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Prostate cancer: There was no increase incidence in Gleason 5-6 or 7-10 prostate cancers. No causal relationship between Dutasteride and high grade prostate cancer has been established. The clinical significance of the numerical imbalance is unknown. Men taking Dutasteride + Tamsulosin HCl should be regularly evaluated for prostate cancer risk including PSA testing.
Prostate specific antigen (PSA): PSA concentration is an important component of the screening to process to detect prostate cancer. Dutasteride + Tamsulosin HCl causes a decrease in mean serum PSA levels by approximately 50% after 6 months of treatment.
Pageants receiving Dutasteride + Tamsulosin HCl should have a new PSA baseline established after 6 months of treatment with Dutasteride + Tamsulosin HCl. It is recommended to monitor PSA values regularly thereafter. Any confirmed increase from lowest PSA level while on Dutasteride + Tamsulosin HCl may signal the presence of prostate cancer or non-compliance to therapy with Dutasteride + Tamsulosin HCl and should be carefully evaluated, even if those values are still within the normal range for men not taking a 5-ARI. In the interpretation of a PSA value for a patient taking Dutasteride + Tamsulosin HCl, previous PSA values should be sought for comparison. Treatment with Dutasteride + Tamsulosin HCl does not interfere with the use of PSA as a tool to assist in the diagnosis of prostate cancer after a new baseline has been established. Total serum PSA levels return to baseline within 6 months of discontinuing treatment. The ratio of free to total PSA remains constant even under the influence of Dutasteride + Tamsulosin HCl. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing Dutasteride + Tamsulosin HCl therapy, no adjustment to its value appears necessary.
Digital rectal examination, as well as other evaluations for prostate cancer, should be performed on patients with BPH prior to initiating therapy with Dutasteride + Tamsulosin HCl and periodically thereafter.
Hypotension: As with other alpha-1 adrenergic blockers, orthostatic hypotension can occur in patients treated with Tamsulosin which in rare cases can result syncope.
Patients begging treatment with Dutasteride + Tamsulosin HCl should be cautioned to sit or lie down at the first signs of orthostatic hypotension (dizziness and vertigo) until the symptoms have resolved.
Caution is advised when alpha adrenergic blocking agents including tamsulosin are co-administered with PDE-5 inhibitors. Alpha adrenergic blockers and PDE-5 inhibitor are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially causes symptomatic hypotension.
Intraoperative Floppy Iris Syndrome: Intraoperative Floppy Iris Syndrome (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients treated with alpha-1 adrenergic blockers after the operation.
During pre-operative assessment, cataract surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with Dutasteride + Tamsulosin HCl in order to ensure that appropriate measures will be in place to manage the IFIS during surgery.
Discontinuing Tamsulosin 1 to 2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of stopping therapy prior to cataract surgery has not yet been established.
Leaking capsules: Dutasteride is absorbed through the skin; therefore, women, children and adolescents must avoid contact with leaking capsules. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water.
Inhibitors of CYP3A4 and CYP2D6: Concurrent administration of tamsulosin hydrochloride with strong inhibitors of CYP3A4 (e.g. ketoconazole) or lesser extent, with strong inhibitors CYP2D6 (e.g. paroxitine) can increase tamsulosin exposure. Tamsulosin hydrochloride is therefore not recommended in patients taking a strong CYP3A4 inhibitor and should be used with caution in patients taking moderate CYP3A4 inhibitor (e.g. erythromycin), a strong or moderate CYP2D6 inhibitor, a combination of both CYP3A4 and CYP2D6 inhibitors, or in patients known to be poor metabolizers of CYP2D6.
Hepatic Impairment: The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied. Because dutasteride is extensively metabolised, and has half-life of three to five weeks, caution should be used in the administration of Dutasteride + Tamsulosin HCl to patients with liver disease.
Effects on Ability to Drive and Use Machines: There have been no studies to investigate the effect of Dutasteride + Tamsulosin HCl on the ability to perform tasks that require the judgement, motor or cognitive skills. However, patients should be informed about the possible occurrence of symptoms related to orthostatic hypotension such as dizziness when taking Dutasteride + Tamsulosin HCl.
