CLARITHROMYCIN Powder for concentrate for solution for infusion Ref.[6722] Active ingredients: Clarithromycin

Posology

Intravenous therapy may be given for 2 to 5 days in the very ill patient and should be changed to oral clarithromycin therapy whenever possible as determined by the physician. The total duration of treatment with clarithromycin should not extend 14 days.

Adults

The recommended dosage of Clarithromycin 500 mg powder for concentrate for solution for infusion is 1.0 gram daily, divided into two 500 mg doses, appropriately diluted as described below.

Paediatric population

Children older than 12 years

As for adults.

Children under 12 years

Use of Clarithromycin 500 mg powder for concentrate for solution for infusion is not recommended for children younger than 12 years.

Clinical trials have been conducted using clarithromycin pediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin pediatric suspension (granules for oral suspension). There are insufficient data to recommend a dosage regimen for use of the clarithromycin IV formulation in patients less than 18 years of age.

Special populations

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.

Method of administration

For intravenous administration only.

For instructions on reconstitution/dilution of the medicinal product before administration, see section 6.6.

Reports indicate that the ingestion of large amounts of clarithromycin orally can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalaemia and hypoxaemia.

Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.

In the case of overdosage, treatment should be discontinued and all other appropriate supportive measures should be instituted.

Shelf life

Unopened: 3 years.

Reconstituted and diluted solution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C/48 hours at 2-8°C for the reconstituted solution.

Chemical and physical in-use stability has been demonstrated 6 hours at 25°C/48 hours at 2-8°C for the final infusion solution.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

This medicinal product does not require any special storage conditions.

For storage conditions after reconstitution/dilution of the medicinal product, see section 6.3.

Uncoloured clear glass vial type I (15 ml), sealed with brombutyl rubber stopper and aluminium cap with plastic flip-off seal.

The following pack sizes are available for Clarithromycin 500 mg powder for concentrate for solution for infusion:

1, 5 or 10 vial(s) containing 500 mg of clarithromycin.

Not all pack sizes may be marketed.

Reconstitution

Clarithromycin 500 mg powder for concentrate for solution for infusion is reconstituted with 10 ml of water for injections, a solution with a concentration of 50 mg/ml is obtained.

Dilution

The reconstituted solution is further diluted to 250 ml with a suitable intravenous diluent prior to infusion: 0.9% Sodium chloride, 5% Dextrose, 5% Dextrose in 0.3% Sodium chloride,

5% Dextrose in 0.45% Sodium chloride, 5% Dextrose in Ringer’s lactate solution and Ringer’s lactate solution.

The concentration of Clarithromycin for the final solution for infusion is 2 mg/ml.

Clarithromycin 500 mg powder for concentrate for solution for infusion 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 not be given as a bolus or an intramuscular injection.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.