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PROSTAM-0.4

Generic Name:                                Tamsulosin HCl

Therapeutic Category:                 Benign Prostatic Hyperplasia Agents/Urinary Tract Antispasmodic

Pharmacological Class:               Alpha-Adrenergic Blocker

Composition:                                  Each capsule contains Tamsulosin HCl USP 0.4 mg

(As controlled release tablets)

Pregnancy Category:                    X

Presentation:                                  Available in the pack size as 10 tablets X 10 blisters

Description

Tamsulosin is a selective antagonist at alpha-1A and alpha-1B-adrenoceptors in the prostate, prostatic capsule, prostatic urethra, and bladder neck. At least three discrete alpha1-adrenoceptor subtypes have been identified: alpha-1A, alpha-1B and alpha-1D; their distribution differs between human organs and tissue. Approximately 70% of the alpha1-receptors in human prostate are of the alpha-1A subtype. Blockage of these receptors causes relaxation of smooth muscles in the bladder neck and prostate.

 

 

Mechanism of Action

Tamsulosin HCl which is alpha-1 adrenoreceptor blockers, selectively blocks alpha 1A -adrenergic receptors causing relaxation of prostate smooth muscle resulting in an increase in urinary flow rate and a reduction in symptoms of benign prostatic hypertrophy.

Indications

  • Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
  • Adjunct treatment of Acute Urinary Retention (AUR): the inability to voluntarily pass urine, Bladder Outlet Obstruction (BOO): blockage at the base of the bladder.
  • Expulsion of ureteral stones up to 5mm.

Dosage

Route of administration: Oral

Initial Dose: 0.4 mg orally once a day

Maximum Dose: 0.8 mg orally once a day

Administered on an empty stomach approximately before one-half hour following the same meal each day.

Pharmacokinetics

Absorption: Essentially complete (>90%) following oral administration under fasting conditions.

Protein binding: Approximately 94%-99%

Metabolism: Hepatic

Route of elimination: Renal

Half-life: 5-7 hours

Adverse Effects

  • Postural Hypotension*
  • Priapism*
  • Immunologic: Higher risk of allergic reaction in those with sulfa allergies
  • Ophthalmologic: Patients taking tamsulosin are prone to a complication known as floppy iris syndrome* during cataract surgery

 

Contraindications

PROSTAM is contraindicated in the following populations and situations:

  • Intraoperative Floppy Iris Syndrome- Patients considering cataract surgery should be advised to tell their ophthalmologist
  • Severe Hypotension

Drug Interactions

  • Enhance hypotensive effect of tamsulosin when given with antihypertensive drugs (e.g ACE inhibitors, B-Blockers, Ca channel blocker etc), adrenergic neurone blocker, alcohol, alpha blockers, Angiotensin-II receptor antagonist, antipsychotic, anxiolytic and hypnotic drugs.
*Terminologies:

Postural hypotension: Also known as orthostatic hypotension is a form of low blood pressure that happens when you stand up from sitting or lying down. It can make you feel dizzy or lightheaded, and maybe even faint.

Priapism: persistent and painful erection of the penis.

Floppy iris syndrome: This syndrome is characterized by a flaccid iris which billows in response to ordinary intraocular fluid current