Drug interactions- Summary

Calcium channl antagonists + Dutasteride

 decrease in clearance of dutasteride was  noticed eg .diltiazem, verapramil noted when co-admininstered with CYP3A4 inhibitors

CYP3A4 inhibitors + Dutasteride

blood conc. of dutasteride may increase (eg. cimetidine , ciprofloxacin, in presence of potent chronic CYP3A ketoconazole, ritrovir, Inhibitors, Co-administer with caution troleandomycin )

Benign prostrate hyperplasia 

Impotence, decreased libido, ejaculation disorder, breast disorders, gynacomastia serious skin reactions Angioedema, Cardiac failure Dutasteride adverse reactions (>/= 1 % )

Reproductive Months 0 to 6 Months 7 to 12 Months 13 to 18 Months 19 to 24

Adverse Reactions

Dutasteride     Dutasteride      Dutasteride      Dutasteride

 Impotence- Dutasteride 4.7 %  1.4 % 1% 0.8%   Placebo 1.7% 1.5% 0.5% 0.9%

Decreased libido Dutasteride 3% 0.7% 0.3% 0.3%   Placebo 1.4% 0.6% 0.2% 0.1%

Ejacculation disorder Dutastride 1.4% 0.5% 0.5% 0.1% Placebo 0.5% 0.3% 0.1% 0%

Breast disorder Dutasteride 0.5% 0.8% 1.1% 0.6% Placebo 0.2% 0.3% 0.3% 0.1%

Children and women Severe hepatic impairment

Pregnant women and those of child bearing potential should not handle the medicine

Special precautions-

Mild to moderate hepatic impairment. evaluate and edxclude prostatic cancer prior to during treatment double PSA values to compare with normal range in untreated men as dutasteride reduces PSA by 50%

Obstructive uropathy Avoid donating blood until at least 6 months after last dose Condoms should be used by men whose partners are or may become pregnant

Indication-

Benign prostrate hyperplasia

Dosage-

Take with or without food

0.5mg 1 capsule tken orally once a day May administer with or without food.

Maximum dosage - 0.5 mg 1 capsule daily Dutasteride is absorbed through the skin .

Dutasteride should not be handled by women who are pregnant or who may become pregnant because of potential absorption of dutasteride and the subsequent potential risk to developing male fetus. If contact is made with the leaky capsule the contact area should be washed immediately with soap and water

Take with or without food

Pregnancy

Dutasteride is absorbed through the skin .

Dutasteride should not be handled by women who are pregnant or who may become pregnant because of potential absorption of dutasteride and the subsequent potential risk to developing male fetus. If contact is made with the leaky capsule the contact area should be washed immediately with soap and wignificant hypersensitivity ater

 Contraindicated in pregnancy in women of child bearing potential and is not indicated for use in other women. Women of child bearing potential, children with previously demonstrated clinically significant hypersensitivity (eg. serious skin reactions, angioedema ) to dutasteride or other -5a- reductase inhibitors