Testosterone Gel (Topical)
This medication is a Schedule III drug.
Brand Name: Androgel, Fortesta, Testim
Generic Available
Common Dosage Forms*:
Topical 1% Gel Pump (Androgel): Each pump contains 75 g or 60 metered 1.25 g doses containing 12.5 mg testosterone
Topical 1% Gel Foil Packets (Androgel): 2.5 g/packet (25 mg testosterone) or 5 g/packet (50 mg testosterone)
Topical 1.62% Gel (Androgel): Each pump contains 75 g or 60 metered 1.25 g doses containing 20.25 mg testosterone
Topical 2% Gel (Fortesta): Each pump actuation contains 10 mg testosterone
*Testosterone is also available in topical patches, injection, and oral formulations
FDA Indications/Dosages:
For replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism and hypogonadotropic hypogonadism: The recommended starting dose is 50 mg applied once daily (5 g of the 1% gel [4 actuations] or 2.5 g of the 1.62% gel [actuations]). Doses should be applied to the upper arms and shoulders. Maximum recommended dose is 81 mg/day.
Monitor: Hematocrit, Hemoglobin, Serum testosterone, PSA, Lipid panel, LFT
Pharmacology/Pharmacokinetics: Endogenous androgens, including testosterone and dihydrotestosterone (DHT) are the major sex hormones in males and are involved in development of the male sex organs and secondary sex characteristics. Testosterone and DHT binds to certain receptor proteins found in the cytoplasm of sensitive hormone-receptor complex. This hormone-receptor complex enters the nucleus of the cell where it reacts with chromatin, or DNA. The hormone, or possibly the receptor, then uses stored information to stimulate, or in some cases inhibit, the transcription of mRNA. The stimulation of mRNA results in the synthesis of specific enzymes that carry out its actions. Topically applied testosterone gel provides continuous absorption of testosterone for 24 hours.
Drug Interactions: May decrease insulin requirements by decreasing blood glucose, may change anticoagulant activity, may increase fluid retention when used with corticosteroids.
Contraindications/Precautions: Contraindicated in males with carcinoma of the breast or prostate and in women. May increase symptoms of BPH and the risk of prostate cancer. May cause polycythemia; check baseline hematocrit and recheck 3-6 months after starting treatment. Use with caution in patients with congestive heart failure due to increased risk for edema. Use with caution in patients with hyperlipidemia. SECONDARY EXPOSURE TO TESTOSTERONE HAS CAUSED VIRILIZATION IN CHILDREN. Pregnancy Category X.
Adverse Effects: The most common adverse reactions include increased PSA, emotional lability (anger, mood swings, aggression), hypertension, increased hematocrit or hemoglobin, contact dermatitis.
Patient Consultation:
Apply to clean, dry skin once daily.
Decrease the risk of transferring the gel to others by applying to areas of the upper body (upper arms and shoulders) which are covered by a short-sleeve shirt. Do not apply to genital areas.
Wash hands after application.
Allow area to dry before covering with clothes.
Women and children should avoid contact with unwashed or unclothed areas of applications.
Avoid showering or swimming for 2 hours after application.
If a dose is missed, skip it and continue with regular dosing schedule. Do not double doses.
Notify your physician if you trouble starting to urinate or if you experience increased urination at night.
Report to your physician any unusual swelling or pain in the legs, ankles, or feet.
