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Tamsustad
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Tamsulosin hydrochloride is a sulfamoylphenethylamine derivative, an alpha 1-adrenoceptor blocking agent, exhibits selectivity for alpha 1-receptors in the human prostate, resulting in an improvement in urine flow rate and a reduction in syndrome of benign prostatic hyperplasia (BPH).

Pack size Box of 30 capsules. Bottle of 100 capsules.
Shelf-life 36 months
Composition Tamsulosin hydrochloride (as tamsulosin hydrochloride pellets 0.12%)
Dosage forms and strengths Hard gelatin capsule: 0.4 mg
Product code :

PRESCRIBING INFORMATION

Indications:

Treatment of the syndrome of benign prostatic hyperplasia.

Dosage:

  • Usual dose: 1 capsule once daily, if not respond to the 0.4 mg dose after 2 – 4 weeks of dosing, the dose of tamsulosin hydrochloride can be increased to 2 capsules daily.
  • If 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 daily.
  • Renal impairment: Dosage adjustment is not necessary. Tamsulosin hydrochloride has not been studied in patients with end-stage renal disease (creatinine clearance < 10 ml/minute/1.73 m2).
  • Hepatic impairment: Patients with moderate hepatic dysfunction do not require an adjustment.

Usage:

Tamsustad is administered orally. Should not crush, chew or open capsule. It is recommended that the drug be taken 30 minutes after the same meal each day.

  • Known hypersensitivity to tamsulosin hydrochloride or any ingredient in the formulation.
  • A history of orthostatic hypotension.
  • Severe hepatic insufficiency.

Headache, infection, asthenia, back pain, chest pain, dizziness, somnolence, insomnia, decreased libido, rhinitis, pharyngitis, increased cough, sinusitis, diarrhea, nausea, tooth disorder, abnormal ejaculation, blurred vision.

  • Patients should be evaluated prior to start of tamsulosin therapy to rule out the presence of carcinoma of the prostate.
  • Tamsustad may cause a reduction in blood pressure, 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.
  • Angio-oedema has been rarely reported after the use of tamsulosin. Treatment should be discontinued immediately, the patient should be monitored until disappearance of the oedema, and tamsulosin should not be re-administered.
  • Tamsustad contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
  • Tamsustad is not indicated for use in women.
  • Patients should be told about the possible occurrence of symptoms related to postural hypotension such as dizziness when taking tamsulosin hydrochloride, and they should be cautioned about driving, operating machinery.