Pentamidine isethionate

FDA label, Fresenius Kabi USA, LLC, intramuscular, effective 2022-09-13. 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 CAUTION: DO NOT USE SODIUM CHLORIDE INJECTION, USP FOR INITIAL RECONSTITUTION BECAUSE PRECIPITATION WILL OCCUR. Pentamidine isethionate should be administered IM or IV only. The recommended regimen for adults and pediatric patients beyond 4 months of age is 4 mg/kg once a day for 14 to 21 days.

Intravenous Injection The contents of one vial (300 mg) should first be dissolved in 3 to 5 mL of Sterile Water for Injection, USP, or 5% Dextrose Injection, USP at 22°- 30°C (72° - 86°F). The calculated dose of pentamidine isethionate should then be withdrawn and diluted further in 50 to 250 mL of 5% Dextrose Injection, USP.

The diluted IV solutions containing pentamidine isethionate should be infused over a period of 60 to 120 minutes. Aseptic technique should be employed in preparation of all solutions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Stability After reconstitution with sterile water, the Pentam solution is stable for 48 hours in the original vial at room temperature if protected from light. To avoid crystallization,store at 22° - 30°C (72° - 86°F). Intravenous infusion solutions of pentamidine isethionate at 1 mg/mL and 2.5 mg/mL prepared in 5% Dextrose Injection, USP are stable at room temperature for up to 24 hours.

Intravenous (IV) solutions of pentamidine isethionate have been shown to be incompatible with fluconazole and foscarnet sodium. IV solutions of pentamidine isethionate have been shown to be compatible with IV solutions of zidovudine (AZT) and diltiazem hydrochloride. Intramuscular Injection The contents of one vial (300 mg) should be dissolved in 3 mL of Sterile Water for Injection, USP at 22° - 30°C (72° - 86°F).

The calculated daily dose should then be withdrawn and administered by deep IM injection. Intravenous Injection The contents of one vial (300 mg) should first be dissolved in 3 to 5 mL of Sterile Water for Injection, USP, or 5% Dextrose Injection, USP at 22°- 30°C (72° - 86°F). The calculated dose of pentamidine isethionate should then be withdrawn and diluted further in 50 to 250 mL of 5% Dextrose Injection, USP.

The diluted IV solutions containing pentamidine isethionate should be infused over a period of 60 to 120 minutes. Aseptic technique should be employed in preparation of all solutions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Stability After reconstitution with sterile water, the Pentam solution is stable for 48 hours in the original vial at room temperature if protected from light. To avoid crystallization,store at 22° - 30°C (72° - 86°F). Intravenous infusion solutions of pentamidine isethionate at 1 mg/mL and 2.5 mg/mL prepared in 5% Dextrose Injection, USP are stable at room temperature for up to 24 hours.

Intravenous (IV) solutions of pentamidine isethionate have been shown to be incompatible with fluconazole and foscarnet sodium. IV solutions of pentamidine isethionate have been shown to be compatible with IV solutions of zidovudine (AZT) and diltiazem hydrochloride.

Drug interactions

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Label text (1 paragraph)

Drug Interactions No drug interaction studies with Pentam 300 have been conducted. 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

Contraindicated in patients with a history of hypersensitivity to pentamidine isethionate.

Pregnancy and lactation

Pregnancy

Pregnancy-Pregnancy Category C Animal reproduction studies have not been conducted with pentamidine isethionate. It is also not known whether pentamidine isethionate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pentamidine isethionate should not be given to a pregnant woman unless the potential benefits are judged to outweigh the unknown risks.

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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