Testosterone Cypionate Injection USP (Sterimax): Uses, Side Effects and Dosage

What the medication is used for:

Your doctor has prescribed Testosterone Cypionate Injection USP because your body is not making enough testosterone. The medical term for this condition is hypogonadism.

What it does:

Testosterone Cypionate Injection USP delivers testosterone into the bloodstream through an injection into your gluteal muscle. Testosterone Cypionate Injection USP 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 Testosterone Cypionate Injection USP, including testosterone USP that is chemically synthesized from soy (see "What the medicinal and nonmedicinal ingredients are" in this section).

Testosterone Cypionate 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 cypionate

What the nonmedicinal ingredients are:

Benzyl alcohol, benzyl benzoate, and cottonseed oil

What dosage forms it comes in:

Testosterone Cypionate Injection USP is available in one strength, 100 mg testosterone cypionate /mL.

Testosterone Cypionate Injection USP is available in the following packaging: 100 mg per mL – In vials of 10 mL. The vial stopper is not made with natural rubber latex.

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 Cypionate Injection USP is not recommended for use in children < 18 years of age.

Testosterone Cypionate Injection USP 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.

Testosterone Cypionate Injection USP 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 Testosterone Cypionate 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 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: Testosterone Cypionate Injection USP contains testosterone. Testosterone is a controlled substance because some people take it in high doses (abuse it), even if their body is making enough testosterone. Taking too much (abusing) testosterone can cause serious health problems, which can even lead to death (see Overdose).

Individuals who have abused testosterone may experience withdrawal symptoms lasting for weeks or months which include, but are not limited to: changes in mood, and appetite, as well as fatigue, insomnia, decreased sex drive and loss of function of the testes and ovaries.

Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

IMPORTANT: PLEASE READ

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:

• Insulin
• Corticosteroids
• Propranolol
• Warfarin

Testosterone Cypionate Injection USP should only be administered by a healthcare professional.

When you are given Testosterone Cypionate Injection USP, your blood testosterone should be checked on a regular basis.

Usual dose:

200 mg is given intramuscularly (in the muscle) every two weeks.

Overdose:

Taking too much (abusing) testosterone for a long time can cause serious health problems, which can even lead to death. Some of the health problems include effects on the cardiovascular system, reproductive system and the liver, as well as serious psychiatric problems.

Missed Dose:

If you have missed a dose of Testosterone Cypionate Injection USP, you should contact your doctor to schedule your next injection.

Like all medicines, Testosterone Cypionate Injection USP 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);
• acne;
• change in mood, depression;

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

• 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 Testosterone Cypionate Injection USP, contact your doctor or pharmacist.

Serious side effects and what to do about them

IMPORTANT: PLEASE READ

Store Testosterone Cypionate Injection USP at controlled room

temperature (15^oC-30^oC). Protect from light. Discard within 56 days

of initial use.

Keep in a safe place out of reach and sight of children and pets.

You should not use your medication after the expiration date printed on the carton and vial labels.

Keep all medications out of the reach and sight of children. This medication could harm them.

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 (canada.ca/drug-device-reporting) 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.

If you want more information about Testosterone Cypionate Injection USP:

• Talk to your healthcare professional.

• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.sterimaxinc.com; or by calling 1-800-881-3550.

SteriMax Inc.

2770 Portland Drive

Oakville, Ontario, Canada

L6H 6R4

Last revised: July 20, 2026