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ETC / RX - Systemic anti-infective agents - Opeclari 250, 500

COMPOSITION:

Clarithromycin: 250 mg, 500 mg.
Per each film coated tablet.


INDICATIONS:

OPECLARI® is indicated for the treatment of following infections caused by susceptible organisms:

  • Combination with other drugs for the eradication of H. pylori in patients with peptic ulcer
  • Lower respiratory tract infections: Community-acquired pneumonia, acute and chronic bronchitis.
  • Upper respiratory tract infections: Pharyngitis, tonsillitis, sinusitis and otitis media.
  • Skin and soft tissue infections.
  • Disseminated mycobacterial infections due toMycobacterium avium, or Mycobacterial intracellular.
  • Prevention of disseminated Mycobacterium aviumcomplex (MAC) disease in patients with advanced HIV infections.

ADMINISTRATION AND DOSAGE:

For oral use. Opeclari may be given without regards to meals.
– Combination with other drugs for the eradication of H. pylori:
Triple therapy: The recommended adult dose is 500 mg Opeclari and 1000 mg amoxicillin, all given twice daily for 10 days. Combination with omeprazole or lansoprazole,
Dual therapy: The recommended adult dose is 500 mg Opeclari three times daily and omeprazole given once daily for 14 days.
– Respiratory tract infections or skin and soft tissue infections:
Adults and children older than 12 years: The usual dose is 250 mg – 500 mg twice daily for 7 – 14 days.
– Mycobacterial infections:
Prophylaxis: The recommended dose of Opeclari for prevention of disseminated Mycobacterium avium disease in adults is 500 mg twice daily.

Treatment: Clarithromycin is recommended the treatment of disseminated infection due to Mycobacterium avium complex. The recommended dose in adults is 500 mg twice daily. Clarithromycin should be used in combination with other antimycobacterial drug.


CONTRAINDICATIONS:

  • In patients with known hypersensitivity to macrolide antibiotic drugs.
  • Concomitant administration of clarithromycin with cisapride, pimozide, terfenadine

WARNINGS AND PRECAUTIONS:

Clarithromycin is principally excreted by the liver and kidney. Clarithromycin may be administered without dosage adjustment to patients with hepatic impairment and normal renal function. However, in the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate.
Pregnancy and lactation: Clarithromycin should not be used during pregnancy and lactation, unless absolutely needed.


SIDE EFFECTS:

Allergy reaction is minor to severe,
Nausea, vomiting, anorexia, diarrhea,
Headache, dizziness, anxiety, insomnia,
Altered liver function tests.
As with other macrolides, QT prolongation, ventricular tachycardia and torsades de pointes have been rarely reported with clarithromycin.


INTERACTIONS:

Elevated cisapride, pimozide and terfenadine levels have been reported in patients receiving either of these drugs and clarithromycin concomitantly. This may result in QT prolongation and cardiac arrhythmia including ventricular tachycardia, ventricular fibrillation and torsades de pointes. Therefore, clarithromycin and either of these drugs are not  used concomitantly. Similar effects have been observed with concomitant administration of astemizole.
As with other macrolide antibiotics, the use of clarithromycin in patients concurrently taking drugs metabolized by the cytochrome P450 system (e.g., carbamazepine, warfarin, ergot alkaloids, triazolam, disopyramide, lovastatin, rifabutin, phenytoin and cyclosporins) may be associated with elevations in serum levels of these other drugs.
The administration of clarithromycin to patients who are receiving theophylline has been associated with an increase in serum theophylline levels. Monitoring of serum theophylline concentrations should be considered for patients receiving theophylline.
The use of clarithromycin in patients receiving warfarin may potentiate the effects of warfarin. Prothrombin time should be carefully monitored in these patients.
Clarithromycin may potentiate the effects of carbamazepine and phenytoin due to inhibition of their metabolism.
Elevated digoxin serum concentrations have been reported in patients receiving clarithromycin and digoxin concomitantly. Monitoring of serum digoxin levels should be considered.
Simultaneous oral administration of clarithromycin and zidovudine to HIV-infected adult patients may result in decreased zidovudine concentration.


PRESENTATION:

Box of 2 blisters x 7 film coated caplets.

Box of 5 blisters x 6 film coated caplets