Uroflo Plus

Indications

Tamsulosin Hydrochloride & Dutasteride Capsules are prescribed for:

• Management of moderate to severe Benign Prostatic Hyperplasia (BPH): These capsules help alleviate symptoms associated with BPH.
• Prevention of acute urinary retention and the need for surgery: They are used to reduce the risk of severe urinary complications in patients experiencing significant BPH symptoms.

Pharmacology

The Tamsulosin & Dutasteride combination leverages two distinct mechanisms to enhance the treatment of Benign Prostatic Hyperplasia (BPH).

• Tamsulosin Hydrochloride: This alpha1A-adrenoreceptor antagonist targets the dynamic aspects of BPH by blocking alpha1-adrenoreceptors in the prostatic smooth muscle and bladder neck. By doing so, it facilitates the relaxation of smooth muscles in these areas. Tamsulosin specifically inhibits alpha1A and alpha1D receptors, with the former predominantly found in the prostate and the latter in the bladder, which helps reduce detrusor overactivity.
• Dutasteride: As a synthetic 4-azasteroid, Dutasteride inhibits both Type I and Type II 5-alpha-reductase isoenzymes. This action prevents the conversion of Testosterone to Dihydrotestosterone (DHT), a key factor in BPH development. By lowering DHT levels, Dutasteride helps decrease prostatic volume and address an underlying cause of BPH. Note that Dutasteride does not interact with the human androgen receptor.

Dosage & Administration

• Adults (including the elderly): The recommended dosage is one capsule (0.4 mg Tamsulosin Hydrochloride & 0.5 mg Dutasteride) taken orally about 30 minutes after the same meal each day. Swallow the capsule whole without chewing or opening. This formulation may replace concurrent Tamsulosin Hydrochloride and Dutasteride therapy to simplify treatment. Switching directly from monotherapy to this combination may be considered where clinically appropriate.
• Renal Impairment: No dosage adjustment is anticipated for patients with renal impairment as its impact on pharmacokinetics has not been studied.
• Hepatic Impairment: Caution is advised for patients with mild to moderate hepatic impairment, as the effect on pharmacokinetics in such patients remains unstudied. The use of this capsule is contraindicated in severe hepatic impairment.

Follow your healthcare provider’s instructions regarding medication use.

Interaction

Drug Interaction Studies: No formal interaction studies have been conducted for the Tamsulosin-Dutasteride combination.

• Effects of Other Drugs: Co-administration with CYP3A4 and/or P-glycoprotein inhibitors may increase Dutasteride serum concentrations, although further inhibition is unlikely. In such cases, adjusting the dosing frequency may be considered. Dutasteride’s interaction with other drugs, such as warfarin or digoxin, has not shown significant effects.
• Effects of Dutasteride on Other Drugs: Dutasteride does not impact the pharmacokinetics of Tamsulosin or other drugs significantly. It does not inhibit or induce major cytochrome P450 enzymes or transporters.
• Effects of Tamsulosin: Caution is advised when used with drugs that lower blood pressure or other alpha-1 blockers. Concomitant use with cimetidine may affect Tamsulosin clearance, and careful monitoring is recommended.

Contraindications

This combination is contraindicated for:

• Women and Children: Not intended for use in these groups.
• Hypersensitivity: Patients allergic to Dutasteride, Tamsulosin, or other components of the formulation.
• Orthostatic Hypotension: Those with a history of significant orthostatic hypotension.
• Severe Hepatic Impairment: Use is contraindicated in patients with severe liver disease.

Side Effects

Common adverse effects include:

• Sexual Dysfunction: Impotence, decreased libido, and ejaculation disorders.
• Breast Disorders: Enlargement and tenderness.
• Dizziness: May occur with combination therapy.

Pregnancy & Lactation

• Pregnancy: The combination is contraindicated for women, particularly those pregnant or potentially pregnant, due to risks to fetal development.
• Lactation: The effects on breast milk are unknown.

Precautions & Warnings

• Cardiac Failure: A slightly higher incidence of cardiac failure has been observed in clinical studies.
• PSA Levels: Regular monitoring is essential as the combination reduces PSA levels by approximately 50%, which can impact prostate cancer detection.
• Prostate Cancer Risk: Patients should be evaluated regularly for prostate cancer risk.
• Renal Impairment: Caution is advised in severely impaired patients.
• Hypotension: Monitor for orthostatic hypotension and manage appropriately.
• Intraoperative Floppy Iris Syndrome: Consider discontinuing Tamsulosin prior to cataract surgery.

Overdose Effects

• Dutasteride: No specific antidote; supportive treatment should be given.
• Tamsulosin: Acute overdose may cause hypotension; treatment involves supportive care and monitoring.

Therapeutic Class

Category: BPH/Urinary Retention/Urinary Incontinence

Storage Conditions

Storage: Keep in a cool, dry place away from light.