Adult Dosing

Hypogonadism

• Apply 4 mg qhs to a clean dry area of the skin on the back, abdomen, upper arms or thighs
• Apply 2 mg qhs or 6 mg qhs if serum concentration is outside 400 – 930 ng/dL range

• Apply TDP immediately after opening the pouch
• Press firmly in place to ensure proper contact, especially around the edges
• Avoid application over bony prominences

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone (primary hypogonadism and hypogonadotropic hypogonadism)

• Hypersensitivity to any of the ingredients of the product
• Prostate CA
• CA breast; male patients
• Severe renal impairment
• Severe hepatic impairment
• Severe cardiac disease
• Female patients who are or may become pregnant

• N/A

Renal Dose Adjustment

• Renal impairment: Use with caution; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Use with caution; dose adjustments not defined

See Supplemental Patient Information

• Prolonged use of high doses can cause serious hepatic adverse effects including peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice
• Gynecomastia may occur
• Aluminum in patch has caused skin burns at application site during MRI
• Geriatric patients are at an increased risk for the development of prostatic hyperplasia. Evaluate geriatric patients for presence of prostate cancer prior to starting therapy
• Monitor Hgb, HCT, LFTs, PSA and Lipid panel periodically

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• CV disease
• CHF
• Edema
• Diabetes mellitus
• Chronic Pulmonary disease
• Obese patients
• Hyperlipidemia
• BPH
• Geriatric population (increased risk of prostate CA)

Supplemental Patient Information

• Instruct patients not to apply TDP to scrotum, and over any bony prominence. Application to these sites may cause burn-like blister reactions
• Should instruct patients to report any of the following side effects of androgens: Too frequent or persistent erections of the penis, any nausea, vomiting, jaundice, or ankle swelling

Pregnancy Category:X

Breastfeeding: Unsafe. Testosterone (transdermal) is not indicated for women and must not be used in women.

• DERM: Application site reactions viz pruritis, burn-like blister reaction, erythema, burning, induration, chronic skin irritation, allergic contact dermatitis, male pattern baldness
• CNS: Headache, fatigue, vertigo
• PSYCHIATRY: Anxiety, confusion, depression
• NEURO: Paresthesias
• GI: GI bleed, increased appetite
• HEPA: Cholestatic jaundice, drug-induced hepatitis, elevated LFTs, hepatocellular neoplasms, peliosis hepatitis
• GU: Dysuria, hematuria, erectile dysfunction, priapism, urinary incontinence, prostatic enlargement, prostate carcinoma, testicular abnormalities
• CV: Edema, hypertension
• ENDO: Accelerated growth, decreased libido, gynecomastia, impotence
• LAB TESTS: Elevated Hct, elevated PSA
• MISC: Body pain, pelvic pain

• Androgen; binds to androgen receptors. Responsible for the normal growth and development of male sex organs. Produces multiple anabolic and androgenic effects
• Metabolized by liver
• Renally excreted: 90% (as metabolites), feces: 6%
• Half-life: 10-100 mins

US Trade Name(s)

• Androderm

US Availability

Androderm

• TDP: 2 mg/24 hrs
• TDP: 4 mg/24 hrs

Canadian Trade Name(s)

• Androderm

Canadian Availability

Androderm

• TDP: 2.5 mg/24 hrs
• TDP: 5 mg/24 hrs

UK Trade Name(s)

• Andropatch
• Intrinsa
• Testim
• Testogel
• Tostran

UK Availability

Andropatch

• TDP: 2.5 mg/24 hrs
• TDP: 5 mg/24 hrs

Intrinsa

• TDP: 0.3 mg/24 hrs

Testim

• GEL: 50 mg/5 g

Testogel

• GEL: 50 mg/5 g

Tostran

• GEL: 10 mg/metered application

Australian Trade Name(s)

• Androderm

Australian Availability

Androderm

• TDP: 2.5 mg/24 hrs
• TDP: 5 mg/24 hrs

[Outline]

Endocrine/Metabolic

Sex Hormones

Androgens & Anabolic Steroids

Urologic

Sex Hormones

Androgens & Anabolic Steroids

Pricing data from www.DrugStore.com in U.S.A.

• Androderm 4 MG/24HR PT24 [Box] (WATSON LABS)
  30 24hr = $332
  90 24hr = $965.99
• Androderm 2 MG/24HR PT24 [Box] (WATSON LABS)
  60 24hr = $352
  180 24hr = $1026.01

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.