Pentamidine diisethionate (inhaled)

FDA label, PAI Holdings, LLC dba PAI Pharma, respiratory (inhalation), effective 2026-06-12. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

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Preparation and administration

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DOSAGE AND ADMINISTRATION IMPORTANT: PENTAMIDINE ISETHIONATE MUST BE DISSOLVED ONLY IN STERILE WATER FOR INJECTION, USP. DO NOT USE SALINE SOLUTION FOR RECONSTITUTION BECAUSE THE DRUG WILL PRECIPITATE. DO NOT MIX THE Pentamidine Isethionate SOLUTION WITH ANY OTHER DRUGS. DO NOT USE THE RESPIRGARD® II NEBULIZER TO ADMINISTER A BRONCHODILATOR.

Reconstitution The contents of one vial (300 mg) must be dissolved in 6 mL Sterile Water for Injection, USP. Place the entire reconstituted contents of the vial into the Respirgard® II nebulizer reservoir for administration. Dosage The recommended adult dosage of Pentamidine Isethionate for the prevention of Pneumocystis jiroveci pneumonia is 300 mg once every four weeks administered via the Respirgard® II nebulizer.

Low pressure (less than 20 PSI) compressors should not be used. Stability Freshly prepared solutions for aerosol use are recommended. After reconstitution with sterile water, the Pentamidine Isethionate solution is stable for 48 hours in the original vial at room temperature if protected from light.

Drug interactions

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Label text (1 paragraph)

Drug Interactions While specific studies on drug interactions with Pentamidine Isethionate have not been conducted, the majority of patients in clinical trials received concomitant medications, including zidovudine, with no reported interactions. Because the nephrotoxic effects may be additive, the concomitant or sequential use of Pentamidine Isethionate and other nephrotoxic drugs such as aminoglycosides, amphotericin B, cisplatin, foscarnet, or vancomycin should be closely monitored and avoided, if possible.

Contraindications

Pentamidine Isethionate is contraindicated in patients with a history of an anaphylactic reaction to inhaled or parenteral pentamidine isethionate.

Pregnancy and lactation

Pregnancy

Pregnancy-Pregnancy Category C There are no adequate and well controlled studies of Pentamidine Isethionate in pregnant women. A literature report indicated that intravenously administered pentamidine in pregnant rats at 4 mg/kg/day was embryolethal; teratogenicity was not observed in this study. It is unknown whether pentamidine administered via the aerosolized route crosses the placenta at clinically significant concentrations. It is not known whether Pentamidine Isethionate can cause fetal harm when administered to a pregnant woman. Pentamidine Isethionate should be given to a pregnant woman only if clearly needed.

Lactation

Nursing Mothers It is not known whether Pentamidine Isethionate is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Pentamidine Isethionate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Because many drugs are excreted in human milk, Pentamidine Isethionate should not be given to a nursing mother unless the potential benefits are judged to outweigh the unknown risks.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

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