CLARITHROMYCIN tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

RedPharm Drug, Inc.

INN (Διεθνής Όνομα):

CLARITHROMYCIN

Σύνθεση:

CLARITHROMYCIN 500 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

1.1 Acute Bacterial Exacerbation of Chronic Bronchitis Clarithromycin 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)]. 1.2 Acute Maxillary Sinusitis Clarithromycin tablets 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)]. 1.3 Community-Acquired Pneumonia Clarithromycin 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) • Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae 1.4 Pharyngitis/Tonsillitis Clarithromycin tablets are indicated for the treatment of mild to moderate infections

Περίληψη προϊόντος:

Clarithromycin tablets, USP 250 mg are white, oval-shaped, film-coated tablets, debossed GG C6 on one side and plain on the reverse side, and are supplied as follows: NDC 0781-1961-60 in bottles of 60 tablets Clarithromycin tablets, USP 500 mg are white, oval-shaped, film-coated tablets, debossed GG C9 on one side and plain on the reverse side, and are supplied as follows: NDC 0781-1962-60 in bottles of 60 tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as described in the USP. Protect from light.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

CLARITHROMYCIN- CLARITHROMYCIN TABLET
REDPHARM DRUG, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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, 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
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
clarithromycin and other antibacterial drugs, clarithromycin tablets
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 tablets 250 mg or 500 mg every 12 hours for
7–14 days ( 2.2)
•
H. pylori eradication (in combination with lansoprazole/amoxicillin,
omeprazole/amoxicillin,
or omeprazole): clarithromycin tablets 500 mg every 8 or 12 hours for
10–14 days. See
full prescribing information (FPI) for additional information. ( 2.3)
•
Pediatric Patients: clarithromycin 15 mg/kg/day divided every 12 hours
for 10 days ( 2.4)
•
Mycobacterial Infections: clarithromycin tablets 500 mg every 12
hours; clarithromycin
tablets 7.5 mg/kg up to 500 mg every 12 hours in pediatric patient