Dutagen (Avodart)0.5 mg – 30 tablet

Dutasteride Information

What is this drug used for?

• In men, it is used to treat the signs of an enlarged prostate.
• It may be given to you for other reasons. Talk with the doctor.

Possible side effects

Dutasteride may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Dizziness.
• This drug may cause a change in sex ability in men or lowered interest in sex. This could go on after you stop this drug. Talk with your doctor if these effects go on or bother you.

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Enlarged breasts.
• A lump in the breast, breast pain or soreness, or nipple discharge.
• Low mood (depression).

Storage/Stability

Store at controlled room temperature of 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)

Adverse Reactions

Frequency of most adverse events (except prostate cancer high grade) tends to decrease with continued use (>6 months). Frequency not always defined.

1% to 10%:

Endocrine & metabolic: Decreased libido (≤3%; incidence highest during first 6 months of therapy), gynecomastia (including breast tenderness, breast enlargement; ≤1%), increased luteinizing hormone, increased testosterone level, increased thyroid stimulating hormone level

Genitourinary: Impotence (≤5%; incidence highest during first 6 months of therapy), ejaculatory disorder (≤2%)

Hematologic & oncologic: Prostate cancer high grade (≤1%)

<1%, postmarketing, and/or case reports: Angioedema, cardiac failure, depressed mood, dermatological reaction (serious), dizziness, hypersensitivity, localized edema, malignant neoplasm of breast (males), pruritus, skin rash, testicular pain, testicular swelling, urticaria