Leishmaniasis, visceral, secondary prophylaxis (off-label use): Note: For patients with HIV and CD4 count <200 cells/mm3 (Ref).
IV: 4 mg/kg (maximum: 300 mg) once every 2 to 4 weeks until CD4 count >350 cells/mm3, HIV viral load undetectable ≥6 months, and no evidence of visceral leishmaniasis relapse (Ref).
Pneumocystis pneumonia (alternative agent):
Prophylaxis (primary and secondary), patients with HIV (off-label use): IV: 300 mg every 28 days. Continue prophylaxis following initiation of antiretroviral therapy (ART) until CD4 count ≥200 cells/mm3 for ≥3 months; may consider discontinuation of prophylaxis in patients with a CD4 count between 100 to 200 cells/mm3 who are receiving ART and have had an undetectable viral load for ≥3 to 6 months (Ref).
Treatment: IV: 4 mg/kg/dose once daily (Ref) for 21 days (Ref); may reduce to 2 to 3 mg/kg/dose once daily if toxicity occurs (Ref).
West African trypanosomiasis (Trypanosoma brucei gambiense infection; sleeping sickness), first-stage disease (off-label use): IM, IV: 4 mg/kg once daily for 7 days (Ref).
IV: The FDA-approved labeling recommends that caution should be used in patients with renal impairment; however, no specific dosage adjustment guidelines are available. The following guidelines have been used by some clinicians (Ref):
CrCl ≥10 mL/minute: No dosage adjustment necessary.
CrCl <10 mL/minute: Administer 4 mg/kg every 24 to 36 hours.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). Use with caution.
Refer to adult dosing.
(For additional information see "Pentamidine (systemic): Pediatric drug information")
Pneumocystis jirovecii pneumonia (PCP), prophylaxis (primary and secondary) in oncology patients (including hematopoietic stem cell transplant recipients) and solid organ transplant recipients (alternative agent): Limited data available:
Infants, Children, and Adolescents: IV: 4 mg/kg/dose every 3 to 4 weeks; maximum dose: 300 mg/dose (Ref); administration as frequently as every 2 weeks has also been described (Ref).
Pneumocystis jirovecii pneumonia (PCP), treatment (alternative agent):
Non-HIV-exposed/-infected: Infants, Children, and Adolescents: IM, IV: 4 mg/kg/dose once daily for 21 days (Ref).
HIV-exposed/-infected:
Infants and Children: IV: 4 mg/kg/dose once daily; if clinical improvement after 7 to 10 days of therapy, may change to an oral regimen to complete a 21-day course (Ref).
Adolescents: IV: 4 mg/kg/dose once daily for 21 days; may reduce to 3 mg/kg/dose once daily if toxicity occurs (Ref).
African trypanosomiasis (sleeping sickness; T. brucei gambiense infection), first-stage disease (without CNS involvement), treatment:
Infants, Children, and Adolescents: IM, IV: 4 mg/kg/dose once daily for 7 days (Ref).
There are no specific dose adjustments provided in the manufacturer's labeling, has not been studied; use with caution. The following guidelines have been used by some clinicians based on usual pediatric dose of 4 mg/kg every 24 hours (Ref):
Infants, Children, and Adolescents: IV:
GFR >30 mL/minute/1.73 m2: No adjustment required.
GFR 10 to 30 mL/minute/1.73 m2: Administer 4 mg/kg/dose every 36 hours.
GFR <10 mL/minute/1.73 m2 and peritoneal dialysis: Administer 4 mg/kg/dose every 48 hours.
Hemodialysis: Administer 4 mg/kg/dose every 48 hours, after dialysis on dialysis days.
Peritoneal dialysis: 4 mg/kg/dose every 48 hours.
Continuous renal replacement therapy: No dosage adjustment required.
