United States - English - NLM (National Library of Medicine)

seton pharmaceuticals - pentamidine isethionate (unii: v2p3k60da2) (pentamidine - unii:673lc5j4lq) - pentamidine isethionate 300 mg in 300 mg - 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.

United States - English - NLM (National Library of Medicine)

xgen pharmaceuticals djb, inc. - pentamidine isethionate (unii: v2p3k60da2) (pentamidine - unii:673lc5j4lq) - 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 sometime during the trial. the analysis of the data demonstrated the efficacy of the 300 mg dose even after adjusting for the effect of zidovudine. the results of the trial further demonstrate that the dose and frequency of dosing are important to the efficacy of pentamidine isethionate prophylaxis in that multiple analyses consistently demonstrated a trend toward greater efficacy with 300 mg every four weeks as compared to 150 mg every two weeks. no dose-response was observed for reduction in overall mortality; however, mortality from pjp was low in all three dosage groups. pentamidine isethionate is contraindicated in patients with a ­history of an anaphylactic reaction to inhaled or parenteral pentamidine isethionate.

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - pentamidine isethionate (unii: v2p3k60da2) (pentamidine - unii:673lc5j4lq) - pentamidine isethionate 300 mg in 3 ml - 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.

United States - English - NLM (National Library of Medicine)

xgen pharmaceuticals djb, inc. - pentamidine isethionate (unii: v2p3k60da2) (pentamidine - unii:673lc5j4lq) - 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.

United States - English - NLM (National Library of Medicine)

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - pentamidine isethionate (unii: v2p3k60da2) (pentamidine - unii:673lc5j4lq) - 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.

United States - English - NLM (National Library of Medicine)

seton pharmaceuticals - pentamidine isethionate (unii: v2p3k60da2) (pentamidine - unii:673lc5j4lq) - 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/mm3. 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 the 300 mg dose even after adjusting for the effect of zidovudine. the results of the trial further demonstrate that the dose and frequency of dosing are important to the efficacy of pentamidine isethionate prophylaxis in that multiple analyses consistently demonstrated a trend toward greater efficacy with 300 mg every four weeks as compared to 150 mg every two weeks. no dose-response was observed for reduction in overall mortality; however, mortality from pjp was low in all three dosage groups. pentamidine isethionate is contraindicated in patients with a history of an anaphylactic reaction to inhaled or parenteral pentamidine isethionate.

Australia - English - Department of Health (Therapeutic Goods Administration)

hospira australia pty ltd - pentamidine isetionate -

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - pentamidine isetionate, quantity: 300 mg - injection, powder for - excipient ingredients: - pentamidine isethionate is indicated for intravenous administration in the treatment of the following conditions: . as an alternative first line treatment for pneumocystis carinii infection in aids patients; . as second line treatment for pneumocystis carinii infection in non-aids patients; . as second line treatment of leishmaniasis (visceral and cutaneous), except leishmania aethiopica where it may be used as first line treatment; . as second line treatment for trypanosomiasis (except for the trypanosomiasis rhodesiense strain due to lack of efficacy).

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

hospira malaysia sdn bhd - pentamidine isethionate -

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - pentamidine isethionate - injection, powder, for solution - 300 mg/vial - pentamidine isethionate 300 mg/vial