CLARITHROMYCIN 500 MG- clarithromycin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

CLARITHROMYCIN

Composition:

CLARITHROMYCIN 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. Clarithromycin 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 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 (in adults and pediatric patients) Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who canno

Product summary:

Clarithromycin Tablets USP, 500 mg are White to off white, film-coated, oval shaped tablets debossed with V 23 on one side and plain on the other side. NDC 68071-4369-4 BOTTLES OF 14 NDC 68071-4369-2 BOTTLES OF 20 NDC 68071-4369-8 BOTTLES OF 28 NDC 68071-4369-3 BOTTLES OF 30 Store in a well closed container at 20°C to 25°C (68°F to 77°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 closures (as required).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLARITHROMYCIN 500 MG- CLARITHROMYCIN TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
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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, Acute Hypersensitivity Reactions (5.1).
06/2017
Warnings and Precautions, All-Cause Mortality in Patients With
Coronary Artery Disease Years After Clarithromycin
Exposure (5.5) 06/2017
INDICATIONS AND USAGE
Clarithromycin tablets are a macrolide antimicrobial indicated for
mild to moderate infections caused by designated,
susceptible bacteria in the following: (1)
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) (1)
DOSAGE AND ADMINISTRATION
Adults: Clarithromycin tablets 250 mg or 500 mg every 12 hours for 7
to 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 to 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 7.5 mg/kg up to