Adult Dosing

Bening prostatic Hypertrophy

Monotherapy

• Dose: 0.5 mg PO Daily

Combination therapy with Alpha-Blocker

• Dose: 0.5 mg PO Daily along with 0.4 mg tamsulosin PO Daily
• Note: Do not chew or open; swallow whole

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of need for BPH-related surgery

• Hypersensitivity to any of the ingredients of the product
• Pregnancy
• Women of childbearing potential
• Pediatric patients

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not indicated

Hepatic Dose Adjustment

• Hepatic impairment: Caution advised; dose adjustments not defined

See Supplemental Patient Information

• Blood donation within 6 months of last dose may present fetal risk if transfusion recipient is pregnant
• Women of childbearing potential should not handle capsule due to possible cutaneous absorption
• Dutasteride reduces serum prostate-specific antigen (PSA) concentration by approximately 50% within 3-6 months of treatment. However, any confirmed increase in PSA while on dutasteride therapy may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men
• Percent free PSA remains constant, even under the influence of dutasteride, and if percent free PSA is used as an aid in the detection of prostate cancer in men receiving dutasteride, no adjustment to its value is required
• Dutasteride may increase the risk of high-grade prostate cancer
• Patients should be assessed to rule out prostate cancer and other urological diseases prior to starting treatment
• It is not intended for use in females. Since dutasteride can be absorbed from skin, it should not be handled by a pregnant woman or a woman who may become pregnant as it may cause fetal harm. It is contraindicated in pregnant women, women of childbearing potential and pediatric patients
• Monitor fluid intake and output. Assess for ease of starting urine stream and for urinary urgency or frequency

Cautions: Use cautiously in

• Hepatic impairment
• Avoid blood donations for 6 months after discontinuing treatment

Supplemental Patient Information

• Advise patient not to donate blood for at least 6 months after final dose
• Advise patient that increases in PSA levels while on treatment with dutasteride may signal the presence of prostate cancer and should be evaluated by a healthcare professional

Pregnancy Category:X

Breastfeeding: Unsafe; use not recommended.

• GU: Impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders
• CNS: Dizziness
• MISC: Angioedema, immune hypersensitivity reaction, angioedema

• 5-alpha-reductase inhibitor, sex hormone; inhibits the conversion of testosterone to 5alpha-dihydrotestosterone (DHT)
• Well absorbed (60%) following oral administration
• Extensively metabolized in liver
• CYP450: 3A4 and 3A5 substrate
• Mainly excreted in feces: 45% (5% unchanged); minimally in urine
• Half-life: 5 wks

US Trade Name(s)

• Avodart

US Availability

dutasteride (generic)

• CAPS: 0.5 mg

Avodart

• CAPS: 0.5 mg

Canadian Trade Name(s)

• Avodart

Canadian Availability

Avodart

• CAPS: 0.5 mg

UK Trade Name(s)

• Avodart

UK Availability

Avodart

• CAPS: 0.5 mg

Australian Trade Name(s)

• Avodart

Australian Availability

Avodart

• CAPS: 0.5 mg

[Outline]

Endocrine/Metabolic

Sex Hormones

5-alpha-reductase Inhibitors

Urologic

Sex Hormones

5-alpha-reductase Inhibitors

Pricing data from www.DrugStore.com in U.S.A.

• Avodart 0.5 MG CAPS [Bottle] (GLAXO SMITH KLINE)
  30 mg = $128.99
  90 mg = $354.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Avodart 0.5 MG Oral Capsule

Pill Image:

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See full size image]

Ingredient(s): Dutasteride

Imprint: GX;CE2

Color(s): Yellow

Shape: Capsule

Size (mm): 19.00

Score: 1

Inactive Ingredient(s): butylated hydroxytoluene / gelatin / glycerin / ferric oxide yellow / caprylic/capric mono/diglycerides

Drug Label Author:
GlaxoSmithKline LLC

DEA Schedule:
Non-Scheduled