ANDROGEL 1% CIII
Generic Name and Formulations:
Testosterone 1%; gel.
Indications for ANDROGEL 1%:
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, intact, dry skin of the shoulders, upper arms, and/or abdomen; do not apply to genitals, chest, axillae, knees, or back. ≥18yrs: 5g (50mg of testosterone) once daily in the AM; check serum testosterone level at intervals until normal range; may increase to 7.5g/day (75mg of testosterone), then to 10g/day (100mg of testosterone) if needed. Wash hands after application. Allow gel to dry before it touches clothing.
<18yrs: not established.
Male breast or prostate cancer. Pregnant women must avoid skin contact with application sites in men. Pregnancy (Cat.X). Nursing mothers.
Not for use in women. Not interchangeable with other topical testosterone products. Other persons (esp. children) must avoid contact with application site. Secondary exposure to testosterone; promptly discontinue if signs of virilization in children and women occurs, until cause is identified. Increased risk for worsening BPH; monitor for signs/symptoms. Evaluate for prostate cancer before starting therapy. Preexisting cardiac, renal, or hepatic disease (discontinue if edema occurs). May worsen sleep apnea. Monitor hematocrit prior to initiation, at 3–6 months after starting therapy, then annually; if elevation occurs, withhold until acceptable level. 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). Monitor for venous thromboembolism; discontinue if suspected. Inform patients of possible increased risk of MI, stroke. Flammable. Elderly.
May alter insulin sensitivity and glycemic control; reduce dose of antidiabetic agents if needed. Increased fluid retention with concomitant ACTH, corticosteroids; monitor. Monitor INR and PT with concomitant oral anticoagulants. May affect thyroid levels.
Acne, local reactions, lab abnormalities, prostate disorders, increased PSA, emotional lability, hypertension, breast pain, gynecomastia, nervousness, testis disorders; edema, virilization in children.
Gel 1% (YES); Gel 1.62% (NO)
Gel 1% (2.5g, 5g)—30 packets; Gel 1.62% (1.25g, 2.5g)—30 packets; Pump 1.62% 88g (60 metered 1.25g doses)—1