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

(tess-TOSS-ter-own)

COMMON BRAND NAME(S): Delatestryl, Everone, Tesamone, Testro

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.

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.

SIDE EFFECTS: Nausea, vomiting, headache, skin color changes, increased/decreased sexual interest, oily skin, hair loss, and acne may occur. Pain and redness at the injection site may also 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), trouble sleeping/snoring, signs of serious liver disease (such as persistent abdominal pain/nausea, unusual tiredness, yellowing eyes/skin, dark urine). If you are male, tell your doctor immediately if any of these unlikely but serious side effects occur: trouble urinating, breast swelling/tenderness, too frequent/prolonged erections. Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and seek immediate medical attention, or permanent problems could occur. This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details. If you are female, tell your doctor immediately if any of these unlikely but serious side effects occur: deepening of the voice, hoarseness, unusual facial/body hair growth, enlarged clitoris, irregular menstrual periods. This medication can cause your body to hold on to extra body water (edema). This can increase your risk of heart failure. Tell your doctor immediately if any of these unlikely but serious signs of water retention or heart failure occur: decreased exercise ability, hands/ankles/feet swelling, unusual tiredness, shortness of breath while lying down. 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: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. 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. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 (such as sesame oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: breast cancer in men, prostate cancer. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (such as heart failure, chest pain, heart attack), liver problems, kidney problems, other types of cancer, high cholesterol, high blood pressure, enlarged prostate, sleep apnea, diabetes. 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 immediately 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. 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 must not be used during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that women using this medication use 2 effective forms of birth control (such as condoms and birth control pills) while using this medication. Consult your doctor. It is not known whether this drug passes into breast milk. It may affect milk production and it may harm a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: 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). Corticosteroids (such as hydrocortisone, prednisone) may increase the risk of edema and heart failure. This medication may interfere with certain laboratory tests (including thyroid tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: Overdose is unlikely, but if overdose is suspected, contact your poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: 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.

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

STORAGE: 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.

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