Urodart0.5 mg

Urodart 0.5 mg 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

BPH/ Urinary retention/ Urinary incontinence

Urodart 0.5 mg 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 Urodart 0.5 mg 0.5 mg orally once daily. The capsules should be swallowed whole. Urodart 0.5 mg may be administered with or without food.

The recommended dose is Urodart 0.5 mg 0.5 mg orally once daily. The capsules should be swallowed whole. Urodart 0.5 mg may be administered with or without food.

Care should be taken when administering Urodart 0.5 mg to patients taking potent, chronic CYP3A4 inhibitors. Urodart 0.5 mg 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 Urodart 0.5 mg does not displace Warfarin, Diazepam, or Phenytoin from plasma protein binding sites, nor do these model compounds displace Urodart 0.5 mg.

Urodart 0.5 mg is contra-indicated for use in women and children and for patients with known hypersensitivity to Urodart 0.5 mg, and other 5 a-reductase inhibitors. Warnings: Exposure of women-risk to male fetus: Urodart 0.5 mg is absorbed through the skin. Therefore, women who are pregnant or may be pregnant should not handle Urodart 0.5 mg capsules because of the possibility of absorption of Urodart 0.5 mg 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.

Pregnancy Category X. Urodart 0.5 mg is contraindicated for use in women.

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 Urodart 0.5 mg. 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 Urodart 0.5 mg 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 Urodart 0.5 mg to a pregnant female transfusion recipient.

In volunteer studies, single doses of Urodart 0.5 mg 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 Urodart 0.5 mg. Therefore, in cases of suspected overdosage symptomatic and supportive treatment should be given as appropriate, taking the long half-life of Urodart 0.5 mg into consideration.

Store in a cool and dry place, protected from light

Pediatric use: Urodart 0.5 mg 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.

BPH/ Urinary retention/ Urinary incontinence

Urodart 0.5 mg 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.

Pregnancy Category X. Urodart 0.5 mg is contraindicated for use in women.

Pediatric use: Urodart 0.5 mg 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.