Avodart 0.500 mg

Generic Name: Dutasteride 0.500 mg
Avodart 0.500 mg Image

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Avodart Facts

Used to treat benign prostatic hyperplasia, AVODART is manufactured by GlaxoSmithKline.

The active ingredient in AVODART has a bioavailability of 60% and is metabolized by the liver.

AVODART is the trade name of a medication containing the active ingredient dutasteride.

AVODART is a 5-alpha-reductase inhibitor, a medication which prevents the conversion of testosterone to dihydrotestosterone.


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What is Avodart

Avodart (dutasteride) has been proven to shrink the prostate and reduce any risky involved such as prostate surgery or acute urinary retention (AUR). The product has even shown to help with long-term improvement as well.

How does Avodart Work

Avodart is a medicine taken to treat an enlarged prostate also known as benign prostatic hyperplasia (BPH). A males' prostate will grow twice in their lives, the first time is around puberty and the second time occurs around the age of twenty-five. Both of these times are normal and okay, however the real problem is when the prostate continues to grow into the persons fifty's which it is called BPH. This disease causes a problem with urinating because as the prostate grows, it pushes on the urethra which is the tube that urine flows through and then out of the body.

When the testosterone in a males body converts into DHT (dihydrotestosterone) that is when the prostate enlarges causing uncomfortable symptoms. Avodart acts as a wall and prevents this conversion from happening thus decreasing the amount of DHT flowing throughout the body and thus shrinking the enlarged prostate.

How do you take Avodart

Avodart is a pill taken by mouth with our without food and with a full glass of water. It should be swallowed whole and not crushed, chewed, or broken before it is swallowed. The pill should be taken on a regular basis even if the person feels better .Take one capsule a day around the same time each day for maximum and efficient effects. If a dose is missed it should be taken right away as soon as it is remembered by the person who is prescribed the pill. However, two pills should not be taken at one time, so if it is almost time to take the next dose just skip the last one and move on to the next pill to continue on with the normal schedule. Also, Avodart should be stored at room temperature and away from moisture and heat. Do not take if there is a leak from the capsule.

Side Effects

There are possible side effects associated with this drug as there normally are with any medicine. Each person's body reacts differently with the things they put into their systems so side effects can vary or possibly not even occur at all. Side effects for Avodart include but are not limited to, erectile dysfunction, a decreased libido, abnormal ejaculation or decreased ejaculation, breast tenderness, lumps, enlargement or even discharge. Other side effects include allergic reactions such as a skin rash, itching, hives, or swelling. A person should always tell their doctor if they obtain any of these side effects because even if it is not due to Avodart, it could be something else that requires medical care. Avodart may also affect those taking other medications such as itraconazole, verapamil, cimetidine, erythromycin, diltiazem, or any protease inhibitors.

Other Brand Names

Other brands of medicine that contain dutasteride (the substance that blocks the conversion of testosterone to DHT) include Dutas, Duprost, and Dutagen. All of these medicines are used to treat benign prostatic hyperplasia with Avodart being the most commonly prescribed.

Safety Information:

Avodart is for the use of men only and should not be taken by women. Avodart can seep through the skin therefore women who are pregnant or may become pregnant should not take Avodart or even touch it in order to keep the future child safe and healthy. Avodart can cause birth defects in a baby so the handling of the product could end up being fatal in some cases. Those with liver disease should talk to their doctor before taking Avodart because it may not be safe for them to take the medicine or the dosage may have to be adjusted. Do not donate blood until it has been at least six months since the last dose was taken as this can be transferred through blood and be harmful to those receiving the blood.

Dosage:

Avodart is a soft gelatin capsule and is prescribed with thirty capsules to every bottle. The dosage is 0.5 mg once a day which is one capsule a day.

Visual Description:

The capsule should look yellowish and have a red inscription on it labeled "GX CE2" on the side of it. The box is red, white, and yellow with the words Avodart (dutasteride) soft gelatin capsules on the front.

About Avodart

What Avodart is used for

AVODART is used in the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with enlarged prostates.

BPH is a non-cancerous enlargement of the prostate gland, which is located at the lower portion of the urinary bladder surrounding the urethra (urine carrying tube). In men with BPH, the prostate gland becomes large enough to squeeze the urine tube running through it. If the urine tube is squeezed it narrows, making it more difficult with urination resulting in some or all of the following symptoms:

  • Difficulty in starting to urinate

  • An interrupted, weak urinary stream

  • More frequent urination, especially at night

  • Urgency and leaking or dribbling

  • A feeling that you cannot empty your bladder completely

As the disease progresses, untreated BPH can lead to an increased risk of complete blockage of urine flow (acute urinary retention) and/or the need for surgery.

How is BPH treated?

There are three main options for treating BPH. You and your doctor should decide which option is best for you after considering the size of your prostate and how troublesome your symptoms are.

  • Watchful waiting: If you have an enlarged prostate but your BPH symptoms are not particularly bothersome, your doctor may recommend regular check-ups to monitor your symptoms and no other treatment at this time.

