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DUODART (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): PRECAUTIONS

Blood Donation

Men being treated with any dutasteride-containing products, including Duodart (Dutasteride, Tamsulosin Hydrochloride), 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.

Intraoperative Floppy Iris Syndrome

Intraoperative Floppy Iris Syndrome (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients treated with alpha-1 adrenergic blockers, including tamsulosin. This syndrome is characterised by the combination of a flaccid iris that billows as a result of intra-operative irrigation currents, prolapse of the iris toward the phaco-emulsification incisions, and progressive intra-operative miosis despite preoperative dilation with standard mydriatic drugs. IFIS may lead to increased procedural complications during the operation.

During pre-operative assessment, cataract surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with Duodart in order to ensure that appropriate measures will be in place to manage IFIS if it occurs during surgery.

Discontinuing tamsulosin 1 - 2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of stopping of therapy prior to cataract surgery has not yet been established.

Effects on Fertility

There have been no studies to investigate the effect of Duodart capsules on pregnancy, lactation and fertility. The following statements reflect the information available on the individual components.

Dutasteride

No animal fertility studies have been conducted with co-administration of dutasteride and tamsulosin.

Treatment of sexually mature male rats with dutasteride at doses up to 500 mg/kg/day (110-fold the expected clinical exposure of parent drug) for up to 31 weeks resulted in dose- and time-dependant decreases in fertility, reduced cauda epididymal (absolute) sperm counts (at 50 and 500 mg/kg/day), reduced weights of the epididymis, prostate and seminal vesicles, and microscopic changes in the male reproductive organs. The fertility effects were reversed by recovery week 6 at all doses and sperm counts were normal at the end of a 14-week recovery period. The 5alpha-reductase-related changes consisted of cytoplasmic vacuolation of tubular epithelium in the epididymides and decreased cytoplasmic content of epithelium, consistent with decreased secretory activity in the prostate and seminal vesicles. The microscopic changes were no longer present at recovery week 14 in the low dose group and were partly recovered in the remaining treatment groups. Low levels of dutasteride were detected in the serum of untreated female rats mated to males dosed at 10 mg/kg/day and above for 29 weeks.

The effects of dutasteride 0.5 mg /day on semen characteristics were evaluated in normal volunteers aged 18 to 52 (n=27 dutasteride, n=23 placebo) throughout 52 weeks of treatment and 24 weeks of post treatment follow-up. At 52 weeks, the mean percent reduction from baseline in total sperm count, semen volume, and sperm motility were 23%, 26%, and 18%, respectively, in the dutasteride group when adjusted for changes from baseline in the placebo group. Sperm concentration and sperm morphology were unaffected. After 24 weeks of follow-up, the mean percent change in total sperm count in the dutasteride group remained 23% lower than baseline. While mean values for all semen parameters at all time points remained within the normal ranges and did not meet predefined criteria for a clinically significant change (30%), two subjects in the dutasteride 14 group had decreases in sperm count of greater than 90% from baseline at 52 weeks, with partial recovery at the 24-week follow-up. The clinical significance of dutasteride's effect on semen characteristics for an individual patient's fertility is not known.

Tamsulosin

High doses of tamsulosin hydrochloride resulted in a reversible reduction in fertility in male rats considered possibly due to changes of semen content of impairment of ejaculation. Effects of tamsulosin hydrochloride on sperm counts or sperm function have not been evaluated.


Duodart (Dutasteride, Tamsulosin) related pharmaceutical drugs and medications

Trade name of the drug Pharmaceutical forms and doses Companies
Minipress precautions - Prazosin Hydrochloride
  • Tablets; Oral; Prazosin Hydrochloride 1 mg
  • Pfizer
  • Laphal Industrie
  • Cialis precautions - Tadalafil
  • Tablets, Film-Coated; Oral; Tadalafil 5 mg
  • Tablets, Film-Coated; Oral; Tadalafil 20 mg
  • Eli Lilly
  • BCN Farma
  • Gervasi Farmacia


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