Class: Antiprotozoals, Miscellaneous
VA Class: AP100
Chemical Name: 4,4′-[1,5-Pentanediylbis(oxy)]bisbenzenecarboximidamide dimethanesulfonate
CAS Number: 140-64-7
Brands: NebuPent, Pentam 300
Uses for Pentamidine Isethionate
Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
Parenteral pentamidine is an alternative to co-trimoxazole (the drug of choice) for treatment of pneumocystis pneumonia; can be used in patients who do not respond to or cannot tolerate co-trimoxazole,88 89 90 91 186 187 199 303 310 311 including those with a history of severe allergic reactions to either component of co-trimoxazole (i.e., sulfonamides or trimethoprim).88 186 199 310 311
Prevention of initial episodes of pneumocystis pneumonia (primary prophylaxis) in immunocompromised individuals at increased risk, including HIV-infected individuals; pentamidine oral inhalation designated an orphan drug by FDA for this use.79 216 219 220 221 230 231 278 285 295 342 343 347 356 357 Pentamidine given by oral inhalation is one of several alternatives that can be used in adults, adolescents, and children who cannot tolerate co-trimoxazole (the drug of choice).299 300 303 351 356 358
Long-term suppressive or chronic maintenance therapy (secondary prophylaxis) to prevent recurrence following an initial episode of pneumocystis pneumonia in immunocompromised patients, including HIV-infected individuals; pentamidine oral inhalation designated an orphan drug by the FDA for this use.79 177 178 187 193 195 198 208 212 213 219 220 221 230 231 285 343 347 356 Pentamidine given by oral inhalation is one of several alternatives that can be used in adults, adolescents, and children who cannot tolerate co-trimoxazole (the drug of choice).299 300 303 351 356 358
Treatment of trypanosomiasis caused by Trypanosoma brucei gambiense† (Gambian sleeping sickness, West African trypanosomiasis).2 15 41 42 43 44 100 101 102 103 105 106 107 145 146 A drug of choice in early (hemolymphatic) stage of T. b. gambiense infection.41 43 44 91 105 303 Should not be used for late disease with CNS involvement since pentamidine penetrates the CNS poorly.15 43 44 100 101 102 103 105 146 303
Has been used with some success for treatment of trypanosomiasis caused by T. b. rhodesiense† (Rhodesian sleeping sickness, East African trypanosomiasis).15 43 44 91 105 106 149 150 Other drugs preferred (e.g., suramin or melarsoprol [drugs not commercially available in US, but may be available from CDC]).91 303
Has been effective for treatment of cutaneous and mucocutaneous leishmaniasis† caused by various Leishmania spp.15 46 47 55 56 57 114 154 155 265 303 Usual drugs of choice are pentavalent antimony compounds (e.g., sodium stibogluconate or meglumine antimonate [drugs not commercially available in the US]);91 265 303 b pentamidine is an alternative and may be a drug of choice in patients who fail to respond to antimony compounds.91 303 b
Has been effective for treatment of visceral leishmaniasis (kala-azar) caused by Leishmania donovani†.15 46 47 113 136 137 138 152 153 265 Usual drugs of choice for initial treatment of visceral leishmaniasis caused by L. donovani (usually endemic in Asia and Africa), L. infantum (usually endemic in the Mediterranean basin), or L. chagasi (usually endemic in Latin America) are pentavalent antimony compounds,46 113 265 but resistance and treatment failures are becoming increasingly common.265 Both IV amphotericin B and parenteral pentamidine are considered alternatives and have been effective in patients who failed to respond to antimony compounds.46 47 91 113 265 303
Pentamidine Isethionate Dosage and Administration
Since severe hypotensive reactions can occur following IV or IM administration of pentamidine, patients should be in a supine position and BP should be monitored closely during and after parenteral administration of the drug.1 (See Hypotension and Other Cardiovascular Effects under Cautions.)
Avoid extravasation; irritating to tissues.1 Position the IV needle or catheter carefully; observe throughout the period of administration.1 If extravasation occurs, immediately stop the infusion and restart at another site.1 (See Local Effects under Cautions.)
