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How Supplied


Duagen (dutasteride) is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate gland.


The recommended dose of Duagen (dutasteride) is 1 capsule (0.5 mg) taken orally once a day. The capsules should be swallowed

whole. Duagen (dutasteride) may be administered with or without food.

No dosage adjustment is necessary for subjects with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatric and Renal Impairment). Due to the absence of data in patients with hepatic impairment, no dosage recommendation can be made (see PRECAUTIONS: General).


Duagen (dutasteride) Soft Gelatin Capsules 0.5 mg are oblong, opaque, dull yellow, gelatin capsules imprinted with "GX CE2" in red ink on one side packaged in bottles of 100 (NDC 0173-0712-00) with child-resistant closures and unit dose blister packs of 70 capsules (NDC 0173-0712-01).

Storage and Handling: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dutasteride is absorbed through the skin. Duagen (dutasteride) Soft Gelatin capsules should not be handled by women who are pregnant or who may become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus (see CLINICAL PHARMACOLOGY: Pharmacokinetics, WARNINGS: Exposure of Women†?Risk to Male Fetus, and PRECAUTIONS: Information For Patients and Pregnancy).

Manufactured by:

RP Scherer Beinheim, France for



Research Triangle Park, NC 27709

©2001 ,GlaxoSmithKline All rights reserved.

(Updated Sep 05, 2003)

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/8/2004

How Supplied

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