Urinom D 0.4 mg+0.5 mg (Capsule)

Therapeutic Class

• BPH/ Urinary retention/ Urinary incontinence

Indications

• Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH)
• Reduction in the risk of acute urinary retention and surgery in patients with moderate to severe symptoms of BPH

Pharmacology

• Combination of Tamsulosin Hydrochloride and Dutasteride
• Mechanisms of action to improve symptoms in patients with BPH

Dosage & Administration

• Recommended dose is one capsule (Tamsulosin Hydrochloride 0.4 mg & Dutasteride 0.5 mg) taken orally approximately 30 minutes after the same meal each day
• Capsules should be swallowed whole and not chewed or opened
• May be used to substitute concomitant Tamsulosin Hydrochloride and Dutasteride in existing dual therapy
• No adjustment in dosage is anticipated for patients with renal impairment
• Caution should be used in patients with mild to moderate hepatic impairment
• Contra-indicated in patients with severe hepatic impairment

Interaction

• No drug interaction studies for Dutasteride-Tamsulosin combination
• Effects of other drugs on the pharmacokinetics of Dutasteride
• Effects of Dutasteride on the pharmacokinetics of other drugs

Contraindications

• Contra-indicated in women and children and adolescents
• Patients with hypersensitivity to Dutasteride, other 5-alpha reductase inhibitors, or Tamsulosin
• Contra-indicated in patients with a history of orthostatic hypotension and severe hepatic impairment

Side Effects

• Most common adverse reactions include impotence, decreased libido, breast disorders, ejaculation disorders, and dizziness

Pregnancy & Lactation

• Contra-indicated for use by women
• No studies available regarding the effect on pregnancy, lactation, and fertility

Precautions & Warnings

• Prescribed after careful benefit-risk assessment
• Caution for potential increased risk of adverse events
• Effects on prostate specific antigen (PSA) and prostate cancer detection
• Regular evaluation for prostate cancer risk including PSA testing
• Caution for renal impairment, hypotension, and Intraoperative Floppy Iris Syndrome
• Avoid contact with leaking capsules
• Caution in the administration of Tamsulosin-Dutasteride to patients with mild to moderate hepatic impairment

Overdose Effects

• No data available for overdose of Tamsulosin-Dutasteride combination
• Single daily doses of Dutasteride up to 40 mg/day have been administered for 7 days without significant safety concerns
• Acute overdose with Tamsulosin Hydrochloride has been reported

Storage Conditions

• Store in a cool and dry place, protected from light

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