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DUODART (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): USE IN SPECIFIC POPULATIONS

Renal Impairment

Severe renal impairment, with creatinine clearance of less than 10 mL/min, is a contraindication, as these patients have not been studied.

Hepatic Impairment

The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied. Because dutasteride is extensively metabolized and has a half-life of 3 to 5 weeks, caution should be used in the administration of dutasteride-tamsulosin to patients with liver disease.

Dutasteride, Tamsulosin (Duodart) is contraindicated in patients with severe hepatic impairment.

Use in Pregnancy

Pregnancy Category X

Duodart (Dutasteride, Tamsulosin Hydrochloride) in capsules is contraindicated for use in women.

Dutasteride

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 foetus, inhibit the development of the external genitalia of the foetus. Small amounts of dutasteride have been recovered from the semen in subjects receiving dutasteride. Based on studies in animals, it is unlikely that a male foetus will 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). However, 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.

Tamsulosin

Administration of tamsulosin hydrochloride to pregnant female rats and rabbits at higher than the therapeutic dose showed no evidence of foetal harm.

Use in Lactation

Dutasteride, Tamsulosin Hydrochloride (Duodart) is contraindicated for use in women.

It is not known whether dutasteride or tamsulosin are excreted in breast milk.


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  • Tablets; Oral; Prazosin Hydrochloride 5 mg
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  • Capsules; Oral; Testosterone Undecanoate 40 mg
  • Merck
  • Euro Registratie
  • LF Asia Distribution
  • Organon
  • R.P. Scherer
  • Schering-Plough
  • Zuellig Pharma


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