Version May 2024
Leishmaniasis, visceral, secondary prophylaxis (off-label use): Note: For patients in East Africa coinfected with HIV and at high risk of visceral leishmaniasis relapse (eg, CD4 count <200 cells/mm3, not receiving antiretroviral therapy) (Ref).
IV: 300 mg once every 3 to 4 weeks until CD4 count >350 cells/mm3 or HIV viral load undetectable ≥6 months and no evidence of visceral leishmaniasis relapse (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; 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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Amisulpride (Oral): May enhance the QTc-prolonging effect of Pentamidine (Systemic). Risk C: Monitor therapy
Androgens: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Bacillus clausii: Antibiotics may diminish the therapeutic effect 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 diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect 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 combination
Dabrafenib: Pentamidine (Systemic) may enhance the QTc-prolonging effect 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 therapy
Domperidone: May enhance the QTc-prolonging effect of Pentamidine (Systemic). Management: Consider alternatives to this drug 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
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Fluorouracil Products: Pentamidine (Systemic) may enhance the QTc-prolonging effect 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 therapy
Foscarnet: Pentamidine (Systemic) may enhance the adverse/toxic effect 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 enhance the QTc-prolonging effect 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 therapy
Herbal Products with Glucose Lowering Effects: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy
Hypoglycemia-Associated Agents: May enhance the hypoglycemic effect of other Hypoglycemia-Associated Agents. Risk C: Monitor therapy
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Maitake: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Mequitazine: Pentamidine (Systemic) may enhance the arrhythmogenic effect of Mequitazine. Management: Consider alternatives to pentamidine or mequitazine when possible. While this combination is not specifically contraindicated, mequitazine labeling describes this combination as discouraged. Risk D: Consider therapy modification
Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Ondansetron: Pentamidine (Systemic) may enhance the QTc-prolonging effect 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 therapy
Pegvisomant: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Pimozide: May enhance the QTc-prolonging effect of Pentamidine (Systemic). Risk X: Avoid combination
Prothionamide: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
QT-prolonging Agents (Highest Risk): May enhance the QTc-prolonging effect 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 enhance the QTc-prolonging effect 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 therapy
QT-prolonging Antipsychotics (Moderate Risk): Pentamidine (Systemic) may enhance the QTc-prolonging effect 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 therapy
QT-prolonging Class IC Antiarrhythmics (Moderate Risk): May enhance the QTc-prolonging effect 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 therapy
QT-Prolonging Inhalational Anesthetics (Moderate Risk): Pentamidine (Systemic) may enhance the QTc-prolonging effect 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 therapy
QT-prolonging Kinase Inhibitors (Moderate Risk): Pentamidine (Systemic) may enhance the QTc-prolonging effect 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 therapy
QT-prolonging Miscellaneous Agents (Moderate Risk): May enhance the QTc-prolonging effect 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 therapy
QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): Pentamidine (Systemic) may enhance the QTc-prolonging effect 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 therapy
QT-prolonging Quinolone Antibiotics (Moderate Risk): Pentamidine (Systemic) may enhance the QTc-prolonging effect 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 therapy
QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): Pentamidine (Systemic) may enhance the QTc-prolonging effect 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 therapy
Quinolones: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect 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 therapy
Salicylates: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Saquinavir: Pentamidine (Systemic) may enhance the QTc-prolonging effect of Saquinavir. Risk X: Avoid combination
Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect 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
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect 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 enhance the therapeutic effect of Vasopressin. Specifically, the pressor and antidiuretic effects of vasopressin may be increased. Risk C: Monitor therapy
Pentamidine crosses the human placenta (Fortunato 1989; Schwebke 1995).
Intravenous pentamidine can be used as an alternative treatment in pregnant females with HIV infection for mild to moderate Pneumocystis pneumonia (PCP) (HHS [OI adult 2020]). Pentamidine may be used to treat stage one trypanosomiasis caused by T. brucei gambiense (CDC 2020); information related to treatment of pregnant females for this indication is 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. Females with HIV infection should completely avoid breastfeeding to decrease the potential transmission of HIV (HHS [perinatal 2019]).
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.
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