Androderm

INDICATIONS

ANDRODERM is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

Important Limitations Of Use

Safety and efficacy of ANDRODERM in males < 18 years old have not been established [see Use In Specific Populations].

DOSAGE AND ADMINISTRATION

Dosing Information

The recommended starting dose is one ANDRODERM 4 mg/day system (not two 2 mg/day systems) applied nightly for 24 hours, delivering approximately 4 mg of testosterone per day. To ensure proper dosing, approximately 2 weeks after starting therapy, the early morning serum testosterone concentration should be measured following system application the previous evening. Serum concentrations outside the range of 400 – 930 ng/dL require increasing the daily dose to 6 mg (i.e., one 4 mg/day and one 2 mg/day system) or decreasing the daily dose to 2 mg (i.e., one 2 mg/day system), maintaining nightly application.

Patients currently maintained on ANDRODERM 2.5 mg/day, 5 mg/day, and 7.5 mg/day may be switched to the 2 mg/day, 4 mg/day, and 6 mg/day dosage using the following schema:

  • Patients using 2.5 mg daily may be switched to 2 mg/day systems at the next scheduled dose.
  • Patients using 5 mg daily may be switched to 4 mg/day systems at the next scheduled dose.
  • Patients using 7.5 mg daily may be switched to 6 mg (2 mg/day and 4 mg/day systems) at the next scheduled dose.

To ensure proper dosing, approximately 2 weeks after switching therapy, the early morning serum testosterone concentration should be measured following system application the previous evening.

The adhesive side of the ANDRODERM system should be applied to a clean, dry area of the skin on the back, abdomen, upper arms, or thighs. Avoid application over bony prominences or on a part of the body that may be subject to prolonged pressure during sleep or sitting (e.g., the deltoid region of the upper arm, the greater trochanter of the femur, and the ischial tuberosity). DO NOT APPLY TO THE SCROTUM. The sites of application should be rotated, with an interval of 7 days between applications to the same site. The area selected should not be oily, damaged, or irritated.

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.

The patient should avoid swimming, showering, or washing the administration site for a minimum of 3 hours after application [see CLINICAL PHARMACOLOGY].

Mild skin irritation may be ameliorated by treatment of the affected skin with over-thecounter topical hydrocortisone cream applied after system removal. Applying a small amount of 0.1% triamcinolone acetonide cream to the skin under the central drug reservoir of the ANDRODERM system has been shown to reduce the incidence and severity of skin irritation.

HOW SUPPLIED

Dosage Forms And Strengths

Transdermal system: 2 mg/day and 4 mg/day.

Storage And Handling

ANDRODERM (testosterone transdermal system) 2 mg/day

Each system contains 9.7 mg testosterone USP for delivery of 2 mg of testosterone per day [see DESCRIPTION].

Cartons of 60 systems NDC 52544-076-60

ANDRODERM (testosterone transdermal system) 4 mg/day

Each system contains 19.5 mg testosterone USP for delivery of 4 mg of testosterone per day [see DESCRIPTION].

Cartons of 30 systems NDC 52544-077-30

Store at 20-25°C (68-77°F). [See USP controlled room temperature.] 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.

Manufactured By: Watson Laboratories, Inc. Salt Lake City, UT 84108 USA. Distributed By: Watson Pharma, Inc. Parsippany, NJ 07054 USA. Revised: June 2014

Last reviewed on RxList: 7/7/2014
This monograph has been modified to include the generic and brand name in many instances.

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