Finasteride + Tadalafil

Finasteride + Tadalafil 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.

Finasteride is a specific inhibitor of steroid Type II 5α-reductase which converts testosterone into 5α-dihydrotestosterone (DHT). Finasteride lowers DHT hormone levels, which is a cause of prostate growth. Tadalafil is a selective inhibitor of PDE5 which relaxes the smooth muscles of the prostate, resulting in the release of the restriction to the flow of urine through the urethra.

• Benign Prostatic Hyperplasia (BPH): Used to initiate treatment of signs and symptoms of BPH in men with an enlarged prostate for up to 26 weeks.

BPH/ Urinary retention/ Urinary incontinence

5-alpha Reductase Inhibitor + PDE5 Inhibitor

This is the combination of Finasteride, a specific inhibitor of steroid Type II 5a-reductase and Tadalafil, a selective inhibitor of phosphodiesterase type-5 (PDE5). Finasteride lowers DHT hormone levels, which is a cause of prostate growth. Tadalafil inhibits PDE5 to relax smooth muscles of the prostate, resulting in release of restriction to urine flow through the urethra.

Finasteride reduces prostate size by lowering DHT; Tadalafil improves urine flow by relaxing prostate smooth muscles through PDE5 inhibition.

Adult Dose:

• One capsule orally once daily at approximately the same time every day for up to 26 weeks.
• Recommended to take on an empty stomach.

Take one capsule orally once daily at approximately the same time every day; up to 26 weeks. Take on an empty stomach.

If you miss a dose, take it as soon as possible; however, if it is almost time for your next dose, skip the missed dose.

Common Side Effects (>=1%):

• Impotence
• Decreased libido
• Decreased volume of ejaculation
• Rash

Tadalafil-associated Side Effects (>=2%):

• Headache
• Dyspepsia
• Back pain
• Myalgia
• Nasal congestion
• Flushing
• Pain in limb

Precautions:

• Nitrates: Contraindicated in patients using any form of organic nitrate (potentiates hypotensive effect).
• Alpha-Blockers: Caution when co-administered; discontinue alpha-blockers at least one day prior to starting this capsule.
• Antihypertensives: Small reductions in blood pressure may occur.
• Hypersensitivity Reactions: Discontinue immediately if occurs.
• Prolonged Erection: Caution in patients with anatomical deformation of the penis; seek emergency treatment if erection lasts more than 4 hours.

Contraindications:

• Concomitant use with any form of organic nitrate
• Pregnancy and lactation (not indicated for females)

Drug Interactions:

• Nitrates: Potentiates hypotensive effect; contraindicated.
• Alpha-Blockers: Caution required; discontinuation of alpha-blockers recommended.
• Antihypertensives (amlodipine, ARBs, enalapril, metoprolol): Small reductions in blood pressure occur.

Food Interactions: Recommended to take on empty stomach; caution with alcohol.

Use in Pregnancy: Contraindicated; not indicated for females; if a pregnant female comes in contact with crushed or broken capsule, wash with soap and water.

Use in Lactation: Not indicated for lactating mothers.

Pediatric Use: Safety and effectiveness not established in patients less than 18 years.

Geriatric Use: No overall differences in safety or effectiveness observed between patients 65 years and older.

Renal Impairment: Not recommended for patients with CrCl <50 mL/min or undergoing hemodialysis.

Hepatic Impairment: Moderate: use with caution; Severe: not recommended.

Overdose: In cases of overdose, standard supportive measures should be adopted.

Storage: Do not store above 30 degree C. Keep in a dry place. Protect from light and keep out of reach of children.

Finasteride + Tadalafil