Andriol - Consumer Medicine Information
|Manufacture:||Merck & Co., Inc.|
|Condition:||Hypogonadism, Male, Hypogonadism|
|Class:||Androgens and anabolic steroids|
|Ingredients:||testosterone undecanoate, castor oil, propylene glycol monolaurate, gelatin, glycerin and Sunset Yellow (E110, FD&C Yellow no. 6)|
testosterone undecanoate capsules
About this Medication
What the medication is used for
Your doctor has prescribed this medicine because your body is not making enough testosterone. The medical term for this condition is hypogonadism. Your doctor will confirm this by blood testosterone measurements and also clinical symptoms such as inability to get or maintain an erection (impotence), infertility, low sex drive, tiredness, depressive moods, or bone loss caused by low hormone levels.
What it does
Andriol is absorbed from the gut and delivers testosterone to your blood stream.
When it should not be used
- If you have or it is suspected that you have prostate or breast cancer.
- If you have difficulty in urinating due to an enlarged prostate.
- Known allergy to any of its components (see “What the important non-medicinal ingredients are” in this section).
- Andriol should NOT be used by women. Pregnant and breast feeding women are especially at risk. Testosterone may cause harm to your unborn baby.
What the medicinal ingredient is
What the nonmedicinal ingredients are
Castor oil, propylene glycol monolaurate, gelatin, glycerin and Sunset Yellow (E110, FD&C Yellow no. 6).
What dosage form it comes in
Each capsule contains 40 mg of testosterone undecanoate.
Warnings and Precautions
The safety and efficacy have not been established for use of Andriol in children under 18 years of age and therefore should not be used in this population.
There is very little information from clinical trials with testosterone in the older male (over 65 years of age) to support safe use for a long period of time.
You should not use testosterone in an attempt to reduce weight and increase muscle, or improve athletic performance as it may cause serious health problems.
You should not use testosterone to treat sexual dysfunction or male infertility.
Your doctor will measure testosterone blood levels before and during your treatment. Based on the blood test results, your doctor may adjust the dose of Andriol.
Before using Andriol, talk to your doctor or pharmacist if you:
- have difficulty urinating due to an enlarged prostate. Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;
- have prostate cancer (confirmed or suspected);
- have liver, kidney or heart disease;
- have high blood pressure (hypertension);
- have diabetes (Andriol may affect blood sugar levels);
- have breathing problems during sleep (sleep apnea);
- are on a low salt diet or low sugar diet;
- have allergies;
- have breast cancer;
- are bedridden;
- have swelling of face, hands, feet or lower legs;
- have heart or blood vessel problems or a history of these problems such as heart attacks, stroke, or blood clot in the lungs or legs.
Andriol contains Sunset Yellow which may cause allergic reactions.
Drug abuse and dependence
Andriol contains testosterone which is a controlled substance under schedule G of the Food and Drugs Act.
Your doctor should check your progress at regular visits in order to make sure this medicine does not cause unwanted side-effects.
Any male adolescent patient receiving androgens for delayed puberty should have bone development checked every six months.
Interactions with this Medication
Tell your doctor or pharmacist if you are taking or have recently taken any other drugs or herbal products (St. John’s Wort), even those without a prescription.
Drugs that may interact with Andriol include:
Proper Use of this Medication
Never share your Andriol with anyone. Your doctor has prescribed Andriol specifically for your needs. It is essential that you take it exactly as your doctor has prescribed.
Usually, the dosage is 3-4 capsules daily during the first 2-3 weeks. Subsequent dosage (1-3 capsules daily) should be based on the clinical effect obtained during the first weeks of therapy.
To ensure adequate absorption, Andriol must be taken with a meal. Swallow the capsules whole without chewing, using some water or other fluid.
Take half of the daily dose in the morning and the other half in the evening, if dose consists of more than one capsule. If the daily dose is an uneven number of capsules, take the larger number in the morning.
|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.|
If you miss a dose, do not double your next dose the next day to catch up. Resume your normal dosing the next day.
Side Effects and what to do about them
Like all medicines, Andriol can have side effects. The following side effects have been reported for products containing testosterone:
- increased prostatic specific antigen (PSA);
- enlarged prostate (benign prostatic hyperplasia);
- increase in the number of red blood cells (the cells which carry the oxygen in your blood);
- increase in the percentage of red blood calls relative to the total blood volume (haematocrit);
- increased concentration of the red blood cell component that carries oxygen (haemogloblin);
- change in mood, depression;
- prolonged or painful erection;
- sleep disturbances caused by breathing problems;
- aggression or aggressive behaviour;
- breast enlargement and breast pain;
- loss of hair and baldness;
- high blood pressure;
- weight gain;
- headache, dizziness;
- increased or irregular heart rate, blood clot in the lungs or the legs.
Serious side effects, how often they happen and what to do about them
|Symptom / Effect||Talk with your|
drug and call
your doctor or
|Uncommon||Liver problems with symptoms such as nausea or vomiting, vomiting of blood, yellow eyes or skin.||✓|
|Swelling of feet or lower legs in patients with heart, kidney or liver damage.||✓|
|Flushing or redness of skin or any changes in skin colour.||✓|
|Skin rash or itching; hives.||✓|
|Black, tarry, or light-coloured stools; dark coloured urine.||✓|
|Purple or red-coloured spots on body or inside the mouth or nose.||✓|
|Sore throat and/or fever.||✓|
|Abdominal or stomach pain (continuing); pain, tenderness, or swelling in the upper abdominal or stomach area.||✓|
|Loss of appetite (continuing); unpleasant breath odour (continuing).||✓|
|Confusion; dizziness, headache (frequent or continuing); mental depression.||✓|
|Feeling of discomfort (continuing).||✓|
|Shortness of breath.||✓|
|Unusual bleeding; unusual tiredness.||✓|
|Erections that are too frequent or continue for too long or too painful; frequent urge to urinate.||✓|
|Heart attack and stroke.||✓|
This is not a complete list of side effects. For any unexpected effects while taking Andriol, contact your doctor or pharmacist.
How to Store it
Keep out of the reach and sight of children.
Store between 15 and 30°C. Protect from light and moisture. Do not refrigerate. Keep the blister in the outer carton. Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
Reporting Suspected 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
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect 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.
Also, you can report any suspected adverse reactions associated with the use of health products to Merck Canada Inc. by one of the following 2 ways:
- Call toll-free at 1-800-567-2594
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1--877-428-8675, or
- Mail to: Merck Canada Inc.
Medical Information Center
16750 route Transcanadienne
Kirkland, QC H9H 4M7
This document plus the full product monograph, prepared for health professionals can be found at: www.merck.ca or by contacting the sponsor, Merck Canada Inc. at: 1-800-567-2594.