Dutasteride Capsules
Dutasteride 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.
Combination With Alpha Adrenergic Antagonist
Dutasteride in combination with the alpha adrenergic antagonist,
tamsulosin, is indicated for the treatment of symptomatic BPH in men
with an enlarged prostate.
Limitations of Use
Dutasteride Capsules are not approved for the prevention of prostate cancer.
Dutasteride Capsules 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. Dutasteride Capsules may be administered with or
without food.
Monotherapy
The recommended dose of dutasteride is 1 capsule (0.5 mg) taken once daily.
Combination With Alpha Adrenergic Antagonist
The recommended dose of dutasteride is 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily.
Dosage Forms and Strengths
0.5 mg are opaque white-colored, oblong-shaped capsules imprinted '641'
with black ink containing clear colorless to slightly yellowish oily
liquid.
Contraindications
Dutasteride is contraindicated for use in:
Pregnancy. In animal reproduction and developmental toxicity studies,
dutasteride inhibited development of male fetus external genitalia.
Therefore, dutasteride may cause fetal harm when administered to a
pregnant woman. If dutasteride is used during pregnancy or if the
patient becomes pregnant while taking dutasteride, the patient should be
apprised of the potential hazard to the fetus [see Warnings and
Precautions (5.4), Use in SpecificPopulations (8.1)] .
Women of childbearing potential [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)] .raw Dutasteride powder
Pediatric patients [see Use in Specific Populations (8.4)] .
Patients with previously demonstrated clinically significant
hypersensitivity (e.g., serious skin reactions, angioedema) to
dutasteride or other 5 alpha-reductase inhibitors [see Adverse Reactions
(6.2)] .
