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Approved for HIV-Infected Individuals at High Risk for Pneumocystis carinii Pneumonia

Frank E. Young, MD, PhD; Stuart L. Nightingale, MD; Ellen C. Cooper, MD; Carol Braun Trapnell, MD

Arch Intern Med. 1989;149(11):2412-2413.

Abstract
• Aerosolized pentamidine isethionate (NebuPent, LyphoMed Inc, Rosemont, III) was recently approved by the US Food and Drug Administration for use in prophylaxis against Pneumocystis carinii pneumonia in individuals infected with the human immunodeficiency virus who are at high risk for this infection. The recommended dose is 300 mg of aerosolized pentamidine isethionate administered every 4 weeks via the Respirgard II nebulizer (Marquest Medical Products Inc, Englewood, Colo). The drug is indicated for individuals infected with the human immunodeficiency virus who have a history of P carinii pneumonia or individuals with a CD4 (T4) lymphocyte count less than or equal to 0.2 x 10⁹/L with no history of P carinii pneumonia. We present information about the drug and its use, including safety information and use of the nebulizer.

(Arch Intern Med. 1989;149:2412-2413)

Author Affiliations
From the Commissioner of Food and Drugs (Dr Young), the Associate Commissioner for Health Affairs (Dr Nightingale), and the Division of Antiviral Drug Products, Office of Drug Evaluation II, Center for Drug Evaluation and Research (Drs Cooper and Trapnell), Food and Drug Administration, Rockville, Md.

Footnotes
Accepted for publication August 11, 1989.

Reprint requests to the Associate Commissioner for Health Affairs, Food and Drug Administration, Rockville, MD 20857 (Dr Nightingale).

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