dutasteride - oral, Avodart

USES: This medication is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It works by reducing the size of the enlarged prostate. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). It may also reduce the need for surgery to treat BPH.This medication should not be used by women or children.

HOW TO USE: Read the Patient Information Silagra Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the medication whole. Do not crush or chew the capsules.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.Since this drug can be absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.It may take 3 to 6 months to notice an improvement in symptoms. Tell your doctor if your symptoms do not improve or if they worsen.

SIDE EFFECTS: Sexual problems (such as decreased sexual interest/ability, decrease in the amount of semen/sperm), increased breast size, or breast tenderness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking dutasteride, tell your doctor or pharmacist if you are allergic to it; or to finasteride; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Do not donate blood while you are taking this medication and for at least 6 months after you stop taking it. This will prevent the possibility of your blood being given to a pregnant woman.This medication is not usually used in women. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as prostate exams, prostate-specific antigen-PSA) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Dutasteride capsules may soften and leak if stored at high temperatures. If your capsules crack and leak, do not use them. If your skin comes in contact with the leaking capsules, wash the area immediately with soap and water. Contact your pharmacist for more information.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Avodart (Dutasteride 0.5mg) Frequently Asked Questions (FAQ)

	Avodart inhibits a hormone known as DHT (dihydrotestosterone). DHT is a hormone that appears to cause hair loss (also known as MPB - Male Pattern Baldness) in most men. DHT is also the main cause of prostate enlargement in many men (also known as BPH - Benign Prostatic Hyperplasia). Avodart works by inhibiting the activities of Vidalista two types of 5-alpha-reductase enzymes. These enzymes are responsible in the body for converting Testosterone to Dihydrotestosterone(DHT). Avodart lowers DHT levels substantially.
	What is the difference between Avodart (Dutasteride) from Propecia (Finasteride) ?
	Both medications work in a similar way, lowering DHT levels. However, Avodart inhibits the action of two types of 5-alpha-reductase enzymes (type I and type II). Propecia (Finasteride) only inhibits one type of the enzyme (type II). Avodart is more potent. Avodart has been shown to decrease levels of DHT by about 30% more than Proepcia (Finasteride).
	Is there any study on the effectiveness of Avodart (Dutasteride) for the treatment of enlarged prostate ?
	A study was made on 2951 men suffering from BPH (Benign Prostatic Hyperplasia - An enlarged prostate condition) with moderate to severe symptoms. They were treated with 0.5mg of Dutasteride (Avodart) daily. The results showed a reduction of acute urinary retention by 57% and the risk reduction of benign prostatic hyperplasia (BPH) related surgical intervention was down 48%. The drug was found to be well tolerated. It was concluded that Dutasteride is a potent inhibitor of dihydrotestosterone and is effective in shrinking the prostate and reducing symptoms.
	Is there any study on the effectiveness of Avodart (Dutasteride) for the treatment of Hair Loss in men ?
	GlaxoSmithKline, the maker of Dutasteride, has completed Phase II trials for the FDA approval of Dutasteride as a treatment for hair loss. After six months of treatment, hair counts measured in a 1 inch diameter increased by about 96 hairs with 0.5mg of Dutasteride. This is compared with an increase of only 72 hairs with the administration of 5mg Finasteride (Propecia). Results so far are very promising, however the FDA has yet to approve the medication for the treatment of hair loss.
	Is Dutasteride going to be approved for treating men hair loss?
	Right now, it is not clear if and when it will be approved for the treatment of hair loss by the FDA. Some speculate that this is going to happen in 2006, some speculate the company may not offer the medication for the treatment of hair loss for purely commercial & marketing reasons. Keep in mind, these are all speculations, nothing is official. It's worth noting that when Finasteride first came into the market (under the brand name Proscar) it was approved only for the treatment of BPH (Benign Prostatic Hyperplasia). Later, the FDA approved the medication for the treatment of hair loss, which was marketed by Merch under the brand name Propecia. It may very well be the same case for Dutasteride, yet this is only a speculation.
	Is Dutastride effective for all men for treating hair loss?
	Dutasteride may increase the number of hair on the scalp, however just like Propecia, it may not work for everyone. It can grow hair for some men, reduce hair loss in others, or have no effect at all for some individuals.
	What are the side effects of Avodart (Dutasteride) ?
	Avodart was proved to be generally well tolerated by most. In trials, most side effects experienced were mild and generally went away while on treatment. Side effects experienced for the first six months were Impotence, decreased libido, breast tenderness and enlargement, lower volume of ejaculations. Interestingly these side effects (at a lower rate) were also experienced to a degree in the placebo group.
	Is Dutasteride Avodart safe for everyone?
	You should never take any medication without your doctor's approval. Consult with your doctor to see if Avodart (Dutasteride) is right for you.