Pentam

Pentam 300 (pentamidine isethionate for injection) is indicated for the treatment of pneumonia due to Pneumocystis carinii .

Contraindicated in patients with a history of hypersensitivity to pentamidine isethionate.

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.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. CAUTION : 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. Nephrotoxic events (increased creatinine, impaired renal function, azotemia, and renal failure) are common with the parenteral administration of pentamidine isethionate.

The administration of the drug should, therefore, be limited to the patients in whom Pneumocystis carinii has been demonstrated. The most frequently reported spontaneous adverse events (1 to 30%) reported in clinical trials, regardless of their relation to pentamidine isethionate therapy were as follows (n=424): Cardiovascular: Hypotension 5.0% Gastrointestinal: Anorexia/Nausea 5.9% Hematologic: Anemia Leukopenia Thrombocytopenia 1.2% 10.4% 2.6% Hepatic: Elevated liver function tests 8.7% Metabolic: Hypoglycemia 5.9% Neurologic: Confusion/hallucinations 1.7% Skin: Sterile abscess and/or necrosis, pain, or induration at the site of IM injection Rash 11.1% 3.3% Special Senses: Bad taste 1.7% Urogenital: Azotemia Elevated serum creatinine Elevated blood urea nitrogen Impaired renal function 8.5% 23.6% 6.6% 28.8% Adverse events with a frequency of less than 1% incidence were as follows (No causal relationship to treatment has been established for these adverse events): Body as a whole: Allergic reaction (i.e. urticaria, itching, rash), anaphylaxis, arthralgia, chills, extrapulmonary pneumocystosis, headache, night sweats, and Stevens-Johnson syndrome.