TAMSULOSIN

What it is

FLOMAXTRA is a film-coated, prolonged release tablet containing 400 µg tamsulosin hydrochloride, an α1-adrenoceptor blocking agent, equivalent to 367 µg of tamsulosin per tablet.

Approved indications

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

Dosing overview

One tablet daily. The tablet must be swallowed whole and not be broken, crunched or chewed, as this compromises the prolonged release properties of the tablet for the active ingredient. FLOMAXTRA can be taken on an empty stomach, or before, with or after food.

Key safety warnings

Patients beginning treatment with FLOMAXTRA tablets should be cautioned to avoid situations where injury could result should syncope occur. Postural hypotension can occur during treatment with FLOMAXTRA, but rarely results in syncope. However, the patient should be warned of this possibility and advised to sit or lie down if symptoms of hypotension should occur. Carcinoma of the prostate and other conditions which can cause the same symptoms as benign prostatic hyperplasia should be excluded before starting therapy with FLOMAXTRA. Digital rectal examination and, as considered appropriate, determination of prostate specific antigen should be performed before treatment and at regular intervals afterwards. Intra-operative Floppy Iris Syndrome (IFIS) has been observed during cataract and glaucoma surgery in some patients taking or who have previously been treated with α1-adrenoceptor antagonists, including tamsulosin. This variant of small pupil syndrome is characterised by the combination of a flaccid iris that billows in response to intra-operative irrigation currents, progressive intra-operative miosis despite pre-operative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phaco-emulsification incisions. Rarely, tamsulosin, like other alpha-1 antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction.

Contraindications

Hypersensitivity, including drug-induced angioedema, to tamsulosin hydrochloride or any other component of the product. A history of orthostatic hypotension. Severe hepatic impairment (Child-Pugh scores > 9). Severe renal impairment with creatinine clearance of less than 10 mL/min. Concurrent use of another α1-adrenoceptor inhibitor.

Regulatory history

FLOMAXTRA received initial approval on 18 January 2006.