Combodart

Combodart is a fixed-dose combination capsule containing dutasteride and tamsulosin hydrochloride, prescribed for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate gland.

Dutasteride is a dual 5-alpha reductase inhibitor that blocks the conversion of testosterone to dihydrotestosterone (DHT) in the prostate.

DHT is the primary androgen driving prostatic growth, and reducing its levels causes a gradual shrinkage of the gland over several months.

Tamsulosin is an alpha-1A adrenoceptor antagonist that relaxes the smooth muscle in the prostate and bladder neck, improving urinary flow and reducing symptoms relatively quickly.

The combination targets both the static (enlarged gland) and dynamic (smooth muscle tone) components of urinary obstruction in BPH.

Clinical trials (the CombAT study) demonstrated that dual therapy with dutasteride and tamsulosin was superior to either agent alone in reducing symptoms, improving flow rates, and reducing the risk of acute urinary retention and BPH-related surgery.

Combodart is typically prescribed for men with a prostate volume of 30 mL or greater and who are at risk of disease progression.

Take one capsule daily, approximately 30 minutes after the same meal each day.

Swallow the capsule whole without chewing or opening it, as contact with dutasteride may irritate the oropharyngeal mucosa.

Combodart should be taken consistently and continued long-term, as the full benefit of dutasteride on prostate size may not be apparent for six months or longer.

Tamsulosin provides symptomatic relief within days to weeks.

Do not stop taking Combodart without consulting your prescriber. Inform any healthcare professional who orders a PSA test that you are taking dutasteride, as it approximately halves PSA levels.

One capsule daily, taken approximately 30 minutes after a meal. Each capsule contains dutasteride 0.5 mg and tamsulosin 0.4 mg (modified release).

No dose adjustment is available within this combination product.

Caution is advised in patients with moderate hepatic impairment. Combodart is not recommended in severe hepatic or severe renal impairment.

There is no need for dose adjustment in elderly patients solely based on age.

Impotence (erectile dysfunction) occurs in approximately 5 to 7 per cent of men and is the most commonly reported sexual side effect.

Decreased libido, ejaculation disorders (including reduced semen volume and retrograde ejaculation), and breast tenderness or enlargement (gynaecomastia) are also recognised.

Dizziness, particularly on standing (postural hypotension), is a known effect of tamsulosin and may occur in about 3 to 5 per cent of patients.

Headache, nasal congestion, and rhinitis are also attributable to the alpha-blocker component.

Intraoperative floppy iris syndrome (IFIS) may occur during cataract surgery in men taking or who have previously taken tamsulosin. Inform your ophthalmologist before any eye surgery.

Mood changes, including depression, have been reported rarely.

An increased incidence of high-grade prostate cancer was observed in one large study of dutasteride, though the clinical significance remains debated.

Dutasteride reduces PSA levels by approximately 50 per cent after six months. This must be factored into any PSA-based screening for prostate cancer.

Any confirmed rise in PSA during dutasteride treatment should be investigated.

Dutasteride is absorbed through the skin and may cause harm to a male foetus. Women who are or may become pregnant must not handle leaking capsules.

Men taking dutasteride should use a condom during intercourse if their partner is or may be pregnant.

Be cautious when rising from a sitting or lying position, as tamsulosin may cause a sudden drop in blood pressure. Inform your ophthalmologist about tamsulosin use before cataract surgery.

Combodart is contraindicated in women, children, and adolescents.

It must not be used in men with known hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, tamsulosin, or any of the excipients, including soya lecithin.

Severe hepatic impairment, a history of orthostatic hypotension, and concomitant use with strong CYP3A4 inhibitors are further contraindications.