Approved for use in 2000, Androgel has been marketed to help men who have deficient endogenous testosterone produce more of the hormone.
General Information
AndroGel is one of the top selling testosterone replacement drugs. It comes in gel form, and it is packaged in two formulations: 1.62% and 1%. The patient applies the gel on the abdomen, shoulder or arms – on clean, dry skin areas. The body then absorbs the product over a 24 hour period. Manufacturers say the drug is indicated for men with testicular failure as well as for men who suffer from conditions like idiopathic gonadotropin or LHRH deficiency.
Per the manufacturer, a research study on 227 men with hypogonadism found that, at least over a 180 day period, the drug restored mean testosterone levels to normal for 87% of the patients. AbbVie, formerly a division of Abbott Labs, manufactures both AndroGel 1% and AndroGel 1.2% as prescription products
Side Effects
The list of potential side effects is impressive. It includes:
- Acne;
- Alopecia;
- Headache;
- Hypertension;
- Nervousness;
- Edema;
- Gynecomastia;
- Depression;
- Reactions at the application site;
- Abnormal lab tests;
- Disorders of testis and prostate.
Absorptions
The formulation is hydroalcoholic; 40% of the testosterone absorbed into the blood is bound to sex hormone binding globulin (SHBG). 2% of the testosterone absorbed remains free and unbounded to other binding molecules. The remainder of the absorbed testosterone binds to albumin and similar proteins in the body, per a Federal Drug Administration (FDA) analysis.
In September 2009, the Federal Drug Administration added a “black box” warning label to AndroGel prescriptions, because regulators were concerned about the effects of second-hand exposure to women and children.
For insight into your Testosterone case, call the Davis & Crump team now at 800-277-0300 or email us at info@daviscrump.com.
