Tamplus Special Precautions

Before therapy with TAMSULOSIN PLUS FINASTERIDE is initiated the patient should be examined in order to exclude the presence of other conditions such as carcinoma of the prostate which can cause the same symptoms as benign prostatic hyperplasia. Digital rectal examination, as well as other evaluations for prostate cancer, should be carried out on patients with BPH prior to initiating therapy with TAMSULOSIN PLUS FINASTERIDE and periodically thereafter.
Finasteride: No clinical benefit has yet been demonstrated in patients with prostate cancer treated with finasteride. Generally, when PSA assays are performed a baseline PSA>10 ng/ml prompts further evaluation and consideration of biopsy; for PSA levels between 4 and 10 ng/mL, further evaluation is advisable. There is considerable overlap in PSA levels among men with and without prostate cancer. Therefore, in men with BPH, PSA values within the normal reference range do not rule out prostate cancer regardless of treatment with finasteride. A baseline PSA <4 ng/ml does not exclude prostate cancer. Finasteride causes a decrease in serum PSA concentrations by approximately 50% in patients with BPH even in the presence of prostate cancer. This decrease in serum PSA levels in patients with BPH treated with Finasteride should be considered when evaluating PSA data and does not rule out concomitant prostate cancer. This decrease is predictable over the entire range of PSA values, although it may vary in individual patients. In patients treated with Finasteride for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men. This adjustment preserves the sensitivity and specificity of the PSA assay and maintains its ability to detect prostate cancer. Any sustained increase in PSA levels of patients treated with Finasteride should be carefully evaluated, including consideration of non-compliance to therapy with Finasteride. Percent free PSA (free to total PSA ratio) is not significantly decreased by Finasteride and remains constant even under the influence of Finasteride. When percent free PSA is used as an aid in the detection of prostate cancer, no adjustment is necessary.
Tamsulosin: As with other α₁ blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin, as a result of which, rarely, syncope can occur. At the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared. The treatment of severely renally impaired patients (creatinine clearance of less than 10 ml/min) should be approached with caution as these patients have not been studied. The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with Tamsulosin. IFIS may lead to increased procedural complications during the operation. The initiation of therapy with TAMSULOSIN PLUS FINASTERIDE in patients for whom cataract surgery is scheduled is not recommended. Discontinuing TAMSULOSIN PLUS FINASTERIDE 1-2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of cessation of therapy prior to cataract surgery has not yet been established. During pre-operative assessment, cataract surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with TAMSULOSIN PLUS FINASTERIDE in order to ensure that appropriate measures will be in place to manage IFIS during surgery should it occur.