Tamsulosin hydrochloride.
Lower urinary tract symptoms associated with benign prostatic hyperplasia.
1 tablet once daily.
Administration: The tablets must be swallowed whole and not be chewed, broken, or crushed.
As with other α-adrenoreceptor antagonists, a decrease in blood pressure may occur in certain individuals during therapy with tamsulosin hydrochloride, and may cause syncope (rare). When the initial symptoms of orthostatic hypotension (dizziness, weakness) occur, the patient should be seated or laid down until the complaints disappear. Before starting tamsulosin hydrochloride therapy, the patient needs to undergo examination to ensure that there are no certain conditions that can cause symptoms similar to benign prostatic hyperplasia (BPH). Rectal examination and if necessary prostate specific antigen (PSA) examination can be done before starting therapy or periodically during therapy. Treatment for patients with severely impaired renal function (creatinine clearance <10 mL/min) should be done with caution as there have been no studies in this group. Ophthalmologists should be aware of the occurrence of Intraoperative Floppy Iris Syndrome (IFIS) that occurs during cataract or glaucoma surgery in patients currently or recently taking tamsulosin hydrochloride. IFIS may increase the risk of eye complications during or after surgery. Tamsulosin hydrochloride should be temporarily discontinued for 1-2 weeks prior to cataract or glaucoma surgery, although the extent of benefit is unknown. IFIS has occurred in patients who have discontinued tamsulosin hydrochloride for a longer period before undergoing surgery. Patients who have been planned to undergo cataract or glaucoma surgery is not recommended to start therapy with tamsulosin hydrochloride. During the pre-operative assessment, the physician should ascertain whether the patient who is planning to undergo cataract or glaucoma surgery has received tamsulosin hydrochloride, to anticipate any possibility associated with the occurrence of IFIS during surgery. Tamsulosin hydrochloride should not be combined with strong CYP3A4 antagonists in patients with CYP2D6 metabolic deficiency - tamsulosin hydrochloride should be administered with caution when combined with strong and moderate strength CYP3A4 antagonists. There have been cases of allergic reactions to tamsulosin hydrochloride in patients with a history of allergy to sulfonamides. If the patient reports a previous history of sulfa allergy, Tamsulosin hydrochloride should be administered with caution. There is a possibility of metabolic waste of tamsulosin hydrochloride being found in the feces.
No interactions occurred when tamsulosin hydrochloride was coadministered with atenolol, enalapril, or theophylline. Co-administration with cimetidine increased the plasma concentration of tamsulosin hydrochloride, while it decreased for furosemide. However, since it was still within the normal posology range, no dose adjustment was required. There was no change in plasma-free fraction of tamsulosin hydrochloride when co-administered with diazepam. Propanolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin, and warfarin. Likewise, tamsulosin hydrochloride did not change the free fraction of diazepam, propanolol, trichlormethiazide, and chlormadinone. There was no interaction at the level of hepatic metabolism with the hepatic microsomal fraction (representing the group of drugs related to the cytochrome P450 metabolizing enzyme system), involving amitriptyline, salbutamol, glibenclamide, and finasteride. However, diclofenac and warfarin may increase the elimination rate of tamsulosin hydrochloride. Concomitant use of tamsulosin hydrochloride with strong antagonists of CYP3A4 might increase the effects of tamsulosin hydrochloride. Concomitant use with ketoconazole (known to be a strong antagonist of CYP3A4) led to an increase in AUC of tamsulosin. Tamsulosin hydrochloride should not be combined with strong CYP3A4 antagonists in patients with CYP2D6 metabolizing deficiency. Tamsulosin hydrochloride should be administered with caution when combined with strong and moderate strength CYP3A4 antagonists. Co-administration of tamsulosin hydrochloride with paroxetine which is a strong antagonist of CYP2D6 resulted in an increase in Cmax and AUC of tamsulosin hydrochloride, but not clinically significant. Co-administration with other α-adrenoreceptor antagonists may cause hypotensive effects.
G04CA02 - tamsulosin ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.
Simlosin MR tab 0.4 mg
3 × 10's