Pentamidine (Systemic, Local) (Monograph)
Brand names: NebuPent, Pentam
Drug class:
- Antiprotozoal Agents
Introduction
Antiprotozoal and antifungal; aromatic diamidine derivative.1 2 3 219
Uses for Pentamidine (Systemic, Local)
Pneumocystis jirovecii Pneumonia
Alternative for treatment and prevention of Pneumocystis jirovecii (formerly Pneumocystis carinii) pneumonia (PCP).1 134 155 156 219 Designated an orphan drug by FDA for treatment and prevention of PCP in patients at high risk for the disease.79 134
Co-trimoxazole is drug of choice for treatment of mild, moderate, or severe PCP in adults, adolescents, and children, including HIV-infected individuals.134 155 156
CDC, NIH, and IDSA recommend IV pentamidine or regimen of primaquine in conjunction with clindamycin as alternatives for treatment of moderate to severe PCP in HIV-infected adults and adolescents who cannot tolerate or have not responded to co-trimoxazole.155 Some clinicians prefer primaquine and clindamycin regimen since it may be more effective and associated with lower toxicity compared with IV pentamidine.155 For treatment of PCP in HIV-infected children who cannot tolerate co-trimoxazole or have not responded after 5–7 days of co-trimoxazole, CDC, NIH, IDSA, and AAP recommend IV pentamidine;156 treatment can be switched to appropriate oral regimen (e.g., atovaquone) after initial response is obtained with IV pentamidine.156
CDC, NIH, IDSA, and AAP recommend pentamidine given by oral inhalation via nebulization (aerosolized pentamidine) as one of several alternatives for prevention of initial episode of PCP (primary prophylaxis) and for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) of PCP in HIV-infected adults, adolescents, and children ≥5 years of age† [off-label] who cannot tolerate drug of choice (co-trimoxazole).155 156
African Trypanosomiasis
Treatment of early or first-stage (hemolymphatic) trypanosomiasis caused by Trypanosoma brucei gambiense† [off-label] (West African trypanosomiasis, gambiense sleeping sickness).2 41 42 43 44 100 101 102 103 107 134 367 368 369 Drug of choice for first-stage T. b. gambiense infection;44 134 367 368 suramin (not commercially available in US, but may be available from CDC) also effective for first-stage disease, but considered an alternative since pentamidine is better tolerated.134 367
Has been used for treatment of early or first-stage (hemolymphatic) trypanosomiasis caused by T. b. rhodesiense† [off-label] (East African trypanosomiasis, rhodesiense sleeping sickness).43 44 134 149 150 367 368 Suramin (not commercially available in US, but may be available from CDC) usually drug of choice for first-stage T. b. rhodesiense infection;44 134 367 368 pentamidine is an alternative,43 44 367 but may be less effective in these infections than in T. b. gambiense infections.41 42 43 44 44 134 367 368
Do not use for treatment of second-stage (meningoencephalitic) T. b. gambiense or T. b. rhodesiense infections with CNS involvement since pentamidine penetrates CNS poorly.15 42 43 44 100 101 102 103 105 134 146 367 368 369 Eflornithine (with or without nitfurtimox) or melarsoprol (drugs not commercially available in US, but may be available from CDC) usually recommended for T. b. gambiense infection with CNS involvement;44 134 368 369 melarsoprol (not commercially available in US, but may be available from CDC) usually recommended for treatment of T. b. rhodesiense infection with CNS involvement.134 367 368
T. b. gambiense and T. b. rhodesiense transmitted to humans by bite of infected tsetse flies;44 105 377 transmission via blood or perinatal transmission from mother to infant is rare.377 T. b. gambiense is endemic in West and Central Africa;44 105 377 T. b. rhodesiense is endemic in Eastern and Southern Africa.44 105 377 Trypanosomiasis reported in short-term travelers to endemic areas and in immigrants and expatriates from such areas.44 105 368
For assistance with diagnosis or treatment of trypanosomiasis in the US, contact CDC Parasitic Diseases Hotline at 404-718-4745 from 8:00 a.m. to 4:00 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after business hours and on weekends and holidays.382 Contact CDC Drug Service at 404-639-3670 for information on how to obtain antiparasitic drugs not commercially available in US.382
Leishmaniasis
Has been used for treatment of cutaneous and mucocutaneous leishmaniasis† [off-label] caused by various Leishmania spp.46 55 56 57 105 114 154 256 369 372 373 374 When systemic treatment indicated, pentavalent antimonials (i.e., sodium stibogluconate or meglumine antimonate [drugs not commercially available in US, but may be available from CDC]) usually used;126 134 256 271 369 371 373 374 other options include amphotericin B, miltefosine, pentamidine, and ketoconazole. 46 126 134 155 369 371 373 374 Although pentamidine has been recommended for treatment of New World cutaneous leishmaniasis† [off-label] caused by L. guyanensis or L. panamensis,369 372 373 374 variable efficacy and potential adverse effects limit its usefulness for other types of cutaneous leishmaniasis.46 372 373 374