There are no dosage adjustment provided in the manufacturer's labeling; has not been studied. Use with caution.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Local: Injection site reaction (intramuscular: 11%; includes sterile abscess, necrosis, pain, induration)
Renal: Renal insufficiency (29%), increased serum creatinine (24%)
1% to 10%:
Cardiovascular: Hypotension (5%)
Central nervous system: Confusion (≤2%), hallucinations (≤2%)
Dermatologic: Skin rash (3%)
Endocrine & metabolic: Hypoglycemia (6%)
Gastrointestinal: Anorexia (≤6%), nausea (≤6%), dysgeusia (2%)
Hematologic & oncologic: Leukopenia (10%), thrombocytopenia (3%), anemia (1%)
Hepatic: Increased liver enzymes (9%)
Renal: Azotemia (9%), increased blood urea nitrogen (7%)
<1%, postmarketing, and/or case reports: Abdominal pain, acute pancreatitis, acute rhinitis, ageusia, amnesia, anaphylaxis, anosmia, anxiety, arthralgia, asthma, blepharitis, blurred vision, bronchitis, bronchospasm, cardiac arrhythmia, cerebrovascular accident, chest congestion, chest tightness, chills, confusion, conjunctivitis, contact lens intolerance, cough, cyanosis, depression, dermatitis, desquamation, diabetes mellitus, diabetic ketoacidosis, diarrhea, disseminated intravascular coagulation, dizziness, drowsiness, dry hair, dyspepsia, dyspnea, emotional lability, eosinophilia, eosinophilic pneumonitis, erythema, extravasation (tissue ulceration, necrosis, and/or sloughing), eye pain, flank pain, gag reflex, hair breakage, headache, hearing loss, hematochezia, hematuria, hemoptysis, hepatic insufficiency, hepatitis, hepatomegaly, hyperglycemia, hyperkalemia, hypersensitivity reaction, hypertension, hyperventilation, hypocalcemia, hypoesthesia, hypomagnesemia, insomnia, interstitial pneumonitis, laryngitis, laryngospasm, melena, nasal congestion, nephritis, nervousness, neuralgia, neuropathy, neutropenia, night sweats, palpitations, pancreatitis, pancytopenia, paranoia, paresthesia, peripheral neuropathy, phlebitis, pleurisy, pneumothorax, prolonged prothrombin time, pruritus, pulmonary disease, rales, renal failure, renal insufficiency, rhinitis, seizure, serious infection (extrapulmonary pneumocystosis), sialorrhea, splenomegaly, Stevens-Johnson syndrome, ST segment changes on ECG, syncope, tachycardia, tachypnea, torsades de pointes, tremor, unsteady gait, urinary incontinence, urticaria, vasodilation, vasculitis, ventricular tachycardia, vertigo, vomiting, xeroderma, xerostomia
Hypersensitivity to pentamidine isethionate or any component of the formulation
Concerns related to adverse effects:
• Hypotension: Severe hypotension (some fatalities) has been observed, even after a single dose. May occur with either IV or IM administration, although more common with rapid IV administration. Monitor blood pressure during (and after) infusion.
• QT prolongation: May cause QT prolongation and subsequent torsade de pointes; avoid use in patients with diagnosed or suspected congenital long QT syndrome.
• Stevens-Johnson syndrome: Has been reported with use.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with preexisting cardiovascular disease; hyper-/hypotension and arrhythmia, including ventricular tachycardia (eg, torsade de pointes) have been reported.
• Diabetes: Use with caution in patients with diabetes mellitus; hyper-/hypoglycemia and pancreatic islet cell necrosis with hyperinsulinemia has been reported. Symptoms may occur months after therapy; monitor blood glucose daily on therapy and periodically thereafter.
• Extravasation: Intravenous pentamidine is an irritant with vesicant-like properties. Ensure proper needle or catheter placement prior to and during infusion; avoid extravasation. Ulceration, tissue necrosis, and/or sloughing have been reported with extravasation.
• Hematologic disorders: Use with caution in patients with current evidence and/or prior history of hematologic disorders; anemia, leukopenia and/or thrombocytopenia have been reported. Concurrent use with other bone marrow suppressants may increase the risk for myelotoxicity.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Hypocalcemia: Use with caution in patients with hypocalcemia.
• Pancreatitis: Use with caution in patients with a history of pancreatic disease or elevated amylase/lipase levels; acute pancreatitis (with fatality) has been reported. Discontinue pentamidine if signs/symptoms of acute pancreatitis occur.
• Renal impairment: Use with caution in patients with renal impairment.
Concurrent drug therapy issues:
• Drugs with QT prolongation potential: Avoid concurrent use with other drugs known to prolong QTc interval.