Reconstitution and Dilution
Reconstitute vial containing 300 mg of pentamidine isethionate for injection with 3, 4, or 5 mL of sterile water for injection or 5% dextrose injection to provide a solution containing 100, 75, or 60 mg/mL, respectively.1
Dilute an appropriate volume of the reconstituted solution in 50–250 mL of 5% dextrose injection.1
Rate of Administration
Reconstitute vial containing 300 mg of pentamidine isethionate for injection with 3 mL of sterile water for injection to provide a solution containing 100 mg/mL.1
Pentamidine isethionate for oral inhalation solution should not be admixed with any other drugs; the Respirgard II jet nebulizer should not be used to administer a bronchodilator.219
Reconstitute vial containing 300 mg of pentamidine isethionate for oral inhalation (NebuPent) with 6 mL of sterile water for injection.219 Do not use sodium chloride solution; precipitation will occur.219
Rate of Administration
Place the reconstituted solution for oral inhalation into the reservoir of the Respirgard II jet nebulizer and deliver until the nebulizer chamber is empty (approximately 30–45 minutes) using a flow rate of 5–7 L/minute and an air or oxygen source at 40–50 PSI.219 231 Alternatively, use an air compressor delivering 40–50 PSI by setting the flowmeter at 5–7 L/minute or the pressure at 22–25 PSI; low-pressure (i.e., less than 20 PSI) air compressors should not be used.219 230
May be available outside the US as the mesylate salt; dosage of the mesylate salt is expressed as the base.160 206 Consider that dosages used in some published references may be unclear since the salt employed may not be specified.15 100 101 102 103 104 108 111 146 149 206 207
Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
TreatmentIV or IM
Adolescents: 3–4 mg/kg once daily for 14–21 days.91
Children ≥5 years of age†: 300 mg every 4 weeks (once monthly).91 219 230 299 300 310 312 319 351 356 The child must be capable of effectively using a nebulizer; other appropriate agents (co-trimoxazole, dapsone, atovaquone) recommended for younger children.356
In HIV-infected children 1–5 years of age, primary prophylaxis should be initiated if CD4+ T-cell counts are <500/mm3 or CD4+ percentage is <15%.356 358 In HIV-infected children 6–12 years of age, primary prophylaxis should be initiated if CD4+ T-cell counts are <200/mm3 or CD4+ percentage is <15%.356 358
Adolescents†: Dosage and criteria for initiation or discontinuance of primary prophylaxis in this age group are the same as those recommended for adults.356 (See Adult Dosage under Dosage and Administration.)
Prevention of Recurrence (Secondary Prophylaxis)Inhalation
Children ≥5 years of age†: 300 mg every 4 weeks (once monthly).91 219 221 230 299 300 310 312 319 351 356 The child must be capable of effectively using a nebulizer; other appropriate agents (co-trimoxazole, dapsone, atovaquone) recommended for younger children.356
The safety of discontinuing secondary prophylaxis in HIV-infected children receiving potent antiretroviral therapy has not been extensively studied.365 Children who have a history pneumocystis pneumonia should receive life-long suppressive therapy to prevent recurrence.356
Adolescents†: Dosage and criteria for initiation or discontinuance of secondary prophylaxis in this age group are the same as those recommended for adults.356 (See Adult Dosage under Dosage and Administration.)