Has been used for treatment of visceral leishmaniasis† (also known as kala-azar).46 136 137 138 152 153 256 375 376 Pentavalent antimonials (i.e., sodium stibogluconate or meglumine antimonate [drugs not commercially available in US, but may be available from CDC]) have historically been considered drugs of first choice for initial treatment of visceral leishmaniasis,46 58 126 256 271 371 375 376 but drug resistance and treatment failures are concerns in some areas (e.g., India, Nepal).126 256 375 376 Other options include amphotericin B, miltefosine, or paromomycin.126 134 155 256 271 371 375 376 Pentamidine not usually recommended because of variable or suboptimal efficacy and potential adverse effects.134 155 371 375 376
Leishmaniasis is caused by >15 different Leishmania species that are transmitted to humans by bite of infected sand flies;46 105 126 371 372 373 377 also can be transmitted via blood (e.g., blood transfusions, needles shared by IV drug abusers) and perinatally from mother to infant.46 105 155 371 377 In Eastern Hemisphere (Old World), leishmaniasis found most frequently in parts of Asia, the Middle East, Africa, and southern Europe; in Western Hemisphere (New World), found most frequently in Mexico and Central and South America and reported occasionally in Texas and Oklahoma.377 Leishmaniasis reported in short-term travelers to endemic areas and in immigrants and expatriates from such areas;46 105 372 373 377 also reported in US military personnel and contract workers serving or working in endemic areas (e.g., Iraq, Afghanistan).46 105 377
Specific form of leishmaniasis and disease severity depend on Leishmania species involved, geographic area of origin, location of sand fly bite, and patient factors (e.g., nutritional and immune status).46 105 126 371 372 373 374 375 Treatment (e.g., drug, dosage, duration of treatment) must be individualized based on region where disease was acquired, likely infecting species, drug susceptibilities reported in area of origin, form of disease, and patient factors (e.g., age, pregnancy, immune status).46 105 134 155 371 372 374 375 377 No single treatment approach is appropriate for all possible clinical presentations.46 Consultation with clinicians experienced in management of leishmaniasis recommended.105 134 371 377
For assistance with diagnosis or treatment of leishmaniasis in the US, contact CDC Parasitic Diseases Hotline at 404-718-4745 from 8:00 a.m. to 4:00 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after business hours and on weekends and holidays.382 Contact CDC Drug Service at 404-639-3670 for information on how to obtain antiparasitic drugs not commercially available in US.382
Babesiosis
Has been used in some patients for treatment of babesiosis† caused by Babesia microti;115 116 117 118 119 efficacy not established.115 120
Has been used in conjunction with co-trimoxazole for treatment of infection caused by B. divergens,178 282 but adverse effects associated with pentamidine limit use of this regimen.178
When anti-infective treatment of babesiosis indicated, IDSA and others recommend regimen of clindamycin and quinine or regimen of atovaquone and azithromycin.105 134 178
Pentamidine (Systemic, Local) Dosage and Administration
Administration
Administer by IM injection or slow IV infusion.1
Administer by oral inhalation via nebulization.219
IV infusion (not IM injection) usually recommended for treatment of PCP;134 155 156 oral inhalation via nebulization used only for prevention of PCP.155 156 219
Since sudden, severe hypotensive reactions can occur following IV or IM administration, keep patient in supine position and closely monitor BP during and after administration.1 (See Hypotension and Other Cardiovascular Effects under Cautions.)
IV Infusion
Position IV needle or catheter carefully; observe throughout period of administration.1 Avoid extravasation;1 if extravasation occurs, immediately stop infusion and restart at another site.1 (See Local Effects under Cautions.)
Reconstitution and Dilution
For IV infusion, reconstitute vial containing 300 mg of pentamidine isethionate for IM or IV use with 3, 4, or 5 mL of sterile water for injection or 5% dextrose injection at 22–30°C to provide a solution containing 100, 75, or 60 mg/mL, respectively.1 Do not reconstitute using sodium chloride solution; precipitation will occur.1
Withdraw desired dose of reconstituted solution and dilute in 50–250 mL of 5% dextrose injection.1
Rate of Administration
Give IV infusion over 60–120 minutes.1 Do not administer by rapid IV injection or infusion.1 124 (See Hypotension and Other Cardiovascular Effects under Cautions.)
