KLACID MR TABLET 500 MG [SIN09884P]

Product Info

KLACID MR TABLET 500 MG

[SIN09884P]

4.1 Therapeutic Indications

Klacid® MR is indicated for treatment of infections caused by susceptible organisms. Indications include:

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)

Upper respiratory tract infections for example, sinusitis and pharyngitis.

Klacid® MR is also indicated in skin and soft tissue infections of mild to moderate severity, for example folliculitis, cellulitis and erysipelas (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).

4.2 Posology and method of administration

Dosage and Administration
Adults: The usual recommended dosage of Klacid® MR in adults is one 500mg modified-release tablet daily to be taken with food. In more severe infections, the dosage can be increased to two 500mg modified-release tablets daily. The usual duration of treatment is 7 to 14 days.

Children older than 12 years: As for adults.

Children younger than 12 years: Use Klacid® Paediatric Suspension. The use of Klacid® MR has not been studied in children less than 12 years of age.

Klacid® MR should not be used in patients with renal impairment (creatinine clearance less than 30 mL/min).
Klacid® immediate release tablets may be used in this patient population (see section 4.3).

Do not crush or chew Klacid® MR tablets.

Renal Impairment
Clarithromycin modified release should not be used in patients with significant renal impairment (creatinine clearance less than 30 ml/min), as appropriate clarithromycin dosage reduction is not possible when administering this product. Clarithromycin immediate release tablets may be utilized in this patient population (see section 4.3). Refer the dosing for immediate release formulation.

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).

• As the dose cannot be reduced from 500 mg once-daily, clarithromycin modified release is contraindicated in patients with creatinine clearance less than 30 mL/min. Clarithromycin immediate release tablets may be utilized in this patient population.

• 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).