Treatment of Trypanosoma brucei gambiense Infections†IM
Treatment of Cutaneous Leishmaniasis†IV or IM
Treatment of Visceral Leishmaniasis Caused by Leishmania donovani (Kala-azar)†IV or IM
Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
TreatmentIV or IM
Initiate primary prophylaxis in patients with CD4+ T-cell counts <200/mm3 or a history of oropharyngeal candidiasis.356 Also consider primary prophylaxis if CD4+ T-cell percentage is <14% or there is a history of an AIDS-defining illness.356
Primary prophylaxis can be discontinued in adults and adolescents responding to potent antiretroviral therapy who have a sustained (≥3 months) increase in CD4+ T-cell counts from <200/mm3 to >200/mm3.356 However, it should be restarted if CD4+ T-cell count decreases to <200/mm3.356
Prevention of Recurrence (Secondary Prophylaxis)Inhalation
Initiate long-term suppressive therapy or chronic maintenance therapy (secondary prophylaxis) in those with a history of P. jiroveci pneumonia to prevent recurrence.356
Discontinuance of secondary prophylaxis is recommended in those who have a sustained (≥3 months) increase in CD4+ T-cell counts to >200/mm3 since such prophylaxis appears to add little benefit in terms of disease prevention and discontinuance reduces the medication burden, the potential for toxicity, drug interactions, selection of drug-resistant pathogens, and cost.356
Reinitiate secondary prophylaxis if CD4+ T-cell count decreases to <200/mm3 or if P. jiroveci pneumonia recurs at a CD4+ T-cell count >200/mm3.356 It probably is prudent to continue secondary prophylaxis for life in those who had P. jiroveci episodes when they had CD4+ T-cell counts >200/mm3.356
Treatment of Trypanosoma brucei gambiense Infections†IM
Treatment of Cutaneous Leishmaniasis†IV or IM
Treatment of Visceral Leishmaniasis Caused by Leishmania donovani (Kala-azar)†IV or IM
Some clinicians suggest that dosage adjustment may be needed if parenteral pentamidine is used in patients with severe renal impairment.77 131 132 133 185 Manufacturer states that parenteral pentamidine should be used with caution in patients with renal impairment and that safety and efficacy of alternative dosage regimens have not been established in these patients.1
Cautions for Pentamidine Isethionate
Hypotension and Other Cardiovascular Effects
Parenteral administration: Hypotension (which may develop suddenly and may be moderate to severe) may occur following IM or IV administration.1 15 41 43 52 83 86 87 124 159 167 188 202 279 Fatalities due to severe hypotension or cardiac arrhythmias reported.1 202 Hypotensive reactions most likely with rapid IV injection or infusion.1 15 21 124 159 188 202 279
Appropriate equipment for maintenance of an adequate airway and other supportive measures and agents (e.g., IV fluids, vasopressor agents)124 159 for the management of hypotensive reactions should be readily available.1
Use with caution in patients with hypertension, hypotension, or ventricular tachycardia.1
IV administration: Extravasation may result in ulceration, tissue necrosis, and/or sloughing at the injection site; long-term sequelae reported.1 Manage symptomatically; surgical debridement and skin grafting may be needed.1
Hypoglycemia and Diabetogenic Effects
Hypoglycemia1 31 32 33 34 35 81 83 84 85 86 87 88 89 90 95 165 167 169 180 188 202 243 (sometimes fatal) associated with pancreatic islet cell necrosis and high plasma insulin concentrations reported with IV or IM pentamidine.1
Hyperglycemia1 81 83 167 and insulin-dependent diabetes mellitus1 31 35 52 275 (which appears to be permanent in some cases)52 has occurred with or without preceding hypoglycemia1 275 and ketoacidosis1 in patients receiving parenteral therapy 31 52 or oral inhalation of the drug;275 these adverse effects sometimes occurred several months after discontinuance of parenteral therapy.1 31 52
Use with caution in patients with hypoglycemia or hyperglycemia.1
Selection and Use for Treatment or Prevention of Pneumocystis Pneumonia
Use pentamidine for treatment of pneumocystis pneumonia only in patients in whom the presence of P. jiroveci has been demonstrated.1
Dosage of orally inhaled pentamidine used for prophylaxis is insufficient for treatment of acute pneumocystis pneumonia.219 Prior to initiating primary prophylaxis, evaluate symptomatic patients to rule out P. jiroveci infection.219
Consider that orally inhaled pentamidine may not be completely protective and some patients receiving the drug for prophylaxis may develop acute pneumocystis pneumonia.219 230 278 Extrapulmonary and/or disseminated infection also reported occasionally during prophylaxis,200 219 231 236 239 240 249 276 278 usually in patients with a history of pneumocystis pneumonia.219 236 240 249 276
Monitor patients for signs and symptoms of pulmonary infection (e.g., fever, cough, dyspnea) prior to and during prophylaxis; evaluate those with signs or symptoms to rule out infection caused by P. jiroveci or other opportunistic or nonopportunistic pathogens.219 223 239 247 249 If pneumocystis pneumonia develops, discontinue prophylaxis and institute treatment with co-trimoxazole, parenteral pentamidine, or another effective regimen.195 221 223 247 248 Prophylaxis can be reinstituted when treatment is complete.221 247
Cough and bronchospasm reported frequently with orally inhaled pentamidine,219 231 277 278 279 especially in those with a history of smoking or asthma.174 208 211 212 217 Bronchospasm also reported after parenteral administration.1 210
Cough or bronchospasm in patients receiving pentamidine by oral inhalation can be controlled in most patients by interrupting pentamidine treatment and administering a bronchodilator.193 211 212 219 278 279 Coughing also may be controlled by slowing the delivery or intensity of the pentamidine aerosol stream.193 195 211 212 217
Parenteral administration: Allergic reactions reported, including pruritus,83 101 210 local or generalized urticaria,52 124 167 210 rash1 83 95 124 167 279 337 (e.g., maculopapular, pruritic),124 337 anaphylaxis,1 Stevens-Johnson syndrome,1 83 and toxic epidermal necrolysis.125 Use with caution in patients with Stevens-Johnson syndrome.1 219
Oral inhalation: Allergic reactions reported.219
Monitor renal function (BUN, Scr) before, during (daily or every other day), and after therapy.1 135 165 169 329 Consider monitoring serum potassium concentrations, particularly in AIDS patients.258 259 Ensure that patients are well hydrated; monitor fluid status.258 259 (See Renal Impairment under Cautions.)