IM Injection
Administer by deep IM injection.1
Some clinicians suggest that local adverse effects may be minimized by using Z-tract technique (i.e., firmly push subcutaneous tissue aside before inserting needle at 90-degree angle).321
Reconstitution
For IM injection, reconstitute vial containing 300 mg of pentamidine isethionate for IM or IV use with 3 mL of sterile water for injection at 22–30°C to provide a solution containing 100 mg/mL.1 Do not reconstitute using sodium chloride solution; precipitation will occur.1
Oral Inhalation via Nebulization
For oral inhalation via nebulization (aerosolized pentamidine), powder for oral inhalation solution (NebuPent) is reconstituted and administered using a Respirgard II jet nebulizer.219 231 255
Consult manufacturer's information for detailed instructions regarding use and operation of the nebulizer.219 231 255
Do not admix reconstituted pentamidine solution for oral inhalation with any other drugs;219 do not use Respirgard II jet nebulizer to administer a bronchodilator.219
Reconstitution
Reconstitute vial containing 300 mg of pentamidine isethionate for oral inhalation with 6 mL of sterile water for injection.219 Do not use sodium chloride solution; precipitation will occur.219
Rate of Administration
Place entire contents of reconstituted vial into reservoir of Respirgard II jet nebulizer and deliver until 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
Dosage
Available as pentamidine isethionate; dosage expressed as pentamidine isethionate.1 219
Pediatric Patients
Pneumocystis jirovecii Pneumonia (PCP)
Treatment of PCP
IM or IVChildren >4 months of age: 4 mg/kg once daily.1 156 CDC, NIH, IDSA, and AAP recommend IV route in HIV-infected children;155 if clinical improvement occurs after 7–10 days, can switch to appropriate oral regimen (e.g., atovaquone) to complete 21 days of treatment.156
Adolescents: 4 mg/kg once daily.1 155 CDC, NIH, and IDSA recommend IV route in HIV-infected adolescents;155 dosage can be reduced to 3 mg/kg IV once daily if necessary because of toxicity.155
CDC, NIH, IDSA, and AAP recommend total treatment duration of 21 days;155 156 manufacturer recommends 14–21 days and cautions that >21 days may be associated with increased toxicity.1
Prevention of Initial Episode (Primary Prophylaxis) of PCP
Oral Inhalation via NebulizationChildren ≥5 years of age†: 300 mg once every 4 weeks (once monthly).156
Adolescents†: 300 mg once every 4 weeks (once monthly).155
HIV-infected children 1 to <6 years of age: Initiate primary PCP prophylaxis if CD4+ T-cell count <500/mm3 or CD4+ percentage <15%.156
HIV-infected children 6–12 years of age: Initiate primary PCP prophylaxis if CD4+ T-cell count <200/mm3 or CD4+ percentage <15%.156
Consider discontinuing primary PCP prophylaxis in HIV-infected children 1 to <6 years of age who have received ≥6 months of antiretroviral therapy and have CD4+ T-cell counts that have remained ≥500/mm3 or CD4+ percentages that have remained ≥15% for >3 months.156 Assess CD4+ T-cell count and CD4+ percentage every 3 months; reinitiate if indicated based on age-specific thresholds.156
Consider discontinuing primary PCP prophylaxis in HIV-infected children 6–12 years of age who have received ≥6 months of antiretroviral therapy and have CD4+ T-cell counts that have remained ≥200/mm3 or CD4+ percentages that have remained ≥15% for >3 months.156 Assess CD4+ T-cell count and CD4+ percentage every 3 months; reinitiate if indicated based on age-specific thresholds.156
Criteria for initiating or discontinuing primary PCP prophylaxis in HIV-infected adolescents are the same as those recommended for adults.155 (See Adult Dosage under Dosage and Administration.)
Prevention of Recurrence (Secondary Prophylaxis) of PCP
Oral Inhalation via NebulizationChildren ≥5 years of age†: 300 mg once every 4 weeks (once monthly).156
Adolescents†: 300 mg once every 4 weeks (once monthly).155
Initiate secondary PCP prophylaxis in all HIV-infected infants and children with a history of PCP.156
Consider discontinuing secondary PCP prophylaxis in HIV-infected children 1 to <6 years of age who have received ≥6 months of antiretroviral therapy and have CD4+ T-cell counts that have remained ≥500/mm3 or CD4+ percentages that have remained ≥15% for >3 months.156 Assess CD4+ T-cell count and CD4+ percentage every 3 months; reinitiate if indicated based on age-specific thresholds.156
Consider discontinuing secondary PCP prophylaxis in HIV-infected children 6–12 years of age who have received ≥6 months of antiretroviral therapy and have CD4+ T-cell counts that have remained ≥200/mm3 or CD4+ percentages that have remained ≥15% for >3 months.156 Assess CD4+ T-cell count and CD4+ percentage every 3 month; reinitiate if indicated based on age-specific thresholds.156
Criteria for initiating or discontinuing secondary PCP prophylaxis in HIV-infected adolescents are the same as those recommended for adults.155 (See Adult Dosage under Dosage and Administration.)
