화이자펜타미딘이세티온산염주300mg

Pentamidine Isethionate is indicated for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined by one or both of the following criteria: i. a history of one or more episodes of PJP ii. a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm 3 . These indications are based on the results of an 18-month randomized, dose-response trial in high risk HIV-infected patients and on existing epidemiological data from natural history studies. The patient population of the controlled trial consisted of 408 patients, 237 of whom had a history of one or more episodes of PJP. The remaining patients without a history of PJP included 55 patients with Kaposi’s sarcoma and 116 patients with other AIDS diagnoses, ARC or asymptomatic HIV infection. Patients were randomly assigned to receive Pentamidine Isethionate via the Respirgard® II nebulizer at one of the following three doses: 30 mg every two weeks (n=135), 150 mg every two weeks (n=134) or 300 mg every four weeks (n=139). The results of the trial demonstrated a significant protective effect (p<0.01) against PJP with the 300 mg every four week dosage regimen compared to the 30 mg every two week dosage regimen. The 300 mg dose regimen reduced the risk of developing PJP by 50 to 70% compared to the 30 mg regimen. A total of 293 patients (72% of all patients) also received zidovudine at some time during the trial. The analysis of the data demonstrated the efficacy of …

Pentamidine Isethionate is contraindicated in patients with a history of an anaphylactic reaction to inhaled or parenteral pentamidine isethionate.

The potential for development of acute PJP still exists in patients receiving 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 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 Pentamidine Isethionate prophylaxis, symptomatic patients should be evaluated appropriately to exclude the presence of PJP. The recommended dose of Pentamidine Isethionate for the prevention of PJP is insufficient to treat acute PJP.

Pregnancy-Pregnancy Category C There are no adequate and well controlled studies of 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 Pentamidine Isethionate can cause fetal harm when administered to a pregnant woman. Pentamidine Isethionate should be given to a pregnant woman only if clearly needed.