Parenteral administration: Elevated liver function test results reported.1 83 87 95 167 169 174 202 Monitor hepatic function (serum bilirubin, alkaline phosphatase, AST, ALT) before, during, and after therapy.1 (See Hepatic Impairment under Cautions.)
Parenteral administration: Leukopenia (e.g., neutropenia)1 95 188 202 279 and thrombocytopenia,1 83 95 167 188 202 279 which can be severe (e.g., leukocyte count <1000/mm3, platelet count <20,000/mm3),1 95 occur occasionally in patients receiving parenteral pentamidine.1 83 95 188 202 Anemia occurs rarely.1 83 167
Oral inhalation: Neutropenia has occurred in several patients receiving the drug by oral inhalation,174 219 but these patients generally had low pretreatment leukocyte counts associated with zidovudine therapy.174
Monitor renal function (BUN, Scr) before, during (daily or every other day), and after parenteral therapy.1 135 165 169 329 Consider monitoring serum potassium concentrations, particularly in AIDS patients.258 259 Also monitor renal function and for hyperkalemia in patients receiving orally inhaled pentamidine.219
Monitor hepatic function (serum bilirubin, alkaline phosphatase, AST, ALT) before, during, and after parenteral therapy.1 Also monitor hepatic function in patients receiving orally inhaled pentamidine.219 (See Hepatic Impairment under Cautions.)
Monitor blood glucose concentrations before, during (daily or every other day), and after parenteral therapy.1 135 169 165 180 329 Also monitor for hypoglycemia and hyperglycemia in patients receiving orally inhaled pentamidine.219
Because hypocalcemia has been reported with parenteral pentamidine, monitor serum calcium concentrations before, during, and after therapy.1 83 167 Also monitor for hypocalcemia in patients receiving orally inhaled pentamidine.219
Environmental Exposure of Health-care Personnel and Visitors
The potential risks of environmental exposure to aerosolized pentamidine by health-care personnel and visitors in contact with patients receiving pentamidine inhalation therapy are unknown.205 211 212 230 247 251 252 261 264 285 Adverse effects have been reported in health-care personnel and others exposed to aerosolized pentamidine (e.g., perioral and perinasal paresthesia;263 burning sensation of the eyes, nose, and throat;264 sinus irritation;264 shortness of breath;262 264 338 cough;264 tightness of the chest;264 338 acute bronchospasm;262 headache;264 light-headedness).264
CDC and others recommend that health-care personnel administering aerosolized pentamidine be familiar with the manufacturer's instructions for use of the nebulizer delivery system, since improper use of the nebulizer potentially could result in release of substantial amounts of pentamidine into the environment.230 247 261 Some clinicians suggest that pregnant women205 261 264 and possibly those planning to become pregnant (e.g., within 8 weeks of potential exposure)264 avoid environmental exposure to aerosolized pentamidine. Consult specialized sources for recommended procedures to minimize environmental exposure to drug.211 212 251 261 262 264
Because cough and bronchospasm frequently occur in patients receiving orally inhaled pentamidine,219 231 277 278 279 health-care personnel who administer pentamidine inhalation therapy may be at risk of exposure to tuberculosis if the patient has undiagnosed Mycobacterium tuberculosis infection.230 250 264 266 285 310 311
Parenteral administration: Safety and efficacy established in children >4 months of age.1 Has been used effectively for treatment of pneumocystis pneumonia in younger children1 81 83 85 86 87 89 90 130 (including neonates);1 83 85 86 90 130 no unusual risks associated with the drug identified.85 89 90 130 134 Also has been used effectively and apparently without unusual risks for treatment of African trypanosomiasis†91 100 101 and leishmaniasis†53 91 in children.
