Product Description

Tamsulosin Hydrochloride Prolonged Release Tablets IP 0.4 mg is a selective alpha-1 adrenergic receptor antagonist used in men to manage lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate gland. It relaxes smooth muscles in the prostate and bladder neck, improving urine flow and reducing symptoms like a weak stream or frequent urination. The prolonged-release formulation provides steady drug release over 24 hours, enabling once-daily dosing with minimal fluctuations in blood levels. It does not shrink the prostate or treat the underlying cause of BPH.

Uses

• Relief of LUTS due to BPH in men, including urinary frequency (especially nocturia), urgency, hesitancy, weak stream, and incomplete emptying

• Adjunctive therapy in patients with BPH and hypertension (may have mild blood pressure-lowering effects)

• Off-label: Facilitation of distal ureteral stone passage (expulsive therapy for kidney stones) under medical supervision

• Not indicated for women, children, or urinary symptoms unrelated to BPH (e.g., infections, prostate cancer)

How it works

Tamsulosin is a uroselective alpha-1A adrenergic receptor blocker with higher affinity for prostate-specific receptors:

• Alpha-1A receptors are predominant in the prostate, prostatic urethra, and bladder neck smooth muscles.

• Tamsulosin competitively inhibits these receptors, preventing norepinephrine (a neurotransmitter) from binding and causing muscle contraction.

• This leads to relaxation of dynamic prostate and bladder neck components, reducing urethral resistance and improving urine flow without significantly affecting vascular alpha-1B receptors (minimizing blood pressure effects).

• The prolonged-release matrix ensures sustained plasma levels (peak at 6 hours, half-life ~9–13 hours), providing 24-hour symptom control.

Effects on urine flow may begin within hours, but full benefits take 2–4 weeks.

Benefits

• Improves urine flow rate and reduces residual urine volume, alleviating BPH symptoms and enhancing quality of life.

• Decreases nocturia and daytime frequency, improving sleep and daily activities.

• Addresses urinary hesitancy and intermittency, making voiding more complete and less effortful.

• Uroselective action minimizes systemic side effects like hypotension compared to non-selective alpha-blockers.

• Convenient once-daily dosing supports long-term adherence for chronic BPH management.

How to use

• Take once daily, approximately 30 minutes after the same meal each day (e.g., after breakfast) to enhance absorption and reduce dizziness risk.

• Swallow the tablet whole with water while sitting or standing; do not crush, chew, break, or open the prolonged-release capsule/tablet, as this alters release and increases side effect risk.

• Standard dose: 0.4 mg daily; may increase to 0.8 mg after 2–4 weeks if response is inadequate (per doctor).

• Maintain consistent timing for steady-state levels. If switching formulations, monitor for differences in bioavailability.

• Continue as prescribed; do not stop abruptly without consulting a doctor, as symptoms may recur. If a dose is missed, take as soon as remembered unless near the next dose—do not double dose.

Side Effects

Common side effects (usually mild and may resolve with time):

• Orthostatic hypotension: dizziness, lightheadedness (especially when standing—sit/lie down if it occurs)

• Abnormal ejaculation: retrograde ejaculation or reduced volume (affects ~10–18% of users, reversible)

• Nasal congestion: runny or stuffy nose due to vascular smooth muscle relaxation

• Headache, fatigue, or drowsiness

Less common/rare but serious side effects (seek immediate medical attention):

• Intraoperative floppy iris syndrome (IFIS): Complicates cataract/glaucoma surgery—increases risk of iris prolapse; inform surgeons of current/past use

• Priapism: Painful, prolonged erection (>4 hours)—emergency

• Cardiovascular: Syncope, chest pain, palpitations (rare)

• Allergic: Rash, itching, swelling, breathing difficulty

• Other: Back pain, diarrhea, nausea, intraoperative complications

• Monitor for first-dose effects; side effects are dose-related.

Safety Advice

• Inform your doctor of: Low blood pressure, liver/kidney disease, heart conditions (e.g., orthostatic hypotension risk), or upcoming eye surgery (IFIS warning).

• Not for women (off-label risks in pregnancy via semen exposure—use barrier contraception if partner is pregnant) or children.

• Interactions: Potentiates hypotension with PDE5 inhibitors (e.g., sildenafil—separate by 4 hours), other alpha-blockers, or antihypertensives. Avoid with strong CYP3A4/CYP2D6 inhibitors (e.g., ketoconazole, paroxetine—increase tamsulosin levels). Inform the doctor of all medications/supplements.

• Avoid alcohol, caffeine, or bladder irritants (e.g., spicy foods, carbonated drinks), as they may worsen symptoms or dizziness.

• Rise slowly from sitting/lying to prevent falls from orthostatic hypotension, especially at the start or dose increase.

• Regular prostate exams are needed to rule out cancer (BPH symptoms mimic it). Do not use for urinary retention without catheterization.

• Pregnancy/breastfeeding: Not applicable for men, but advise caution if partner is pregnant.

Storage Conditions

Store at a temperature below 86°F (30 °C). Protect from light and moisture.

FAQs

Does Tamsulosin cure BPH?

No, Tamsulosin does not cure benign prostatic hyperplasia (BPH) and does not shrink the prostate gland. It provides symptomatic relief by relaxing the muscles in the prostate and bladder neck, making it easier for urine to flow. For a more permanent solution, surgical options or other medications may be necessary, which a doctor can discuss with you.

How long does it take for Tamsulosin to work?

Tamsulosin may improve urine flow within 4 to 8 hours after taking the first dose. However, it may take 2 to 4 weeks of regular use to experience the full effect of the medication.

Can alcohol be consumed while taking Tamsulosin?

No, consuming alcohol while taking Tamsulosin is not recommended. Combining alcohol and Tamsulosin increases the risk of dizziness, drowsiness, and fainting, as both can cause a drop in blood pressure.

Why is it necessary to inform a doctor about eye surgery?

It's important to inform an eye surgeon if taking, or if you have previously taken, Tamsulosin before cataract or glaucoma surgery. Tamsulosin can cause Intraoperative Floppy Iris Syndrome (IFIS), which can make the surgery more difficult and increase the risk of complications.

Can women take Tamsulosin?

No, Tamsulosin is only approved for use in men to treat BPH symptoms. It is unsafe for women, especially if they are pregnant, could become pregnant, or are breastfeeding.

Can Tamsulosin be stopped if feeling better?

Do not stop taking Tamsulosin abruptly without consulting a doctor, even if you feel better. Suddenly stopping the medication can cause symptoms to return or worsen.

What are some long-term side effects of Tamsulosin?

Clinical studies show that long-term use of Tamsulosin is safe and well-tolerated. While a long-term risk of increased infections, pharyngitis, pain, and rhinitis has been noted, these are not universal. The risk of serious side effects is generally low.

Can Tamsulosin be used for kidney stones?

Some doctors may prescribe Tamsulosin off-label to help pass kidney stones, particularly those in the lower part of the ureter. The smooth muscles of the urinary tract are relaxed, which can help the stone pass more easily. This should only be done under medical supervision.

Why does Tamsulosin cause a stuffy nose?

Tamsulosin relaxes the smooth muscles in the blood vessels, including those in the nose. This vasodilation can cause a stuffy or runny nose as a side effect