Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with pentamidine isethionate, both by the I.M. and I.V. routes. Severe hypotension may result after a single dose (see

PRECAUTIONS

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.

General

Pentamidine isethionate should be used with caution in patients with hypertension, hypotension, hypoglycemia, hyperglycemia, hypocalcemia, leukopenia, thrombocytopenia, anemia, and hepatic or renal dysfunction.

Patients may develop sudden, severe hypotension after a single dose of pentamidine isethionate, whether given I.V. or I.M. Therefore, patients receiving the drug should be lying down and the blood pressure should be 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. If pentamidine isethionate is administered I.V., it should be infused over a period of 60 minutes.

Pentamidine isethionate- induced hypoglycemia has been associated with pancreatic islet cell necrosis and inappropriately high plasma insulin concentrations. Hyperglycemia and diabetes mellitus, with or without preceding hypoglycemia, have also occurred, sometimes several months after therapy with pentamidine isethionate. Therefore, blood glucose levels should be monitored daily during therapy with pentamidine isethionate, and several times thereafter.

Laboratory Tests

The following tests should be carried out before, during and after therapy:

a) Daily blood urea nitrogen and serum creatinine determinations.
b) Daily blood glucose determinations.
c) Complete blood count and platelet count .
d) Liver function tests, including bilirubin, alkaline phosphatase, AST (SGOT, and ALT (SGPT).
e) Serum calcium determinations.
f) Electrocardiograms at regular intervals.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted to evaluate the potential of pentamidine isethionate as a carcinogen, mutagen, or cause of impaired fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with pentamidine isethionate. It is also not known whether pentamidine isethionate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pentamidine isethionate should be given to a pregnant woman only if clearly needed.

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