Dutasteride 0.5 MG Oral Capsule

1 INDICATIONS AND USAGE Dutasteride Capsules are a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: ( 1.1 ) improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. Dutasteride Capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. ( 1.2 ) Limitations of Use: Dutasteride Capsules are not approved for the prevention of prostate cancer. ( 1.3 ) 1.1 Monotherapy 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. 1.2 Combination With Alpha Adrenergic Antagonist Dutasteride Capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.3 Limitations of Use Dutasteride Capsules are not approved for the prevention of prostate cancer.

Intergel Pharmaceuticals Inc

FDA Reported Adverse Reactions
`[1] vulvovaginal burning sensation` `[2] drug ineffective` `[3] drug interaction` `[4] off label use` `[5] condition aggravated` `[6] international normalised ratio increased` `[7] vulvovaginal pruritus` `[8] vulvovaginal pain` `[9] abdominal pain` `[10] constipation`

4 years ago

OVAL YELLOW IPI 068

16 HOW SUPPLIED/STORAGE AND HANDLING Dutasteride capsules are 0.5 mg are oblong, opaque, light yellow, gelatin capsules imprinted with “IPI 068” with black edible ink on one side, packaged in bottles of 30 (NDC 62112-8068-1) and bottles of 90 (NDC 62112-8068-2) 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. Dutasteride 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 ( 5.4 )] .

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Dutasteride 0.5 MG Oral Capsule

FDA Reported Adverse Reactions [1] vulvovaginal burning sensation [2] drug ineffective [3] drug interaction [4] off label use [5] condition aggravated [6] international normalised ratio increased [7] vulvovaginal pruritus [8] vulvovaginal pain [9] abdominal pain [10] constipation

OVAL YELLOW IPI 068

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