KLACID IV FOR INJECTION 500 MG/VIAL [SIN09119P]

Product Info

KLACID IV FOR INJECTION 500 MG/VIAL

[SIN09119P]

4.1 Therapeutic Indications
Klacid® I.V. is indicated whenever parenteral therapy is required for treatment of sensitive microorganisms in adults 18 years and older in the following conditions:

1. Upper respiratory tract infections

2. Lower respiratory tract infections (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)

3. Skin and soft tissue infections (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. Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localized infections due to Mycobacterium chelonae, Mycobacterium fortuitum, or Mycobacterium kansasii.

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
Intravenous therapy may be given for 2 to 5 days and should be changed to oral clarithromycin therapy when appropriate. Klacid® IV should be administered into one of the larger proximal veins as an IV infusion over 60 minutes using a solution concentration of about 2 mg/ml. Clarithromycin should be given as a bolus or an intramuscular injection.

Adults: The recommended dosage of Klacid® IV in adults 18 years of age or older is 1.0 g daily divided into two 500 mg doses, appropriately diluted as described below.
Pediatric: There are insufficient data to recommend a dosage regimen for use of the Klacid® IV formulation in patients less than 18 years of age (see Pediatric Suspension).
Elderly: As for adults.

Renal Impairment
In patients with renal impairment who have creatinine clearance less than 30 ml/min, the dosage of clarithromycin should be reduced to one half of the normal recommended dose.

Preparation for Use
See section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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)

• 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 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).