Generic Name and Formulations:
Testosterone 1%; gel.
Indications for TESTIM:
Testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
Limitations Of use:
Not established in men with age-related hypogonadism.
Prior to treatment, confirm diagnosis by ensuring serum testosterone is below normal range as measured in the AM on at least 2 separate days. Advise patients to strictly adhere to recommended instructions. Apply to clean, dry intact skin of the shoulders and/or upper arms; do not apply to genitals or abdomen. ≥18yrs: initially apply 5g (1 tube) once daily in the AM; measure serum testosterone level to ensure response; may increase to 10g after 2 weeks. Do not wash site for at least 2hrs after application. Not interchangeable with other testosterone products.
<18yrs: not established.
Male breast or prostate cancer. Pregnant and nursing women must avoid skin contact with application sites on men. Pregnancy (Cat.X). Nursing mothers.
Not for use in women. Secondary exposure to testosterone; promptly discontinue if signs of virilization in children and women occurs, until cause is identified. Children and women must avoid contact with unwashed or unclothed application sites. Increased risk for worsening BPH; monitor for signs/symptoms. Evaluate for prostate cancer prior to and during therapy. Monitor hematocrit prior to initiation, at 3–6 months after starting therapy, then annually; if elevation occurs, withhold until acceptable level. Pre-existing cardiac, renal, or hepatic disease (discontinue if edema occurs). Discontinue and evaluate if signs/symptoms of hepatic dysfunction (eg, jaundice) occur. Possible sleep apnea in patients with obesity or chronic lung diseases. Testosterone and/or other anabolic androgenic steroid abuse. Monitor serum testosterone, PSA, liver function, cholesterol, lipid profile, serum calcium (in cancer patients at risk for hypercalcemia/hypercalciuria) periodically. Monitor for venous thromboembolism; discontinue if suspected. Inform patients of possible increased risk of MI, stroke. Avoid showering or swimming for at least 2hrs after application. Flammable.
May alter insulin sensitivity and glycemic control; reduce dose of antidiabetic agents if needed. Increased fluid retention with concomitant corticosteroids; monitor. Monitor INR and PT with concomitant oral anticoagulants. May affect thyroid levels.
Application site reactions, headache, increased hemoglobin/hematocrit or BP, depression, hot flushes, insomnia, mood swings, gynecomastia, sleep apnea, dysgeusia; virilization in children, reduced sperm count.
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