Urofi

Indications

Urofi is used for the long-term treatment of Benign Prostatic Hyperplasia (BPH) in men, specifically to manage symptoms and reduce the size of an enlarged prostate. The treatment period should not exceed 26 weeks.

Pharmacology

• Finasteride inhibits the Type II 5α-reductase enzyme, which converts testosterone into dihydrotestosterone (DHT). By lowering DHT levels, Finasteride helps shrink the prostate.
• Tadalafil is a selective phosphodiesterase type-5 (PDE5) inhibitor that relaxes smooth muscles in the prostate and urethra, improving urine flow and reducing BPH symptoms.

Dosage & Administration

• Adults: Take one capsule orally once daily at the same time each day for up to 26 weeks, ideally on an empty stomach.
• Pediatric Use: Safety and effectiveness for those under 18 have not been established.
• Geriatric Use: No significant differences in safety or effectiveness between older and younger patients.
• Hepatic Impairment: Use with caution in moderate hepatic impairment; not recommended for severe impairment.
• Renal Impairment: Not advised for patients with creatinine clearance less than 50 mL/min or those undergoing hemodialysis.

Interactions

• Nitrates: Contraindicated with organic nitrates due to potential hypotensive effects.
• Alpha-Blockers: Exercise caution when used together; consider discontinuing alpha-blockers one day before starting Urofi.
• Antihypertensives: May cause mild blood pressure reductions when used with medications like amlodipine or enalapril.

Contraindications

Not for use in combination with organic nitrates or for patients with recent myocardial infarction, unstable angina, heart failure, or uncontrolled arrhythmias.

Side Effects

Common Reactions: Include impotence, decreased libido, headache, dyspepsia, and back pain. Monitor for hypersensitivity reactions.

Pregnancy & Lactation

Contraindicated in pregnancy and not recommended for breastfeeding women. Immediate washing is required if contact with a crushed or broken capsule occurs.

Precautions & Warnings

Avoid use in patients with recent cardiovascular events or severe hypersensitivity reactions. Use cautiously to prevent prolonged erections.

Overdose Effects

Standard supportive measures should be applied in case of overdose.

Therapeutic Class

Medications for Benign Prostatic Hyperplasia (BPH), urinary retention, and incontinence.

Storage Conditions

Store at or below 30°C, in a dry place, protected from light, and out of reach of children.