Clarithromycin

CLARITHROMYCIN- clarithromycin tablet, film coated, extended release
Actavis Pharma, Inc.

1 INDICATIONS AND USAGE

1.1 Acute Bacterial Exacerbation of Chronic Bronchitis

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)].

1.2 Acute Maxillary Sinusitis

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)].

1.3 Community-Acquired Pneumonia

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 (in adults)
  • Moraxella catarrhalis (in adults)
  • Mycoplasma pneumoniae, Streptococcus pneumoniae , Chlamydophila pneumoniae (in adults)

1.9 Limitations of Use

Clarithromycin extended-release tablets are indicated only for acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia in adults. The efficacy and safety of clarithromycin extended-release tablets in treating other infections for which clarithromycin immediate-release tablets and clarithromycin granules are approved have not been established.

There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated.

1.10 Usage

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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Clarithromycin extended-release tablets should be taken with food. Swallow clarithromycin extended-release tablets whole; do not chew, break or crush clarithromycin extended-release tablets.

2.2 Adult Dosage

The recommended dosages of clarithromycin extended-release tablets for the treatment of mild to moderate infections in adults are listed in Table 1.

Table 1. Adult Dosage Guidelines

Clarithromycin Extended-Release Tablets

Infection

Dosage

(e very 24 hours)

Duration

( d ays)

Acute bacterial exacerbation of chronic bronchitis

1 gram

7

Acute maxillary sinusitis

1 gram

14

Community-acquired pneumonia

1 gram

7

2.6 Dosage Adjustment in Patients with Renal Impairment

See Table 2 for dosage adjustment in patients with moderate or severe renal impairment with or without concomitant atazanavir or ritonavir-containing regimens [see Drug Interactions (7)].

Table 2. Clarithromycin Dosage Adjustments in Patients with Renal Impairment

Recommended Clarithromycin

Dosage Reduction

Patients with severe renal impairment (CLcr of <30 mL/min)

Reduce the dosage of

Clarithromycin by 50%

Patients with moderate renal impairment (CLcr of 30 to 60 mL/min) taking concomitant atazanavir or ritonavir-containing regimens

Reduce the dosage of

Clarithromycin by 50%

Patients with severe renal impairment (CLcr of <30 mL/min) taking concomitant atazanavir or ritonavir-containing regimens

Reduce the dosage of

Clarithromycin by 75%


2.7 Dosage Adjustment Due to Drug Interactions

Decrease the dose of clarithromycin by 50% when coadministered with atazanavir [see Drug Interactions (7)]. Dosage adjustments for other drugs when coadministered with clarithromycin may be recommended due to drug interactions [see Drug Interactions (7)].

3 DOSAGE FORMS AND STRENGTHS

Clarithromycin Extended-release Tablets USP (yellow, film coated, oval shaped, unscored tablets) are available as:

• 500 mg: debossed with 1 and “777” on one side.

4 CONTRAINDICATIONS

4.1 Hypersensitivity

Clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs [see Warnings and Precautions (5.1)].

4.2 Cardiac Arrhythmias

Concomitant administration of clarithromycin with cisapride and pimozide is contraindicated [see Drug Interactions (7)].

There have been postmarketing reports of drug interactions when clarithromycin is coadministered with cisapride or pimozide, resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes) most likely due to inhibition of metabolism of these drugs by clarithromycin. Fatalities have been reported.

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