Duoflow Special Precautions

Effects on Ability to Drive and Use Machine: There have been no studies to investigate the effect of combination of dutasteride and tamsulosin on the ability to perform tasks that required 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 combination of dutasteride and tamsulosin.
Dutasteride: Prostate-specific antigen (PSA) effects: In clinical trials, dutasteride reduced serum PSA concentration by approximately 50% within 3 to 6 months of treatment. Dutasteride may also cause decreased in serum PSA in the presence prostate cancer. To interpret serial PSAs in men taking a 5-alpha reductase inhibitor, establish a new PSA baseline at least 3 months after starting dutasteride treatment and periodically monitor PSA thereafter. Any confirmed increase from the lowest PSA value may signal the presence prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5-alpha reductase inhibitor. Noncompliance may also affect PSA test results.
To interpret an isolated PSA value in a man treated with dutasteride for 3 months or more, double the PSA value for comparison with normal values in untreated men.
The free-to-total PSA ratio (percent-free PSA) remains constant, even under the influence of a 5-alpha reductase inhibitor. If health care providers elect to use percent-free PSA as an aid in the detection of prostate cancer in men receiving a 5-alpha reductase inhibitor, no adjustment to its value appears necessary.
PSA increased while on a 5-alpha reductase inhibitor should be considered suspicious; obtain serial PSA measurements and evaluate.
Prostate cancer: When compared with placebo, 5-alpha-reductase inhibitors have been associated with an increase in the incidence of high-grade prostate cancers. In clinical trials, there was an increased incidence of Gleason score 8 to 10 prostate cancer for men taking dutasteride compared with men taking placebo (dutasteride 1% vs placebo 0.5%).
Breast cancer: 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-ARIs. Prescribers should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge.
Blood donation: Men being treated with a 5-alpha reductase inhibitor should not donate blood until at least 6 months have passed following their last dose. The purpose of this deferred period to prevent administration of 5-alpha reductase inhibitor to a pregnant female transfusion recipient.
Reproductive effects: The effects of dutasteride 0.5 mg/day on semen characteristics were evaluated in healthy volunteers. At 52 weeks, the mean percent reduction from baseline in total sperm count, semen volume, and sperm motility were 23%, 26%, and 18%, respectively, in the dutasteride group when adjusted for changes from baseline in the placebo group. After 24 weeks of follow-up, the mean percent change in total sperm count in the dutasteride group remained 23% lower than baseline. While mean values for all semen parameters at all time points remained within the normal ranges and did not meet predefined criteria for a clinically significant change (30%), 2 subjects in the dutasteride group had decreases in sperm count of more than 90% from baseline at 52 weeks, with partial recovery at the 24-week follow-up. The clinical significance of dutasteride's effect on semen characteristics for an individual patient's fertility is not known.
Hepatic function impairment: Use caution in patients with liver function abnormalities; dutasteride is metabolized extensively in the liver.
Monitoring: Assess patients to rule out other urological diseases, including prostate cancer, prior to treatment and periodically thereafter. Establish a new PSA baseline at least 3 months after starting dutasteride treatment and periodically monitor PSA thereafter.
Objective and subjective signs of relief of benign prostatic hyperplasia, including improvement in urinary flow, reduction in symptoms of urgency, and relief of difficulty in micturition.
Tamsulosin: Postural hypotension: Potential for postural hypotension, dizziness, or vertigo; syncope may occur.
Priapism: Rarely, alpha-1 antagonists have been associated with priapism (painful penile erection, sustained for hours and unrelieved by sexual intercourse or masturbation). Because this condition can lead to permanent impotence if not promptly treated, patients must be advised about the seriousness of the condition.
Allergic reactions: Rash, pruritus, urticaria, and angioedema of the tongue, lips, and face reported; positive rechallenge in some patients.
Sulfa sensitivity: Allergic reaction to tamsulosin reported rarely in patients with sulfa sensitivity. Use with caution in patients with serious or life-threatening sulfa sensitivity.
Prostate cancer: Exclude possibility of prostate cancer prior to initiation of therapy.
Intraoperative floppy iris syndrome: Intraoperative floppy iris syndrome (IFIS) observed during phacoemulsification cataract surgery in some patients receiving α1-adrenergic blocking agents, including tamsulosin. Most reported cases were in patients who continued such therapy at the time of cataract surgery.
Use in Pregnancy: Dutasteride: Active ingredient of crushed or broken capsules can be absorbed through the skin. Women should avoid contact with crushed or broken capsules and the semen from a male partner exposed to 5-alpha reductase inhibitors, as they may negatively impact fetal development.
Use in Children: Dutasteride: Dutasteride is contraindicated for use in pediatric patients.