Androgel Indications, Dosage, Storage, Stability - Testosterone Gel

Androgel Indications, Dosage, Storage, Stability - Testosterone Gel

INDICATIONS AND USAGE

AndroGel® is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:

1. Primary hypogonadism (congenital or acquired) – testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range.

2. Hypogonadotropic hypogonadism (congenital or acquired) – idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.

AndroGel® has not been clinically evaluated in males under 18 years of age.

The recommended starting dose of AndroGel® 1% is 5 g delivering 5 mg of testosterone systemically, applied once daily (preferably in the morning) to clean, dry, intact skin of the shoulders and upper arms and/or abdomen. Serum testosterone levels should be measured approximately 14 days after initiation of therapy to ensure proper dosing. If the serum testosterone concentration is below the normal range, or if the desired clinical response is not achieved, the daily AndroGel® 1% dose may be increased from 5 g to 7.5 g and from 7.5 g to 10 g as instructed by the physician.

AndroGel® is available in either unit-dose packets or multiple-dose pumps. The metered-dose pump delivers 1.25 g of product when the pump mechanism is fully depressed once.

AndroGel® must not be applied to the genitals.

If using the multi-dose AndroGel® Pump, patients should be instructed to prime the pump before using it for the first time by fully depressing the pump mechanism (actuation) 3 times and discard this portion of the product to assure precise dose delivery. After the priming procedure, patients should completely depress the pump one time (actuation) for every 1.25 g of product required to achieve the daily prescribed dosage. The product may be delivered directly into the palm of the hand and then applied to the desired application sites, either one pump actuation at a time or upon completion of all pump actuations required for the daily dose. Please refer to the chart below for specific dosing guidelines when the AndroGel® Pump is used.

If using the packets, the entire contents should be squeezed into the palm of the hand and immediately applied to the application sites. Alternately, patients may squeeze a portion of the gel from the packet into the palm of the hand and apply to application sites. Repeat until entire contents have been applied.

Application sites should be allowed to dry for a few minutes prior to dressing. Hands should be washed with soap and water after AndroGel® has been applied.

AndroGel® contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.

AndroGel® 1% is supplied in non-aerosol, metered-dose pumps. The pump is composed of plastic and stainless steel and an LDPE/aluminum foil inner liner encased in rigid plastic with a polypropylene cap. Each individual packaged 88 g AndroGel® Pump is capable of dispensing 75 g or 60 metered 1.25 g doses.

AndroGel® 1% is also supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 2.5 g or 5 g gel contains 25 mg or 50 mg testosterone, respectively.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Used AndroGel® pumps or used AndroGel® packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets. In addition, any discarded gel should be thoroughly rinsed down the sink or discarded in the household trash in a manner that prevents accidental application or ingestion by children or pets.

Manufactured by: Laboratoires Besins International Montrouge, France, For: Unimed Pharmaceuticals, Inc., A Solvay Pharmaceuticals, Inc. Company Marietta, GA 30062-2224, USA, 500122/500127 Rev Jun 2004, U.S. Patent No. 6,503,894, © 2004 Solvay Pharmaceuticals, Inc.