Dutamax Capsule

Dutamax is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

• Improve symptoms.
• Reduce the risk of acute urinary retention.
• Reduce the risk of the need for BPH-related surgery.

Dutasteride is a dual inhibitor of 5α-reductase. It inhibits both type 1 and type 2, 5α-reductase isoenzymes, which are responsible for the conversion of testosterone to 5α-dihydrotestosterone (DHT). DHT is the androgen primarily responsible for hyperplasia of glandular prostatic tissue.

The recommended dose is Dutasteride 0.5 mg orally once daily. The capsules should be swallowed whole. Dutasteride may be administered with or without food. No dosage adjustment is necessary for subjects with renal impairment or for the elderly. Due to the absence of data in patients with hepatic impairment, no dosage recommendation can be made.

Pediatric use: Dutasteride is not indicated for use in the pediatric population. Safety and effectiveness in the pediatric population have not been established.

Geriatric use: No overall differences in safety or efficacy were observed between elderly and adult subjects.

Care should be taken when administering Dutamax to patients taking potent, chronic CYP3A4 inhibitors. Dutamax does not inhibit the in vitro metabolism of model substrates for the major human cytochrome P450 isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at a concentration of 1,000 ng/ml, 25 times greater than steady-state serum concentrations in humans. In vitro studies demonstrate that Dutamax does not displace Warfarin, Diazepam, or Phenytoin from plasma protein binding sites, nor do these model compounds displace Dutamax.

Dutasteride is contra-indicated for use in women and children and for patients with known hypersensitivity to Dutasteride, and other 5 a-reductase inhibitors. Warnings: Exposure of women-risk to male fetus: Dutasteride is absorbed through the skin. Therefore, women who are pregnant or may be pregnant should not handle Dutasteride capsules because of the possibility of absorption of Dutasteride and the potential risk of a fetal anomaly to a male fetus. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water.

• Sexual problems (such as decreased sexual interest/ ability, decrease in the amount of semen/ sperm released during sex)
• Impotence (trouble getting or keeping an erection)
• Testicle pain or swelling
• Increased breast size
• Breast tenderness.

The clinical significance of Dutasteride’s effect on semen characteristics for an individual patient’s fertility is not known. Pregnancy Category X. Dutasteride is contra-indicated for use in women.

General: Lower urinary tract symptoms of BPH can be indicative of other urological diseases, including prostate cancer. Patients should be assessed to rule out other urological diseases prior to treatment with Dutamax. Patients with a large residual urinary volume and/or severely diminished urinary flow may not be good candidates for 5 a-reductase inhibitor therapy and should be carefully monitored for obstructive uropathy. Blood Donation: Men being treated with Dutamax 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 Dutamax to a pregnant female transfusion recipient.

Use in hepatic impairment: The effect of hepatic impairment on Dutamax pharmacokinetics has not been studied. Because Dutamax is extensively metabolized and has a half-life of approximately 5 weeks at steady state, caution should be used in the administration of Dutamax to patients with liver disease.

Effects on prostate-specific antigen and prostate cancer detection: Digital rectal examinations, as well as other evaluations for prostate cancer, should be performed on patients with BPH prior to initiating therapy with Dutamax and periodically thereafter. Dutamax reduces total serum PSA concentration by approximately 40% following 3 months of treatment and approximately 50% following 6, 12, and 24 months of treatment. This decrease is predictable over the entire range of PSA values, although it may vary in individual patients.

In volunteer studies, single doses of Dutamax up to 40 mg (80 times the therapeutic dose) for 7 days have been administered without significant safety concerns. In a clinical study, daily doses of 5 mg (10 times the therapeutic dose) were administered to 60 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 Dutamax. Therefore, in cases of suspected overdosage symptomatic and supportive treatment should be given as appropriate, taking the long half-life of Dutamax into consideration.

BPH/ Urinary retention/ Urinary incontinence

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.