Patient Medication Information: uses, side effects, how to take - Testosterone Enanthate Injection, USP
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.
What it does:
Testosterone Enanthate Injection, USP delivers medicine into your bloodstream by intramuscular injection. Testosterone Enanthate Injection, USP helps raise your testosterone to normal levels.
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.
- If you have known allergy to any of its components [the active ingredient is testosterone, which may be synthesized from soy; (see “What the nonmedicinal ingredients are” in this section)]
Testosterone Enanthate Injection, USP 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:
testosterone enanthate
What the nonmedicinal ingredients are:
sesame oil chlorobutanol
What dosage forms it comes in:
A 200 mg/mL solution for intramuscular injection.
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.
Testosterone Enanthate Injection, USP is not recommended for use in children < 18 years of age.
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.
Before using Testosterone Enanthate Injection, USP, 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 heart or blood vessel problems or a history of these problems such as heart attacks, stroke, or blood clot in the lungs or legs;
- have liver or kidney;
- have high blood pressure (hypertension); have diabetes;
- have breathing problems during sleep (sleep apnea).
Drug Abuse and Dependence:
Testosterone Enanthate Injection, USP contains testosterone, which is a controlled substance under Schedule G of the Food and Drugs Act.
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 may interact with Testosterone Enanthate Injection, USP include:
- Insulin
- Corticosteroids
- Propranolol
- Warfarin
Usual Dose:
The usual dose is 100-400 mg every four weeks.
What should I do if I miss a dose of Testosterone Enanthate Injection, USP? If you missed a dose, you should consult your health care provider (physician).
What should I do in case of overdose?
If you think you, or a person you are caring for, have taken too much Testosterone Enanthate Injection, USP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
INTERACTIONS WITH THIS MEDICATION
PROPER USE OF THIS MEDICATION
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
IMPORTANT: PLEASE READ
Never share your Testosterone Enanthate Injection, USP with anyone.
Every patient is different. Your doctor has prescribed
Testosterone Enanthate Injection, USP specifically for your needs. To get the best results from Testosterone Enanthate Injection, USP, it is essential that you take it exactly as your doctor has prescribed.
Use Testosterone Enanthate Injection, USP only for the condition for which it was prescribed. If you have any questions or concerns about Testosterone Enanthate Injection, USP treatment, ask your health care provider or pharmacist. They can answer your questions and may be able to give you additional printed information about Testosterone Enanthate Injection, USP.
Like all medicines, Testosterone Enanthate Injection, USP can have side effects. The following side effects have been reported for products containing testosterone:
- increased or irregular heart rate, blood clot in the lungs or legs;
- 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);
- acne;
- 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.
This is not a complete list of side effects. For any unexpected effects while taking Testosterone Enanthate Injection, USP, contact your doctor or pharmacist.
Serious side effects and what to do about them
| Symptom/Effect | Talk to your Health Care professional | Stop taking drug and get immediate medical help | ||
|---|---|---|---|---|
| Only if severe | In all cases | |||
| Common | Urinary symptoms (i.e. change in frequency/color , dribbling, pain on urination straining, weak stream, small amounts) | ✓ | ||
| Common (after prolonged use) | Breast enlargement or breast pain | ✓ | ||
| Uncommon | Heart attack and stroke | ✓ | ||
| Uncommon | Swelling of ankles and legs (in patients with heart, kidney or liver damage) | ✓ | ||
| Uncommon | Erections that are too frequent or continue for too long | ✓ | ||
| Uncommon | Liver problems, with symptoms such as nausea, vomiting, along with yellowed or darkened skin | ✓ | ||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
IMPORTANT: PLEASE READ
Testosterone Enanthate Injection, USP should be stored at controlled room temperature between 15°C and 30°C.
Keep out of reach of children and pets.
HOW TO STORE IT
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html ) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
If you want more information about Testosterone Enanthate Injection, USP:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html the manufacturer’s website https://www.hikma.com, or by calling 1-800-656-0793.
5995 Avebury Road, Suite 804, Mississauga, ON L5R 3P9.
Importer / Distributor: Innomar Strategies Inc., 8030 Esquesing Line, Milton, ON L9T 6W3.