African Trypanosomiasis†
Treatment of First-stage Trypanosoma brucei gambiense Infection†
IM or IV4 mg/kg once daily for 7–10 days recommended by WHO and others.44 134 367 368 369 Give IM44 134 367 368 369 or, alternatively, by IV infusion over 2 hours.44 367 368
Treatment of First-stage Trypanosoma brucei rhodesiense Infection†
IM or IV4 mg/kg once daily for 7 days recommended by WHO.44 Give IM or, alternatively, by IV infusion over 2 hours.44
Leishmaniasis†
Treatment of Cutaneous Leishmaniasis†
IM or IV2–3 mg/kg once daily or every other day for 4–7 doses.134 369 Alternatively, 3–4 mg/kg once every other day for 4–10 doses.373 374
New World cutaneous leishmaniasis caused by L. guyanensis or L. panamensis: 4 mg/kg once every other day for 3 doses recommended by WHO.46
Treatment of Visceral Leishmaniasis†
IM or IV4 mg/kg once every other day or 3 times weekly for 15–20 doses.375
Adults
Pneumocystis jirovecii Pneumonia (PCP)
Treatment of Moderate to Severe PCP
IM or IV4 mg/kg once daily.1 155 CDC, NIH, and IDSA recommend IV route in HIV-infected adults;155 dosage can be reduced to 3 mg/kg IV once daily if necessary because of toxicity.155
CDC, NIH, and IDSA recommend total treatment duration of 21 days;155 manufacturer recommends 14–21 days and cautions that >21 days may be associated with increased toxicity.1
Prevention of Initial Episode (Primary Prophylaxis) of PCP
Oral Inhalation via Nebulization300 mg once every 4 weeks (once monthly).155 219
Initiate primary PCP prophylaxis in HIV-infected adults with CD4+ T-cell counts <200/mm3 or a history of oropharyngeal candidiasis.155 Also consider primary PCP prophylaxis if CD4+ T-cell percentage <14% or there is a history of an AIDS-defining illness.155 Also consider in those with CD4+ T-cell counts >200/mm3 but <250/mm3 if frequent monitoring (e.g., every 3 months) not possible.155
Discontinue primary PCP prophylaxis in HIV-infected adults responding to antiretroviral therapy who have CD4+ T-cell counts that have remained >200/mm3 for >3 months.155
Reinitiate primary PCP prophylaxis if CD4+ T-cell count decreases to <200/mm3.155
Prevention of Recurrence (Secondary Prophylaxis) of PCP
Oral Inhalation via Nebulization300 mg once every 4 weeks (once monthly).155 219
Initiate secondary PCP prophylaxis in all HIV-infected adults with a history of PCP.155
Consider discontinuing secondary PCP prophylaxis in HIV-infected adults who have responded to antiretroviral therapy and have CD4+ T-cell counts that have remained >200/mm3 for >3 months.155 Reinitiate if CD4+ T-cell count decreases to <200/mm3 or PCP recurs when CD4+ T-cell count >200/mm3.155
Consider continuing secondary PCP prophylaxis for life (regardless of CD4+ T-cell count) if PCP occurred or recurred when CD4+ T-cell count >200/mm3.155
African Trypanosomiasis†
Treatment of First-stage Trypanosoma brucei gambiense Infection†
IM or IV4 mg/kg once daily for 7–10 days recommended by WHO and others.44 134 367 368 369 Give IM44 134 367 368 369 or, alternatively, by IV infusion over 2 hours.44 367 368
Treatment of First-stage Trypanosoma brucei rhodesiense Infection†
IM or IV4 mg/kg once daily for 7 days recommended by WHO.44 Give IM or, alternatively, by IV infusion over 2 hours.44
Leishmaniasis†
Treatment of Cutaneous Leishmaniasis†
IM or IV2–3 mg/kg once daily or every other day for 4–7 doses.134 369 Alternatively, 3–4 mg/kg once every other day for 4–10 doses.373 374
New World cutaneous leishmaniasis caused by L. guyanensis or L. panamensis: 4 mg/kg once every other day for 3 doses recommended by WHO.46
Treatment of Visceral Leishmaniasis†
IM or IV4 mg/kg once every other day or 3 times weekly for 15–20 doses.375
Special Populations
Hepatic Impairment
Manufacturer states use IM or IV pentamidine with caution in patients with hepatic impairment; safety and efficacy of alternative dosage regimens not established in these patients.1
Renal Impairment
Manufacturer states use IM or IV pentamidine with caution in patients with renal impairment; safety and efficacy of alternative dosage regimens not established in these patients.1
If IV pentamidine used for treatment of PCP in HIV-infected adults or adolescents with renal impairment, some clinicians recommend 3 mg/kg once every 24 hours in those with Clcr 10–50 mL/minute and 4 mg/kg once every 48 hours in those with Clcr <10 mL/minute.155
Cautions for Pentamidine (Systemic, Local)
Contraindications
-
IV or IM: Known hypersensitivity to pentamidine.1
-
Oral inhalation via nebulization: History of anaphylactic reaction to pentamidine administered parenterally or by oral inhalation.219
Warnings/Precautions
Warnings
Hypotension and Other Cardiovascular Effects
IV or IM: Hypotension, which may develop suddenly and may be moderate to severe, can occur.1 15 41 43 52 83 86 124 159 167 188 202 279 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
Oral inhalation via nebulization: Hypotension, hypertension, and cardiac arrhythmias also reported rarely.219 278
When administering IM or IV, place patient in a supine position.1 Monitor BP during and after administration until stable; perform ECG before, during, and after administration.1
Appropriate equipment for maintenance of an adequate airway and other supportive measures and agents (e.g., IV fluids, vasopressor agents)124 159 for management of hypotensive reactions should be readily available.1
Use with caution in patients with hypertension, hypotension, or ventricular tachycardia.1
Local Effects
IV: Extravasation may result in ulceration, tissue necrosis, and/or sloughing at injection site; long-term sequelae reported.1 Properly position and closely observe IV needle and catheter throughout infusion; if extravasation occurs, immediately discontinue infusion and restart in another vein.1 Phlebitis also reported.183
IM: Sterile abscess and/or necrosis,1 81 83 86 124 pain,1 83 124 erythema,85 89 tenderness,85 89 and induration at injection site.1 85 89
Hypoglycemia and Diabetogenic Effects
Hypoglycemia, which may be severe and has been fatal in some cases, reported with IM or IV pentamidine.1 31 32 33 34 35 81 83 84 85 86 89 90 165 167 169 180 188 202 243 Has been associated with pancreatic islet cell necrosis and inappropriately high plasma insulin concentrations.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 pentamidine.31 52
Hypoglycemia,203 217 219 277 279 hyperglycemia,219 275 and diabetes219 also have occurred in patients receiving pentamidine by oral inhalation via nebulization.
