DBL PENTAMIDINE ISETHIONATE FOR INJECTION BP 300 MG/VIAL [SIN06766P]

Product Info

DBL PENTAMIDINE ISETHIONATE FOR INJECTION BP 300 MG/VIAL

[SIN06766P]

4.1 Therapeutic indications

Pentamidine isethionate is indicated for intravenous administration in the treatment of the following conditions:

1. As an alternative first line treatment for Pneumocystis carinii infection in AIDS patients;

2. As second line treatment for Pneumocystis carinii infection in non-AIDS patients;

3. As second line treatment of Leishmaniasis (visceral and cutaneous), except Leishmania aethiopica where it may be used as first line therapy;

4. As second line treatment for Trypanosomiasis (except for the Trypanosomiasis rhodesiense strain due to lack of efficacy).

4.2 Dose and method of administration

Dosage

The following dosage regimens are recommended.

P. carinii pneumonia

4 mg/kg bodyweight Pentamidine Isethionate once daily for 14 days, preferably by slow intravenous infusion.

Leishmaniasis

On the basis of current knowledge the following dosage are suggested however the optimal treatment regimen has yet to be established.

• Visceral (Kala-azar): 3 to 4 mg/kg bodyweight Pentamidine Isethionate on alternate days (3 times a week) to a maximum of 10 injections.

• Cutaneous: 3 to 4 mg/kg bodyweight Pentamidine Isethionate once or twice weekly, until the condition resolves.

Trypanosomiasis

Haemolymphete stage only.

4 mg/kg bodyweight Pentamidine Isethionate daily or on alternate days to a total of 7 to 10 injections.

Dosage adjustment

Renal impairment

Creatinine clearance <35 mL/min: There is little information on the kinetics or the adverse effects profile of pentamidine in patients with impaired renal function.

Hepatic impairment

No information available.

Method of administration

DBL™ Pentamidine Isethionate for Injection should be given as a slow intravenous infusion with a patient in a supine position in order to reduce the incidence of sudden severe hypotension. Direct bolus intravenous injection or rapid administration must not be used.

Reconstitution

The contents of a 300 mg vial should be dissolved in 3 mL to 5 mL of Water for Injections. The required dose of Pentamidine Isethionate should then be diluted further in 50 to 250 mL of Glucose Intravenous Infusion 5% or Sodium Chloride Intravenous Infusion 0.9%. The reconstituted solutions should be visually examined before use. Any solutions which are hazy, discoloured or contain visible particulate matter should not be used. Diluted solutions containing Pentamidine Isethionate should be infused over a period of at least 60 minutes under close medical supervision, whilst the patient is kept lying down.

Compatibilities

Reconstituted solutions at concentrations of 100 mg/mL and 60 mg/mL are chemically stable for 48 hours when stored at 2 to 8°C and room temperature under fluorescent light. DBL™ Pentamidine Isethionate for Injection when reconstituted with Water for Injections and diluted to 1.0 mg/mL and 2.5 mg/mL in Sodium Chloride Intravenous Infusion 0.9% and Glucose Intravenous Infusion 5% retained its potency for at least 48 hours when stored under fluorescent light at 21 ± 2°C. However, to avoid microbial contamination, the prepared solution should be used within 24 hours.

4.3 Contraindications

Patients with a known hypersensitivity to pentamidine.

Pentamidine should not be administered to patients who are pregnant or breastfeeding unless considered essential by the physician.