Indications & Uses
AndroGel is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Prior to starting testosterone gel 1.62 percent, hypogonadism should be confirmed by measuring serum testosterone in the morning on at least two separate days and verifying that both readings fall below the normal range. The starting dose of testosterone gel 1.62 percent is 40.5 mg of testosterone, given as 2 pump actuations or a single 40.5 mg packet, applied topically once daily in the morning. Apply to clean, dry, intact skin on the shoulders and upper arms only. Testosterone gel 1.62 percent should not be applied to any other part of the body, including the abdomen, genitals, chest, armpits (axillae), or knees. Dose adjustment: the dose of testosterone gel 1.62 percent may be adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation or a single 20.25 mg packet) and a maximum of 81 mg of testosterone (4 pump actuations or two 40.5 mg packets). Titration should be guided by the pre-dose morning serum testosterone concentration measured at approximately 14 days and 28 days after starting treatment or after any dose adjustment. Serum testosterone concentration should also be checked periodically afterward. Patients should wash their hands immediately with soap and water after applying testosterone gel 1.62 percent and should cover the application site with clothing once the gel has dried. The application site should be washed thoroughly with soap and water before any anticipated skin to skin contact with another person.
Side Effects
Increased prostate specific antigen (PSA) is the most common side effect, occurring in 5% or more of people using this medicine.
Cautions & Contraindications
Warnings & Precautions
Monitor patients with benign prostatic hyperplasia (BPH) for worsening of BPH signs and symptoms. Keep AndroGel gel 1.62% away from women and children, since accidental contact can transfer the hormone and cause signs of virilization in them. If virilization occurs, AndroGel gel 1.62% should be stopped until the cause is found. Cases of venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported with AndroGel products, so patients showing signs or symptoms of DVT or PE should be evaluated. Some postmarketing studies have also linked AndroGel replacement therapy to a higher risk of heart attack and stroke. Giving testosterone from outside the body can reduce sperm count to the point of azoospermia. In patients who already have heart, kidney, or liver disease, treatment may bring on edema, with or without congestive heart failure (CHF). Sleep apnea may develop in those who already have risk factors for it (see section 5.12). Check serum testosterone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function, and lipid levels from time to time during treatment. AndroGel gel 1.62% is flammable until it dries.
Contraindications
Men who have breast cancer or a known or suspected prostate cancer should not use this medicine. It should also be avoided in pregnant women, as testosterone may harm the developing baby.