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 ( 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 ) Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tabl …

• Adults : clarithromycin tablets 250 mg or 500 mg every 12 hours for 7 to 14 days H. pylori eradication (in combination with lansoprazole/amoxicillin, omeprazole/amoxicillin, or omeprazole): clarithromycin tablets 500 mg every 8 or 12 hours for 10 to 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 tablets 500 mg every 12 hours; clarithromycin tablets 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 Important Administration Instructions Clarithromycin tablets may be given with or without food
• Adult Dosage The recommended dosages of clarithromycin tablets
• For the treatment of mild to moderate infections
• In adults are listed in Table 1
• Table 1. …

Clarithromycin tablets, USP (white, oval shaped, film-coated tablets) 250 mg: debossed GG C6 on one side and plain on the reverse side 500 mg: debossed GG C9 on one side and plain on the reverse side Tablets: 250 mg and 500 mg ( 3 )

• The safety and effectiveness of clarithromycin tablets have been established
• For the treatment of the following conditions or diseases
• In pediatric patients 6 months and older. Use in these indications is based on clinical trials
• In pediatric patients or adequate and well- controlled studies
• In adults with additional pharmacokinetic and safety data
• In pediatric patients: Pharyngitis/Tonsillitis Community-Acquired Pneumonia Acute maxillary sinusitis Acute otitis media [see Clinical Studies ] Uncomplicated skin and skin structure infections The safety and effectiveness of clarithromycin …

In a steady-state study in which healthy elderly subjects (65 years to 81 years of age) were given 500 mg of clarithromycin tablets every 12 hours, the maximum serum concentrations and area under the curves of clarithromycin and 14-OH clarithromycin were increased compared to those achieved in healthy young adults. These changes in pharmacokinetics parallel known age-related decreases in renal function. …

• Provide the following instructions or information about clarithromycin tablets to patients: Important Administration Instructions Advise patients that clarithromycin tablets can be taken with or without food and can be taken with milk
• Drug Interactions Advise patients that clarithromycin may interact with some drugs; therefore, advise patients to report to their healthcare provider the use of any other medications
• Diarrhea Advise patients that diarrhea is a common problem caused by antibacterials including clarithromycin which usually ends when the antibacterial is discontinued. …

Hypersensitivity to clarithromycin or any macrolide drug ( 4.1 ) Cisapride and pimozide ( 4.2 ) History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin ( 4.3 ) Colchicine in renal or hepatic impairment ( 4.4 ) Lomitapide, lovastatin, and simvastatin ( 4.5 ) Ergot alkaloids (ergotamine or dihydroergotamine) ( 4.6 ) Lurasidone ( 4.7 ) 4.1 Hypersensitivity Clarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or …

Co-administration of clarithromycin tablets 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 tablets 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. …

Severe Acute Hypersensitivity Reactions : Discontinue clarithromycin tablets if occurs ( 5.1 ) QT Prolongation : Avoid clarithromycin tablets 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 ( 5.2 ) Hepatotoxicity : Discontinue if signs and symptoms of hepatitis occur ( 5.3 ) Serious adverse reactions can occur due to drug interactions of clarithromycin tablets with colchicine, some lipid-lowering agents, some calcium channel blockers, and other drugs ( 5.4 ) Risk of all-cause mortality one year or more after …

The following serious adverse reactions are described below and elsewhere in the labeling: Acute Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] QT Prolongation [see Warnings and Precautions ( 5.2 )] Hepatotoxicity [see Warnings and Precautions ( 5.3 )] Serious Adverse Reactions Due to Concomitant Use with Other Drugs [see Warnings and Precautions ( 5.4 )] Clostridium difficile Associated Diarrhea [see Warnings and Precautions ( 5.6 )] Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.8 )] Most frequent adverse reactions for both adult and pediatric populations in clinical trials: abdominal pain, diarrhea, nausea, vomiting, dysgeusia ( 6.1 ) To report SUSP …

8.1 Pregnancy Risk Summary Based on findings from animal studies, clarithromycin tablets are not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If pregnancy occurs while taking clarithromycin tablets, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions ( 5.7 )]. …

Overdosage of clarithromycin tablets can cause gastrointestinal symptoms such as abdominal pain, vomiting, nausea, and diarrhea. Treat adverse reactions accompanying overdosage by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum concentrations are not expected to be appreciably affected by hemodialysis or peritoneal dialysis.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.