Dusorac Special Precautions

Combination therapy should be prescribed after careful benefit-risk assessment due to the potential increased risk of adverse events (including cardiac failure) and after consideration of alternative treatment options including monotherapies.
Prostate cancer and high-grade tumors: The REDUCE study, a 4-year, multicentre, randomized, double-blind, placebo-controlled study investigated the effect of Dutasteride 0.5 mg daily on patients with a high risk for prostate cancer (including men 50 to 75 years of age with PSA levels of 2.5 to 10 ng/mL and a negative prostate biopsy 6 months before study enrolment) compared to placebo. Results of this study revealed a higher incidence of Gleason 8-10 prostate cancers in Dutasteride-treated men (n=29, 0.9%) compared to placebo (n=19, 0.6%). The relationship between Dutasteride and Gleason 8-10 prostate cancers is not clear. Thus, men taking Dutasteride should be regularly evaluated for prostate cancer.
Cardiovascular adverse events: In two 4-year clinical studies, the incidence of cardiac failure was marginally higher among subjects taking the combination of Dutasteride and an alpha₁-adrenoceptor antagonist, primarily Tamsulosin, than it was among subjects not taking the combination. However, the incidence of cardiac failure in these trials was lower in all actively treated groups compared to the placebo group, and other data available for Dutasteride or alpha₁-adrenoceptor antagonists do not support a conclusion on increased cardiovascular risks.
Breast neoplasia: There have been rare reports of male breast cancer reported in men taking Dutasteride in clinical trials and during the post-marketing period. However, epidemiological studies showed no increase in the risk of developing male breast cancer with the use of 5-alpha reductase inhibitors. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge.
Renal impairment: The treatment of patients with severe renal impairment (creatinine clearance of less than 10 mL/min) should be approached with caution as these patients have not been studied.
Hypotension: Orthostatic: As with other alpha₁-adrenoceptor antagonists, a reduction in blood pressure can occur during treatment with Tamsulosin, as a result of which, rarely, syncope can occur. Patients beginning treatment with Dutasteride + Tamsulosin HCl should be cautioned to sit or lie down at the first signs of orthostatic hypotension (dizziness, weakness) until the symptoms have resolved.
In order to minimize the potential for developing postural hypotension the patient should be hemodynamically stable on an alpha₁-adrenoceptor antagonist prior to initiating the use of PDE5 inhibitors.
Symptomatic: Caution is advised when alpha adrenergic blocking agents including tamsulosin are coadministered with PDE5 inhibitors (e.g., sildenafil, tadalafil, vardenafil). Alpha₁-adrenoceptor antagonists and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause 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 on or previously treated with Tamsulosin. IFIS may increase the risk of eye complications during and after the operation. The initiation of therapy with Dutasteride + Tamsulosin HCl (Dusorac) in patients for whom cataract surgery is scheduled is therefore not recommended.
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 (Dusorac) in order to ensure that appropriate measures will be in place to manage the IFIS during surgery.
Discontinuing Tamsulosin 1-2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of stopping therapy prior to cataract surgery have not yet been established.
Leaking Capsule: 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.
Hepatic impairment: Dutasteride + Tamsulosin HCl (Dusorac) has not been studied in patients with liver disease. Caution should be used in the administration of Dutasteride + Tamsulosin HCl (Dusorac) to patients with mild to moderate hepatic impairment.