Avodart (Dutasteride) - Indications and Dosage

INDICATIONS AND USAGE

Monotherapy

AVODART^® (dutasteride) Soft Gelatin Capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

• improve symptoms,
• reduce the risk of acute urinary retention (AUR), and
• reduce the risk of the need for BPH-related surgery.

DOSAGE AND ADMINISTRATION

The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. AVODART may be administered with or without food.

Monotherapy

The recommended dose of AVODART is 1 capsule (0.5 mg) taken once daily.

Combination With Alpha Adrenergic Antagonist

The recommended dose of AVODART is 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily.

DOSAGE FORMS AND STRENGTHS

0.5-mg, opaque, dull yellow, gelatin capsules imprinted with “GX CE2” in red ink on one side.

HOW SUPPLIED/STORAGE AND HANDLING

AVODART Soft Gelatin Capsules 0.5 mg are oblong, opaque, dull yellow, gelatin capsules imprinted with “GX CE2” with red edible ink on one side packaged in

bottles of 30	NDC 54868-5114-0
bottles of 90	NDC 54868-5114-1

with child-resistant closures.

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. AVODART Capsules should not be handled by women who are pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see Warnings and Precautions].