Depo Testosterone - Consumer Medicine Information
|Condition:||Breast Cancer, Palliative, Delayed Puberty, Male, Hypogonadism, Male, Postpartum Breast Pain|
|Class:||Androgens and anabolic steroids, Hormones|
|Form:||Liquid solution, Intramuscular (IM)|
|Ingredients:||testosterone cypionate, benzyl alcohol, benzyl benzoate, cottonseed oil|
Testosterone cypionate injection USP
About This Medication
What the Medication is Used For
Your doctor has prescribed DEPO-TESTOSTERONE because your body is not making enough testosterone. The medical term for this condition is hypogonadism.
What it Does
DEPO-TESTOSTERONE delivers testosterone into the bloodstream through an injection into your gluteal muscle. DEPO-TESTOSTERONE helps raise your testosterone to normal levels.
When it Should not Be Used
- if you have prostate or breast cancer (confirmed or suspected by your doctor);
- if you have difficulty in urinating due to an enlarged prostate;
- if you have a known allergy or sensitivities to any of the ingredients contained in DEPO-TESTOSTERONE,including testosterone USP that is chemically synthesized from soy (see "What the medicinal and nonmedicinal ingredients are" in this section).
DEPO-TESTOSTERONE 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
Benzyl alcohol, benzyl benzoate, and cottonseed oil
What Dosage Forms it Comes In
DEPO-TESTOSTERONE is available in one strength, 100 mg testosterone cypionate /mL.
DEPO-TESTOSTERONE is available in the following packaging: 100 mg per mL – In vials of 10 mL.
Warnings and Precautions
There is very little information from clinical trials with testosterone in the older male (>65 years of age) to support safe use for a long period of time.
DEPO-TESTOSTERONE is not recommended for use in children < 18 years of age.
DEPO -TESTOSTERONE can cause changes in your vision. It is called chorioretinopathy.
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.
DEPO-TESTOSTERONE contains benzyl alcohol. The preservative benzyl alcohol has been associated with serious adverse events, including the "gasping syndrome" (difficulty in catching breath, low blood pressure, slow heart rate), and death in pediatric patients. Premature and low-birth weight infants may be more likely to develop toxicity.
Pregnancy: Benzyl alcohol can cross the placenta.
Before using DEPO-TESTOSTERONE, talk to your doctor 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;
- have breathing problems during sleep (sleep apnea);
- have heart or blood vessels problems or a history of these problems such as heart attack, stroke, or blood clots in the lungs or the legs.
Drug Abuse and Dependence: DEPO-TESTOSTERONE contains testosterone, which is a controlled substance under Schedule G of the Food and Drugs Act.
Interactions With This Medication
Tell your doctor or pharmacist if you are taking or have recently taken any other drugs or herbal products, even those without a prescription.
Drugs that include:
Proper Use of This Medication
DEPO-TESTOSTERONE should be used only under the supervision of a doctor, with regular follow-up.
To treat hypogonadism, 200 mg is given intramuscularly (in the muscle) every two weeks.
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 have missed a dose of DEPO-TESTOSTERONE, you should contact your doctor to schedule your next injection.
Side Effects And What to Do About Them
Like all medicines, DEPO-TESTOSTERONE can have side effects. The following side effects have been reported for testosterone products:
- skin irritation or redness or rash at the application site;
- increased prostatic specific antigen (PSA);
- enlarged prostate (benign prostatic hyperplasia);
- an increase in red blood cell count, (hematocrit and hemoglobin);
- 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;
This is not a complete list of side effects. For any unexpected effects while taking DEPO-TESTOSTERONE, contact your doctor or pharmacist.
Serious Side Effects how Often They Happen and What to Do About Them
|Symptom/ Effect||Talk with your|
(i.e. change in
dribbling, pain on
weak stream, small
|Breast enlargement or|
|Uncommon||Swelling of ankles|
and legs (in patients
with heart, kidney or
|Uncommon||Erections that are too|
frequent or continue
for too long, or are
|Uncommon||Liver problems, with|
symptoms such as
along with yellowed
or darkened skin
Crushing chest pain
sharp pain in the
blood, or sudden
shortness of breath
severe headache or
disturbance of vision
or speech, or
numbness in the face,
arm or leg
blurred vision, blind
spot, objects seeming
smaller or distortion
of straight lines
How to Store It
Store DEPO-TESTOSTERONE at controlled room temperature (15°C-30°C). Protect from light.
Keep in a safe place out of reach of children and pets.
You should not use your medication after the expiration date printed on the carton and label.
Keep all medications out of the reach of children. This medication could harm them.
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
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 the side effect, please contact your health care professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full Product Monograph, prepared for health professionals can be found at:http://www.pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001.