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 twice a day.
• 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
  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.

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.

Most frequent

• Abdominal pain,
• Diarrhea,
• Nausea,
• Vomitting,
• Taste perversion.

Common

• Insomnia,
• Dysgeusia, headache,
• Diarrhea, vomiting, dyspepsia, nausea, abdominal pain,
• Liver function test abnormal,
• Rash, hyperhidrosis.

• 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.