FLOMAXTRA

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 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. FLOMAXTRA may cause dizziness, and patients should be warned to take care whilst operating machinery or driving. 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. During pre-operative assessment, ophthalmologists and ophthalmic teams should consider whether patients scheduled for cataract or glaucoma surgery are being, or have been, treated with α1-adrenoceptor antagonists in order to ensure that appropriate measures will be in place to manage IFIS during surgery if it occurs. The patient's ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilisation of iris hooks, iris dilator rings, or visco-elastic substances. Cases of allergic reaction to tamsulosin in patients with a past history of sulphonamide allergy have been reported. If a patient reports a sulfa allergy, caution is warranted when administering FLOMAXTRA.

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 tamsulosin hydrochloride 400 microgram prolonged release tablet was first listed on the ARTG on 18 January 2006.