Sold Under Brand Name: Avodart

Dutasteride belongs to a class of medications called 5-alpha-reductase inhibitors and is used to relieve symptoms of benign prostatic hyperplasia (BPH). BPH is a non-cancerous enlargement of the prostate gland that usually occurs in men after the age of 50.

Manufacturer: Cipla		Average Delivery Time: 12 Days
Brand Name: Avodart		Exp. Date: Approx. March 2009

Before using Dutasteride

Some medical conditions may interact with Dutasteride . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you plan to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver disease, prostate cancer, urinary tract disease, or problems urinating

Some MEDICINES MAY INTERACT with Dutasteride . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Certain medicines that act on the liver (eg, ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, ciprofloxacin, troleandomycin) because side effects of Dutasteride may be increased.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dutasteride may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Dutasteride

Use Dutasteride as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Dutasteride may be taken with or without food
• Swallow Dutasteride whole. Do not break, crush, or chew before swallowing
• It may take 3 to 6 months for Dutasteride to work.
• If you miss a dose of Dutasteride, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Dutasteride.

What Is Avodart?
Avodart® (dutasteride) is a prescription medicine that has been licensed to treat an enlarged prostate. An enlarged prostate is also known medically as benign prostatic hyperplasia, benign prostatic hypertrophy, or BPH.

(Click Avodart Uses for more information on what Avodart is used for, including possible off-label uses.)

Who Makes Avodart?
Avodart is manufactured by GlaxoSmithKline.

How Does Avodart Work?
Avodart works by blocking the conversion of testosterone into DHT (dihydrotestosterone), thereby decreasing the amount of DHT in the body. Since DHT is responsible for enlarging the prostate, using Avodart to decrease DHT levels can treat an enlarged prostate. In most men, Avodart can help shrink the enlarged prostate, helping to relieve their enlarged prostate symptoms.

Avodart Effects
There have been several studies looking at how well Avodart treats an enlarged prostate. These studies showed the following effects related to Avodart and men with BPH.

Symptoms of BPH
In these studies, the men were asked to rate the following symptoms of BPH:

Incomplete bladder emptying
Frequent urination
Intermittent stops and starts in the urine flow
Feeling of urgency when needing to urinate
Weak urine stream
Having to get up to urinate frequently during the night.

The men who took Avodart had significant improvement in their BPH symptoms compared with the men who did not take Avodart. While some patients saw improvement right away, in general it took about 3 to 12 months to see the improvement for most men. This improvement lasted throughout the entire study period (two years).

INDICATIONS

AVODART is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

· Improve symptoms

· Reduce the risk of acute urinary retention

· Reduce the risk of the need for BPH-related surgery
DOSAGE AND ADMINISTRATION

The recommended dose of AVODART is 1 capsule (0.5 mg) taken orally once a day. The capsules should be swallowed whole. AVODART may be administered with or without food.

No dosage adjustment is necessary for subjects with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Special Populations: Geriatric and Renal Impairment). Due to the absence of data in patients with hepatic impairment, no dosage recommendation can be made (see PRECAUTIONS: General).