Monitor blood glucose concentrations before, during (daily or every other day), and after IM or IV pentamidine.1 135 169 165 180
Use with caution in patients with hypoglycemia or hyperglycemia.1
Pancreatitis
Acute pancreatitis1 128 166 168 322 335 (sometimes fatal)168 reported with IM or IV pentamidine. Acute pancreatitis also reported rarely in patients receiving pentamidine by oral inhalation via nebulization.219 246 274
Use with caution in patients with pancreatitis.1 Discontinue if acute pancreatitis occurs.166 219
Selection and Use for Treatment or Prevention of Pneumocystis jirovecii Pneumonia
Use IM or IV pentamidine for treatment of PCP only in patients in whom the presence of P. jirovecii has been demonstrated.1
Prior to initiating pentamidine oral inhalation via nebulization for prevention of PCP, evaluate symptomatic patients to rule out P. jirovecii infection.219 Dosage of orally inhaled pentamidine used for prevention of PCP is insufficient for treatment of PCP.219
Patients receiving the drug for prevention of PCP may still develop acute PCP.219 278 Extrapulmonary and/or disseminated P. jirovecii infection also reported occasionally during PCP prophylaxis,200 219 231 236 239 240 249 276 278 usually in patients with a history of PCP.219 236 240 249 276
Monitor patients receiving PCP prophylaxis for signs and symptoms of pulmonary infection (e.g., fever, cough, dyspnea); evaluate those with signs or symptoms to rule out infection caused by P. jirovecii or other opportunistic or nonopportunistic pathogens.219 223 239 247 249 If PCP develops, discontinue prophylaxis and initiate treatment with co-trimoxazole, parenteral pentamidine, or another effective regimen.195 221 223 247 248 PCP prophylaxis can be reinstituted when treatment is complete.221 247
Respiratory Effects
Cough and bronchospasm reported frequently when pentamidine administered by oral inhalation via nebulization,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
Pretreatment with an orally inhaled bronchodilator may minimize occurrence of coughing and bronchospasm.176 177 193 208 211 212 279 315 316
Sensitivity Reactions
IM or IV: Anaphylaxis,1 anaphylactoid reactions with shock,52 53 Stevens-Johnson syndrome,1 83 and toxic epidermal necrolysis reported.125 Use with caution in patients with Stevens-Johnson syndrome.1 219
Oral inhalation via nebulization: Anaphylaxis, allergic reaction, and nonspecific allergy reported.219
Pruritus,1 83 83 101 210 local or generalized urticaria,1 52 124 167 210 rash1 83 124 167 279 337 (e.g., maculopapular, pruritic)124 337 also reported with IM or IV administration.
Rash,174 193 219 242 including severely pruritic, maculopapular eruption on upper chest and back,242 also reported in patients receiving the drug by oral inhalation via nebulization.1 219 278
Major Toxicities
Renal Effects
IM or IV: Nephrotoxicity (increase in Scr and/or BUN, azotemia, renal insufficiency, renal failure) reported.1 52 83 84 85 86 89 90 96 167 169 188 202 271 279
Oral inhalation via nebulization: Flank pain,219 incontinence,219 increased BUN and Scr,219 nephritis,219 renal failure,219 renal pain,219 and syndrome of inappropriate antidiuretic hormone secretion (SIADH)219 reported rarely.219 244
Monitor renal function (BUN, Scr) before, during (daily or every other day), and after therapy.1 135 165 169 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.)
Hepatic Effects
IM or IV: Elevated liver function test results reported.1 83 167 169 174 202
Hepatitis,1 219 hepatomegaly,1 219 and hepatic dysfunction1 219 reported in patients receiving the drug parenterally or by oral inhalation via nebulization.
Monitor hepatic function (serum bilirubin, alkaline phosphatase, AST, ALT) before, during, and after therapy.1 (See Hepatic Impairment under Cautions.)
Hematologic Effects
IM or IV: Leukopenia (e.g., neutropenia)1 188 202 279 and thrombocytopenia,1 83 167 188 202 279 which can be severe (e.g., leukocyte count <1000/mm3, platelet count <20,000/mm3),1 occur occasionally.1 83 188 202 Anemia,1 83 167 167 eosinophilia,1 pancytopenia,1 and prolonged clotting time1 reported rarely.1
Oral inhalation via nebulization: Anemia reported occasionally; eosinophilia, neutropenia, nonspecific cytopenia, pancytopenia, and thrombocytopenia also reported.219
Monitor CBCs and platelet counts.1 Use with caution in patients with leukopenia, thrombocytopenia, or anemia.1 219
General Precautions
Consider that serious adverse effects reported with parenteral pentamidine also may occur when the drug is administered by oral inhalation via nebulization.174 203 219
Laboratory Monitoring
Monitor renal function (BUN, Scr) before, during (daily or every other day), and after IM or IV pentamidine;1 135 165 169 consider monitoring serum potassium concentrations, particularly in AIDS patients.258 259 Also monitor renal function and for hyperkalemia in patients receiving the drug by oral inhalation via nebulization.219 (See Renal Impairment under Cautions.)
