Dutasteride 0.5 mg Tablets (Dutasteride)

Adult dose

The recommended dose of this medicine is 1 tablet (0.5mg) once daily. Swallow this medicine whole without chewing or splitting it. This medicine may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or elderly patients. Since no data are available on administration of this medicine to patients with hepatic impairment, the recommended dose in these patients has not been established.

This drug is absorbed through the skin, so women who are pregnant or may become pregnant should not handle this medicine directly. Exposure to the broken or crushed pieces of this drug poses a risk of congenital disabilities in male fetuses. In addition, children should be prevented from touching the broken pieces of this drug, and it should not be administered to children under 18 years of age. This drug is not for use in women, and those with allergies to this drug or its ingredients should not use it. Patients with lactose intolerance or certain genetic metabolic disorders should also refrain from taking this medicine. Adult males planning to conceive should use this drug cautiously after consulting a physician, as it may affect fertility. Patients with severely impaired urinary function or liver dysfunction should also use this drug with caution. Care should be taken when co-administering with strong CYP3A4 inhibitors, as it may increase drug concentration. While taking this drug, erectile dysfunction, decreased libido, and ejaculation disorders may occur, and these symptoms can persist even after discontinuation. Some patients may experience gynecomastia or breast tenderness. This drug lowers prostate-specific antigen (PSA) levels, so caution is needed when interpreting PSA test results, and regular prostate cancer screening is recommended. Blood donation should be avoided for at least 6 months while taking this drug to prevent it from being transmitted to pregnant women. There is no specific antidote for overdose, thus appropriate supportive care is needed according to the symptoms, and prolonged observation is required due to the long half-life of this drug. It should be stored out of reach of children and kept in its original container for safety. This drug is reported not to affect driving or machine operation abilities; however, caution is advised in case of adverse reactions. In patients with heart failure, the risk of developing heart failure may increase if this drug is taken in conjunction with other medications, thus consultation with healthcare professionals is necessary. There are no significant interactions with this drug and various medications, but caution is needed when co-administering with certain drugs, hence consulting with a physician or pharmacist about medications being taken is advised. Pregnant and breastfeeding women should not use this drug, especially during pregnancy, as it may affect the genital development of male fetuses. It can be safely used in the elderly, but the effectiveness in men over 50 with androgenetic alopecia has not been sufficiently established.

• erectile dysfunction
• decreased libido
• ejaculation disorders
• gynecomastia
• headache
• gastrointestinal discomfort and pain
• sexual dysfunction
• breast disorders
• dizziness
• rash

This medicine should be stored in a tightly closed container to prevent exposure to air or moisture. Additionally, it is advisable to avoid extremely hot or cold conditions when storing the drug, and keep it at a temperature between 1 to 30 degrees Celsius, which is room temperature.

Appearance

Light yellow round film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP X 3)]