Testosterone Gel: Indications, Side Effects, Warnings
The Official AndroGel testosterone gel 1 62% CIII Website
In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis. Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use testosterone gel 1.62%. Testosterone gel 1.62% should be applied to clean, dry, intact skin of the upper arms and shoulders.
Testim 1% (testosterone gel) is a prescription medicine that contains testosterone. Testim is used to treat adult males who have low or no testosterone due to certain medical conditions. Testim is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Virilization has been reported in children who were secondarily exposed to testosterone gel. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. Serious side effects include worsened symptoms of an enlarged prostate.
Alcohol based products, including testosterone gel 1.62%, are flammable; therefore, patients should be advised to avoid fire, flame or smoking until the testosterone gel 1.62% has dried. Gynecomastia may develop and persist in patients being treated with androgens, including testosterone gel 1.62%, for hypogonadism. Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration. An increase in red blood cell mass may increase the risk of thromboembolic events.
Do not start, stop, or change the dose of any drug without checking with your doctor. Testosterone therapy did appear to have some positive effects on short-distance mobility, which may require further study to confirm. Therefore from a 1%, 5g testosterone gel formulation, approximately 5mg would be absorbed in the average male. Since this is an average, some men will be “super responders” with higher than normal testosterone levels, while with others the gel may barely register an effect.
Children and women should avoid contact with the unwashed or unclothed area where the testosterone gel has been applied. If another person does accidentally get this medicine on the skin, wash the area with soap and water as soon as possible. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. AndroGel® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone due to certain medical conditions. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take testosterone gel with all of your drugs and health problems.
No studies were conducted in patients with hepatic impairment. No studies were conducted involving patients with renal impairment. Enter medications to view a detailed interaction report using our Drug Interaction Checker. Store at room temperature away from moisture, heat, and light. Follow all storage instructions provided with testosterone. Certain brand forms of testosterone contain alcohol and are flammable until dry.
Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. Topical testosterone may increase your risk of prostate cancer. Keep all appointments with your health care provider so they can monitor you while you are there any side effects of taking testosterone using topical testosterone. There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone gel 1.62% to determine whether efficacy in those over 65 years of age differs from younger subjects. Of the 234 patients enrolled in the clinical trial utilizing testosterone gel 1.62%, 21 were over 65 years of age. Additionally, there is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer.
You must either stop breastfeeding or stop topical testosterone. Topical testosterone should not be used if you have or might have breast or prostate cancer. People who are allergic to any of the following should not use topical testosterone. Thankfully, this is a completely treatable condition through testosterone replacement therapy (TRT). Testosterone Gel 1.62% is supplied in non-aerosol, metered-dose pumps that deliver 20.25 mg of testosterone per complete pump actuation.
