1 Dosing Considerations Pentamidine Isetionate for Injection BP may be administered intravenously or intramuscularly. e. over a period of 2 to 3 hours). Intramuscular administration should be reserved for patients with adequate muscle mass and for whom a slow intravenous infusion is not practical.
Intramuscular administration is normally not recommended because of poor local tolerance (see 7 WARNINGS AND PRECAUTIONS). Since severe hypotension reactions may occur, patients receiving Pentamidine Isetionate for Injection BP should be in a supine position and blood pressure should be closely monitored during administration of the drug and several times thereafter until blood pressure is stable.
2 Recommended Dose and Dosage Adjustment Adults: The recommended regimen is 4 mg/kg once a day for 14 to 21 days. The benefits and risks of therapy for longer than 14 doses are not well defined. Patients with Renal Failure (creatinine clearance < 35 mL/min): Life-threatening infections: 4 mg/kg once daily for 7 to 10 days, followed by 4 mg/kg on alternate days to complete the course of 14 doses.
Less severe infections: 4 mg/kg on alternate days for 14 doses.
Children:
Clinical and pharmacokinetic data are extremely limited and further investigation is necessary to fully characterize the pharmacokinetics of pentamidine isetionate in this age group. However, a dosage of 4 mg/kg has been used in children.
Pentamidine Isetionate for Injection BP should be considered only if there is no other appropriate treatment. 3 Reconstitution Parenteral Products: Preparation for Use and Reconstitution For Intravenous Infusion: RECONSTITUTE ONLY WITH STERILE WATER FOR INJECTION.
9% sodium chloride injection. The reconstituted solution should not be mixed with any other injection solution.
For Intramuscular Injection:
Reconstitute as for intravenous injection and do not further dilute. PrPentamidine Isetionate for Injection BP – Product Monograph Page 6 of 21 As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discolouration and leakage prior to administration whenever solution and container permit.
Solutions showing haziness, particulate matter, precipitate, discolouration or leakage should not be used. 4 Administration Intravenous infusion: The reconstituted and further diluted solution should be administered over a period of at least 60 minutes and preferably over a period of 2 to 3 hours.
Intramuscular injection:
The appropriate volume of reconstituted solution should be administered well within the body of a relatively large muscle mass. 5 OVERDOSAGE There are apparently no reports of acute toxicity associated with overdosage of pentamidine isetionate.
In general, overdosage would be expected to produce effects that are an extension of common adverse effects or of the serious metabolic sequelae observed. In case of suspected overdosage, treatment should be symptomatic and supportive.
Neither peritoneal dialysis nor hemodialysis appear to remove the drug rapidly enough to cause a precipitous decline in the plasma concentration of pentamidine isetionate. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table – Dosage Forms, Strengths, Composition and Packaging Pentamidine Isetionate for Injection BP is supplied as a sterile lyophilized powder or plug in vials containing 300 mg of pentamidine isetionate; cartons of 5 single-use vials.
Contains no preservative. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Pentamidine Isetionate for Injection BP should only be administered under close medical supervision, and the patient should be very carefully monitored for the development of serious adverse reactions (see 8 ADVERSE REACTIONS).
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous Intramuscular Lyophilized powder for solution 300 mg per vial The formulation does not contain any non- medicinal ingredients. PrPentamidine Isetionate for Injection BP – Product Monograph Page 7 of 21 The administration of Pentamidine Isetionate for Injection BP should be limited to patients in whom Pneumocystis jirovecii infection has been confirmed.
Some patients may become nauseated or develop fever after taking each dose of Pentamidine Isetionate for Injection BP. In such cases, the prophylactic use of an antiemetic and/or acetaminophen may be considered. Cardiovascular Patients may develop sudden, severe hypotension after receiving a single intramuscular or intravenous dose of pentamidine isetionate.
Therefore, patients receiving Pentamidine Isetionate for Injection BP should be in a supine position and the blood pressure monitored closely during administration of the drug and several times thereafter until the blood pressure is stable.
Equipment for emergency resuscitation should be readily available. Pentamidine Isetionate for Injection BP should be infused over a period of at least 60 minutes and preferably over 2 to 3 hours to minimize the risk of hypotension. Severe hypotension with accompanying bradycardia has been observed in a patient after the sixth dose of pentamidine isetionate.
This hypotension did not respond to intravenous colloids, graded compression stockings or […]