Details for: DELATESTRYL
Company: BAUSCH HEALTH, CANADA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00029246 | DELATESTRYL | TESTOSTERONE ENANTHATE | 200 MG / ML | SOLUTION | INTRAMUSCULAR |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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
DELATESTRYL delivers medicine into your bloodstream by intramuscular injection. DELATESTRYL 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)]
DELATESTRYL 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 non-medicinal ingredients are
sesame oil
chlorobutanol
What dosage form it comes in
A 200 mg/mL solution for intramuscular injection.
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.
DELATESTRYL 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 DELATESTRYL, 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:
DELATESTRYL 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 may interact with DELATESTRYL include:
- Insulin
- Corticosteroids
- Propranolol
- Warfarin
Proper use of this medication
Usual Dose
The usual dose is 100-400 mg every four weeks.
Overdose
Never share your DELATESTRYL with anyone.
Every patient is different. Your doctor has prescribed DELATESTRYL specifically for your needs. To get the best results from DELATESTRYL, it is essential that you take it exactly as your doctor has prescribed.
Use DELATESTRYL only for the condition for which it was prescribed. If you have any questions or concerns about DELATESTRYL treatment, ask your health care provider or pharmacist. They can answer your questions and may be able to give you additional printed information about DELATESTRYL.
Missed Dose
If you missed a dose, you should consult your health care provider (physician).
Side effects and what to do about them
Like all medicines, DELATESTRYL 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 DELATESTRYL, contact your doctor or pharmacist.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Urinary symptoms (i.e. change in frequency/color, dribbling, pain on urination straining, weak stream, small | ✔ | ||
| Common (after prolonged use) | |||
| Breast enlargement or breast pain | ✔ | ||
| Uncommon | |||
| Heart attack and stroke | ✔ | ||
| Swelling of ankles and legs (in patients with heart, kidney or liver damage) | ✔ | ||
| Erections that are too frequent or continue for too long | ✔ | ||
| Liver problems, with symptoms such as nausea, vomiting, along with yellowed or darkened skin | ✔ | ||
How to store
DELATESTRYL should be stored at controlled room temperature between 15°C and 30°C.
Keep out of reach of children and pets
Reporting 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
Health Canada
Postal Locator 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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.
More information
This document plus the full prescribing information, prepared for health professionals can be obtained by contacting the sponsor, Valeant Canada LP, at: 1-800-361-4261
This leaflet was prepared by Valeant Canada.
Last revised: August 19, 2014.