Generic Name

Tamsulosin Hydrochloride

Precaution

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.

Indication

Benign prostatic hyperplasia

Contra Indication

Hypersensitivity to sulfonamide, severe hepatic impairment, lactation. History of orthostatic hypotension.

Dose

N/A

Side Effect

>10% Headache (19-21%),Orthostatic hypotension (6-19%),Rhinitis (13-18%),Abnormal ejaculation (8-18%),Dizziness (15-17%),Arthralgia (11%),Infection (9-11%) 1-10% Asthenia (8%),Back pain (7-8%),Skin rash (7%),Pharyngitis (5-6%),Diarrhea (4-6%),Myalgia (5%),Chest pain (4%),Cough (3-4%),Somnolence (3-4%),Nausea (2-4%),Sinusitis (2-4%),Abdominal discomfort (2-3%),Bitter taste (2-3%),Decreased libido (1-2%),Insomnia (1-2%)

Pregnancy Category

Mode of Action

Tamsulosin is a selective alpha1 adrenoreceptor-blocking agent. Smooth muscle tone is mediated by the sympathetic nervous stimulation of alpha1 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.

Pregnancy Category Note

Pregnancy No data are available on use in pregnant women No adverse developmental effects observed in animal studies administering tamsulosin to rats or rabbits during organogenesis Infertility Males: Abnormal ejaculation including ejaculation failure, ejaculation disorder, retrograde ejaculation, and ejaculation decrease has been associated with therapy; studies in rats revealed significantly reduced fertility in males considered to be due to impairment of ejaculation, which was reversible Females: Drug is not indicated for use in women; female fertility in rats was significantly reduced, considered to be due to impairment of fertilization Lactation There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production No data are available; owing to potential of tamsulosin to cause hypotension, breastfeeding is not recommended if taking tamsulosin

Adult Dose

Oral Benign prostatic hyperplasia Adult: 1 (400mcg) capsule once daily. If response is inadequate after 2-4 weeks, may be increased to 800 mcg once daily; if therapy is interrupted, should be resumed at 400 mcg once daily Hepatic impairment Mild to moderate: Dosage adjustment not necessary Severe: Not studied

Child Dose

N/A

Renal Dose

Renal impairment CrCl ?10 mL/min: Dosage adjustment not necessary CrCl <10 mL/min: Not studied

Administration

Prolonged release tab: May be taken with or without food. Swallow whole, do not chew/crush. Cap: Should be taken with food. Take ½ hr following the same meal daily. Swallow whole, do not open/chew/crush.