Generic

Tamsulosin Hydrochloride

Indications

Pharmacology

Tamsulosin, a selective alpha1 adrenoceptor blocking agent, exhibits its selectivity for alpha1A adrenoceptors in human prostate. Blockade of these adrenoceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine ‑ow rate and a reduction in symptoms of BPH. Absorption of Tamsulosin Hydrochloride capsules 0.4 mg is essentially complete (90%) following oral administration under fasting condition. The time to maximum concentration (Tmax) is reached by four to ­ve hours under fasting conditions and by six to seven hours when administered with food. Tamsulosin Hydrochloride is extremely bound to human plasma protein (94% to 99%). Tamsulosin Hydrochloride is extensively metabolized by cytochrome P 450 enzymes in the liver and less than 10% of the dose is excreted in urine as unchanged form. Following intravenous or oral administration of an immediate-release formulation the elimination half-life of Tamsulosin Hydrochloride in plasma ranges from ­ve to seven hours. Because of the absorption rate controlled pharmcokinetics with MaxrinTM Capsule, the apparent half-life of Tamsulosin Hydrochloride is approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population.

Dosage & Administration

The recommended dose of MaxrinTM capsule 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 MaxrinTM capsules can be increased to 0.8mg once daily. If MaxrinTM 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.

Interaction

Contraindications

Hypersensitivity to Tamsulosin Hydrochloride. A history of orthostatic hypotension; severe hepatic insuciency. 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 ­rst 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 thepresence of other conditions which can cause the same symptoms as Benign Prostatic Hyperplasia. Digital rectal examination and when necessary determination of Prostate Speci­c Antigen (PSA) should be performed before treatment and at regular intervals afterwards. The treatment of severely renal impaired patients (creatinine clearance is less than 10 ml/min) should be approached with caution as these patients have not been studied.

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 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

Once in a while, temporal postural side effects have happened amid orthostatic incitement testing after the primary dosage. Utilize in patients with micturition syncope isn’t advised.

Effects on capacity to drive and utilize machines: No information is accessible on whether Tamsulosin unfavorably influences the capacity to drive or work machines. Be that as it may, in this regard, patients ought to be mindful of the truth that tipsiness can occur.

Therapeutic Class

BPH/ Urinary maintenance/ Urinary incontinence

Storage Conditions

Store in a cool (below 300 C) and dry place, protected from light and moisture. Keep out of reach of children.

Pharmaceutical Name

Square Pharmaceuticals Ltd.