Clarithromycin

CLARITHROMYCIN- clarithromycin tablet, film coated
RedPharm Drug, Inc.

These highlights do not include all the information needed to use CLARITHROMYCIN TABLETS, USP safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS, USP.
Clarithromycin tablets USP, 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)

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)

DOSAGE AND ADMINISTRATION

Adults: clarithromycin 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 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 500 mg every 12 hours; clarithromycin 7.5 mg/kg up to 500 mg every 12 hours in pediatric patients (2.5)
Reduce dose in moderate renal impairment with concomitant atazanavir or ritonavir-containing regimens and in severe renal impairment (2.6)

DOSAGE FORMS AND STRENGTHS

Tablets: 250 mg and 500 mg (3)

CONTRAINDICATIONS

Hypersensitivity to clarithromycin or any macrolide drug (4.1)
Cisapride, pimozide, lovastatin/simvastatin, ergotamine/dihydroergotamine (4.2, 4.5, 4.6)
History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin (4.3)
Colchicine in renal or hepatic impairment (4.4)

WARNINGS AND PRECAUTIONS

Severe acute hypersensitivity reactions: Discontinue clarithromycin if occurs (5.1)
QT prolongation: Avoid clarithromycin in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia (torsade de pointes), hypokalemia/hypomagnesemia, significant bradycardia, or taking Class IA or III antiarrhythmics (5.2)
Hepatotoxicity: Discontinue if signs and symptoms of hepatitis occur (5.3)
Serious adverse reactions can occur due to drug interactions of clarithromycin with colchicine, some HMG CoA reductase inhibitors, some calcium channel blockers, and other drugs (5.4)
Clostridium difficile associated diarrhea (CDAD): Evaluate if diarrhea occurs (5.5)
Embryofetal toxicity: Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate (5.6)
Exacerbation of myasthenia gravis (5.7)

ADVERSE REACTIONS

Most frequent adverse reactions for both adult and pediatric populations in clinical trials: abdominal pain, diarrhea, nausea, vomiting, dysgeusia (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Co-administration of clarithromycin can alter the concentrations of other drugs. The potential for drug-drug interactions must be considered prior to and during therapy. (4, 5.2, 5.4, 7)

USE IN SPECIFIC POPULATIONS

Geriatric: Increased risk of torsades de pointes(8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 11/2016

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE
1.1 Acute Bacterial Exacerbation of Chronic Bronchitis
1.2 Acute Maxillary Sinusitis
1.3 Community-Acquired Pneumonia
1.4 Pharyngitis/Tonsillitis
1.5 Uncomplicated Skin and Skin Structure Infections
1.6 Acute Otitis Media
1.7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections
1.8 Helicobacter pylori Infection and Duodenal Ulcer Disease
1.9 Limitations of Use
1.10 Usage
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 Adult Dosage
2.3 Combination Dosing Regimens for H. pylori Infection
2.4 Pediatric Dosage
2.5 Dosage Regimens for Mycobacterial Infections
2.6 Dosage Adjustment in Patients with Renal Impairment
2.7 Dosage Adjustment Due to Drug Interactions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Cardiac Arrhythmias
4.3 Cholestatic Jaundice/Hepatic Dysfunction
4.4 Colchicine
4.5 HMG-CoA Reductase Inhibitors
4.6 Ergot Alkaloids
4.7 Contraindications for Co-administered Drugs
5 WARNINGS AND PRECAUTIONS
5.1 Acute Hypersensitivity Reactions
5.2 QT Prolongation
5.3 Hepatotoxicity
5.4 Serious Adverse Reactions Due to Concomitant Use with Other Drugs
5.5 Clostridium difficile Associated Diarrhea
5.6 Embryofetal Toxicity
5.7 Exacerbation of Myasthenia Gravis
5.8 Development of Drug Resistant Bacteria
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal and Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Mycobacterial Infections
14.2 Otitis Media
14.3 H. pylori Eradication to Decrease the Risk of Duodenal Ulcer Recurrence
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE

1.1 Acute Bacterial Exacerbation of Chronic Bronchitis

Clarithromycin tablets, USP 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, USP 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, USP 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, USP 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.

1.5 Uncomplicated Skin and Skin Structure Infections

Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus, or Streptococcus pyogenes.

1.6 Acute Otitis Media

Clarithromycin tablets, USP are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[see Clinical Studies (14.2)] .

1.7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections

Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium or Mycobacterium intracellulare in patients with advanced HIV infection [see Clinical Studies (14.1)] .

1.8 Helicobacter pylori Infection and Duodenal Ulcer Disease

Clarithromycin tablet, USP is given in combination with other drugs in adults as described below to eradicate H. pylori. The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.3)] .

Clarithromycin tablets, USP in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori.
Clarithromycin tablets, USP in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. Regimens which contain clarithromycin tablets, USP as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting.

1.9 Limitations of Use

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.