Orange coloured, round, biconvex, plain on both side and film-coated tablets.
Each film-coated tablet contains: Dutasteride 500 mcg.
Pharmacotherapeutic group: Testosterone-5-alpha-reductase inhibitors.
Pharmacology: Pharmacodynamics: Dutasteride reduces circulating levels of dihydrotestosterone (DHT) by inhibiting both type 1 and type 2, 5α-reductase isoenzymes which are responsible for the conversion of testosterone to DHT.
Pharmacokinetics: Dutasteride is absorbed from the gastrointestinal tract, reaching a peak serum concentration of 1 to 3 hours, with bioavailability of about 60%. It is highly bound to plasma proteins. Dutasteride is metabolised by the cytochrome P450 isoenzymes CYP3A5, and most of a dose is excreted as metabolites in the feces. At steady state, the elimination half-life is about 3 to 5 weeks.
Dutasteride is used in the treatment of benign prostatic hyperplasia.
Dutasteride is given in doses of 500 mcg daily by mouth. Response may be delayed and treatment for 5 to 6 months may be required to assess whether benefit has been achieved.
Or as directed by the physician.
Do not crush.
Single daily doses of Dutasteride up to 40 mg/day (80 times the therapeutic dose) have been administered for 7 days without significant safety concerns. In clinical studies, doses of 5 mg daily have been administered to subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg. There is no specific antidote for Dutasteride, therefore, in suspected overdosage, symptomatic and supportive treatment should be given as appropriate.
Dutasteride is contraindicated for use in: Pregnancy. In animal reproduction and developmental toxicity studies, Dutasteride inhibited development of male fetus external genitalia. Therefore, Dutasteride may cause fetal harm when administered to a pregnant woman. If Dutasteride is used during pregnancy or if the patient becomes pregnant while taking Dutasteride, the patient should be apprised of the potential hazard to the fetus.
Women of childbearing potential.
Pediatric patients.
Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to Dutasteride or other 5 alpha-reductase inhibitors.
Effects on Prostate-specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection: In clinical trials, Dutasteride reduced serum PSA concentration by approximately 50% within 3 to 6 months of treatment. This decrease was predictable over the entire range of PSA values in subjects with symptomatic BPH, although it may vary in individuals. Dutasteride may also cause decreases in serum PSA in the presence of prostate cancer. To interpret serial PSAs in men taking Dutasteride, a new PSA baseline should be established at least 3 months after starting treatment and PSA monitored periodically thereafter. Any confirmed increase from the lowest PSA value while on Dutasteride may signal the presence of 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 with Dutasteride may also affect PSA test results: To interpret an isolated PSA value in a man treated with Dutasteride for 3 months or more, the PSA value should be doubled for comparison with normal values in untreated men. The free-to-total PSA ratio (percent free PSA) remains constant, even under the influence of Dutasteride. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men receiving Dutasteride, no adjustment to its value appears necessary.
Co-administration of dutasteride and tamsulosin resulted in similar changes to serum PSA as Dutasteride monotherapy.
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 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%).
5 alpha-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5 alpha-reductase inhibitors to reduce prostate volume or trial-related factors impacted the results of these trials has not been established.
Evaluation for Other Urological Diseases: Prior to initiating treatment with Dutasteride, consideration should be given to other urological conditions that may cause similar symptoms. In addition, BPH and prostate cancer may coexist.
Exposure of Women-Risk to Male Fetus: Dutasteride 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 fetal exposure. If a woman who is pregnant or who could become pregnant comes in contact with dutasteride, the contact area should be washed immediately with soap and water.
Blood Donation: Men being treated with Dutasteride should not donate blood until at least 6 months have passed following their last dose. The purpose of this deferred period is to prevent administration of Dutasteride to a pregnant female transfusion recipient.