Oral inhalation: Safety and efficacy not established in children ≤16 years of age.219 AAP, USPHS/IDSA, and others state that use of orally inhaled pentamidine can be considered in children ≥5 years of age who are capable of effectively using a nebulizer.299 300 303 356
Common Adverse Effects
Parenteral administration: Nephrotoxicity;1 83 84 85 86 87 89 96 167 169 188 202 271 hypotension;1 15 41 43 52 83 86 87 124 159 167 188 202 279 hepatic effects;1 83 87 95 167 169 174 202 GI effects (anorexia, nausea, vomiting);1 52 83 90 167 202 219 278 279 hematologic effects (leukopenia);1 95 188 202 279 hypoglycemia;1 31 32 33 34 35 81 83 84 85 86 87 88 89 90 95 165 167 169 180 188 202 243 injection site reactions.1 81 83 86 124
Interactions for Pentamidine Isethionate
Nephrotoxic effects may be additive; the concurrent or sequential use of other drugs with similar toxic potentials (e.g., aminoglycosides, amphotericin B, capreomycin, colistin, cisplatin, foscarnet, methoxyflurane, polymyxin B, vancomycin) should be closely monitored or avoided, if possible.1 83 84 85 87 219
Pentamidine Isethionate Pharmacokinetics
Bronchoalveolar lavage fluid concentrations attained following oral inhalation are substantially higher (at least 5–10 times) than those attained following IV administration.174 181 182 211 212 213 219 277
Peak plasma concentrations following oral inhalation are ≤5% of those attained following IV administration.182
Rapidly and extensively distributed and/or bound to tissues.77 171 183 Following parenteral administration, highest concentrations are found in the liver, followed by the kidneys, adrenals, spleen, lungs, and pancreas in AIDS patients.183
Deposition of orally inhaled pentamidine shows considerable interindividual variation; appears to depend on several factors, including delivery device, particle size of aerosolized drug, dose, patient position, and nebulization efficiency.181 182 219 284 293 296
Plasma Protein Binding
Not appreciably removed by hemodialysis or peritoneal dialysis.185
Parenteral administration: Half-life not substantially altered in patients with mild to moderate renal impairment, but half-life may be prolonged up to ≥2 days in those with severe renal impairment.185
Oral inhalation: Information not available on pharmacokinetics of the drug in patients with renal or hepatic impairment.219
Powder for Injection
15–30°C; protect from light.1
Following dilution with 5% dextrose in water to a concentration of 1 mg/mL or 2.5 mg/mL, stable at room temperature for up to 24 hours.1
Powder for Inhalation Solution
For information on systemic interactions resulting from concomitant use, see Interactions.
Dextrose 5% in water
Sodium chloride 0.9%
Do not mix with other drugs.219
Actions and Spectrum
The exact mechanism(s) of antiprotozoal action not fully elucidated;1 2 8 9 10 11 12 13 14 15 16 17 18 19 interferes with protozoal nuclear metabolism by inhibiting DNA, RNA, phospholipid and protein synthesis.1 219
Active in vivo and in vitro against P. jiroveci (formerly P. carinii).1 15 26 28 29 30 79 80 81 82 83 84 85 86 87 88 89 90 92 93 94 95 96 Directly lethal to the organism in vitro at concentrations attainable in vivo.28 29 30
Active in vitro and/or in vivo against most strains of T. b. gambiense,2 15 41 42 43 44 145 146 147 148 L. donovani (including antimony-resistant strains),50 52 53 54 153 and L. aethiopica.46 47 55 56 Active against some strains of T. b. rhodesiense;2 15 27 41 42 43 44 59 149 150 151 not active against T. (Schizotrypanum) cruzi.2 15 45 59
Advice to Patients
Importance of completing full course of therapy.219
When used for the prevention of pneumocystis pneumonia, importance of informing clinicians if symptoms of a pulmonary infection (cough, fever, dyspnea) occur.219
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
For inhalation solution
Pentamidine Isethionate for Injection
Baxter, Hospira, Steris
AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions June 3, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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