1/5/2024 0 Comments Pamfax login![]() (the frequency cannot be estimated from the available data) ![]() Tamsulosin hydrochloride should be used with caution in combination with strong and moderate inhibitors of CYP3A4.Ĭoncomitant administration of tamsulosin hydrochloride with paroxetine, a strong inhibitor of CYP2D6, resulted in a Cmax and AUC of tamsulosin that had increased by a factor of 1.3 and 1.6, respectively, but these increases are not considered clinically relevant.Ĭoncurrent administration of other α1-adrenoceptor antagonists could lead to hypotensive effects. Concomitant administration with ketoconazole (a known strong CYP3A4 inhibitor) resulted in an increase in AUC and Cmax of tamsulosin hydrochloride by a factor of 2.8 and 2.2, respectively. Neither does tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone.ĭiclofenac and warfarin, however, may increase the elimination rate of tamsulosin.Ĭoncomitant administration of tamsulosin hydrochloride with strong inhibitors of CYP3A4 may lead to increased exposure to tamsulosin hydrochloride. In vitro, neither diazepam nor propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin change the free fraction of tamsulosin in human plasma. No interactions have been seen when tamsulosin was given concomitantly with either atenolol, enalapril or theophylline.Ĭoncomitant cimetidine brings about a rise in plasma levels of tamsulosin, whereas furosemide a fall, but as levels remain within the normal range posology need not be adjusted. Interaction studies have only been performed in adults. This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release capsule, hard, that is to say essentially 'sodium-free'. ![]() Tamsulosin hydrochloride should be used with caution in combination with strong and moderate inhibitors of CYP3A4 (see section 4.5). Tamsulosin hydrochloride should not be given in combination with strong inhibitors of CYP3A4 in patients with poor metaboliser CYP2D6 phenotype. During pre-operative assessment, cataract surgeons and ophthalmic teams should consider whether patients scheduled for cataract or glaucoma surgery are being or have been treated with tamsulosin in order to ensure that appropriate measures will be in place to manage the IFIS during surgery. The initiation of therapy with tamsulosin in patients for whom cataract or glaucoma surgery is scheduled is not recommended. IFIS has also been reported in patients who had discontinued tamsulosin for a longer period prior to cataract surgery. IFIS may increase the risk of eye complications during and after the operation.ĭiscontinuing tamsulosin 1-2 weeks prior to cataract or glaucoma surgery is anecdotally considered helpful, but the benefit of treatment discontinuation has not yet been established. The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract or glaucoma surgery in some patients on or previously treated with tamsulosin. The treatment of patients with severe renal impairment (creatinine clearance of < 10 ml/min) should be approached with caution, as these patients have not been studied. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the symptoms have disappeared.īefore therapy with tamsulosin is initiated, the patient should be examined in order to exclude the presence of other conditions, which can cause the same symptoms as benign prostatic hyperplasia.ĭigital rectal examination and, when necessary, determination of prostate specific antigen (PSA) should be performed before treatment and at regular intervals afterwards. Date of first authorisation/renewal of the authorisationĪs with other α 1-adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during treatment with tamsulosin as a result of which, rarely, syncope can occur.
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