin, or omeprazole):
clarithromycin 500 mg every 8