Pentamidine

Allyson K. Bloom, Edward T. Ryan

Description

4,4-[1,5-pentanediylbis(oxy)]bis-benzenecarboximidamid.

Available Products

1. Pentamidine isethionate for injection (Pentam-300®, APP Pharmaceuticals); available in 15-ml vials as 300 mg of lyophilized powder for reconstitution.

2. Pentamidine isethionate for aerosolization (Nebu-Pent®, APP Pharmaceuticals); available in 15-ml vials as 300 mg of lyophilized powder.

3. Dosing recommendations are usually based on the pentamidine isethionate formulation, which is labeled according to the weight of the isethionate salt compound. A mesylate salt compound is also available; dosing of the mesylate salt is based on the weight of pentamidine alone; 1.74 mg of pentamidine isethionate is equivalent to 1 mg of pentamidine alone.

4. Inhaled and injectable pentamidine can also be found under other names in other countries, including Pentacarinat®.

Indications

1. Treatment and prophylaxis of Pneumocystic jiroveci pneumonia (PCP).

2. Treatment and prophylaxis of Trypanosoma brucei gambiense (unlabeled):

a. early stage without central nervous system (CNS) involvement.

3. Possible treatment of visceral leishmaniasis (unlabeled):

a. in relapse after pentavalent antimony;
b. some clinical trials report efficacy in cutaneous leishmaniasis.

Mode of Action

Unclear in vivo mechanism.

Pharmacokinetics

Peak levels achieved at end of intravenous (IV) infusion or 40 minutes following intramuscular (IM) administration. Half-life: 6–9 hours. Distributes to kidneys, liver, spleen, lungs. Unknown metabolism. Excreted unchanged in the urine. Aerosol administration results in low systemic absorption.

DOse Adjustments in Renal Failure

CrCl 10–50 ml/min: administer dose every 24–36 hours.

CrCl <10: administer dose every 48 hours.

Not removed by renal replacement therapy, including dialysis.

Dose Adjustments in Liver Failure

None.

Dose

Injectable

Treatment of PCP:

3–4 mg/kg IV or IM daily × 14–21 days.

Prevention of PCP:

4 mg/kg IV or IM once every month.

Treatment of blood-stage trypanosomiasis caused by T. b. gambiense:

4 mg/kg IV or IM daily × 7–10 days.

Prophylaxis of trypanosomiasis caused by T. b. gambiense:

4 mg/kg IV or IM once every 3–6 months.

Treatment of leishmaniasis (alternative agent for certain types of cutaneous leishmaniasis):

2–3 mg/kg IV or IM daily or every other day for 4–7 doses.

Inhaled

Prevention of PCP:

300 mg inhaled via Respirgard II nebulizer once every four weeks.

Route of Administration

IV, IM or inhaled. No oral preparation.

How to Give the Drug

Do not reconstitute with sodium chloride (precipitation will occur).

IM: dissolve the 300 mg contents of the vial in 3 ml sterile water. Administer the calculated dose via deep IM injection.

IV: dissolve the 300 mg contents of the vial in 3 ml sterile water. Further dilute the calculated dose in 250 ml 5% dextrose in water. Infuse the calculated dose over 1–2 hours to a supine patient; monitor blood pressure.

Inhaled: dissolve the 300 mg contents of the vial in 6 ml sterile water. Transfer into Respirgard II nebulizer reservoir. Using a 40–50 pounds per square inch (PSI) air or oxygen source, set the flow rate at 5–7 liters per minute.

Adverse Events and Serious Adverse Events

Administration of parenteral pentamidine has been associated with severe hypotension, hypoglycemia, pancreatitis, cardiac arhythmias and death. Extravasation of IV preparation can lead to necrosis. Sterile abscesses can occur at IM administration site.

Renal: nephrotoxicity common. Hyperkalemia, hypocalcemia, hypomagnesemia.

Endocrine: damages pancreatic islet cells; can lead to insulin release, hypoglycemia and eventual diabetes.

Gastrointestinal: anorexia, nausea, vomiting common. Pancreatitis and hepatitis.

Cardiac: prolonged QT prolongation and torsades de pointes.

Respiratory: inhalational administration induces cough and bronchospasm.

Hematologic: leukopenia, anemia, thrombocytopenia.

Key Drug Interactions

Do not administer with other drugs associated with QT prolongation (particularly arthemether, lumefantrine, nilotinib, quinine, chloroquine, ciprofloxacin, tetrabenazine, thioridazine, ziprasidone). As a substrate of CYP2C19, levels may be decreased by strong CYP2C9 inducers, such as carbamazepine, phenytoin, ritonavir and rifampin. Avoid concurrent use with other nephrotoxins, including amphotericin B, aminoglycosides and foscarnet.

Contraindications

As above.

Use in Special Populations

Pregnancy

Category C.

Lactation

Unknown.

Pediatrics

Dosing and safety in children >4 months old comparable to use in adults.

Elderly (Age >60 Years)

No specific recommendations.

Resistance

Leishmania resistance reported. Resistance may relate to decreased transport across protozoal membranes (for Trypanosoma) and into mitochrondria (for Leishmania).

Storage

Room temperature; protect from light.

Availability in the USA

Available in the USA.

Comments on Use

Monitor glucose, electrolytes, renal function, hepatic function, blood pressure and EKG-QTc.

Further Reading

Bray PG, Barrett MP, Ward SA, Koning HP. Pentamidine uptake and resistance in pathogenic protozoa: past, present, and future. Trends Parasitol. 2003;19:232–239.

Ena J, Amador C, Pasqau F, et al. Once-a-month administration of intravenous pentamidine to patients infected with Human Immunodeficiency Virus as prophylaxis for Pneumocystis carinii pneumonia. Clin Inf Dis. 1994;18:901–904.

Lexi-Comp Online. Available at http://online.lexi.com (last accessed 1st March 2012)

O’Brien JG, Dong BJ, Coleman RL, et al. A 5-year retrospective review of adverse drug reactions and their risk factors in Human Immunodeficiency Virus-infected patients who were receiving intravenous pentamidine therapy for Pneumocystic carinii pneumonia. Clin Inf Dis. 1997;24:854–859.

Soto-Mancipe J, Grogl M, Berman JD. Evaluation of pentamidine for the treatment of cutaneous leishmaniasis in Colombia. Clin Inf Dis. 1993;16:417–425.