Dosage Forms. Transdermal Patch: 2 mg/24 h, 4 mg/24 h; Topical Gel: 1%; 1.62%, 2%; Transdermal Cream: 2%; Mucoadhesive for Buccal Application: 30 mg; Topical Solution: 30 mg/actuation
Common FDA Label Indication, Dosing, and Titration.
1. Hypogonadism: 5 g gel (50 mg active drug) daily to clean, dry, intact skin, may increase dose to 7.5-10 g daily or one 5 mg patch daily × 24 h; may increase to 7.5 mg/d or decrease to 2.5 mg/d
Off-Label Uses. None
MOA. Testosterone is an endogenous androgen. Androgens are responsible for normal growth and development of male sex organs. Testosterone is involved in the growth and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male hair distribution; laryngeal enlargement; vocal cord thickening; alterations in body musculature; and fat distribution.
Drug Characteristics: Testosterone
Medication Safety Issues: Testosterone
Drug Interactions: Testosterone
Adverse Reactions: Testosterone
Efficacy Monitoring Parameters. Development of secondary gender characteristics (hair growth, masculinization).
Toxicity Monitoring Parameters. Hematocrit levels should be monitored, especially in older men. Instruct patients to report signs and symptoms of unusual bleeding/bruising, rapid weight gain, edema, or liver toxicity (jaundice, dark urine, pale stools).
Key Patient Counseling Points. Gel to be applied to clean, dry, intact skin of the shoulders and upper arms and/or abdomen, but should not be applied to genitals. Gel should be allowed to dry well; swimming and showering should be avoided for 5-6 h after application. Patients should keep application site covered, as direct skin contact can transfer drug to others. Virilization has been reported in children who were secondarily exposed to testosterone gel (coming in contact with bare skin around gel application site). Male patients should report too frequent or persistent erections. Female sexual partners of patients using drug should report male-like changes.
Clinical Pearls. In addition to topical dosage forms (gel and patch), other dosage forms include subcutaneous implants and injectable, which are indicated for delayed puberty, breast cancer, female-to-male gender identity disorder, and others. Avoid other medications containing testosterone, including those purchased without a prescription in health food stores or on the Internet.