PRODUCT DESCRIPTION

Dutasteride is used to treat an enlarged prostate (benign prostatic hyperplasia, or BPH). Dutasteride is a 5-alpha reductase inhibitors. It works by blocking the production of a natural substance that enlarges the prostate. Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT). This drug help shrinks the prostate, relieves symptoms of BPH, such as frequent and difficult urination, and decreases the chance that surgery will be needed to treat this condition.

Reducing the size of your prostate and improving your symptoms will take time. While some men have fewer problems and symptoms after 3 months of treatment with Dutasteride, a treatment period of at least 6 months is usually necessary to see if Dutasteride will work for you. Studies have shown that treatment with Dutasteride for 2 years reduces the risk of complete blockage of urine flow (acute urinary retention) and/or the need for surgery for BPH. Dutasteride has also shown very positive effects as a hair loss treatment for sufferers of male pattern baldness and also reduce the risk of acute urinary retention. Brand names are Avodart, Avidart, Avolve, Duagen, Dutas, Dutagen, Duprost.

PRECAUTIONS

Before taking dutasteride, tell your doctor and pharmacist if you are allergic to any other medications. Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antifungals such as fluconazole, (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); cimetidine (Tagamet); ciprofloxacin (Cipro); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); isoniazid (INH, Nydrazid); metronidazole (Flagyl); nefazodone (Serzone); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Tell your doctor if you have or have ever had liver disease or prostate cancer.

You should know that dutasteride is for use only in men. Women, especially those who are or may become pregnant, should not handle dutasteride capsules. Dutasteride is absorbed through the skin. Touching the contents of the capsules may harm the fetus. Women who accidentally touch leaking capsules should wash the area with soap and water immediately. You should know that you should not donate blood while you are taking dutasteride and for 6 months after you stop taking this medication.

It may take 6 months or more to see the full effects of this medication. Dutasteride reduces the likelihood of prostate surgery for men with BPH. It must be taken on a regular basis to be effective. If the medication is stopped, the prostate will start to grow again.

DOSAGE & ADMINISTRATION

Take this drug by mouth once daily, with or without food. Swallow the medication whole. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Swallow the capsules whole; do not split, chew, or crush them.

Dutasteride is a white to pale yellow powder with a melting point of 242° to 250° C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water.

Each AVODART Soft Gelatin Capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are gelatin (from certified BSE-free bovine sources), glycerin, and ferric oxide (yellow). The soft gelatin capsules are printed with edible red ink.