Prostanil MR

Generic

Tamsulosin Hydrochloride

 

Indications

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

 

Pharmacology

Tamsulosin is a selective α1 adrenergic receptor blocker, which is selective for the α1a adrenergic receptor in the human prostate. Blocking these adrenergic receptors relaxes the smooth muscles of the bladder neck and prostate, thereby improving the rate of urine flow and reducing the symptoms of BPH. After oral administration under fasting conditions, the absorption of the 0.4 mg tamsulosin hydrochloride capsule is almost complete (90%). Time to maximum concentration (Tmax) under fasting conditions is 4 to 5 hours, and 6 to 7 hours when administered with food. Tamsulosin hydrochloride is strongly bound to human plasma proteins (94% to 99%). Tamsulosin hydrochloride is extensively metabolized by the cytochrome P 450 enzyme in the liver, and less than 10% of the dose is excreted in the urine in its original form. The elimination half-life of tamsulosin hydrochloride in plasma is 5 to 7 hours after intravenous or oral immediate release of the preparation. Due to the controlled pharmacokinetics of the absorption rate of Prostam capsules, 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

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 simultaneous use of other alpha1 adrenergic receptor antagonists may produce hypotensive effects. When tamsulosin was co-administered with atenolol, enalapril, or nifedipine, no interaction was observed. Concomitant cimetidine causes an increase in the plasma level of tamsulosin and furosemide, but since the level remains within the normal range, it is not necessary to change the dosimetry. In the in vitro study of hepatic microsomal components (representing the drug metabolizing enzyme system related to cytochrome P450), no interaction was observed at the level of hepatic metabolism, including amitriptyline, salbutamol, glibenclamide and finasteride. However, diclofenac and warfarin can increase the elimination rate of tamsulosin.

 

Contraindications

Disabled for patients allergic to tamsulosin hydrochloride; history of orthostatic hypotension; severe liver failure.

Like other α1 blockers, in individual cases, blood pressure may drop during tamsulosin treatment. Therefore, in rare cases, syncope may occur; in the presence of orthostatic hypotension (dizziness, At the first signs of weakness), the patient should sit down. Or lie down until the symptoms disappear. And they should be warned to avoid situations where injury may occur (such as driving, operating machinery, or performing dangerous tasks).

Before starting treatment with tamsulosin, the patient should be checked for other conditions that may cause the same symptoms as benign prostatic hyperplasia. Digital rectal examination and necessary prostate-specific antigen (PSA) measurement should be performed before and regularly after treatment.

 

Side Effects

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

 

Pregnancy & Lactation

Use of Tamsulosin in pregnancy and lactation is not recommended.

 

Precautions & Warnings

During orthostatic provocation testing following the initial dose, 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 informed, 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

Aristopharma Ltd.