Clarithromycin STELLA 500 mg

Rx

Indications:

Treatment of infections due to susceptible organisms. Such infections include:

• Lower respiratory tract infections.
• Upper respiratory tract infections.
• Skin and soft tissue infections.
• Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localized infections due to Mycobacterium chelonae, Mycobacterium fortuitum or Mycobacterium kansasii.
• Prevention of disseminated Mycobacterium avium complex infection in HIV-infected patients with CD4 lymphocyte counts less than or equal to 100/mm³.
• Combination with acid suppression agents for the eradication of H. pylori in patients with recurrence of duodenal ulcer.

Dosage:

Patients with respiratory tract/skin and soft tissue infections.

• Adults: Severe infections: can be increased to 500 mg twice daily. The duration of therapy is 5 – 14 days, excluding treatment of community acquired pneumonia and sinusitis which require 6 – 14 days.
• Mycobacterial infections: The recommended dose for adults is 500 mg b.i.d.
• Treatment of disseminated MAC infections in AIDS patients should be continued, as long as clinical and microbiological benefit is demonstrated. Clarithromycin should be used in conjunction with other antimycobacterial agents.
• Treatment of nontuberculous mycobacterial infections should continue at the discretion of the physician.
• Dosage for MAC prophylaxis: in adults: 500 mg twice daily.

Eradication of Helicobacter pylori: 500 mg twice daily in combination with other appropriate anti-microbial treatments and a proton pump inhibitor for 7 – 14 days.

Triple therapy regimen: 500 mg twice daily in conjunction with amoxicillin 1000 mg twice daily and a proton pump inhibitor in standard dose twice daily for 14 days.

Four- drug regimen: A proton pump inhibitor take twice a day together with amoxicillin 1000 mg twice daily, clarithromycin 500 mg twice daily in conjunction with tinidazole 500 mg or metronidazole 500 mg twice daily for 14 days.

10 days continuous regimen:

• A proton pump inhibitor take twice a day together with amoxicillin 1000 mg twice daily for 5 days continuous.
• A proton pump inhibitor take twice a day together with clarithromycin 500 mg twice daily and tinidazole 500 mg twice daily for 5 days.

Renal impairment: ClCr < 30 ml/min, the dosage should be reduced by one-half. Treatment should not be continued beyond 14 days.

Pediatric: The use of clarithromycin has not been studied in children less than 12 years of age.

Usage:

Clarithromycin STELLA 500 mg is administered orally and may be given without regard to meals.

• Hypersensitivity to macrolide antibiotic drugs or any of its excipients.
• Concomitant administration of clarithromycin and any of the following drugs is contraindicated: astemizole, cisapride, pimozide, terfenadine.
• Concomitant administration of clarithromycin and ergot alkaloids.
• Concomitant administration of clarithromycin and oral midazolam.
• Patients with history of QT prolongation or ventricular cardiac arrhythmia, including torsades de pointes; patients with hypokalaemia (risk of prolongation of QT-time).
• Patients who suffer from severe hepatic failure in combination with renal impairment.
• Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin).
• Clarithromycin (and other strong CYP3A4 inhibitors) should not be used concomitantly with colchicine.
• Concomitant administration with ticagrelor or ranolazine is contraindicated.

The most frequent and common adverse reactions related to clarithromycin therapy are abdominal pain, diarrhea, nausea, vomiting and taste perversion.

• Use of any antimicrobial therapy, such as clarithromycin, to treat H. pylori infection may select for drug-resistant organisms.
• The physician should not prescribe clarithromycin to pregnant and breast-fedding women without carefully weighing the benefits against risk, particularly during the first three months of pregnancy.
• Caution in patients with: impaired hepatic function; severe renal insufficiency; coronary artery disease, severe cardiac insufficiency, conduction disturbances or clinically relevant bradycardia; electrolyte disturbances such as hypomagnesemia.
• Discontinue clarithromycin immediately if occur: signs and symptoms of hepatitis, such as anorexia, jaundice, dark urine, pruritus, or tender abdomen; severe acute hypersensitivity reactions.
• Risk of pseudomembranous colitis; Clostridium difficile associated diarrhea (CDAD) (mild diarrhea to fatal colitis).
• Caution is advised regarding concomitant administration of clarithromycin and triazolobenzodiazepines, such as triazolam, and intravenous midazolam; medications that induce the cytochrome CYP3A4 enzyme; oral hypoglycemic agents (such as sulphonylurias) and/or insulin; oral anticoagulants.
• Clarithromycin must not be used in patients with congenital or documented acquired QT prolongation or history of ventricular arrhythmia.
• In hospital-acquired pneumonia, clarithromycin should be used in combination with additional appropriate antibiotics.
• The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should be taken into account before patients drive or use machines.