Solifenacin Succinate / Tamsulosin Hydrochloride

What it is and how it works

Solifenacin is a competitive muscarinic (mainly M3) receptor antagonist that relaxes the detrusor muscle and reduces bladder overactivity. Tamsulosin selectively blocks alpha1A/1D-adrenoceptors in the prostate and bladder neck, relaxing smooth muscle and improving urinary flow.

Indications

Moderate to severe storage symptoms (urgency, increased frequency) and voiding symptoms associated with benign prostatic hyperplasia in men not adequately responding to monotherapy.

Dosage and administration (summary)

Taken orally as one modified-release tablet (solifenacin 6 mg/tamsulosin 0.4 mg) once daily, swallowed whole with or without food.

Contraindications

Urinary retention, severe gastrointestinal conditions (including toxic megacolon), myasthenia gravis, narrow-angle glaucoma, history of orthostatic hypotension, severe hepatic impairment, and severe renal impairment or moderate hepatic impairment with strong CYP3A4 inhibitors; haemodialysis.

Warnings and precautions

Orthostatic hypotension and dizziness may occur, especially at the start of treatment; there is a risk of intraoperative floppy iris syndrome during cataract or glaucoma surgery. Use with caution in bladder outflow obstruction, gastrointestinal obstruction, QT prolongation risk and with strong CYP3A4 inhibitors.

Pregnancy

Not indicated for use in women.

Storage and supply

Store below 30 °C.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.