pentamidine isethionate

FDA Drug Profile — pentamidine isethionate

Drug Details

Generic Name
pentamidine isethionate
Brand Names
pentamidine isethionate
Application Number
ANDA213806
Sponsor
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR, INTRAVENOUS
Active Ingredients
PENTAMIDINE ISETHIONATE

Indications and Usage

INDICATIONS AND USAGE Pentamidine isethionate for injection is indicated for the treatment of pneumonia due to Pneumocystis carinii.

Warnings

WARNINGS Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with pentamidine isethionate, both by the IM and IV routes. Severe hypotension may result after a single IM or IV dose and is more likely with rapid IV administration (see PRECAUTIONS ). The administration of the drug should, therefore, be limited to the patients in whom Pneumocystis carinii has been demonstrated. Patients should be closely monitored for the development of serious adverse reactions (see PRECAUTIONS and ADVERSE REACTIONS ). Extravasations have been reported which, in some instances, proceeded to ulceration, tissue necrosis and/or sloughing at the injection site. While not common, surgical debridement and skin grafting has been necessary in some of these cases; long-term sequelae have been reported. Prevention is the most effective means of limiting the severity of extravasation. The intravenous needle or catheter must be properly positioned and closely observed throughout the period of pentamidine isethionate administration. If extravasation occurs, the injection should be discontinued immediately and restarted in another vein. Because there are no known local treatment measures which have proven to be useful, management of the extravasation should be symptomatic.