No adjustment in dosage is anticipated for patients with renal impairment.
Renal impairment: The effect of renal impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied. Where clinically appropriate, direct change from Tamsulosin Hydrochloride or Dutasteride monotherapy to this capsule may be considered. Where appropriate, this capsule may be used to substitute concomitant Tamsulosin Hydrochloride and Dutasteride in existing dual therapy to simplify treatment. The capsules should be swallowed whole and not chewed or opened. Dutasteride does not bind to the human androgen receptor.Īdults (including elderly): The recommended dose is one capsule (Tamsulosin Hydrochloride 0.4 mg & Dutasteride 0.5 mg) taken orally approximately 30 minutes after the same meal each day. Dutasteride lowers DHT levels and leads to a reduction in prostatic volume, thereby treating an underlying cause of BPH. Dissociation from this complex has been evaluated under in vitro and in vivo conditions and is extremely slow. It has been observed that compared to normal tissue, the expression of both isoenzymes are increased in BPH tissue. 5 alpha-reductase exists as 2 isoforms, Type I and Type II, both of which are present in the prostate. It is further believed that blockade of the alpha 1D subtypes in the human obstructed bladder may be responsible for reducing detrusor overactivity and subsequent relief of storage symptoms.ĭutasteride: A synthetic 4-azasteriod compound is a competitive and specific inhibitor of both Type I and Type II 5 alpha-reductase isoenzymes that affects the static component of BPH by inhibiting the conversion of Testosterone to Dihydrotestosterone (DHT) by the enzyme 5 alpha-reductase.
Whereas approximately 70% of the alpha 1-receptors in human prostate are of the alpha 1A subtype, the human bladder contains predominantly the alpha 1D subtype while blood vessels express predominantly alpha 1B subtype. These three adrenoreceptor subtypes have a distinct distribution pattern in human tissue. Specifically, Tamsulosin exhibits selectivity for both alpha 1A and alpha 1D receptors over the alpha 1B-adrenoreceptor subtype. Blockade of these adrenoreceptors can cause smooth muscles in the bladder neck and prostate to relax. Tamsulosin: An alpha1-adrenoreceptor blocking agent that affects the dynamic component of BPH by inhibiting alpha 1-adrenoreceptors in the stromal prostatic smooth muscle and bladder neck. Treatment of BPH with alpha 1-adrenoreceptor blocking agents and 5ARIs results in an improvement in urine flow rate and a reduction in symptoms of BPH. Tamsulosin Hydrochloride, an antagonist of alpha 1A-adrenoreceptors and Dutasteride, a dual 5 alpha reductase inhibitor (5ARI). Tamsulosin & Dutasteride is a combination of two drugs with complementary mechanisms of action to improve symptoms in patients with Benign Prostatic Hyperplasia (BPH).
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