Clinical Information
Gen. Code and Des.
9599 pentamidine isethionate INJECTION VIAL 300 MG
GCN and Des.
42990 pentamidine isethionate INJECTION VIAL 300 MG
Strength
300MG
Dose Form
VIAL (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
8309200 ANTIPROTOZOALS, MISCELLANEOUS
Active Ingredients
2971 pentamidine isethionate 140647
PENTAM 300- pentamidine isethionate injection, powder, lyophilized, for solution
APP Pharmaceuticals, LLC
For Injection Only
DESCRIPTION
Pentam 300 (pentamidine isethionate for injection), an anti-protozoal agent, is a sterile, nonpyrogenic, lyophilized product. After reconstitution, it should be administered by intramuscular (IM) or intravenous (IV) routes (see DOSAGE AND ADMINISTRATION). Pentamidine isethionate is a white crystalline powder soluble in water and glycerin, slightly soluble in alcohol and insoluble in ether, acetone, and chloroform. It is chemically designated as 4,4-[1,5-pentanediylbis(oxy)]bis-benzenecarboximidamid.
Each vial contains:
Pentamidine isethionate . . . . . . . . . . . . . 300 mg
CLINICAL PHARMACOLOGY
Pentamidine isethionate, an aromatic diamidine, is known to have activity against Pneumocystis carinii. The mode of action of pentamidine is not fully understood. In vitro studies indicate that the drug interferes with protozoal nuclear metabolism by inhibition of DNA, RNA, phospholipid and protein synthesis.
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� - 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 The calculated daily dose should then be withdrawn and administered by deep IM injection.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.
