Uromax-D

Generic

Tamsulosin Hydrochloride + Dutasteride

Indications

• Treatment of moderate to severe symptoms of benign prostatic hyperplasia with Tamsulosin Hydrochloride and Dutasteride capsules (BPH).
• In individuals with moderate to severe BPH symptoms, the risk of acute urine retention and surgery is reduced.

Pharmacology

Tamsulosin & Dutasteride is a medication combination that improves symptoms in people with Benign Prostatic Hyperplasia by combining two medicines with complementary mechanisms of action (BPH). Dutasteride, a dual 5 alpha-reductase inhibitor, and Tamsulosin Hydrochloride, an antagonist of alpha1A-adrenoreceptors (5ARI). The use of alpha1-adrenoreceptor blockers with 5ARIs to treat BPH leads to an increase in urine flow rate and a reduction in BPH symptoms.

Tamsulosin: An alpha1-adrenoreceptor blocking operator that influences the energetic component of BPH by restraining alpha1-adrenoreceptors within the stromal prostatic smooth muscle and bladder neck. Bar of these adrenoreceptors can cause smooth muscles within the bladder neck and prostate to unwind. Particularly, Tamsulosin shows selectivity for both alpha 1A and alpha 1D receptors over the alpha1B-adrenoreceptor subtype. These three adrenoreceptor subtypes have a particular conveyance design in human tissue. While roughly 70% of the alpha1-receptors in the human prostate are of the alpha 1A subtype, the human bladder contains overwhelmingly the alpha 1D subtype whereas blood vessels express overwhelmingly the alpha 1B subtype. It is encouraging to believe that bar of the alpha 1D subtypes within the human deterred bladder may be mindful for decreasing detrusor overactivity and consequent alleviation of capacity indications.

Dutasteride: A manufactured 4-asteroid compound may be a competitive and particular inhibitor of both Sort I and Sort II 5 alpha-reductase isoenzymes that influence the inactive component of BPH by repressing the change of testosterone to Dihydrotestosterone (DHT) by the protein 5 alpha-reductase. 5 alpha-reductase exists as 2 isoforms, Sort I and Type II, both of which are shown within the prostate. It has been watched that compared to typical tissue, the expression of both isoenzymes is expanded in BPH tissue. Separation from this complex has been assessed beneath in vitro and in vivo conditions and is greatly moderate. Dutasteride brings down DHT levels and leads to a lessening in prostatic volume, in this manner treating a basic cause of BPH. Dutasteride does not tie to the human androgen receptor.

Dosage & Administration

Adults (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. The capsules should be swallowed whole and not chewed or opened. Where appropriate, this capsule may be used to substitute concomitant Tamsulosin Hydrochloride and Dutasteride in existing dual therapy to simplify treatment. Where clinically appropriate, direct change from Tamsulosin Hydrochloride or Dutasteride monotherapy to this capsule may be considered.

Renal impairment: The effect of renal impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment.

Hepatic impairment: The effect of hepatic impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the use of this capsule is contra-indicated.

Interaction

There has been no medicate interaction considers for the Dutasteride-Tamsulosin combination.

Impacts of other drugs on the pharmacokinetics of Dutasteride: Utilize at the side CYP3A4 and/or P-glycoprotein-inhibitors: Dutasteride is primarily dispensed with by means of digestion system. In vitro considers showing that this digestion system is catalyzed by CYP3A4 and CYP3A5. No formal interaction thinks about has been performed with powerful CYP3A4 inhibitors. In any case, in a populace pharmacokinetic think about, Dutasteride serum concentrations were on normal 1.6 to 1.8 times more prominent, separately, in a little number of patients treated concurrently with verapamil or diltiazem (direct inhibitors of CYP3A4 and inhibitors of P-glycoprotein) than in other patients. Long-term combination of Dutasteride with drugs that are powerful inhibitors of the protein CYP3A4 (e.g. ritonavir, indinavir, nefazodone, itraconazole, ketoconazole managed orally) may increment serum concentrations of Dutasteride. Assist hindrance of 5-alpha reductase at expanded Dutasteride presentation, isn't likely. Be that as it may, a lessening of the Dutasteride dosing recurrence can be considered in case side impacts are famous. It ought to be noted that within the case of chemical hindrance, the long half-life maybe encourage drawn out and it can take more than 6 months of concurrent treatment sometimes recently an unused unfaltering state is come to. The organization of 12 g cholestyramine one hour after a 5 mg single dosage of Dutasteride did not influence the pharmacokinetics of Dutasteride.

Contraindications

Patients with hypersensitivity to Dutasteride, other 5-alpha reductase inhibitors, Tamsulosin (including Tamsulosin-induced angioedema), soya, peanut, or any of the other excipients, patients with a history of orthostatic hypotension, and patients with severe hepatic impairment should not take Tamsulosin-Dutasteride together.

Side Effects

Impotence, decreased libido, breast disorders (including breast growth and soreness), ejaculation abnormalities, and dizziness were the most prevalent adverse events recorded in participants undergoing combo medication. When compared to either monotherapy or combination therapy, the percentages of participants with ejaculation problems, decreased libido, and impotence were higher in the combination therapy group.

Pregnancy & Lactation

The combination of Tamsulosin and Dutasteride is not recommended for women. There have been no research on the effects of combining Tamsulosin with Dutasteride on pregnancy, breastfeeding, or fertility. The following claims are based on data from studies involving the individual components. Fertility: In healthy men, dutasteride has been shown to impact sperm parameters (such as sperm count, volume, and motility). Reduced male fertility is a risk that cannot be ruled out. Tamsulosin Hydrochloride has not been studied for its effects on sperm counts or function.

Precautions & Warnings

Due to the possibility for increased risk of adverse effects (including cardiac failure), combination therapy should only be administered after careful review of other treatment options, including monotherapies.

Cardiac failure: In two 4-year clinical investigations, participants taking the combination of Dutasteride plus an alpha-blocker, primarily Tamsulosin, had a greater rate of cardiac failure than those not taking the combination. The frequency of cardiac failure in these two trials was low (1%) and varied between the studies.

Therapeutic Class

Urinary incontinence/BPH/ Urinary retention.

Storage Conditions

Store in a cold, dry, and light-protected location.

Pharmaceutical Name

UniMed UniHealth Pharmaceuticals Ltd