KLACID FORTE TABLET 500 MG [SIN09193P]

Product Info

KLACID FORTE TABLET 500 MG

[SIN09193P]

4.1 Therapeutic Indications
Klacid® is indicated for treatment of infections caused by one or more susceptible organisms in adults and children 12 years and older. Indications include:

1. Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia (see section 4.4 and 5.1 regarding Sensitivity Testing – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

2. Upper respiratory tract infections for example, sinusitis and pharyngitis.

3. Klacid® is appropriate for initial therapy in community acquired respiratory infections and has been shown to be active in vitro against common and atypical respiratory pathogens as listed in the microbiology section.

4. Klacid® is also indicated in skin and soft tissue infections of mild to moderate severity (see section 4.4 and 5.1 regarding Sensitivity Testing – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

5. Klacid® in the presence of acid suppression effected by omeprazole is also indicated for the eradication of H. pylori in patients with proven duodenal ulcers. See Dosage and Administration section.

Consideration should be given to national official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Dosage and Administration

Respiratory tract/skin and soft tissue infections
Adults: The usual dose in adults and children 12 years of age or older, is 250 mg twice daily for 7 days although this may be increased to 500 mg twice daily for up to 14 days in severe infections.

Children older than 12 years: As for adults.
Children younger than 12 years: Use Klacid® Paediatric Suspension. The use of Klacid® IR has not been studied in children less than 12 years of age.

Eradication of H. pylori (Adults)
Triple Therapy Regimen
Clarithromycin 500 mg twice daily in conjunction with amoxicillin 1000 mg twice daily and a proton pump inhibitor in standard dose twice daily for seven days.
Dual Therapy Regimen
Clarithromycin 500 mg three times daily in conjunction with omeprazole 40 mg once daily for 14 days, followed by omeprazole 40 mg once daily for an additional 14 days. Supportive studies have been conducted with omeprazole 40 mg once daily for 14 days.

Elderly: As for adults.

Renal Impairment: In patients with renal impairment with creatinine clearance less than 30ml/min, the dosage of clarithromycin should be reduced by one-half, i.e., 250mg once daily or 250mg twice daily in more severe infections. Treatment should not be continued beyond 14 days in these patients.

Klacid® may be given without regard to meals as food does not affect the extent of bioavailability.

4.3. Contraindications

• Hypersensitivity to macrolide antibiotic drugs or any of its excipients (see section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Concomitant administration of clarithromycin and any of the following drugs is contraindicated: astemizole, cisapride, pimozide, terfenadine as this may result in QT prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, and torsades de pointes (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Concomitant administration of clarithromycin and ergot alkaloids (e.g., ergotamine or dihydroergotamine) is contraindicated, as this may result in ergot toxicity (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Concomitant administration of clarithromycin and oral midazolam is contraindicated (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Clarithromycin should not be given to patients with history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including torsades de pointes (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Clarithromycin should not be given to patients with electrolyte disturbances (hypokalemia or hypomagnesaemia, due to the risk of prolongation of the QT-interval).

• Clarithromycin should not be used in 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), due to the increased risk of myopathy, including rhabdomyolysis (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Clarithromycin (and other strong CYP3A4 inhibitors) should not be used concomitantly with colchicine (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Concomitant administration with ticagrelor, ivabradine or ranolazine is contraindicated.

• Concomitant administration of clarithromycin and lomitapide is contraindicated (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).