CLARITHROMYCIN- 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:

Preferred 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. 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. Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to: 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 cannot use first line therapy. Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus , or Streptococcus pyogenes . Clarithromycin tablets are indicated in pediatric patients for t

Product summary:

Clarithromycin Tablets USP, 500 mg are light yellow colored, oval shaped, biconvex film-coated tablets, with ‘D’ debossed on one side and ‘63’ on the other side. Bottles of   14       NDC 68788-6936-1 Bottles of    20      NDC 68788-6936-2 Bottles of    28      NDC 68788-6936-8 Bottles of    30      NDC 68788-6936-3 Store 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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED
PREFERRED 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, QT Prolongation (5.2) 11/2018
Warnings and Precautions, Serious Adverse Reactions Due to
Concomitant Use with Other Drugs (5.4) 11/2018
Warnings and Precautions, Embryo-fetal Toxicity (5.7) 12/2018
INDICATIONS AND USAGE
Clarithromycin tablets are a macrolide antimicrobial indicated for
mild to moderate infections caused by designated,
susceptible bacteria in the following:
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To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clarithromycin tablets 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. (1.10)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
· Tablets: 250 mg and 500 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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)
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)
Pediat