Each enteric coated tablet contains: Tamsulosin Hydrochloride BP 400 mcg.
Action
Pharmacology:Pharmacokinetics: Tamsulosin is absorbed from the gastrointestinal tract and is almost completely bioavailable. The extent and rate of absorption are reduced in the presence of food. Following oral administration of an immediate release preparation, peak plasma concentrations occur about 1 hour after a dose. Tamsulosin is metabolized slowly in the liver and is excreted mainly in the urine as metabolites and some unchanged drug. The plasma elimination half-life has been reported to be between 4 and 5.5 hours. Tamsulosin is about 99% bound to plasma proteins.
Some of the pharmacokinetic value cited above may be altered when tamsulosin is administered as a modified-release preparation, the form in which it is usually employed; for instance, peak plasma concentrations occur about 6 hours after a dose and the apparent elimination half-life may be 10 to 15 hours.
Indications/Uses
Used in benign prostatic hyperplasia (BPH) to relieve symptoms of urinary obstruction.
Dosage/Direction for Use
Benign Prostatic Hyperplasia: 400 mcg once daily, may be increased after 2 weeks, if necessary to 800 mcg once daily or as prescribed by a physician. Best taken without food. Swallow whole, do not chew/crush or open.
Contraindications
Impaired renal function.
Warnings
Do not use in women, children.
Special Precautions
Potential risk of syncope, intraoperative floppy iris syndrome, patient with serious or life-threatening allergy with sulfa drugs. Monitor BP closely on patient receiving antihypertensive drugs. Rule out carcinoma of the prostate prior to treatment with tamsulosin.
Adverse Reactions
Infection, back pain, headache, dizziness, somnolence, rhinitis, increased cough, chest pain, diarrhea, nausea, sinusitis, abnormal ejaculation, decreased libido and blurred vision. Symptomatic postural hypotension, vertigo, skin rash, pruritus, urticaria, angioedema of tongue, lips and face. Arrhythmia, dipsosis, nervousness, stomach heaviness, stomachache, decrease in appetite, edema, urinary incontinence, impaired swallowing, generalized fatigue, burning sensation of the pharynx, palpitations, hypotension, constipation, vomiting and skin desquamation.
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