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Pentam (Pentamidine Isethionate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Pentam 300 (pentamidine isethionate for injection) is indicated for the treatment of pneumonia due to Pneumocystis carinii .

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. Therapy for longer than 21 days with pentamidine isethionate has also been used but may be associated with increased toxicity.

Intramuscular Injection

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 The calculated daily dose should then be withdrawn and administered by deep IM injection.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 The calculated dose of pentamidine isethionate should then be withdrawn and diluted further in 50 to 250 mL of 5% Dextrose Injection, USP.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

HOW SUPPLIED

Product

No

NDC

No.


11310

63323-113-10

PENTAM 300 (pentamidine isethiionate for injection) 300 mg, lyophilized product in single-dose vials, packages of 10.

Store dry product at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from light.

Preservative Free. Discard unused portion.

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