  • Medication: If your symptoms are too bothersome for you, your doctor may recommend treatment with a medicine to relax smooth muscle in the prostate and/or a medicine to decrease prostate size.

  • Surgery: For some patients, BPH may be treated by surgery. Your doctor can describe the different surgical procedures for BPH. Your doctor will be able to evaluate whether this is the best treatment for you.

What Avodart does

AVODART belongs to a group of medicines called 5 alpha-reductase enzyme inhibitors. AVODART works to lower the production of dihydrotestosterone (DHT) in the body, leading to reduced prostate size, improved urinary flow, reduced risk of acute urinary retention (AUR), and reduced risk of the need for BPH related surgery. While some men have fewer problems and symptoms after 3 months of treatment with AVODART, a treatment period of at least 6 months is usually necessary to see if AVODART will work for you.

When Avodart should not be used

  • Women and children should never take AVODART.

  • Do not take AVODART if you are allergic to dutasteride or other alpha-reductase inhibitors or any of the other ingredients of AVODART.

What the medicinal ingredient is

Dutasteride.

What the important nonmedicinal ingredients for Avodart are

Nonmedicinal ingredients in your medicine include butylated hydroxytoluene, gelatin, glycerol, iron oxide yellow, lecithin, medium chain triglycerides, monodiglycerides of caprylic/capric acid, purified water, titanium dioxide, and red printing ink containing iron oxide red as the colourant.

What dosage forms Avodart comes in

Soft gelatin capsules. Each capsule contains 0.5 mg of dutasteride.


Warnings and Precautions

Serious Warnings and Precautions

  • AVODART is for use by men only.

  • Women who are pregnant, or who may become pregnant, should not handle AVODART as it may pass through the skin. AVODART may affect the normal development of the external genital organs in a male baby.

What are the special precautions about AVODART?

  • Men treated with AVODART should not donate blood until at least 6 months after their final dose in order to prevent giving AVODART to a pregnant woman through blood transfusion.

  • Before taking AVODART tell your doctor if you have or have had liver problems or cancer of the prostate.

Checking for prostate cancer

Your doctor has prescribed AVODART for symptomatic BPH and not for cancer. But a man can have BPH and prostate cancer at the same time. Doctors usually recommend that men be checked for prostate cancer once a year when they turn 50 (or 40 if a family member has had prostate cancer). These checks should continue while you take AVODART.

About Prostate Specific Antigen (PSA)

Your physician may have done a blood test called PSA. AVODART can alter PSA values. AVODART does lower your PSA test result by about 50%. This low PSA Level may give you a false sense of security. Keep a written record of your yearly PSA levels and notify your treating doctors that you have been taking AVODART for the exact number of months you have used. For more information, talk to your physician.

Prior to treatment with AVODART, you should have a thorough urological evaluation to determine the severity of your condition, and to exclude the need for immediate surgery or the possibility of prostate cancer. A thorough urological examination generally includes a digital rectal examination (DRE) and an evaluation of urinary symptoms. Your physician may also obtain a blood test for prostate specific antigen (PSA) (see About Prostate Specific Antigen (PSA):).

You must have a regular checkup by your doctor while taking AVODART, including digital rectal examination and PSA determination.


Interactions with Avodart

Interactions with other medicines

Make sure your doctor knows what other medicines you are taking, or have recently taken. Remember to include all medicines, herbal remedies or dietary supplements, such as vitamins, iron or calcium, which you have bought yourself. Please inform your doctor about regular consumption of grapefruit juice. This drink is known to increase the blood levels of some drugs in the body.

AVODART can alter the results of a prostate specific antigen (PSA) test. AVODART can lower your prostate specific antigen (PSA) test result by about 50%.


Proper Use of Avodart

Usual dose

  • Take one AVODART capsule once a day.

  • Swallow the capsule whole. Do not chew or open the capsules. Contact with the contents of the capsules may make your mouth or throat sore.

  • You can take AVODART with or without food.

Do not share your AVODART with others.

Overdose

If you accidentally take too many capsules, ask your doctor what to do or contact your nearest hospital emergency department for further advice.

Missed dose

If you miss a dose, you can just take the next scheduled dose. Don't take any extra capsules to make up for doses you forgot to take.


Side Effects for Avodart and What to Do About Them

The most common side effects of AVODART are impotence (not able to achieve or maintain an erection), decrease in libido (decreased desire to have sex or a reduced sex drive), changes or problems with ejaculations (including a decrease in amount of semen released during sex) and breast swelling or tenderness.

Serious Side Effects, How Often They Happen and What to Do About Them
Symptom/Effect Talk with your doctor or pharmacist Stop taking drug and call your doctor or pharmacist
Only if severe In all cases
Rare Sudden wheeziness or chest tightness    
Swelling of eyelids, face or lips    
Lumpy skin rash or “hives” anywhere on the body    

If you notice these side effects and any other side effects not mentioned in this leaflet, tell your doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking AVODART, contact your doctor or pharmacist.


Technical Information