"The US Food and Drug Administration (FDA) has approved class-wide labeling changes for all prescription testosterone products, the agency announced today.
New safety information from published literature and case reports on the risks "...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
TESTOSTERONE - INTRAMUSCULAR
COMMON BRAND NAME(S): Delatestryl, Tesamone
USES: 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. It may also be used to treat certain types of breast cancer in women.
HOW TO USE: This medication is given by injection into the buttock muscle as directed by your doctor, usually every 1 to 4 weeks. Do not inject this medication into a vein. Dosage is based on your medical condition, testosterone blood levels, and response to treatment.
If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.
Use this medication regularly in order to get the most benefit from it. To help you remember, use a calendar to mark the days you will receive an injection.
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 immediately.
Abnormal drug-seeking behavior is possible with this medication, and it is frequently misused for its muscle-enhancing effects. Do not increase your dose, use it more frequently, or use 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 if it worsens.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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