Monitor hepatic function (serum bilirubin, alkaline phosphatase, AST, ALT) before, during, and after IM or IV pentamidine.1 Also monitor hepatic function in patients receiving the drug by oral inhalation via nebulization.219 (See Hepatic Impairment under Cautions.)
Monitor blood glucose concentrations before, during (daily or every other day), and after IM or IV pentamidine.1 135 169 165 180 Also monitor for hypoglycemia and hyperglycemia in patients receiving the drug by oral inhalation via nebulization.219
Because hypocalcemia has been reported, monitor serum calcium concentrations before, during, and after IM or IV pentamidine.1 83 167 Also monitor for hypocalcemia in patients receiving the drug by oral inhalation via nebulization.219
Environmental Exposure of Health-care Personnel and Visitors
Potential risks of environmental exposure to aerosolized pentamidine in health-care personnel and visitors or other individuals present when patients are receiving pentamidine by oral inhalation via nebulization not known.205 211 212 247 251 252 261 264 285 378 380 381 Measurable levels of pentamidine can be present in room air when pentamidine is administered by oral inhalation via nebulization.261 294 378 380 381
Adverse effects reported in health-care personnel and others exposed to aerosolized pentamidine in the environment include eye irritation (e.g., conjunctivitis);204 263 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 and light-headedness.264
Cough and bronchospasm frequently occur in patients receiving pentamidine by oral inhalation via nebulization;219 231 277 278 279 health-care personnel and other individuals present during administration of the drug may be at risk of exposure to pathogens that can be transmitted when patients cough (e.g., Mycobacterium tuberculosis).250 264 266 285 380
Because of concerns about potential risks of environmental exposure to aerosolized pentamidine and lack of data regarding potential effects of the drug on the fetus or pregnancy,205 247 251 252 261 264 285 294 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.
Health-care personnel administering aerosolized pentamidine should be familiar with the manufacturer's instructions for use of the nebulizer delivery system; improper use potentially could result in release of substantial amounts of pentamidine into the environment.247 261
Because potential risks, particularly long-term and cumulative effects, associated with environmental exposure to aerosolized pentamidine not established,205 247 251 252 261 264 285 378 380 381 health-care facilities should have procedures to minimize environmental exposure to aerosolized pentamidine.205 251 261 262 264 378 380 381 Consult specialized sources for recommended procedures.211 212 251 261 262 264
Specific Populations
Pregnancy
For treatment of first-stage (hemolymphatic) trypanosomiasis† or treatment of leishmaniasis† in pregnant women, WHO states do not use IM or IV pentamidine during first trimester of pregnancy, but may use after first trimester.44 46
Some clinicians suggest that pregnant women and possibly those planning to become pregnant (e.g., within 8 weeks of potential exposure) avoid environmental exposure to aerosolized pentamidine.205 261 264 (See Environmental Exposure of Health-care Personnel and Visitors under Cautions.)
Lactation
Not known whether distributed into milk.1 219 Discontinue nursing or the drug.1 219
Pediatric Use
IM or IV: Safety and efficacy established for treatment of PCP in children >4 months of age;1 no unusual risks identified.85 89 90 130 Also has been used effectively and apparently without unusual risks in children for treatment of first-stage (hemolymphatic) African trypanosomiasis†100 101 and for treatment of leishmaniasis†.53
Oral inhalation via nebulization: Manufacturer states safety and efficacy not established in children ≤16 years of age.219 Recommended by CDC, NIH, IDSA, and AAP as an alternative for prevention of PCP in children ≥5 years of age† capable of effectively using the Respirgard II jet nebulizer.156
Hepatic Impairment
IM or IV: Use with caution in patients with hepatic impairment;1 219 safety and efficacy of alternative dosage regimens not established in these patients.1
Oral inhalation via nebulization: Pharmacokinetic data not available.219
Renal Impairment
IM or IV: Use with caution in patients with renal impairment;1 safety and efficacy of alternative dosage regimens not established in these patients.1 (See Renal Impairment under Dosage and Administration.)
