PENTACARINAT Powder for reconstitution Ref.[9290] Active ingredients: Pentamidine

All indications can be treated by deep intramuscular injection or intravenous injection.

Pentamidine powder is reconstituted before use with Water for Injections. For intravenous use the required dose of pentamidine isetionate is diluted further in 50-250ml of glucose intravenous infusion or 0.9% (normal) Sodium Chloride Injection.

The following dosage regimens are recommended for adults, children and infants.

Treatment

Pneumocystis carinii pneumonia

The preferred route of administration is by slow IV infusion, 4 mg/kg bodyweight of pentamidine isetionate once daily for at least 14 days. The IM route is not recommended for the treatment of PCP.

Leishmaniasis

Cutaneous: 4 mg/kg bodyweight, every other day for 3 doses by IM or IV injection.

Trypanosomiasis

4mg/kg bodyweight of pentamidine isetionate per day for 7 days. The preferred route is by deep IM injection. Otherwise slow IV infusion over 60-120 minutes may be used.

Prevention

In the prophylaxis of P. carinii pneumonia, administration is by the inhalation route; the adult dosage is 300 mg every 4 weeks or 150mg every 2 weeks.

Dissolve the contents of one pentacarinat vial (300 mg pentamidine isetionate) in 4-6 ml water for injections and the resultant solution should be administered by a suitable nebuliser.

Elderly

There are no specific dosage recommendations for the elderly.

Renal impairment

In renal failure the following recommendations are made for a creatinine clearance of less than 10ml/min.:

Pneumocystis carinii pneumonia: In life threatening cases, 4 mg/kg bodyweight once daily for 7 to 10 days, then 4 mg/kg bodyweight on alternate days, to complete the course of at least 14 doses. In less severe cases, 4 mg/kg bodyweight on alternate days, to complete the course of at least 14 doses.

Leishmaniasis: No dosage reductions are necessary.

Trypanosomiasis: No dosage reductions are necessary.

Hepatic impairment: No specific dosage recommendations.

Treatment is symptomatic. Cardiac rhythm disorders, including Torsades de Pointes, have been reported following overdose of pentamidine isetionate.

Shelf life: 5 years when unopened. After reconstitution 24 hours.

Store the dry product below 30°C.

Store the reconstituted product (for intravenous infusion) at 2-8°C. Use within 24 hours.

Cardboard carton containing 5 × 10 ml glass vials each with rubber bung and aluminium ring. Each vial contains 300 mg Pentamidine Isetionate BP.

This product should be reconstituted in a fume cupboard. Store the dry product below 30°C. Store dilute reconstituted drug solutions between 2-8°C, and discard all unused portions within 24 hours of preparation. Concentrated solutions for administration by the inhalation or intramuscular routes should be used immediately.

After reconstitution with Water for Injections, pentacarinat should not be mixed with any injection solutions other than Glucose Intravenous Infusion 5% and 0.9% (normal) Sodium Chloride Injection.

The optimal particle size for alveolar deposition is between 1 and 2 microns.

The freshly prepared solution should be administered by inhalation using a suitable nebuliser such as a Respirgard II (trade mark of Marquest Medical Products Inc.), Modified Acorn system 22 (trade mark of Medic-Aid) or an equivalent device with either a compressor or piped oxygen at a flow rate of 6 to 10 Litres/Minute.

The nebuliser should be used in a vacated, well ventilated room. Only staff wearing adequate protective clothing (mask, goggles, gloves) should be in the room when nebulisers are being used.

A suitable well fitted one-way system should be employed such that the nebuliser stores the aerosolised drug during exhalations and disperses exhaled pentamidine into a reservoir. A filter should be fitted to the exhaust line to reduce atmospheric pollution. It is advisable to use a suitable exhaust tube which vents directly through a window to the external atmosphere. Care should be taken to ensure that passers-by will not be exposed to the exhaust.

All bystanders including medical personnel, women of child bearing potential, pregnant women, children, and people with a history of asthma, should avoid exposure to atmospheric pentamidine resulting from nebuliser usage.

Dosage equivalence: 4 mG of pentamidine isetionate contains 2.3 mG pentamidine base; 1 mg of pentamidine base is equivalent to 1.74 mG pentamidine isetionate.

Displacement value: 300 mG of pentamidine isetionate displace approximately 0.15 ml of water.

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