Tamsulosin hydrochloride (uromax)....#use,doses......side effect . #contraindicatin......details of tamsulosin

Indications

Benign prostatic hyperplasia

Dosage & administrations

Oral

Adult: As HCl: As modified-release preparation: 1 (one) capsule once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-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 capsules can be increased to 0.8 mg once daily. 

If capsules 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.

Renal impairment:

CrCl (ml/min)

>10 No dose adjustment needed.

<10         Not studied.

Hepatic impairment: Moderate hepatic impairment (Child-Pugh classification A and B): No dose adjustment needed. Severe hepatic impairment: Avoid.

Contraindications

Hypersensitivity to sulfonamide, severe hepatic impairment, lactation.

Side effects

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 oedema can occur. Syncope has been reported rarely, and there have been very rare reports of angioedema and priapism.

Precautions & warnings

Hypersensitivity to Tamsulosin Hydrochloride. A history of orthostatic hypotension; severe hepatic insufficiency. As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin, as a result of which, rarely, syncope can occur. At the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared. And they should be cautioned to avoid situations where injury could result (like driving, operating machinery or performing hazardous tasks). Before therapy with Tamsulosin is initiated the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as Benign Prostatic Hyperplasia. Digital rectal examination and when necessary determination of Prostate Specific Antigen (PSA) should be performed before treatment and at regular intervals afterwards. The treatment of severely renal impaired patients (creatinine clearance is less than10ml/min) should be approached with caution as these patients have not been studied. Caution should be exercised in porphyria or allergic reaction to this or any other medicine.

Pregnancy Category - B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Therapeutic class

BPH/Urinary retention/Urinary incontinence

Mode of action

Tamsulosin is a selective a1 adrenoreceptor-blocking agent. Smooth muscle tone is mediated by the sympathetic nervous stimulation of ?1 adrenoreceptors, which are abundant in the prostate, prostatic capsule, prostatic urethra, and bladder neck. Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and reduction in symptoms in BPH.

Interaction

Increased plasma concentration w/ 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 w/ cimetidine. Additive effect w/ other ?-adrenergic blocking agents. Concomitant use w/ PDE5 inhibitors may lead to symptomatic hypotension. Decreased plasma concentration w/ furosemide.