Androderm (testosterone transdermal system) is indicated for testosterone replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone.

Primary hypogonadism (congenital or acquired)¾Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations accompanied by gonadotropins (FSH, LH) above the normal range.

Secondary, i.e., hypogonadotropic hypogonadism (congenital or acquired)¾idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone concentrations without associated elevation in gonadotropins. Appropriate adrenal cortical and thyroid hormone replacement therapy may be necessary in patients with multiple pituitary or hypothalamic abnormalities.

The system should be applied immediately after opening the pouch and removing the protective release liner. The system should be pressed firmly in place, making sure there is good contact with the skin, especially around the edges.

To ensure proper dosing, the morning serum testosterone concentration should be measured following system application the previous evening. If the serum concentration is outside the normal range, sampling should be repeated with assurance of proper system adhesion as well as appropriate application time. Confirmed serum concentrations outside the normal range may require increasing the daily dose to 7.5 mg (i.e., one 5 mg and one 2.5 mg systems or three 2.5 mg systems) or decreasing the daily dose to 2.5 mg (i.e., one 2.5 mg system), maintaining nightly application. Because of variability in analytical values among diagnostic laboratories, this laboratory work and any later analyses for assessing the effect of Androderm therapy, should be performed at the same laboratory so results can be compared.

Mild skin irritation may be ameliorated by treatment of the affected skin with over-the-counter topical hydrocortisone cream applied after system removal.

Applying a small amount of 0.1% triamcinolone acetonide cream (Rx) to the skin under the central drug reservoir of the Androderm system has been shown to reduce the incidence and severity of skin irritation. The administration of 0.1% triamcinolone acetonide cream (Rx) does not significantly alter transdermal absorption of testosterone from the system. Ointment formulations should not be used for pretreatment as they may significantly reduce testosterone absorption.

Androderm (testosterone transdermal system) therapy for non-virilized patients may be initiated with one 2.5 mg/day system applied nightly.

Androderm (testosterone transdermal system) 2.5 mg/day.

Each system contains 12.2 mg testosterone USP for delivery of 2.5 mg of testosterone per day (see DESCRIPTION).

Cartons of 60 systems NDC 52544-469-60

Androderm (testosterone transdermal system) 5 mg/day

Each system contains 24.3 mg testosterone USP for delivery of 5 mg of testosterone per day (see DESCRIPTION).

Cartons of 30 systems NDC 52544-470-30

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Apply to skin immediately upon removal from the protective pouch. Do not store outside the pouch provided. Damaged systems should not be used. The drug reservoir may be burst by excessive pressure or heat. Discard systems in household trash in a manner that prevents accidental application or ingestion by children, pets or others.

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