BIAXIN Filmtab (clarithromycin tablets, USP) and BIAXIN Granules (clarithromycin for oral suspension, USP) are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below:

Acute Bacterial Exacerbation of Chronic Bronchitis: (Adult Patients)

• BIAXIN (Filmtab, Granules) and BIAXIN XL Filmtab 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.

Acute Maxillary Sinusitis: (Adult Patients if using BIAXIN XL)

• BIAXIN (Filmtab, Granules) and BIAXIN XL Filmtab (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.

Community-Acquired Pneumonia: (Pediatric Patients and Adult Patients if using BIAXIN XL)

• BIAXIN (Filmtab, Granules) and BIAXIN XL Filmtab are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to:

• Haemophilus influenzae (in adults)
• Haemophilus parainfluenzae (BIAXIN XL Filmtab in adults)
• Moraxella catarrhalis (BIAXIN XL Filmtab in adults)
• Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae (BIAXIN XL Filmtab in adults); BIAXIN Filmtab and BIAXIN Granules (in adult and pediatric patients)

Pharyngitis/Tonsillitis: (Pediatric Patients and Adult Patients)

• BIAXIN Filmtab and BIAXIN Granules 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.

Uncomplicated Skin and Skin Structure Infections: (Pediatric Patients and Adult Patients)

• BIAXIN Filmtab and BIAXIN Granules are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus, or Streptococcus pyogenes.

Acute Otitis Media: (Pediatric Patients)

• BIAXIN Filmtab and BIAXIN Granules 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.

Treatment and Prophylaxis of Disseminated Mycobacterial Infections: 

• BIAXIN Filmtab and BIAXIN Granules 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.

Helicobacter pylori Infection and Duodenal Ulcer Disease: (Adult Patients)

• BIAXIN Filmtab 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.

• BIAXIN Filmtab 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.
• BIAXIN Filmtab 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 BIAXIN Filmtab 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.

BIAXIN XL Filmtab is indicated only for acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia in adults. The efficacy and safety of BIAXIN XL Filmtab in treating other infections for which BIAXIN Filmtab and BIAXIN 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.

Safety and effectiveness of BIAXIN in pediatric patients under 6 months of age have not been established. The safety of BIAXIN has not been studied in MAC patients under the age of 20 months.

In patients with severe renal impairment (CLcr of <30 mL/min) Reduce the dosage of BIAXIN by 50%. In patients with moderate renal impairment (CLcr of 30 to 60 mL/min) taking concomitant atazanavir or ritonavir-containing regimens reduce the dosage of BIAXIN by 50%. In patients with severe renal impairment (CLcr of <30 mL/min) taking concomitant atazanavir or ritonavir-containing regimens reduce the dosage of BIAXIN by 75%.

In one clinical trial evaluating treatment with clarithromycin on outcomes in patients with coronary artery disease, an increase in risk of all-cause mortality one year or more after the end of treatment was observed in patients randomized to receive clarithromycin. Clarithromycin for treatment of coronary artery disease is not an approved indication. The cause of the increased risk has not been established.

FDA recommends caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. Because of the increased risk of death in patients with heart disease prescribers are advised to consider using other antibiotics in such patients.

BIAXIN 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 BIAXIN. Fatalities have been reported. Avoid BIAXIN 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
• patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or
• hypomagnesemia, clinically significant bradycardia and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents

Elderly patients may be more susceptible to drug-associated effects on the QT interval.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including BIAXIN, and may range in severity from mild diarrhea to fatal colitis.Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome has been reported in patients receiving BIAXIN therapy.

Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been reported with clarithromycin. This hepatic dysfunction may be severe and is usually reversible. In some instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications.

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

Concomitant administration of clarithromycin and any of the following drugs is contraindicated: cisapride, pimozide, astemizole, terfenadine, lovastatin, simvastatin, atorvastatin, pravastatin, fluvastatin, clarithromycin, ergotamine or dihydroergotamine.

Decrease the dose of BIAXIN by 50% when co-administered with atazanavir.

Serious adverse reactions have been reported in patients taking BIAXIN concomitantly with CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; hypoglycemia and cardiac arrhythmias (e.g., torsades de pointes) with disopyramide; hypotension and acute kidney injury with calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem, nifedipine). Most reports of acute kidney injury with calcium channel blockers metabolized by CYP3A4 involved elderly patients 65 years of age or older.

Use BIAXIN with caution when administered concurrently with medications that induce the cytochrome CYP3A4 enzyme. The use of BIAXIN with simvastatin, lovastatin, ergotamine, or dihydroergotamine is contraindicated.

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

Do not use BIAXIN concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis.

