Tablet Presentation

Each Film Coated Tablet Contains:
Tamsulosin Hydrochloride IP (As Modified Release) 0.4 mg
Dutasteride IP 0.5 mg

Dutasteride is the 5- alpha reductase inhibitor. It is used to treat enlarged prostate gland .it is also used in men to prevent hair loss.
Tamsulosin is the sympatholytic drugs, it selectively blocks the alpha-1 and alpha-2 antagonist, Blockage of these receptors in the smooth muscles promotes relaxation of the smooth muscles of the bladder.
This combination is used in the treatment of the benign prostate hyperplasia or in the condition of prostate enlargement due to which urination becomes difficult.

Indication

• Enlarged prostate
• In prostate Hyperplasia
• Reduces the risk of urinary retention
• Promotes hypotension
• Prostatitis
• Ureteral stones

Mechanism of Action

Dutasteride prevents the conversion of the testosterone to dihydrosterone by inhibiting the enzyme 5-alpha reductase , as dihydrotesterone causes enlargement of the prostate gland. Tamsulosine acts in the alpha-1 & 2 receptors and blocks it action therefore relaxes the smooth muscles in the prostate gland and detrusor muscle in the bladder , improves the flow of urine.

Pharmacokinetics

Absorption:Both the drugs are orally absorbed
Protein binding: Dutasteride is about 99.9% bound to serum albumin and 96.8% bound to alpha-1 acid glycoprotein whereas tamsulosine is about 98% bound to alpha acid -1 glycoprotein
Metabolism:It is metabolized in the liver to 4, 5 hydroxydutasteride whereas tamsulosine undergoes sulphate conjugation
Excretion:Both the drugs are Excreted via kidney

Side effects

• Impotence
• Tenderness in breast and increase in breast size
• Swelling and pain in the testicles
• Nausea
• Vomiting
• Blurring of vision
• Back pain
• Dizziness
• Drowsiness

Contraindications

• Contraindicated in patients with renal impairment
• Contraindicated in patients with known hypersensitivity
• Contraindicated in pregnant women
• Contraindicated in patients with liver problems

Storage

Store it at 20°C to 25°C