"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
The potential for development of acute PJP still exists in patients receiving NebuPent (pentamidine isethionate) prophylaxis. Therefore, any patient with symptoms suggestive of the presence of a pulmonary infection, including but not limited to dyspnea, fever or cough, should receive a thorough medical evaluation and appropriate diagnostic tests for possible acute PJP as well as for other opportunistic and nonopportunistic pathogens. The use of NebuPent (pentamidine isethionate) may alter the clinical and radiographic features of PJP and could result in an atypical presentation, including but not limited to mild disease or focal infection.
Prior to initiating NebuPent (pentamidine isethionate) prophylaxis, symptomatic patients should be evaluated appropriately to exclude the presence of PJP. The recommended dose of NebuPent (pentamidine isethionate) for the prevention of PJP is insufficient to treat acute PJP.
IMPORTANT: DO NOT MIX THE NEBUPENT (pentamidine isethionate) SOLUTION WITH ANY OTHER DRUGS. DO NOT USE THE RESPIRGARD® II NEBULIZER TO ADMINISTER A BRONCHODILATOR. (See DOSAGE AND ADMINISTRATION).
Inhalation of NebuPent (pentamidine isethionate) may induce bronchospasm or cough. This has been noted particularly in some patients who have a history of smoking or asthma. In clinical trials, cough and bronchospasm were the most frequently reported adverse experiences associated with NebuPent (pentamidine isethionate) administration (38% and 15%, respectively of patients receiving the 300 mg dose); however less than 1% of the doses were interrupted or terminated due to these effects. For the majority of patients, cough and bronchospasm were controlled by administration of an aerosolized bronchodilator (only 1% of patients withdrew from the study due to treatmentassociated cough or bronchospasm). In patients who experience bronchospasm or cough, administration of an inhaled bronchodilator prior to giving each NebuPent (pentamidine isethionate) dose may minimize recurrence of the symptoms.
The extent and consequence of pentamidine accumulation following chronic inhalation therapy are not known. As a result, patients receiving NebuPent (pentamidine isethionate) should be closely monitored for the development of serious adverse reactions that have occurred in patients receiving parenteral pentamidine, including hypotension, hypoglycemia, hyperglycemia, hypocalcemia, anemia, thrombocytopenia, leukopenia, hepatic or renal dysfunction, ventricular tachycardia, pancreatitis, Stevens-Johnson syndrome, hyperkalemia and abnormal ST segment of ECG.
Extrapulmonary infection with P. jiroveci has been reported infrequently. Most, but not all, of the cases have been reported in patients who have a history of PJP. The presence of extrapulmonary pneumocystosis should be considered when evaluating patients with unexplained signs and symptoms.
Cases of acute pancreatitis have been reported in patients receiving aerosolized pentamidine. NebuPent (pentamidine isethionate) should be discontinued if signs or symptoms of acute pancreatitis develop.
Carcinogenesis, Mutagenesis and Impairment of Fertility
Literature reports indicate that pentamidine was not mutagenic in the Ames bacterial (S. typhimurium) test and did not induce an increase in chromosomal aberrations in Chinese Hamster Ovary (CHO) cell or in human lymphocytes in vitro . No studies have been conducted to determine effects of pentamidine isethionate on carcinogenicity or fertility.
Pregnancy–Pregnancy Category C
There are no adequate and well controlled studies of NebuPent (pentamidine isethionate) in pregnant women. A literature report indicated that intravenously administered pentamidine in pregnant rats at 4 mg/kg/day was embryolethal; teratogenicity was not observed in this study. It is unknown whether pentamidine administered via the aerosolized route crosses the placenta at clinically significant concentrations. It is not known whether NebuPent (pentamidine isethionate) can cause fetal harm when administered to a pregnant woman. NebuPent (pentamidine isethionate) should be given to a pregnant woman only if clearly needed.
It is not known whether NebuPent (pentamidine isethionate) is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from NebuPent (pentamidine isethionate) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Because many drugs are excreted in human milk, NebuPent (pentamidine isethionate) should not be given to a nursing mother unless the potential benefits are judged to outweigh the unknown risks.
The safety and effectiveness of NebuPent (pentamidine isethionate) in pediatric patients (birth to 16 years of age) have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/4/2011
Additional Nebupent Information
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