Avodart 0.500 mg
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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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90 capsules for $197.75 ($2.20 per capsule)
Avodart from online pharmacy: United Kingdom
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100 capsules for $122.26 ($1.22 per capsule)
Dutasteride from online pharmacy: India
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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.
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.
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.
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.
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.
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
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
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.
If you accidentally take too many capsules, ask your doctor what to do or contact your nearest hospital emergency department for further advice.
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.
Administration of a single 5 mg dose of AVODART followed 1 hour later by 12 g cholestyramine did not affect the relative bioavailability of dutasteride in 12 normal volunteers.
Dutasteride absorption is not affected by food. The effects of CYP3A4 inhibitors found in foods on dutasteride pharmacokinetics have not been studied. Care should be taken when administering dutasteride to patients who chronically consume CYP3A4 inhibitors found in foods and beverages such as grapefruit juice.
In a single sequence, crossover study in healthy volunteers, the administration of tamsulosin or terazosin in combination with AVODART had no effect on the steady state pharmacokinetics of either alpha adrenergic blocker. The percent change in DHT concentrations was similar for AVODART alone compared with the combination treatment.
A clinical trial was conducted in which dutasteride and tamsulosin were administered concomitantly for 24 weeks followed by 12 weeks of treatment with either the dutasteride and tamsulosin combination or dutasteride monotherapy. Results from the second phase of the trial revealed no excess of serious adverse events or discontinuations due to adverse events in the combination group compared to the dutasteride monotherapy group.
If AVODART is administered in combination with the alpha-blocker tamsulosin, please refer to the Adverse Reactions.
Effects on Prostate Specific Antigen: PSA levels generally decrease in patients treated with AVODART as the prostate volume decreases. In approximately one-half of the subjects, a 20% decrease in PSA is seen within the first month of therapy. After 6 months of therapy, PSA levels stabilize to a new baseline that is approximately 50% of the pre-treatment value. Results of subjects treated with AVODART for up to 2 years indicate this 50% reduction in PSA is maintained. Therefore, a new baseline PSA concentration should be established after 3 to 6 months of treatment with AVODART (see Warnings and Precautions, Effects on PSA and Prostate Cancer Detection).
In a population pharmacokinetics analysis, a decrease in clearance of dutasteride was noted when coadministered with the CYP3A4 inhibitors verapamil (−37%, n=6) and diltiazem (−44%, n=5). In contrast, no decrease in clearance was seen when amlodipine, another calcium channel antagonist that is not a CYP3A4 inhibitor, was coadministered with dutasteride (+7%, n=4).
The decrease in clearance and subsequent increase in exposure to dutasteride in the presence of verapamil and diltiazem is not considered to be clinically significant. No dose adjustment is recommended.
The effects of herbal remedies on the pharmacokinetics of dutasteride have not been studied. Care should be taken when administering dutasteride to patients who chronically consume herbal remedies containing CYP3A4 inhibitors (e.g., milk thistle) or CYP3A4 inducers (e.g., St. John's wort).
In a study of 23 healthy volunteers, 3 weeks of treatment with AVODART 0.5 mg/day did not alter the steady-state pharmacokinetics of the S- or R-warfarin isomers or alter the effect of warfarin on prothrombin time when administered with warfarin.
Although specific interaction studies were not performed with other compounds, approximately 90% of the subjects in the 3 Phase III pivotal efficacy studies receiving AVODART were taking other medications concomitantly. No clinically significant adverse interactions could be attributed to the combination of AVODART and concurrent therapy when AVODART was coadministered with anti-hyperlipidemics, angiotensin converting enzyme (ACE) inhibitors, beta adrenergic blocking agents, calcium channel blockers, corticosteroids, diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), phosphodiesterase Type V inhibitors and quinolone antibiotics.
In a study of 20 healthy volunteers, AVODART did not alter the steady-state pharmacokinetics of digoxin when administered concomitantly at a dose of 0.5 mg/day for 3 weeks.
Care should be taken when administering dutasteride to patients taking potent, chronic CYP3A4 inhibitors such as ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, troleandomycin, and ciprofloxacin. Based on the in vitro data, blood concentrations of dutasteride may increase in the presence of CYP3A4 inhibitors.
Dutasteride does not inhibit the in vitro metabolism of model substrates for the major human cytochrome P450 isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at a concentration of 1000 ng/mL, 25 times greater than steady-state serum concentrations in humans. In vitro studies demonstrate that dutasteride does not displace warfarin, diazepam, or phenytoin from plasma protein binding sites, nor do these model compounds displace dutasteride.
Information for the Patient
Special Handling Instructions
Dutasteride is absorbed through the skin; therefore, women and children must avoid contact with leaking capsules. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water (see Contraindications and Warnings and Precautions).
Dosage and Administration
The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied. Because dutasteride is extensively metabolized and has a half-life of 3 to 5 weeks, caution should be used in the administration of dutasteride to patients with liver disease.
The recommended dose of AVODART (dutasteride) soft gelatin capsules is one 0.5 mg capsule taken orally once a day.
The effect of renal impairment on dutasteride pharmacokinetics has not been studied. However, less than 0.1% of a steady state 0.5 mg dose of dutasteride is recovered in human urine, and no adjustment in dose is anticipated for patients with renal impairment.
If a dose is missed the capsule can be taken at the next scheduled dose. Extra capsules taken for missed doses are not necessary.
AVODART capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. AVODART may be taken with or without food (see Warnings and Precautions, Exposure of Women—Risk to Male Fetus and Special Handling Instructions).
Most adverse reactions were mild or moderate and generally resolved while on treatment in both the AVODART and placebo groups. The most common adverse events leading to withdrawal in both treatment groups were associated with the reproductive system.
Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.
|Adverse Reactions||Adverse Reaction Onset|
|Month 0–6||Month 7–12||Month 13–18||Month 19–24|
b. Includes breast tenderness and breast enlargement.
The relationship between long-term use of Dutasteride and Leydig cell tumours of the testis, Hepatocellular adenomas, and the Gleason score (grade of malignancy) of prostate cancer in patients taking long term Alpha reductase inhibitors is currently unknown.
In postmarketing experience with AVODART, adverse events related to allergic reactions, including rash, pruritus, urticaria, localized oedema and angioedema, have been reported very rarely.
Indications and Clinical Use
AVODART (dutasteride) soft gelatin capsules are indicated for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH) in men with enlarged prostates.
AVODART has been shown to: