Tamsoli

Moderate to severe storage (urgency, increased micturition frequency) & voiding symptoms associated w/ benign prostatic hyperplasia (BPH) in men who are inadequately responding to treatment w/ monotherapy.

Adult male (including elderly) 1 tab once daily. Max daily dose: 1 tab. Severe renal (CrCl ≤30 mL/min) & moderate hepatic (Child-Pugh score 7-9) impairment; concomitant use w/ moderate or strong CYP3A4 inhibitors (eg, verapamil, ketoconazole, ritonavir, nelfinavir, itraconazole) Max daily dose: 1 tab.

May be taken with or without food: Swallow whole, do not bite/chew/crush.

Hypersensitivity. Patients w/ or at risk for severe GI conditions (eg, toxic megacolon), myasthenia gravis or narrow-angle glaucoma; history of orthostatic hypotension; undergoing haemodialysis. Severe hepatic impairment. Patients w/ severe renal & moderate hepatic impairment treated w/ strong CYP3A4 inhibitor eg, ketoconazole.

Discontinue if angioedema occurs & appropriate therapy &/or measures should be taken. Caution in patients w/ risk of urinary retention, GI obstruction disorders, risk of decreased GI motility, hiatus hernia/gastroesophageal reflux &/or who are concurrently taking medicinal products (eg, bisphosphonates) that can cause or exacerbate oesophagitis, autonomic neuropathy; concomitant use w/ moderate & strong CYP3A4 inhibitors. Sit or lie down at the 1st signs of orthostatic hypotension (dizziness, weakness) until symptoms disappear. Examine patient to exclude the presence of other conditions that can cause similar symptoms to BPH. Assess for other causes of frequent urination before treatment initiation. Not to be used in combination w/ strong CYP3A4 inhibitors (eg, ketoconazole) in patients w/ poor CYP2D6 metaboliser phenotype or those using strong CYP2D6 inhibitors (eg, paroxetine). May affect ability to drive or use machines. Severe renal & moderate hepatic impairment. Not indicated for use in women. Pregnancy & lactation. Solifenacin succinate: Discontinue use in patients who develop anaphylactic reactions & appropriate therapy &/or measures should be taken. QT prolongation & Torsade de Pointes in patients w/ risk factors eg, pre-existing long QT syndrome & hypokalemia. Tamsulosin HCl: Decrease in BP may occur during therapy; may cause syncope. Intraoperative Floppy Iris Syndrome (IFIS) during cataract or glaucoma surgery; may increase risk of eye complications during or after surgery. Initiation of therapy is not recommended in patients w/ scheduled cataract or glaucoma surgery; discontinue treatment 1-2 wk prior surgery.

Dizziness; blurred vision; dry mouth, dyspepsia, constipation; ejaculation disorders including retrograde ejaculation & ejaculation failure; fatigue. Solifenacin: Nausea, abdominal pain.

More pronounced therapeutic & undesirable effects w/ anticholinergics. Increased exposure w/ strong CYP3A4 inhibitors eg, ketoconazole, ritonavir, nelfinavir & itraconazole. Concomitant use w/ moderate CYP3A4 inhibitor eg, verapamil. Decreased plasma conc w/ CYP3A4 inducers (eg, rifampicin). Solifenacin succinate: Reduced therapeutic effect w/ cholinergic receptor agonists. Reduced effect of medicinal products that stimulate GIT motility eg, metoclopramide & cisapride. Tamsulosin HCl: Increased AUC w/ cimetidine. Increased C_max & AUC w/ paroxetine. Hypotensive effects w/ other α₁-adrenoceptor antagonists. Increased elimination rate w/ diclofenac & warfarin. Decreased plasma levels w/ furosemide.

Drugs for Bladder & Prostate Disorders

G04CA53 - tamsulosin and solifenacin ; Belongs to the class of anticholinergics and alpha-adrenoceptor antagonist. Used in the treatment of benign prostatic hypertrophy.

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