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These highlights do not include all the information needed to use Avodart safely and effectively. See full prescribing information for Avodart.

AvodartВ® (dutasteride) Soft Gelatin Capsules
Initial U.S. Approval: 2001

RECENT MAJOR CHANGES
Indications and Usage, Combination With Alpha-Blocker (1.2) 6/2008
Dosage and Administration, Combination With Alpha-Blocker (2.2) 6/2008


Indications and Usage for Avodart

Avodart, a 5О±-reductase inhibitor, is 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.

Avodart in combination with the alpha-blocker tamsulosin is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (1.2)

Avodart Dosage and Administration

Monotherapy: 0.5 mg once daily. (2.1)

Combination with tamsulosin: 0.5 mg once daily and tamsulosin 0.4 mg once daily. (2.2)

Dosing considerations: Swallow whole. May take with or without food. (2)

Dosage Forms and Strengths

0.5-mg soft gelatin capsules (3)



Contraindications
Pregnancy and women of childbearing potential. (4, 5.1, 8.1)
Pediatric patients. (4)
Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to Avodart or other 5О±-reductase inhibitors. (4)

Warnings and Precautions
Women who are pregnant or may become pregnant should not handle Avodart Capsules. (5.1, 8.1)
Patients should be assessed to rule out other urological diseases, including prostate cancer, prior to prescribing Avodart. (5.2)
Avodart reduces total serum prostate-specific antigen concentration by approximately 50%. (5.3)
Patients should not donate blood until 6 months after their last dose. (5.4)

Adverse Reactions

The most common adverse reactions, reported in ≥1% of patients treated with Avodart and more commonly than in patients treated with placebo, are impotence, decreased libido, ejaculation disorders, and breast disorders. (6.1)



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Hypertension

Single doses of 20 mg of Accupril provide over 80% inhibition of plasma ACE for 24 hours. Inhibition of the pressor response to angiotensin I is shorter-lived, with a 20 mg dose giving 75% inhibition for about 4 hours, 50% inhibition for about 8 hours, and 20% inhibition at 24 hours. With chronic dosing, however, there is substantial inhibition of angiotensin II levels at 24 hours by doses of 20–80 mg.

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Hemodynamic assessments in patients with hypertension indicate that blood pressure reduction produced by quinapril is accompanied by a reduction in total peripheral resistance and renal vascular resistance with little or no change in heart rate, cardiac index, renal blood flow, glomerular filtration rate, or filtration fraction.

Use of Accupril with a thiazide diuretic gives a blood-pressure lowering effect greater than that seen with either agent alone.

In patients with hypertension, Accupril 10–40 mg was similar in effectiveness to captopril, enalapril, propranolol, and thiazide diuretics.

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