Oral inhalation via nebulization: Pharmacokinetic data not available.219
Common Adverse Effects
IM or IV: Nephrotoxicity,1 83 84 85 86 89 96 167 169 188 202 271 hypotension,1 41 43 52 83 86 124 159 167 188 202 279 hepatic effects,1 83 167 169 174 202 GI effects (anorexia, nausea, vomiting),1 52 83 90 167 202 219 278 279 hematologic effects (leukopenia),1 188 202 279 hypoglycemia,1 31 32 33 34 35 81 83 84 85 86 89 90 165 167 169 180 188 202 243 injection site reactions.1 81 83 86 124
Oral inhalation via nebulization: Respiratory effects (cough, bronchospasm, wheezing, shortness of breath),219 222 231 278 279 GI effects (diarrhea, nausea, decreased appetite).219
Drug Interactions
Nephrotoxic Drugs
Closely monitor or avoid concurrent or sequential use with other nephrotoxic drugs since nephrotoxic effects may be additive.1 83 84 85 219
Specific Drugs
|
Drug |
Interaction |
Comments |
|---|---|---|
|
Aminoglycosides |
Closely monitor or avoid concurrent or sequential use1 83 84 85 219 |
|
|
Amphotericin B |
Closely monitor or avoid concurrent or sequential use1 83 84 85 219 |
|
|
Capreomycin |
Closely monitor or avoid concurrent or sequential use1 83 84 85 219 |
|
|
Colistin (commercially available in US as colistimethate sodium) |
Closely monitor or avoid concurrent or sequential use1 83 84 85 219 |
|
|
Cisplatin |
Closely monitor or avoid concurrent or sequential use1 83 84 85 219 |
|
|
Foscarnet |
Closely monitor or avoid concurrent or sequential use1 83 84 85 219 |
|
|
Polymyxin B |
Closely monitor or avoid concurrent or sequential use1 83 84 85 219 |
|
|
Vancomycin |
Closely monitor or avoid concurrent or sequential use1 83 84 85 219 |
Pentamidine (Systemic, Local) Pharmacokinetics
Absorption
Bioavailability
Well absorbed following IM administration.1 77
Bronchoalveolar lavage fluid concentrations attained following oral inhalation are substantially higher (at least 5–10 times) than those attained following IV administration.174 181 182 211 212 219 277
Appears to undergo limited absorption from the respiratory tract into systemic circulation,174 181 182 but possible extent of accumulation following chronic oral inhalation therapy not known.219
Plasma Concentrations
Peak plasma concentrations attained following oral inhalation via nebulization are substantially lower than those attained following IV administration.182 219
Special Populations
Plasma pentamidine concentrations following parenteral administration are higher in patients with renal impairment.1 77
Distribution
Extent
Rapidly and extensively distributed and/or bound to tissues.77 171 183 Following parenteral administration, highest concentrations are found in liver, followed by kidneys, adrenals, spleen, lungs, and pancreas in AIDS patients.183
Penetrates the CNS poorly.2 15 43 44 100 101 102 103
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
Crosses the placenta;355 not known whether distributed into milk.
Plasma Protein Binding
69%.172
Elimination
Elimination Route
Excreted in urine as unchanged drug;77 171 185 renal clearance accounts for ≤5% of total body clearance.171 172 185
Not appreciably removed by hemodialysis or peritoneal dialysis.185
Half-life
Eliminated very slowly from tissues where the drug accumulates (e.g., liver, lungs);182 183 terminal half-lives of 2.8–12 days reported with IV dosage of 2–4 mg/kg daily.1
Special Populations
Parenteral: Limited data indicate half-life not substantially altered in patients with mild to moderate renal impairment, but may be prolonged up to ≥2 days in those with severe renal impairment.185
Oral inhalation via nebulization: Information not available on pharmacokinetics in patients with renal or hepatic impairment.219
Stability
Storage
Parenteral
Powder for IM or IV Use
20–25°C; protect from light.1
Following reconstitution with sterile water for injection, stable in original vial for 48 hours at room temperature if protected from light.1 Store at 22–30°C to avoid crystallization.1
Following dilution with 5% dextrose in water to a concentration of 1 or 2.5 mg/mL, stable at room temperature for up to 24 hours.1
Oral Inhalation via Nebulization
Powder for Inhalation Solution
20–25°C; protect from light.219
Following reconstitution with sterile water for injection, stable in original vial for 48 hours if protected from light.219
Compatibility
Parenteral
Solution CompatibilityHID
|
Compatible |
|---|
|
Dextrose 5% in water |
|
Sodium chloride 0.9% |
Drug Compatibility
|
Compatible |
|---|
|
Diltiazem HCl |
|
Zidovudine |
|
Incompatible |
|
Aldesleukin |
|
Cefazolin sodium |
|
Cefotaxime sodium |
|
Cefoxitin sodium |
|
Ceftazidime |
|
Ceftriaxone sodium |
|
Fluconazole |
|
Foscarnet sodium |
|
Lansoprazole |
|
Linezolid |
Oral Inhalation
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 44 219 interferes with protozoal nuclear metabolism by inhibiting DNA, RNA, phospholipid, and protein synthesis.1 219
-
Spectrum of activity includes many protozoa2 8 9 10 11 12 13 15 22 23 27 41 42 43 44 46 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 80 81 82 83 84 85 86 89 90 96 and some fungi.1 15 28 29 30 79 80 81 82 83 84 85 86 89 90 96
-
Active in vivo and in vitro against P. jirovecii (formerly P. carinii).1 15 28 29 30 79 80 81 82 83 84 85 86 89 90 96 In vitro studies indicate the drug appears to be directly lethal to P. jirovecii at concentrations attainable in vivo.28 29 30
-
Active in vitro and/or in vivo against causative agents of African trypanosomiasis, including most strains of T. b. gambiense2 15 41 42 43 44 146 147 148 and some strains of T. b. rhodesiense;2 15 27 41 42 43 44 59 149 150 151 not active against T. cruzi (causative agent of American trypanosomiasis [Chagas disease]).2 15 59
-
Active in vitro and/or in vivo against L. donovani (including antimony-resistant strains)50 52 53 54 153 and L. aethiopica.46 55 56
-
Resistance to pentamidine has been reported in some trypanosomes;74 75 76 resistance appears to occur primarily because of reduced uptake of the drug.44 74 75 76
Advice to Patients
-
Importance of completing full course of therapy.219
-
When used for the prevention of PCP, importance of informing clinicians if symptoms of a pulmonary infection (cough, fever, dyspnea) occur.219
-
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 219
-
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 219
-
Importance of informing patients of other important precautionary information.1 219 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
|
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
|---|---|---|---|---|
|
Oral Inhalation |
For solution, for nebulization |
300 mg |
NebuPent |
APP |
|
Parenteral |
For injection |
300 mg* |
Pentam 300 |
APP |
|
Pentamidine Isethionate for Injection |
AHFS DI Essentials™. © Copyright 2024, Selected Revisions April 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
1. APP Pharmaceuticals, LLC. Pentam 300 (pentamidine isethionate) lyophilized powder, for injection for intramuscular or intravenous use prescribing information. Schaumburg, IL; 2008 Mar.
