Generic

Tamsulosin Hydrochloride

Indications

Tamsulosin Hydrochloride is a medication used to treat the symptoms of benign prostatic hyperplasia (BPH).

Pharmacology

Tamsulosin, a selective alpha1 adrenoceptor blocker, shows alpha1 A adrenoceptor selectivity in the human prostate. Blocking these adrenoceptors causes smooth muscle in the bladder neck and prostate to relax, resulting in increased urine flow and a decrease in BPH symptoms. Following oral administration of Tamsulosin hydrochloride capsule 0.4mg in fasting conditions, absorption is nearly full (90 percent). When given without food, the time to maximum concentration (Tmax) is four to five hours, while when given with food, it is six to seven hours. Human plasma protein is highly bound to tamsulosin hydrochloride (94 percent to 99 percent ). Tamsulosin hydrochloride is extensively processed in the liver by cytochrome P 450 enzymes, with less than 10% of the dosage eliminated unaltered in urine. Tamsulosin hydrochloride has a plasma elimination half-life of five to seven hours after intravenous or oral administration of an immediate-release formulation. The apparent half-life of Tamsulosin hydrochloride is around 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target group due to the absorption rate regulated pharmacokinetics with Prostam capsules.

Dosage & Administration

Tamsulosin Hydrochloride 0.4 mg (one capsule) daily, to be taken after meal at night. The dose may be increased after 2 to 4 weeks, if necessary, to Tamsulosin Hydrochloride 0.8 mg (two capsules) once daily. If Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride 0.4 mg (one capsule) once daily dose. The capsule should be swallowed whole with a glass of water (about 150 ml) in the standing or sitting position. The capsule should not be crunched or chewed, as this will interfere with the modified release of the active ingredient.

Interaction

The use of additional alfa1-adrenoceptor antagonists at the same time may cause hypotension. When Tamsulosin was used with atenolol, enalapril, or nifedipine, no interactions were observed. Tamsulosin plasma levels rise with concomitant cimetidine and decline with concomitant frusemide, but because levels stay within the normal range, posology does not need to be altered.

Contraindications

Patients with hypersensitivity to tamsulosin hydrochloride, a history of orthostatic hypotension, or severe hepatic insufficiency should not use it.

As with other alpha1 blockers, a decrease in blood pressure can occur in rare situations during therapy with Tamsulosin, leading to syncope. If the patient experiences the first indications of orthostatic hypotension (dizziness, weakness), he or she should sit or lay down until the symptoms resolve. They should also be warned to avoid circumstances that might end in harm (like driving, operating machinery or performing hazardous tasks).

Side Effect

Dizziness, abnormal ejaculation, and, less often, headache, asthenia, postural hypotension, and palpitations have all been described as side effects of Tamsulosin usage.

Pregnancy & Lactation

Tamsulosin should not be used during pregnancy or breastfeeding.

Precautions & Warnings

During orthostatic provocation testing following the initial dosage, temporary postural symptoms have occurred on rare occasions. It is not recommended for use in people who have micturition syncope.

Effects on ability to drive and operate equipment: There is no evidence that Tamsulosin impairs one’s ability to drive or operate machines. Patients should be warned, however, that dizziness can arise in this situation.

Therapeutic Class

BPH/ Urinary retention/ Urinary incontinence

Storage Conditions

Store in a cool and dry place, below 30°C, protected from light.

Pharmaceutical Name

General Pharmaceuticals Ltd.