Silocin 8Mg

DESCRIPTION

Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2- [2-(2,2, trifluoromethoxy) phenoxy] ethyl} amino) propyI]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25 H32 F3 N3 O4 with a molecular weight of 495.53. 

CONTAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients. 

SPECIAL WARNING & PRECAUTIONS FOR USE

Intraoperative Floppy Iris Syndrome (IFIS): IFIS (a variant of small pupil syndrome) has been observed during cataract surgery in some patients on α 1-blockers or previously treated with α 1-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.

UNDESIRBLE EFFECTS

Summary of the safety profile: The safety of Silodosin has been evaluated in four Phase 11-111 double-blind controlled clinical studies (with 931 patients receiving Silodosin 8 mg once daily and 733 patients receiving placebo) and in two long-term open-label extension phase studies. In total, 1 ,581 patients have received Silodosin at a dose of 8 mg once daily, including 961 patients exposed for at least 6 months and 384 patients exposed for 1 year. The most frequent adverse reactions reported with Silodosin in placebo controlled clinical studies and during long-term use were ejaculatory disorders such as retrograde ejaculation and anejaculation (ejaculatory volume reduced or absent), with a frequency of 23 %. This may temporarily affect male fertility. It is reversible within a few days upon discontinuation of treatment.  

OVERDOSE

Silodosin was evaluated at doses of up to 48 mg/day in healthy male subjects. The dose-limiting adverse reaction was postural hypotension. If ingestion is recent, induction of vomiting or gastric lavage may be considered. Should overdose of Silodosin lead to hypotension, cardiovascular support has to be provided. Dialysis is unlikely to be of significant benefit since Silodosin is highly (96.6 %) protein bound. 

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