Uropass-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 with complementary mechanisms of action to improve BPH symptoms
• Tamsulosin is an alpha1-adrenoreceptor blocking agent affecting the dynamic component of BPH
• Dutasteride is a competitive and specific inhibitor of both Type I and Type II 5 alpha-reductase isoenzymes affecting the static component of BPH

Dosage & Administration

• Recommended dose: Tamsulosin Hydrochloride 0.4 mg & Dutasteride 0.5 mg capsule
• Orally taken approximately 30 minutes after the same meal each day
• Capsules should be swallowed whole and not chewed or opened

Renal impairment

• Effect on Tamsulosin-Dutasteride pharmacokinetics not studied
• No anticipated dosage adjustment for patients with renal impairment

Hepatic impairment

• Effect on Tamsulosin-Dutasteride pharmacokinetics not studied
• Caution in patients with mild to moderate hepatic impairment
• Contra-indicated in severe hepatic impairment

Interaction

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

Contraindications

• Contra-indicated in women, children, adolescents, patients with hypersensitivity to Dutasteride, Tamsulosin, soya, peanut, or any of the excipients
• Patients with history of orthostatic hypotension, severe hepatic impairment

Side Effects

• Common adverse reactions: impotence, decreased libido, breast disorders, ejaculation disorders, dizziness

Pregnancy & Lactation

• Contra-indicated for use in women
• No studies on pregnancy, lactation, fertility for Tamsulosin-Dutasteride combination
• Effects of Dutasteride on semen characteristics reported

Precautions & Warnings

• Prescribed after careful benefit risk assessment
• Increased risk of adverse events including cardiac failure
• Effects on prostate-specific antigen (PSA) and prostate cancer detection
• Regular evaluation for prostate cancer risk, renal impairment, orthostatic hypotension, breast neoplasia
• Not studied in patients with liver disease

Overdose Effects

• No data available for Tamsulosin-Dutasteride combination overdose
• In volunteer studies, single daily doses of Dutasteride up to 40 mg/day have been administered without significant safety concerns
• Acute hypotension and vomiting observed with Tamsulosin overdose

Storage Conditions

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

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