• Nephrotoxic drugs: Concurrent use with other nephrotoxic drugs may increase the risk for nephrotoxicity.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Injection, as isethionate [preservative free]:
Pentam: 300 mg (1 ea)
Generic: 300 mg (1 ea)
Yes
Solution (reconstituted) (Pentam Injection)
300 mg (per each): $200.27
Solution (reconstituted) (Pentamidine Isethionate Injection)
300 mg (per each): $112.50 - $180.50
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Injection:
Generic: 200 mg (1 ea)
Solution Reconstituted, Injection, as isethionate:
Generic: 300 mg (1 ea)
IM: Administer deep IM.
IV: Infuse slowly over 60 to 120 minutes; rapid IV administration can cause severe hypotension.
Irritant with vesicant-like properties; ensure proper needle or catheter placement prior to and during infusion. Avoid extravasation.
Extravasation management: If extravasation occurs, stop infusion immediately; leave cannula/needle in place temporarily but do NOT flush the line; gently aspirate extravasated solution, then remove needle/cannula; elevate extremity; apply dry warm compresses (Ref).
Parenteral:
IM: Administer deep IM.
IV: Administer by slow IV infusion over a period of at least 60 to 120 minutes; rapid IV administration can cause severe hypotension.
Irritant with vesicant-like properties; ensure proper needle or catheter placement prior to and during infusion. Avoid extravasation. If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity. Apply dry warm compresses (Ref).
Pneumocystis pneumonia, treatment: Treatment of pneumonia caused by Pneumocystis jirovecii.
Leishmaniasis, visceral, secondary prophylaxis; Pneumocystis pneumonia, prophylaxis; West African trypanosomiasis (Trypanosoma brucei gambiense infection; sleeping sickness), first stage
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Amisulpride (Oral): May increase QTc-prolonging effects of Pentamidine (Systemic). Risk C: Monitor
Androgens: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Antidiabetic Agents: Hyperglycemia-Associated Agents may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Antidiabetic Agents: May increase hypoglycemic effects of Hypoglycemia-Associated Agents. Risk C: Monitor
Bacillus clausii: Antibiotics may decrease therapeutic effects of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider Therapy Modification
BCG (Intravesical): Antibiotics may decrease therapeutic effects of BCG (Intravesical). Risk X: Avoid
BCG Vaccine (Immunization): Antibiotics may decrease therapeutic effects of BCG Vaccine (Immunization). Risk C: Monitor
Cholera Vaccine: Antibiotics may decrease therapeutic effects of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid
Dabrafenib: Pentamidine (Systemic) may increase QTc-prolonging effects of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Domperidone: May increase QTc-prolonging effects of Pentamidine (Systemic). Risk X: Avoid
Fecal Microbiota (Live) (Oral): May decrease therapeutic effects of Antibiotics. Risk X: Avoid
Fecal Microbiota (Live) (Rectal): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Rectal). Risk X: Avoid
Fluorouracil Products: Pentamidine (Systemic) may increase QTc-prolonging effects of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Foscarnet: Pentamidine (Systemic) may increase adverse/toxic effects of Foscarnet. The specific toxicities may include hypocalcemia, renal failure, and QT-prolongation. Management: Consider alternatives to this combination when possible. If this combination must be used, monitor patients more closely for hypocalcemia, renal dysfunction, and QT interval prolongation. Risk D: Consider Therapy Modification
Haloperidol: May increase QTc-prolonging effects of Pentamidine (Systemic). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Herbal Products with Glucose Lowering Effects: May increase hypoglycemic effects of Hypoglycemia-Associated Agents. Risk C: Monitor
Hypoglycemia-Associated Agents: May increase hypoglycemic effects of Hypoglycemia-Associated Agents. Risk C: Monitor
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor
Lactobacillus and Estriol: Antibiotics may decrease therapeutic effects of Lactobacillus and Estriol. Risk C: Monitor
Levoketoconazole: Pentamidine (Systemic) may increase QTc-prolonging effects of Levoketoconazole. Risk X: Avoid
Maitake: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Monoamine Oxidase Inhibitors: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Mycophenolate: Antibiotics may decrease active metabolite exposure of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor
Ondansetron: Pentamidine (Systemic) may increase QTc-prolonging effects of Ondansetron. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Pegvisomant: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Pimozide: May increase QTc-prolonging effects of Pentamidine (Systemic). Risk X: Avoid
Piperaquine: Pentamidine (Systemic) may increase QTc-prolonging effects of Piperaquine. Risk X: Avoid
Prothionamide: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
QT-prolonging Agents (Highest Risk): May increase QTc-prolonging effects of Pentamidine (Systemic). Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
QT-prolonging Antidepressants (Moderate Risk): Pentamidine (Systemic) may increase QTc-prolonging effects of QT-prolonging Antidepressants (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
QT-prolonging Antipsychotics (Moderate Risk): Pentamidine (Systemic) may increase QTc-prolonging effects of QT-prolonging Antipsychotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
QT-prolonging Class IC Antiarrhythmics (Moderate Risk): May increase QTc-prolonging effects of Pentamidine (Systemic). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
QT-Prolonging Inhalational Anesthetics (Moderate Risk): Pentamidine (Systemic) may increase QTc-prolonging effects of QT-Prolonging Inhalational Anesthetics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
QT-prolonging Kinase Inhibitors (Moderate Risk): Pentamidine (Systemic) may increase QTc-prolonging effects of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
QT-prolonging Miscellaneous Agents (Moderate Risk): May increase QTc-prolonging effects of Pentamidine (Systemic). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): Pentamidine (Systemic) may increase QTc-prolonging effects of QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
QT-prolonging Quinolone Antibiotics (Moderate Risk): Pentamidine (Systemic) may increase QTc-prolonging effects of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): Pentamidine (Systemic) may increase QTc-prolonging effects of QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Quinolones: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Quinolones may decrease therapeutic effects of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor
Salicylates: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Saquinavir: Pentamidine (Systemic) may increase QTc-prolonging effects of Saquinavir. Risk X: Avoid
Selective Serotonin Reuptake Inhibitor: May increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Risk C: Monitor
Sertindole: Pentamidine (Systemic) may increase QTc-prolonging effects of Sertindole. Risk X: Avoid
Sodium Picosulfate: Antibiotics may decrease therapeutic effects of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider Therapy Modification
Thioridazine: Pentamidine (Systemic) may increase QTc-prolonging effects of Thioridazine. Risk X: Avoid
Typhoid Vaccine: Antibiotics may decrease therapeutic effects of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider Therapy Modification
Vasopressin: Drugs Suspected of Causing SIADH may increase therapeutic effects of Vasopressin. Specifically, the pressor and antidiuretic effects of vasopressin may be increased. Risk C: Monitor
Pentamidine crosses the human placenta (Fortunato 1989; Schwebke 1995).
Intravenous pentamidine can be used as an alternative treatment in pregnant patients with HIV infection for mild to moderate Pneumocystis pneumonia (HHS [OI adult 2024]). Pentamidine may be used to treat stage one trypanosomiasis caused by T. brucei gambiense (CDC 2020); data related to treatment of pregnant patients for this indication are limited (Pohlig 2016).
It is not known if pentamidine is present in breast milk.
Due to the potential for serious adverse reactions in the breastfeeding infant, the manufacturer recommends a decision be made whether to discontinue breastfeeding or to discontinue the drug, considering the importance of treatment to the mother.
LFTs, renal function tests, blood glucose, serum potassium and calcium, CBC and platelets; ECG; BP (during and after infusion).
Interferes with microbial RNA/DNA, phospholipids and protein synthesis, through inhibition of oxidative phosphorylation and/or interference with incorporation of nucleotides and nucleic acids into RNA and DNA
Absorption: IM: Well absorbed.
Distribution: Vdss: Binds to tissues and plasma protein; high concentrations are found in the liver, kidney, adrenals, spleen, lungs, and pancreas; poor penetration into CNS; IV: 821 ± 535 L; IM: 2724 ± 1066 L.
Half-life elimination: IV: 6.4 ± 1.3 hours; IM: 9.4 ± 2 hours; may be prolonged with severe renal impairment.
Excretion: Urine (IV: ≤12% as unchanged drug).
Altered kidney function: Pentamidine may accumulate in renal failure.