Prescription Drug Information: 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 co-administered with atazanavir [see Drug Interactions (7)]. Dosage adjustments for other drugs when co-administered 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 Cisapride and Pimozide

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 co-administered 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.

4.3 Cholestatic Jaundice/Hepatic Dysfunction

Clarithromycin is contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin.

4.4 Colchicine

Concomitant administration of clarithromycin and colchicine is contraindicated in patients with renal or hepatic impairment.

4.5 Lomitapide, Lovastatin, and Simvastatin

Concomitant administration of clarithromycin with lomitapide is contraindicated due to potential for markedly increased transaminases [see Warnings and Precautions (5.4) and Drug Interactions (7)].

Concomitant administration of clarithromycin with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin) is contraindicated, due to the increased risk of myopathy, including rhabdomyolysis [see Warnings and Precautions (5.4) and Drug Interactions (7)].

4.6 Ergot Alkaloids

Concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated [see Drug Interactions (7)].

4.7 Contraindications for Co-administered Drugs

For information about contraindications of other drugs indicated in combination with clarithromycin, refer to their full prescribing information (contraindications section).

5 WARNINGS AND PRECAUTIONS

5.1 Severe Acute Hypersensitivity Reactions

In the event of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, and acute generalized exanthematous pustulosis, discontinue clarithromycin therapy immediately and institute appropriate treatment.

5.2 QT Prolongation

  • Clarithromycin has been associated with prolongation of the QT interval and infrequent cases of arrhythmia. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving clarithromycin. Fatalities have been reported.

Avoid clarithromycin in the following patients:

  • patients with known prolongation of the QT interval, ventricular cardiac arrhythmia, including torsades de pointes
  • patients receiving drugs known to prolong the QT interval [see also Contraindications (4.2)]
  • patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia and in patients receiving Class IA (e.g., quinidine, procainamide, disopyramide) or Class III (e.g., dofetilide, amiodarone, sotalol) antiarrhythmic agents.

Elderly patients may be more susceptible to drug-associated effects on the QT interval [see Use in Specific Populations (8.5)].

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