Sodez Special Precautions

Intraoperative Floppy Iris Syndrome (IFIS): IFIS (a variant of small pupil syndrome) has been observed during cataract surgery in some patients on α₁-blockers or previously treated with α₁-blockers. This may lead to increased procedural complications during the operation.
The initiation of therapy with silodosin is not recommended in patients for whom cataract surgery is scheduled. Discontinuing treatment with an α_1-blocker 1-2 weeks prior to cataract surgery has been recommended, but the benefit and duration of stopping the therapy prior to cataract surgery has not yet been established.
During pre-operative assessment, eye surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with silodosin, in order to ensure that appropriate measures will be in place to manage IFIS during surgery.
Orthostatic effects: The incidence of orthostatic effects with silodosin is very low. However, 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 the symptoms have disappeared. In patients with orthostatic hypotension, treatment with silodosin is not recommended.
Renal impairment: The use of silodosin in patients with severe renal impairment (CL_CR <30 mL/min) is not recommended (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Since no data are available in patients with severe hepatic impairment, the use of silodosin in these patients is not recommended (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Carcinoma of the prostate: 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. This effect disappears after discontinuation of silodosin (see Adverse Reactions).
Effects on ability to drive and use machines: Silodosin has minor or moderate influence on the ability to drive and use machines. Patients should be informed about the possible occurrence of symptoms related to postural hypotension (such as dizziness) and should be cautioned about driving or operating machines until they know how silodosin will affect them.