Details for: AVODART
Company: GLAXOSMITHKLINE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02247813 | AVODART | DUTASTERIDE | 0.5 MG | CAPSULE | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
AVODART® is used alone (monotherapy) in the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with enlarged prostates.
AVODART® is also used in combination with the alpha blocker, tamsulosin, in the treatment of moderate to severe symptomatic BPH in men with enlarged prostates. Combination therapy was also shown to be better than tamsulosin, but not AVODART® at reducing the risk of acute urinary retention (or where patient suddenly cannot urinate at all) and/or the need for BPH related surgery.
AVODART® is not approved for use in the prevention of prostate cancer.
What it does
Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT). AVODART® belongs to a group of medicines called 5 alpha-reductase enzyme inhibitors. AVODART® lowers DHT production in the body, leading to a shrinkage of the enlarged prostate in most men, which leads to improvements in BPH symptoms and improved urinary flow, reduced risk of acute urinary retention (or where patient suddenly cannot urinate at all), and reduced risk of the need for BPH related surgery.
AVODART® is also used with another medicine called tamsulosin, an alpha blocker, which acts by relaxing smooth muscle in the prostate and bladder neck at the site of obstruction, resulting in improvements in BPH symptoms and improved urinary flow.
Symptoms of BPH may be seen to improve after 3 months of treatment with AVODART®, however, it may take up to 6 months to know if treatment with AVODART® will be beneficial.
When it 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 non-medicinal ingredients are
Nonmedicinal ingredients in your medicine include butylated hydroxytoluene, gelatin, glycerin, iron oxide yellow, lecithin, medium chain triglycerides, monodiglycerides of caprylic/capric acid, purified water and titanium dioxide.
What dosage form it 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.
Heart failure (the heart does not pump blood as well as it should) was reported more often in patients taking AVODART® and an alpha-blocker, tamsulosin, in clinical studies than in patients taking AVODART®. It is not known if taking AVODART® and an alpha-blocker caused heart failure.
BEFORE you use AVODART®, talk to your doctor or pharmacist if:
- You have or have had liver problems.
- You have or have had prostate cancer or urinary tract disease.
What are the special precautions about AVODART®?
- Do not donate blood while taking AVODART® and for at least 6 months after you have stopped taking AVODART® in order to prevent giving AVODART® to a pregnant woman through blood transfusion.
- In a clinical study of men aged 50 to 75 years with a recent negative biopsy for prostate cancer and an increased prostate specific antigen (PSA) blood test, men taking AVODART® had a serious form of prostate cancer more often than men who did not take AVODART®.
You must see your doctor regularly. While taking AVODART®, you must have regular checkups, including digital rectal examination and PSA examination. Follow your doctor’s advice about when to have these checkups.
Checking for prostate cancer
A man can have BPH and prostate cancer at the same time. Prior to treatment with AVODART®, you should have a thorough urological evaluation to determine the severity of your condition, and to rule out the need for immediate surgery or the possibility of prostate cancer.
About Prostate Specific Antigen (PSA)
If a doctor asks you to have a Prostate Specific Antigen (PSA) test which is used for screening prostate cancer, you should tell your doctor that you are taking AVODART®. AVODART® can lower the PSA test result. A low PSA level may give you a false sense of security about your risk for prostate cancer. Your doctor is aware of this effect and can still use PSA to see if you might have prostate cancer. Increases in your PSA levels while on treatment with AVODART® (even if the PSA levels are in the normal range) should be evaluated by your doctor
Interactions with this medication
Interactions with other medicines
Some medicines can react with AVODART® and may make it more likely that you will have side effects. Some of these medicines may include:
- Verapamil or diltiazem (for high blood pressure).
- Ritonavir (for HIV).
- Ketaconazole (for fungal infections).
- Ciprofloxacin or troleandomycin (for bacterial infections).
- Cimetidine (for heart burn).
- Certain herbal medicines such as St. John’s Wort or Milk Thistle.
Make sure your doctor knows if you are taking any of these, or other medicines. Your dose of AVODART® may need to be reduced. Remember to include all medicines, herbal remedies or dietary supplements, such as vitamins, iron or calcium, which you have bought yourself without a prescription.
Do not eat grapefruit or drink grapefruit juice while taking AVODART®. This drink is known to increase the blood levels of some drugs in the body.
Proper use of this medication
Always take AVODART® exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual dose
Monotherapy: One AVODART® 0.5 mg capsule once a day.
Combination therapy: One AVODART® 0.5 mg capsule once a day with one tamsulosin 0.4 mg 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.
- The capsules can be taken with or without food.
Do not share your medication with others.
Overdose
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
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 and what to do about them
The most common side effects of AVODART®, taken alone or in combination with tamsulosin, are not being able to achieve or maintain an erection* (impotence), 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.
If breasts swelling or tenderness becomes troublesome, or if you notice breast lumps or nipple discharge, you should talk to your doctor about these changes. Additionally, some people may experience dizziness when taking AVODART® with tamsulosin.
Rare side effects (may affect up to 1 in 1,000 people) of hair loss (usually from the body) or abnormal hair growth have been reported.
Very rare side effects (1 in 10,000 people) of allergic reactions depressed mood, and pain and swelling in the testicles have been reported.
Breast cancer has been reported in patients taking AVODART® however, the relationship between long-term use of AVODART® and breast cancer is not known.
*In a small number of people some of these events may continue after you stop taking AVODART®
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Very Rare | |||
| Allergic Reactions: Sudden wheeziness or chest tightness | ✔ | ||
| Allergic Reactions: Swelling of eyelids, face or lips | ✔ | ||
| Allergic Reactions: 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.
How to store
- Store AVODART® capsules between 15°C and 30°C.
- Keep out of the reach and sight of children.
- Return any cracked or leaking capsules to your pharmacist for replacement.
- Return any unused capsules to a pharmacist.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found at:
www.gsk.ca or by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
This leaflet was prepared by GlaxoSmithKline Inc.
Last revised: January 21, 2013
©2013 GlaxoSmithKline Inc., All Rights Reserved
® AVODART is a registered trademark, used under license by GlaxoSmithKline Inc.