Uromax-D

Tamsulosin & Dutasteride is a combination of two drugs that work in different but complementary ways to improve symptoms in patients with Benign Prostatic Hyperplasia (BPH). Tamsulosin Hydrochloride is an antagonist of alpha1A-adrenoreceptors, and Dutasteride is a dual 5 alpha reductase inhibitor (5ARI). Treating BPH with alpha1-adrenoreceptor blocking agents and 5ARIs improves urine flow rate and reduces the symptoms of BPH.

Tamsulosin is an alpha1-adrenoreceptor blocking agent. It acts on the dynamic component of BPH by inhibiting alpha1-adrenoreceptors in the stromal prostatic smooth muscle and bladder neck. Blocking these adrenoreceptors can make the smooth muscles in the bladder neck and prostate relax. Tamsulosin is selective for both alpha 1A and alpha 1D receptors over the alpha1B-adrenoreceptor subtype. The three subtypes are distributed differently in human tissue. About 70% of the alpha1-receptors in the human prostate are the alpha 1A subtype, the human bladder contains mainly the alpha 1D subtype, and blood vessels mainly express the alpha 1B subtype. It is further believed that blocking the alpha 1D subtypes in the human obstructed bladder may reduce detrusor overactivity, and so relieve storage symptoms.

Dutasteride is a synthetic 4-azasteriod compound and a competitive, specific inhibitor of both Type I and Type II 5 alpha-reductase isoenzymes. It acts on the static component of BPH by stopping the enzyme 5 alpha-reductase from converting Testosterone to Dihydrotestosterone (DHT). 5 alpha-reductase exists as 2 isoforms, Type I and Type II, and both are present in the prostate. Compared with normal tissue, both isoenzymes are expressed more in BPH tissue. Dissociation from this complex has been evaluated under in vitro and in vivo conditions, and it is extremely slow. Dutasteride lowers DHT levels and reduces prostatic volume, so it treats an underlying cause of BPH. It does not bind to the human androgen receptor.

Women must not use the Tamsulosin-Dutasteride combination. No studies have looked at how this combination affects pregnancy, breastfeeding or fertility, so what follows comes from studies of the two ingredients on their own.

Fertility: Dutasteride has been reported to affect semen in healthy men, with a lower sperm count, less semen volume and reduced sperm movement (motility). So the possibility of reduced male fertility can't be ruled out. The effect of Tamsulosin Hydrochloride on sperm counts or sperm function has not been evaluated.

Pregnancy: Dutasteride, like other 5 alpha reductase inhibitors, stops testosterone from being converted to dihydrotestosterone. If a woman carrying a male foetus takes it, the development of the baby's external genitalia may be inhibited. Small amounts of Dutasteride have been recovered from the semen of men taking it. It is not known whether a male foetus will be harmed if his mother is exposed to the semen of a man being treated with Dutasteride. As with all 5 alpha reductase inhibitors, if the patient's partner is pregnant or may become pregnant, he is advised to avoid exposing her to his semen by using a condom. When Tamsulosin Hydrochloride was given to pregnant female rats and rabbits, there was no evidence of harm to the foetus.

Lactation: It is not known whether Tamsulosin or Dutasteride passes into human milk.

There's no data on overdose with the Tamsulosin and Dutasteride combination itself. What follows comes from information on the two components separately.

For Dutasteride, volunteers have taken single daily doses of up to 40 mg/day (80 times the therapeutic dose) for 7 days without significant safety concerns. In clinical studies, people took 5 mg daily for 6 months and had no adverse effects beyond those seen at the therapeutic dose of 0.5 mg. There is no specific antidote for Dutasteride, so if an overdose is suspected, give symptomatic and supportive treatment as appropriate.

For Tamsulosin, an acute overdose with 5 mg Tamsulosin Hydrochloride has been reported. The patient had acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea. These were treated with fluid replacement, and the patient could go home the same day. If acute hypotension happens after an overdose, give cardiovascular support. Lying the patient down can restore blood pressure and bring the heart rate back to normal. If that doesn't help, volume expanders can be used, and vasopressors when necessary. Monitor renal function and apply general supportive measures. Dialysis is unlikely to help, because Tamsulosin is very highly bound to plasma proteins. Measures such as emesis can be taken to slow absorption. When large quantities are involved, gastric lavage can be used, and activated charcoal and an osmotic laxative such as sodium sulphate can be given.

Keep Tamsulosin Hydrochloride + Dutasteride in a cool, dry place, away from light.