UROREC

What it is

UROREC is a hard gelatin capsule formulation containing silodosin, available in 4 mg and 8 mg strengths.

Approved indications

— Relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult men.

Dosing overview

The recommended dose is one capsule of UROREC 8 mg daily. A capsule should be taken with food, preferably at the same time every day, and should not be broken or chewed but swallowed whole, preferably with a glass of water. No dose adjustment is required in the elderly. No dose adjustment is required for patients with mild renal impairment. A starting dose of 4 mg once daily is recommended in patients with moderate renal impairment, with a dose increase to 8 mg once daily considered after a minimum of one week depending on individual patient response. The use in patients with severe renal impairment is not recommended. No dose adjustment is required for patients with mild to moderate hepatic impairment.

Key safety warnings

The incidence of orthostatic effects with silodosin is very low, although a reduction in blood pressure can occur in individual patients, leading in rare cases to syncope; at the first signs of orthostatic hypotension (such as postural dizziness), the patient should sit or lie down until symptoms have disappeared. In patients with orthostatic hypotension, treatment with silodosin is not recommended. Since BPH and prostate carcinoma may present the same symptoms and can co-exist, patients thought to have BPH should be examined prior to starting therapy with silodosin to rule out the presence of carcinoma of the prostate; digital rectal examination and, when necessary, determination of prostate specific antigen (PSA) should be performed before treatment and at regular intervals afterwards. Treatment with silodosin leads to a decrease in the amount of semen released during orgasm that may temporarily affect male fertility, although this effect disappears after discontinuation of treatment. Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in a significant proportion of patients on α₁-blockers or previously treated with α₁-blockers, which may lead to increased procedural complications; the initiation of therapy with silodosin is not recommended in patients for whom cataract surgery is scheduled.

Contraindications

UROREC is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

PBS listing

UROREC 4 mg capsules are listed on the PBS with authority required restriction at an ex-manufacturer price of A$24.92, and UROREC 8 mg capsules are listed with authority required restriction at an ex-manufacturer price of A$29.33.

Regulatory history

The TGA approved UROREC (silodosin) for registration on the Australian Register of Therapeutic Goods on 23 May 2017, for the relief of lower urinary tract symptoms associated with benign prostatic hyperplasia in adult men. The TGA's evaluation concluded that UROREC met acceptable standards of quality, safety, and efficacy for its proposed use, with the benefits of the drug for relieving lower urinary tract symptoms associated with benign prostatic hyperplasia found to outweigh the risks.