Dutamax

Indications

Dutasteride is used in men to treat moderate to severe symptoms of an enlarged prostate (benign prostatic hyperplasia, BPH), alone or together with Tamsulosin. It:

• improves urinary symptoms such as a weak stream, frequent urination and getting up at night;
• lowers the risk of sudden inability to pass urine (acute urinary retention);
• lowers the chance of needing prostate surgery.

How It Works

Dutasteride is a 5-alpha reductase inhibitor. It blocks the enzyme that turns testosterone into dihydrotestosterone (DHT), the hormone that makes the prostate grow. Lower DHT levels slowly shrink the prostate. Improvement may take 3 to 6 months.

Dosage and Administration

Adult men: 0.5 mg once a day, with or without food, or as prescribed. Swallow the capsule whole; do not chew or open it, as the contents can irritate the mouth and throat. In combination capsules with Tamsulosin, take once a day about 30 minutes after the same meal each day.

Not for women or children. No dose change is usually needed in older men or with kidney problems.

Interactions

Strong CYP3A4 blockers such as Ketoconazole, Ritonavir, Clarithromycin, Verapamil and Diltiazem can raise Dutasteride levels. Tell your doctor about all medicines, vitamins and herbal products you take.

Contraindications

• Women and children
• Severe liver disease
• Allergy to Dutasteride, other 5-alpha reductase inhibitors, soya or peanut (some capsules contain soya oil)

Side Effects

Common: reduced sex drive, difficulty getting or keeping an erection, less semen or ejaculation problems, and breast tenderness or enlargement. With Tamsulosin, dizziness, especially on standing up, is also common.

Less often: low mood or depression, hair changes and skin rash.

Get medical help at once for swelling of the face, lips or throat or difficulty breathing. See a doctor soon about any breast lump, pain or nipple discharge.

Pregnancy and Lactation

Dutasteride is not for women. It can harm the development of a male unborn baby, so women who are or may be pregnant should not handle broken or leaking capsules; if skin contact happens, wash with soap and water at once. Dutasteride is found in semen, so men should use a condom if their partner is or may become pregnant.

Precautions and Warnings

• Dutasteride lowers the PSA blood test by about half; tell any doctor checking your PSA that you take it.
• Your doctor will check for prostate cancer before and during treatment, as Dutasteride may slightly raise the risk of a more serious type.
• Do not donate blood during treatment and for at least 6 months after the last dose.
• Take extra care with liver disease.

Overdose

Large doses have been taken in studies without serious harm. If too much is taken, contact a doctor; treatment is supportive.

Therapeutic Class

Medicine for enlarged prostate (5-alpha reductase inhibitor).

Storage

Store below 30°C in a dry place, away from light and out of the reach of children.