testosterone transdermal system

testosterone transdermal system

(tess-toss-te-rone tranz-derm-al) ,

Androderm

(trade name)

Classification

Therapeutic: hormones
Pharmacologic: androgens
Pregnancy Category: X

Indications

Hypogonadism in androgen-deficient men.

Action

Responsible for the normal growth and development of male sex organs.
Maintenance of male secondary sex characteristics:
  • Growth and maturation of the prostate, seminal vesicles, penis, scrotum,
  • Development of male hair distribution,
  • Vocal cord thickening,
  • Alterations in body musculature and fat distribution.

Therapeutic effects

Correction of hormone deficiency in male hypogonadism.

Pharmacokinetics

Absorption: Well absorbed through skin.
Distribution: Crosses the placenta.
Metabolism and Excretion: Metabolized by the liver; 90% eliminated in urine as metabolites.
Half-life: 70 min.

Time/action profile (androgenic effects†)

ROUTEONSETPEAKDURATION
Transdermal (patch)unknown6–8 hr‡24 hr§
†Response is highly variable among individuals; may take months‡Plasma testosterone levels following applications of patch§Following patch removal

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Obstetric / Lactation: Pregnancy and lactation; Male patients with breast or prostate cancer; Women.
Use Cautiously in: Pre-existing cardiac, renal, or liver disease; Geriatric: ↑ risk of prostatic hyperplasia/carcinoma; Males <18 yr (safety and effectiveness not established).

Adverse Reactions/Side Effects

Central nervous system

  • anxiety
  • confusion
  • depression
  • fatigue
  • headache
  • vertigo

Cardiovascular

  • edema
  • hypertension

Gastrointestinal

  • bleeding
  • ↑ appetite

Genitourinary

  • dysuria
  • erectile dysfunction
  • priapism
  • prostatic enlargement
  • urinary incontinence

Dermatologic

  • application site reactions (e.g. pruritis, blisters, erythema, burning) (most frequent)
  • rash

Endocrinologic

  • acne
  • ↓ libido
  • gynecomastia

Neurologic

  • paresthesia

Local

  • chronic skin irritation (most frequent)

Interactions

Drug-Drug interaction

May ↑ action of warfarin, oral hypoglycemic agents andinsulin.Concurrent use with corticosteroids may ↑ risk of edema formation.

Route/Dosage

Transdermal (Adults) One 4–mg/day system applied q 24 hr in the evening; adjust dose based on serum testosterone concentrations (dosing range = 2–6 mg/day).

Availability

Transdermal patch: 2 mg/day in packages of 60, 4 mg/day in packages of 30

Nursing implications

Nursing assessment

  • Monitor intake and output ratios, weigh patient twice weekly, and assess patient for edema. Report significant changes indicative of fluid retention.
  • Monitor for breast enlargement, persistent erections, and increased urge to urinate in men. Monitor for difficulty urinating in elderly men, because prostate enlargement may occur.
  • Lab Test Considerations: Monitor serum testosterone concentrations 2 weeks after starting therapy; these concentrations should be obtained in the morning (following application of patch during the previous evening). Serum testosterone concentrations measured in the early morning outside range of 400 – 930 ng/dL require increasing daily dose to 6 mg (one 4 mg/day and one 2 mg/day system) or decreasing daily dose to 2 mg (one 2 mg/day system), maintaining nightly application.
    • Monitor hemoglobin and hematocrit periodically during therapy; may cause polycythemia.
    • Monitor hepatic function tests, prostate specific antigen, and serum cholesterol levels periodically during therapy. May ↑ serum AST, ALT, and bilirubin, ↑ cholesterol levels, and suppress clotting factors II, V, VII, and X.
    • Monitor blood glucose closely in patients with diabetes who are receiving oral hypoglycemic agents or insulin.

Potential Nursing Diagnoses

Sexual dysfunction (Indications,  Side Effects)

Implementation

  • Apply patch to clean, dry, hairless skin on the back, abdomen, upper arms, or thighs. Do not apply to the scrotum. Also avoid application over bony prominences or a part of the body that may be subject to prolonged pressure during sleep or sitting. The patch does not need to be removed while swimming or taking a shower or bath.
  • The sites of application should be rotated; once a patch is removed, the same site should not be used again for at least 1 week.
  • If skin irritation occurs, apply a small amount of OTC topical hydrocortisone cream after system removal. To minimize the development of skin irritation, a small amount of 0.1% triamcinolone cream may be applied to the skin under the central drug reservoir of the Androderm system without affecting the absorption of testosterone. Ointment formulations should not be used for pretreatment because they may significantly reduce testosterone absorption.
  • Patch should be removed if patient is undergoing a magnetic resonance imaging (MRI) scan. The system contains aluminum and may predispose the patient to skin burns during the test.

Patient/Family Teaching

  • Advise patient to report the following signs and symptoms promptly: priapism (sustained and often painful erections), difficulty urinating, gynecomastia, edema (unexpected weight gain, swelling of feet), hepatitis (yellowing of skin or eyes and abdominal pain), or unusual bleeding or bruising.
    • Explain rationale for prohibiting use of testosterone for increasing athletic performance. Testosterone is neither safe nor effective for this use and has a potential risk of serious side effects.
    • Advise diabetic patients to monitor blood closely for alterations in blood glucose concentrations.
    • Emphasize the importance of regular follow-up physical exams and lab tests to monitor progress.
  • Advise patient to notify health care professional if their female sexual partner develops signs/symptoms of virilization (e.g. change in body hair distribution, significant increase in acne, deepening of voice, menstrual irregularities).
  • Instruct patient that the protective plastic liner must be removed before applying the patch.
  • Instruct patient to apply patch to a clean, dry area of skin on back, abdomen, upper arms, or thighs. The patch should not applied to their genitals or over bony areas (e.g. upper shoulders or upper hip).
  • Instruct patient to rotate the sites of application. Once a patch is removed, the site should not be used again for at least 1 week.
  • Advise patient that the patch does not need to be removed while showering, bathing, or swimming.
  • If a patch falls off before noon, advise patient to replace it with a fresh patch which should be worn until a new patch is applied in the evening. If a patch falls off after noon, advise patient that it does not need to be replaced until a fresh patch is applied in the evening.
  • Advise patient that the patch should be removed prior to undergoing a MRI scan.

Evaluation/Desired Outcomes

  • Resolution of the signs of androgen deficiency without side effects.
References in periodicals archive ?
The company plans to market the Intrinsa testosterone transdermal system pending approval by the Food and Drug Administration.