Combination of Tamsulosin Hydrochloride & Dutasteride capsules are indicated for the treatment of moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH) in men with enlarged prostates. Tamsulosin in combination with Dutasteride has been shown to reduce symptoms of BPH, improve urinary flow and reduce prostate size and was statistically significant to Tamsulosin monotherapy. Tamsulosin in combination with Dutasteride was statistically significant to Tamsulosin monotherapy but not Dutasteride monotherapy at reducing the relative risk of Acute Urinary Retention (AUR) or BPH-related surgery.

BPH/ Urinary retention/ Urinary incontinence

Dutasteride & Tamsulosin combination capsules contain Dutasteride (a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT) and Tamsulosin (an antagonist of alpha1A-adrenoceptors in the prostate). Dutasteride is a synthetic 4-azasteroid compound which inhibits the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. Dutasteride is a competitive and specific inhibitor of both type 1 and type 2 5 alpha-reductase isoenzymes, with which it forms a stable enzyme complex. Smooth muscle tone is mediated by the sympathetic nervous stimulation of alpha1-adrenoceptors, which are abundant in the prostate, prostatic capsule, prostatic urethra, and bladder neck. Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH. Tamsulosin, an alpha1-adrenoceptor blocking agent, exhibits selectivity for alpha1-receptors in the human prostate.

The recommended dosage is 1 capsule (0.5 mg Dutasteride and 0.4 mg Tamsulosin Hydrochloride) taken once daily approximately 30 minutes after the same meal each day.

The capsules should be swallowed whole and not chewed or opened. Contact with the contents of the capsule may result in irritation of the oropharyngeal mucosa.

Dutasteride-Tamsulosin combination capsules are used with caution because it-

• Can occur orthostatic hypotension and syncope
• Reduces serum prostate-specific antigen (PSA) concentration by approximately 50%
• Do not use with strong inhibitors of cytochrome P450 (CYP) 3A4 (e.g. Ketoconazole)
• Exercise caution with concomitant use of PDE-5 inhibitors, as this may increase the risk of hypotension
• Drugs that contain Dutasteride, may increase the risk of high-grade prostate cancer
• Women who are pregnant or could become pregnant should not handle due to potential risk to a male fetus
• Advise patients about the possibility and seriousness of priapism
• Patients should not donate blood until 6 months after their last dose
• Intraoperative Floppy Iris Syndrome has been observed during cataract surgery after alpha adrenergic antagonist exposure
• Exercise caution with concomitant use of Warfarin

Tamsulosin-Dutasteride combination is contra-indicated in women and children and adolescents, patients with hypersensitivity to Dutasteride, other 5-alpha reductase inhibitors, Tamsulosin (including Tamsulosin- induced angio-edema), soya, peanut or any of other the excipients, patients with a history of orthostatic hypotension and patients with severe hepatic impairment.

Impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, erectile dysfunction and dizziness etc. may occur. Again, infection, asthenia, back pain, chest pain, somnolence, insomnia, rhinitis, pharyngitis, cough, sinusitis, and diarrhea etc. may occur.

Tamsulosin & Dutasteride combination is contraindicated for use by women. There have been no studies to investigate the effect of Tamsulosin & Dutasteride combination on pregnancy, lactation and fertility. The following statements reflect the information available from studies with the individual components. Fertility: Dutasteride has been reported to affect semen characteristics (reduction in sperm count, semen volume, and sperm motility) in healthy men. The possibility of reduced male fertility cannot be excluded. Effects of Tamsulosin Hydrochloride on sperm counts or sperm function have not been evaluated.

Pregnancy: 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. It is not known whether a male foetus will be adversely affected if his mother is exposed to the semen of a patient being treated with Dutasteride. 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. Administration of Tamsulosin Hydrochloride to pregnant female rats and rabbits showed no evidence of foetal harm.

Lactation: It is not known whether Tamsulosin or Dutasteride are excreted in human milk.

Dutasteride-Tamsulosin combination capsules are used with caution because it-

• Can occur orthostatic hypotension and syncope
• Reduces serum prostate-specific antigen (PSA) concentration by approximately 50%
• Do not use with strong inhibitors of cytochrome P450 (CYP) 3A4 (e.g. Ketoconazole)
• Exercise caution with concomitant use of PDE-5 inhibitors, as this may increase the risk of hypotension
• Drugs that contain Dutasteride, may increase the risk of high-grade prostate cancer
• Women who are pregnant or could become pregnant should not handle due to potential risk to a male fetus
• Advise patients about the possibility and seriousness of priapism
• Patients should not donate blood until 6 months after their last dose
• Intraoperative Floppy Iris Syndrome has been observed during cataract surgery after alpha adrenergic antagonist exposure
• Exercise caution with concomitant use of Warfarin

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 Tamsulosin & Dutasteride capsule is contraindicated.

No data are available with regard to over dosage of Tamsulosin-Dutasteride combination.

Store in a cool and dry place, protected from light.