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ALFUSIN-D (ALFUZOSIN/DUTASTERIDE) TABLETS: WARNINGS
Evaluation for Other Urological Diseases
Prior to initiating treatment with Alfusin-D, consideration should be given to other urological conditions that may cause similar symptoms. In addition, BPH and prostate cancer may coexist.
Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of Alfusin-D tablets. There is a potential for syncope. Patients should be warned of the possible occurrence of such events and should avoid situations where injury could result, should syncope occur. There may be an increased risk of hypotension/postural hypotension and syncope when taking Alfusin-D tablets concomitantly with antihypertensive medication and nitrates. Care should be taken when Alfusin-D are administered to patients with symptomatic hypotension or patients who have had a hypotensive response to other medications.
Rarely (probably less than 1 in 50,000), alfuzosin hcl, like other alpha-adrenergic antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Because this condition can lead to permanent impotence if not properly treated, patients should be advised about the seriousness of the condition.
Intraoperative Floppy Iris Syndrome (IFIS)
IFIS has been observed during cataract surgery in some patients on or previously treated with alpha-adrenergic antagonists. This variant of small-pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs and potential prolapse of the iris toward the phacoemulsification incisions. The patient's ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings or viscoelastic substances. There does not appear to be a benefit of stopping alpha-adrenergic antagonist therapy prior to cataract surgery.
Increased Risk of High-grade Prostate Cancer
In men aged 50 to 75 years, with a prior negative biopsy for prostate cancer and a baseline PSA between 2.5 ng / mL and 10.0 ng / mL, who were taking dutasteride in the 4-year Reduction by Dutasteride of prostate Cancer Events (REDUCE) trial, there was an increased incidence of Gleason score 8-10 prostate cancer compared with men taking placebo (dutasteride 1.0% versus placebo 0.5%). In a 7-year, placebo-controlled clinical trial with another 5 alpha-reductase inhibitor (finasteride 5 mg), similar results for Gleason score 8-10 prostate cancer were observed (finasteride 1.8% versus placebo 1.1%). The 5 alpha-reductase inhibitors may increase the risk of development of high-grade prostate cancer. It has not been established as to whether the effect of 5 alpha-reductase inhibitors to reduce prostate volume, or study-related factors, impacted the results of these studies.
Exposure of Women - Risk to Male Foetus
Alfusin-D tablets should not be handled by a woman who is pregnant or who could become pregnant. Dutasteride is absorbed through the skin and could result in unintended foetal exposure. If a woman who is pregnant or who could become pregnant comes in contact with leaking Alfusin-D, the contact area should be washed immediately with soap and water.
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||Capsules; Oral; Dutasteride 0.5 mg; Tamsulosin Hydrochloride 0.4 mg
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