Manufacturer: Sun Pharmaceuticals
Substance: Testosterone undecanoate
Package: 40mg (60 pills)
This medication is used in men who do not make enough of a natural substance called testosterone. In males, testosterone is responsible for many normal functions, including growth and development of the genitals, muscles, and bones. It also helps cause normal sexual development (puberty) in boys. Testosterone belongs to a class of drugs known as androgens. It works by affecting many body systems so that the body can develop and function normally.
Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty.
This medication should not be used in women.
How To Use
Take this medication by mouth, usually twice daily with breakfast and with an evening meal, or as prescribed by your doctor. Swallow the capsules whole. Do not chew or open the capsules. Doing so can change how well the medication works.
Dosage is based on your medical condition, testosterone blood levels, and response to treatment.
Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.
Do not suddenly stop using testosterone if you have been using it regularly for an extended time or if it has been used in high doses. In such cases, your body will no longer make its own testosterone, and withdrawal reactions (such as tiredness, weakness, depression) may occur. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
Abnormal drug-seeking behavior is possible with this medication, and it is frequently misused for its muscle-enhancing effects. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Doing so may increase serious side effects (such as increased risk for heart disease, stroke, liver disease, ruptured tendons/ligaments, improper bone development in adolescents). Properly stop the medication when so directed.
Tell your doctor if your condition does not improve or worsens.
Nausea, vomiting, headache, skin color changes, increased/decreased sexual interest, oily skin, hair loss, and acne may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects when it is used at normal doses.
Tell your doctor right away if you have any serious side effects, including:
mental/mood changes (such as anxiety, depression, increased anger)
signs of serious liver disease (such as persistent abdominal pain/nausea, unusual tiredness, yellowing eyes/skin, dark urine)
too frequent/prolonged erections
Get medical help right away if you have any very serious side effects, including:
shortness of breath/rapid breathing
chest/jaw/left arm pain
pain/swelling/warmth in the groin/calf
weakness on one side of the body
sudden vision changes
Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.
This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:
itching/swelling (especially of the face/tongue/throat)
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US –
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of:
cancer (such as breast cancer in men, prostate cancer)
blood clots (such as in the leg, lungs)
heart disease (such as heart failure, chest pain, heart attack)
certain mineral imbalance (high calcium blood level)
high blood pressure
breathing problems (such as sleep apnea, chronic obstructive pulmonary disease-COPD)
If you have diabetes, this product may decrease your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor right away if you have symptoms of low blood sugar, such as increased hunger, dizziness, or unusual sweating. Your anti-diabetic medication or diet may need to be adjusted.
This drug may affect your cholesterol and may increase your risk of heart or blood vessel problems (coronary artery disease). Your doctor will monitor your cholesterol level closely.
Tell your doctor if you become bed-ridden (unable to walk) for a prolonged time while using this medication. Your doctor may monitor your blood calcium level to prevent problems.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially prostate/liver problems, swelling of arms/legs.
Caution is advised when using this drug in children because bone growth may be affected, causing shorter adult height. Your child’s doctor will monitor growth and bone development during treatment.
This medication should not be used in women, especially during pregnancy or breast-feeding. It may harm an unborn or breast-feeding baby. Consult your doctor for more details.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Some products that may interact with this drug include:
“blood thinners” (such as warfarin)
This medication may interfere with certain laboratory tests (including thyroid function tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If overdose is suspected, contact a poison control center or emergency room right away. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. US residents can call their local poison control center at 1-800-222-1222.
Do not share or sell this medication to others. It is against the law.
Laboratory and/or medical tests (such as blood testosterone levels, red blood cell counts, liver function tests, blood cholesterol levels, PSA test) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414 for additional advice on missed doses.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised October 2015.
Copyright(c) 2015 First Databank, Inc.
Conditions of use: The information in this database is intended to supplement, not substitute for the expertise and judgment of healthcare professionals. The information in not intend to cover all possible uses, directions, precautions, drug interactions or adverse effects nor should it be construed in indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.