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3. Wien R. The pharmacological actions of certain aromatic diamidines possessing trypanocidal activity. Ann Trop Med Parasit. 1943; 37:1-18.
4. Lourie EM, Yorke W. Studies in chemotherapy. XXI. The trypanocidal action of certain aromatic diamidines. Ann Trop Med Parasit. 1939; 33:289-304.
5. Ashley JN, Barber HJ, Ewins AJ et al. A chemotherapeutic comparison of the trypanocidal action of some aromatic diamidines. J Chem Soc. 1942; 20:103-16.
6. The British pharmacopoeia. London: Her Majesty's Stationery Office; 1980:330.
7. Windholz M, ed. The Merck index. 10th ed. Rahway, NJ: Merck & Co, Inc; 1983:1023.
8. Chesters JK. Protein synthesis by cell-free extracts of Crithidia oncopelti. Biochim Biophys Acta. 1966; 114:385-97.
9. Wallis DC. The effect of pentamidine on ribosomes of the parasitic flagellate Crithidia (Strigomonas) oncopelti. J Protozool. 1966; 13:234-9.
10. Bachrach U, Brem S, Wertman SB et al. Leishmania spp.: effect of inhibitors on growth and on polyamine and macromolecular syntheses. Exp Parasitol. 1979; 48:464-70. http://www.ncbi.nlm.nih.gov/pubmed/510448?dopt=AbstractPlus
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12. Kaplan HG, Myers CE. Complex inhibition of thymidylate synthetase by aromatic diamidines: evidence for both rapid, freely reversible and slowly progressive, nonequilibrium inhibition. J Pharmacol Exp Ther. 1977; 201:554-63. http://www.ncbi.nlm.nih.gov/pubmed/864595?dopt=AbstractPlus
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90. Siegel SE, Wolff LJ, Baehner RL et al. Treatment of Pneumocystis carinii pneumonitis. A comparative trial of sulfamethoxazole-trimethoprim v pentamidine in pediatric patients with cancer: report from the Children's Cancer Study Group. Am J Dis Child. 1984; 138:1051-4. http://www.ncbi.nlm.nih.gov/pubmed/6388315?dopt=AbstractPlus
96. Kovacs JA, Hiemenz JW, Macher AM et al. Pneumocystis carinii pneumonia: a comparison between patients with the acquired immunodeficiency syndrome and patients with other immunodeficiencies. Ann Intern Med. 1984; 100:663-71. http://www.ncbi.nlm.nih.gov/pubmed/6231873?dopt=AbstractPlus
100. Lawson TL. Trypanosomiasis treated with ″pentamidine'. Lancet. 1942; 2:480-3.
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102. Harding RD. Trypanosomiasis treated with pentamidine. Br Med J. 1944; 2:447. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=2286361&blobtype=pdf
103. Van Hoof L, Henrard C, Peel E. Pentamidine in the prevention and treatment of trypanosomiasis. Trans R Soc Trop Med Hyg. 1944; 37:271-80.
104. Van Hoof L, Lewillon R, Henrard C et al. A field experiment on the prophylactic value of pentamidine in sleeping sickness. Trans Roy Soc Trop Med Hyg. 1946: 39:327-9.
105. American Academy of Pediatrics. Red Book: 2012 Report of the Committee on Infectious Diseases. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012.
107. Molyneux DH. Selective primary health care: strategies for control of disease in the developing world. VIII. African trypanosomiasis. Rev Infect Dis. 1983; 5:945-56. http://www.ncbi.nlm.nih.gov/pubmed/6635428?dopt=AbstractPlus
113. Chulay JD, Manson-Bahr PEC. Visceral leishmaniasis (kala-azar). In: Strickland GT, ed. Hunter's tropical medicine. 6th ed. Philadelphia: WB Sauders Company; 1984:578-85.
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