Clarithromycin

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. Acute Maxillary Sinusitis. Community-Acquired Pneumonia. Pharyngitis/Tonsillitis. Uncomplicated Skin and Skin Structure Infections. Acute Otitis Media in Pediatric Patients. Treatment and Prophylaxis of Disseminated Mycobacterial Infections. Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults. Limitations of Use 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.

Clarithromycin is a macrolide antimicrobial drug.

Adults: clarithromycin 250 mg or 500 mg every 12 hours for 7–14 days. Adults: 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. Pediatric Patients: clarithromycin 15 mg/kg/day divided every 12 hours for 10 days. Mycobacterial Infections: clarithromycin 500 mg every 12 hours, clarithromycin 7.5 mg/kg up to 500 mg every 12 hours in pediatric patients. Reduce dose in moderate renal impairment with concomitant atazanavir or ritonavir-containing regimens and in severe renal impairment

Hypersensitivity to clarithromycin or any macrolide drug. Cisapride and pimozide. History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin. Colchicine in renal or hepatic impairment. Lomitapide, lovastatin, and simvastatin. Ergot alkaloids (ergotamine or dihydroergotamine). Lurasidone

Severe Acute Hypersensitivity Reactions: Discontinue clarithromycin if occurs. QT Prolongation: Avoid clarithromycin in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia ( torsades de pointes ), hypokalemia/hypomagnesemia, significant bradycardia, or taking Class IA or III antiarrhythmics. Hepatotoxicity: Discontinue if signs and symptoms of hepatitis occur. Serious adverse reactions can occur due to drug interactions of clarithromycin with colchicine, some lipid-lowering agents, some calcium channel blockers, and other drugs. Risk of all-cause mortality one year or more after the end of treatment in patients with coronary artery disease. Balance this potential risk with the treatment benefits when prescribing clarithromycin tablets in these patients.

The following serious adverse reactions are described below and elsewhere in the labeling: Acute Hypersensitivity Reactions QT Prolongation Hepatotoxicity Serious Adverse Reactions Due to Concomitant Use with Other Drugs Clostridium difficile Associated Diarrhea Exacerbation of Myasthenia Gravis Most frequent adverse reactions for both adult and pediatric populations in clinical trials: abdominal pain, diarrhea, nausea, vomiting, dysgeusia

Co-administration of clarithromycin 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. Clarithromycin should be used with caution in patients receiving treatment with other drugs known to be CYP3A enzyme substrates, especially if the CYP3A substrate has a narrow safety margin (e.g., carbamazepine) and/or the substrate is extensively metabolized by this enzyme. Adjust dosage when appropriate and monitor serum concentrations of drugs primarily metabolized by CYP3A closely in patients concurrently receiving clarithromycin.

Store clarithromycin tablets, USP at controlled room temperature 20° to 25°C (68° to 77°F) in a well-closed container.