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Prostanil MR Capsule
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Tamsulosin Hydrochloride is indicated for the treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH).
BPH/ Urinary retention/ Urinary incontinence
Tamsulosin is an antagonist of α1A-adrenoreceptors in the prostate. It binds selectively and competitively to postsynaptic α1A-adrenoreceptors, which convey smooth muscle contraction, thereby relaxing prostatic and urethral smooth muscle.
Dosage & Administration
The recommended dose of Tamsulosin is 0.4 mg once daily. It should be administered approximately half/hour following the same meal each day. For those patients who fail to respond to the 0.4 mg dose after two to four weeks of dosing, the dose of Tamsulosin can be increased to 0.8mg once daily. If Tamsulosin administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once daily dose.
Increased plasma concentration with strong CYP3A4 inhibitors (e.g. ketoconazole). Moderate CYP3A4 inhibitors (e.g. erythromycin), strong (e.g. paroxetine) or moderate (e.g. terbinafine) CYP2D6 inhibitors may increase exposure of tamsulosin. Increased plasma concentration with cimetidine. Additive effect with other α-adrenergic blocking agents. Concomitant use with PDE5 inhibitors may lead to symptomatic hypotension. Decreased plasma concentration with furosemide.
History of orthostatic hypotension. Severe hepatic impairment.
The following adverse reactions have been reported during the use of Tamsulosin: dizziness, abnormal ejaculation, and less frequently (1-2%) headache, asthenia, postural hypotension, palpitations, and rhinitis.
Gastrointestinal reactions such as nausea, vomiting, diarrhoea, and constipation can occasionally occur. Hypersensitivity reactions such as rash, pruritus, and urticaria can occur occasionally. As with other alpha-blockers, drowsiness, blurred vision, dry mouth, or edema can occur. Syncope has been reported rarely, and there have been very rare reports of angioedema and priapism.
Pregnancy & Lactation
Tamsulosin Hydrochloride capsules are not indicated for use in women.
Precautions & Warnings
Not indicated for use in women. Severe renal impairment (CrCl <10 mL/min). Pregnancy and lactation.
Use in Special Populations
Tamsulosin Hydrochloride capsules are not indicated for use in pediatric populations.
As overdose of Tamsulosin Hydrochloride capsules lead to hypotension, support the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in supine position. If this measure is inadequate, then administration of intravenous fuid should be considered. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.
Store between 20-25° C.
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