Exercise caution when prescribing BIAXIN with atorvastatin or pravastatin. In situations where the concomitant use of BIAXIN with atorvastatin or pravastatin cannot be avoided, atorvastatin dose should not exceed 20 mg daily and pravastatin dose should not exceed 40 mg daily. Use of a statin that is not dependent on CYP3A metabolism (e.g. fluvastatin) can be considered. It is recommended to prescribe the lowest registered dose if concomitant use cannot be avoided.

The concomitant use of BIAXIN and oral hypoglycemic agents and/or insulin can result in significant hypoglycemia. With certain hypoglycemic drugs such as nateglinide, pioglitazone, repaglinide and rosiglitazone, inhibition of CYP3A enzyme by clarithromycin may be involved and could cause hypoglycemia when used concomitantly.

Use quetiapine and clarithromycin concomitantly with caution. Co-administration could result in increased quetiapine exposure and quetiapine related toxicities such as somnolence, orthostatic hypotension, altered state of consciousness, neuroleptic malignant syndrome, and QT prolongation.

Increased sedation and prolongation of sedation have been reported with concomitant administration of BIAXIN and triazolobenzodiazepines, such as triazolam and midazolam.

Co-administration of BIAXIN is known to inhibit CYP3A, and a drug primarily metabolized by CYP3A may be associated with elevations in drug concentrations that could increase or prolong both therapeutic and adverse effects of the concomitant drug.

There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with alfentanil, methylprednisolone, cilostazol, bromocriptine, vinblastine, phenobarbital, and St. John’s Wort.

Co-administration of clarithromycin with sildenafil, tadalafil, or vardenafil will result in increased exposure of these phosphodiesterase inhibitors. Co-administration of these phosphodiesterase inhibitors with clarithromycin is not recommended.

Clarithromycin may increase the plasma concentrations of itraconazole.

Clarithromycin may result in increases in maraviroc exposures by inhibition of CYP3A metabolism.

Hypotension and peripheral edema were observed when clarithromycin was taken concomitantly with nifedipine.

There is a risk of serious hemorrhage and significant elevations in INR and prothrombin time when BIAXIN is co-administered with warfarin.

Elevated digoxin serum concentrations in patients receiving clarithromycin and digoxin concomitantly.

Concomitant administration of single doses of clarithromycin and carbamazepine has been shown to result in increased plasma concentrations of carbamazepine.

Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent verapamil.

Clarithromycin use in patients who are receiving theophylline may be associated with an increase of serum theophylline concentrations.

Concomitant administration of rifabutin and clarithromycin resulted in an increase in rifabutin, and decrease in clarithromycin serum levels together with an increased risk of uveitis.

Clarithromycin concentrations in the gastric tissue and mucus were also increased by concomitant administration of omeprazole.

Administration of clarithromycin and zidovudine should be separated by at least two hours.

Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If BIAXIN is used during pregnancy, or if pregnancy occurs while the patient is taking this drug, the patient should be apprised of the potential hazard to the fetus.

Caution should be exercised when BIAXIN is administered to nursing women. Clarithromycin and its active metabolite 14-hydroxy clarithromycin are excreted in human milk.

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• Adjunct to nonsurgical periodontal therapy for chronic periodontitis. GoToSource

• Use with tanshinone for rhinosinusal and laryngeal radiation injury induced by radiotherapy in nasopharyngeal carcinoma patients. GoToSource

• Follicular B-cell lymphoma. GoToSource 

• Asthma as add-on therapy in children with acute asthma. GoToSource

• Hansen’s disease (leprosy). GoToSource

• Nail discoloration. GoToSource 

Acute psychotic episodes. GoToSource

Fulminant hepatitis (liver failure). GoToSource

Sepsis. GoToSource

Rhabdomyolysis (breakdown of muscle fibers). GoToSource

Long QT prolongation syndrome. GoToSource

Erythroderma (inflammatory skin disease). GoToSource

Aggravation of myasthenia gravis (neuromuscular disease causing weakness in skeletal muscle). GoToSource

Hypersensitivity reactions (including anaphylaxis, fixed drug eruptions, toxic epidermal necrolysis and leukocytoclastic vasculitis). GoToSource

Clostridium difficile-associated diarrhea. GoToSource

Significant hypotension and shock occurring when macrolide antibiotics (such as clarithromycin) are administered with calcium-channel blockers. GoToSource

Cardiac death. GoToSource 

Sensorineural hearing loss. GoToSource 

Smell and taste disorders. GoToSource

Increased risk of kidney injury and death when used with statins. GoToSource

Lawsuits filed for heart attacks, liver failure and strokes.