Effect on Semen Characteristics: The effects of Dutasteride 0.5 mg/day on semen characteristics were evaluated in normal volunteers aged 18 to 52 (n=27 Dutasteride, n=23 placebo) throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up. At 52 weeks, the mean percent reductions 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. Sperm concentration and sperm morphology were unaffected. 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 greater 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.
Dutasteride should be used with caution in hepatic impairment. When used for benign prostatic hyperplasia, Dutasteride should be used with caution in men at risk of obstructive uropathy. Patients should be evaluated for prostatic carcinoma before and during therapy.
Effects on Ability to Drive and Use Machines: Based on the pharmacodynamic properties of Dutasteride, treatment with Dutasteride would not be expected to interfere with the ability to drive or operate machinery.
Dutasteride is contraindicated for use by women.
Pregnancy: As with other 5 alpha-reductase inhibitors, Dutasteride inhibits the conversion of testosterone to dihydrotestosterone and may, if administered to a woman carrying a male fetus, inhibit the development of the external genitalia of the fetus. Small amounts of Dutasteride have been recovered from the semen in subjects receiving Dutasteride 0.5 mg day. It is not known whether a male fetus may be adversely affected if his mother is exposed to the semen of a patient being treated with Dutasteride (the risk of which is greatest during the first 16 weeks of pregnancy).
As with all 5 alpha-reductase inhibitors, when the patient's partner is or may potentially be pregnant it is recommended that the patient avoids exposure of his partner to semen by use of a condom.
Breastfeeding: It is not known whether Dutasteride is excreted in human milk.
Fertility: Dutasteride has been reported to affect semen characteristics (reduction in sperm count, semen volume, and sperm motility) in healthy men. The possibility of reduced male fertility cannot be excluded.
The most commonly reported adverse effects of Dutasteride are decreased libido, erectile dysfunction, ejaculation disorders, and reduced volume of ejaculate. Breast tenderness and enlargement may occur, and there have been reports of hypersensitivity reactions such as swelling of the lips and face, pruritus, urticaria, rashes. Testicular pain has also been reported.
Effects on mental function: Depression has been reported. In most cases the depression began 3 to 4 months after starting Dutasteride, and resolved within a few weeks of stopping it.
Cytochrome P450 3A Inhibitors: Dutasteride is extensively metabolized in humans by the CYP3A4 and CYP3A5 isoenzymes. The effect of potent CYP3A4 inhibitors on Dutasteride has not been studied. Because of the potential for drug-drug interactions, use in caution when prescribing Dutasteride to patients taking potent, chronic CYP3A4 enzyme inhibitors (e.g., ritonavir).
Alpha-adrenergic Antagonists: The administration of Dutasteride in combination with tamsulosin or terazosin has no effect on the steady-state pharmacokinetics of either alpha-adrenergic antagonist. The effect of administration of tamsulosin or terazosin on dutasteride pharmacokinetic parameters has not been evaluated.
Calcium Channel Antagonists: Co-administration of verapamil or diltiazem decreases Dutasteride clearance and leads to increased exposure to Dutasteride. The change in Dutasteride exposure is not considered to be clinically significant. No dose adjustment is recommended.
Cholestyramine: Administration of a single 5-mg dose of Dutasteride followed 1 hour later by 12 g of cholestyramine does not affect the relative bioavailability of Dutasteride.
Digoxin: Dutasteride does not alter the steady-state pharmacokinetics of digoxin when administered concomitantly at a dose of 0.5 mg/day for 3 weeks.
Warfarin: Concomitant administration of Dutasteride 0.5 mg/day for 3 weeks with warfarin does not alter the steady-state pharmacokinetics of the S- or R-warfarin isomers or alter the effect of warfarin on prothrombin time.
Store at temperatures not exceeding 30°C.
G04CB02 - dutasteride ; Belongs to the class of testosterone-5-alpha reductase inhibitors. Used in the treatment of benign prostatic hypertrophy.
Dutarid tab 500 mcg
10's;30's
Sign Out
