Indications

Urofi capsule is indicated to initiate treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks.

Pharmacology

Combination of Finasteride (specific inhibitor of steroid Type II 5α-reductase) and Tadalafil (selective inhibitor of phosphodiesterase type-5 [PDE5]).
Finasteride lowers dihydrotestosterone (DHT) levels, reducing prostate growth and causing shrinkage of the enlarged prostate.
Tadalafil inhibits PDE5, relaxing smooth muscles of the prostate and urethra, improving urinary flow and reducing BPH symptoms.

Dosage & Administration

Adults: One capsule orally once daily at the same time, up to 26 weeks. Take on an empty stomach. Not recommended beyond 26 weeks.
Pediatric use: Not established under 18 years.
Geriatric use: No significant differences in safety or efficacy in patients ≥65 years.
Hepatic impairment: Use with caution in moderate impairment; not recommended in severe impairment.
Renal impairment: Not recommended if creatinine clearance <50 mL/min or on hemodialysis.

Interactions

Nitrates: Contraindicated; tadalafil potentiates hypotensive effects.
Alpha-blockers: Caution; discontinue alpha-blockers at least one day before starting.
Antihypertensives: Mild BP reductions with agents like amlodipine, ARBs, bendrofluazide, enalapril, metoprolol.

Contraindications

Side Effects

Finasteride: Impotence, decreased libido, reduced ejaculate volume, rash.
Tadalafil: Headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, limb pain.

Pregnancy & Lactation

Precautions & Warnings

Not recommended in patients with:
- Myocardial infarction within 90 days
- Unstable angina
- Heart failure within 6 months
- Uncontrolled arrhythmias, hypotension (<90/50 mmHg), uncontrolled hypertension
- Stroke within 6 months
Hypersensitivity reactions: Discontinue immediately if occur.
Prolonged erection: Use with caution in penile anatomical deformities; seek emergency care if erection >4 hours.

Overdose Effects