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Dutamax Capsule (Liquid Filled) contains Dutasteride

Dutamax Capsule (Liquid Filled) side effects

  • 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.

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 Dutasteride. 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 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.

Care should be taken when administering Dutasteride to patients taking potent, chronic CYP3A4 inhibitors. Dutasteride 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 Dutasteride does not displace Warfarin, Diazepam, or Phenytoin from plasma protein binding sites, nor do these model compounds displace Dutasteride.

Pregnancy Category X. Dutasteride is contraindicated for use in women.

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.

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.

Elderly use: No dosage adjustment is necessary for subjects with renal impairment or for the elderly. 

Hepatic impairment: Due to the absence of data in patients with hepatic impairment, no dosage recommendation can be made.

 

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