Urofi 5 mg+5 mg (Capsule)

Indications

• Initiate treatment of Benign Prostatic Hyperplasia (BPH) in men
• Enlarged prostate
• Treatment duration up to 26 weeks

Pharmacology

• Combination of Finasteride and Tadalafil
• Finasteride inhibits steroid Type II 5a-reductase
• Tadalafil is a selective inhibitor of phosphodiesterase type-5 (PDE5)
• Finasteride lowers DHT hormone level
• Tadalafil inhibits PDE5, relaxing smooth muscles of the prostate

Dosage & Administration

• Recommended adult dosage: one capsule orally once daily
• Take on an empty stomach
• Not recommended for pediatric use
• No observed differences in geriatric use
• Use caution in case of moderately impaired hepatic function
• Not recommended for severe hepatic impairment
• Not recommended for renal impairment with creatinine clearance <50 mL/min or undergoing hemodialysis

Interaction

• Contraindicated with organic nitrate use
• Caution with co-administration of alpha-blockers
• Mild systemic vasodilator effect with antihypertensives

Contraindications

• Contraindicated with concomitant organic nitrate use

Side Effects

• Common adverse reactions of finasteride monotherapy: impotence, decreased libido, decreased volume of ejaculation, rash
• Common adverse reactions of tadalafil: headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, limb pain

Pregnancy & Lactation

• Contraindicated in pregnancy
• Not indicated for use in females
• Contact with crushed or broken capsule should be washed immediately with soap and water
• Not indicated for use in lactating mothers

Precautions & Warnings

• Not recommended for patients with recent myocardial infarction, unstable angina, recent heart failure, uncontrolled arrhythmias, hypotension, uncontrolled hypertension, recent stroke
• Discontinue immediately if hypersensitivity reaction occurs
• Use with caution in patients with anatomical deformation of the penis
• Seek emergency treatment if erection lasts more than 4 hours

Overdose Effects

• Standard supportive measures should be adopted

Therapeutic Class

• BPH/ Urinary retention/ Urinary incontinence

Storage Conditions

• Do not store above 30°C
• Keep in a dry place
• Protect from light
• Keep out of the reach of children

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