How does this medication work? What will it do for me?
Testosterone belongs to the class of medications called androgens (male hormones). This medication is used to replace testosterone in males who have conditions caused by low testosterone levels. It is also used to treat erectile dysfunction (erectile difficulties or the inability to attain or maintain an erection) and other male sexual problems when they are caused by low testosterone levels.
This medication works by replacing the testosterone that would normally be produced by the body. Testosterone should only be used if testosterone deficiency has been confirmed by symptoms and blood tests.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each oval, orange, soft gelatin capsule marked "ORG DV3" contains 40 mg of testosterone undecanoate. Nonmedicinal ingredients: castor oil, propylene glycol monolaurate, and gelatin.
How should I use this medication?
The dose of testosterone undecanoate is adjusted according to the response of the person taking the medication. For the first 2 to 3 weeks of treatment, a daily dose of 120 mg to 160 mg in two divided doses is used. After this, the dose of testosterone undecanoate usually ranges from 40 mg to 120 mg daily. Take capsules with a meal and swallow them whole without chewing them.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this mediction if you:
- are allergic to testosterone or to any of the ingredients of the medication
- are female (especially if you are pregnant or breast-feeding)
- have, or are suspected to have, prostate or breast cancer
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- abdominal pain
- aggressive behaviour
- changes in sexual desire or drive
- enlarged prostate
- hair loss, thinning hair, or baldness
- mood changes
- skin rash or itching
- sleep disturbances caused by breathing problems (sleep apnea)
- sore throat and/or fever
- unpleasant breath odour
- weight gain
Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- black, tarry, or light-coloured stools, or dark urine
- breast soreness or enlargement
- flushing or redness of skin or any changes in skin colour
- high blood pressure
- problems with urination (change in frequency or colour, dribbling, pain or straining when urinating, weak urine stream, small urine amounts)
- prolonged (more than 4 hours) or painful erections, or erections that happen too often
- purple or red-coloured spots on the body or inside the mouth or nose
- swelling of ankles and legs (for people with heart, liver, or kidney problems)
- symptoms of liver problems, such as:
- abdominal pain
- dark urine
- loss of appetite
- nausea or vomiting
- pale stools
- yellow eyes or skin
- unusual fatigue or bleeding
Stop taking the medication and seek immediate medical attention if any of the following occur:
- shortness of breath
- symptoms of a serious allergic reaction, such as:
- difficulty breathing
- swollen face or throat
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
July 15, 2014
Health Canada has issued new restrictions concerning the use of testosterone products. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Blood tests: Your doctor may recommend that you have regular blood tests while using this medication to check whether the medication is working and whether you are having certain side effects. Also, the use of testosterone may interfere with a number of laboratory tests. Tell all health professionals administering these tests that you are using this medication.
Diabetes: This medication may affect blood sugar levels. If you have diabetes, monitor your blood sugar carefully while using this medication.
Heart disease: If you have heart disease, your doctor should monitor your condition closely while you are using this medication. Report any swelling in the feet and lower legs to a doctor immediately.
Kidney or liver disease: If you have kidney or liver disease, your doctor should monitor your condition closely while you are using this medication. Report any swelling in the feet and lower legs to a doctor immediately.
Sleep disorders: Treatment with testosterone may cause sleep apnea (interruption of breathing during sleep) and high blood pressure for some people, especially those with risk factors such as being overweight or having a chronic lung disease.
Sperm counts: This medication may reduce sperm counts if high doses are used, or if it is used for a prolonged period.
Pregnancy: This medication is not recommended for pregnant women.
Breast-feeding: This medication is not recommended for breast-feeding women.
Children: The safety and effectiveness of using this medication have not been established for children. This medication is not recommended for children under 18 years of age.
Seniors: Seniors may have an increased risk for prostate enlargement and should be evaluated for prostate cancer before starting testosterone replacement therapy.
What other drugs could interact with this medication?
There may be an interaction between testosterone undecanoate and any of the following:
- adrenocorticotropic hormone (ACTH)
- corticosteroids (e.g., prednisone)
- diabetes medications (e.g., insulin)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.