This medication may raise your blood pressure. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Redness/irritation at the application site and acne may occur. This medicated gel contains testosterone. You are encouraged to report negative side effects of prescription drugs to the FDA. Additionally, there were no clinically significant changes from baseline for SHBG (slight decrease), estradiol (slight increase), and ratio of DHT to total testosterone (slight increase) at Day 90. A mean (SD) of 0.24 (0.009) mg of residual testosterone (ie, 94.3% reduction compared to when application site was not washed) was recovered after application site washing. Avoid smoking or being near open flames while using the medication and until the medication has dried. This medication is flammable until dry. These symptoms may last from weeks to months. Use this medication regularly in order to get the most benefit from it. Be sure to always wear clothing (such as shorts or pants) to cover the application site until you wash the areas well with soap and water. Due to the lack of controlled evaluations in women and potential virilizing effects, FORTESTA is not indicated for use in women see CONTRAINDICATIONS and Use In Specific Populations. If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions see Drug Abuse And Dependence. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Testosterone gel should be promptly discontinued until the cause of virilization has been identified. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. Abuse and misuse of testosterone are seen in male and female adults and adolescents. FORTESTA contains testosterone, a Schedule III controlled substance in the Controlled Substances Act. Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application see CLINICAL PHARMACOLOGY. Wait a few minutes for the application site to dry completely before dressing. The dosage is based on your medical condition, lab tests, and response to treatment. Do not let others apply this medication to your body. Use one finger to rub the gel in evenly. Your risk of prostate problems should be checked by your doctor before you start testosterone. Some men, particularly older adults, are at a higher risk for developing enlarged prostate or prostate cancer while using this medication. If this medication accidentally gets into your eyes, rinse the eyes right away with clean, warm water. If it is near the time of the next dose, skip the missed dose. If you miss a dose, use it as soon as you remember. A different medication may be necessary in that case. This medication has been prescribed for your current condition only. Do not share this medication with others. Make sure lab personnel and all your doctors know you use this drug. This medication may interfere with certain lab tests (such as thyroid function tests, creatinine level), possibly causing false test results. This document does not contain all possible drug interactions. This medication may harm an unborn or breastfeeding baby. Women who are pregnant or breastfeeding must avoid contact with this medication. If you notice symptoms in a woman such as changes in body hair or a large increase in acne, talk to her doctor and your doctor right away. This medication can affect fertility in males. In children, it may affect bone growth.
