Andropatch


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Related to Andropatch: Testogel, Testerone

testosterone

Axiron, Androderm, AndroGel, Andropatch, Fortesta, Striant, Testim, Testogel, Testopel Pellets, Testos

testosterone cypionate

Depo-Testosterone

testosterone enanthate

Delatestryl, PMS-Testosterone Enthanate

Pharmacologic class: Hormone

Therapeutic class: Androgenic and anabolic steroid, antineoplastic

Controlled substance schedule III

Pregnancy risk category X

FDA Box Warning

Virilization has occurred in children secondarily exposed to testosterone gel.

Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.

Health care providers should advise patients to strictly adhere to recommended instructions for use.

Action

Responsible for normal growth and development of male sex organs and maintenance and maturation of secondary sex characteristics. Also decreases estrogen activity, which aids treatment of some breast cancers.

Availability

testosterone

Buccal system: 30 mg

Gel: 1% (25 mg, 50 mg), 1.62% (metered-dose pump delivers 20.25 mg/actuation), 2% (10 mg/one metered-dose pump actuation)

Injection (aqueous suspension): 100 mg/ml

Pellets (subcutaneous implant): 75 mg

Solution (topical): 30 mg/metered-dose pump actuation

Transdermal system: 2 mg/day, 4 mg/day

testosterone cypionate

Injection: 100 mg/ml, 200 mg/ml

testosterone enanthate

Injection (in oil): 200 mg/ml

Indications and dosages

Male hypogonadism

Adult males: 10 to 25 mg (testosterone) I.M. two to three times weekly or 50 to 400 mg (enanthate) I.M. q 2 to 4 weeks for 3 to 4 years. Or 150 to 450 mg (pellet) implanted subcutaneously q 3 to 6 months. Or, 4 mg (transdermal system) daily, adjusted to 2 mg or 6 mg based on serum testosterone level. Or, 60 mg (one 30-mg actuation of Axiron topical solution applied to each axilla) daily at same time each morning, adjusted to 30 mg (one pump actuation) or increased from 60 to 90 mg (three pump actuations) or from 90 to 120 mg (four pump actuations) based on serum testosterone concentration from single blood draw 2 to 8 hours after applying solution and at least 14 days after starting treatment or following dosage adjustment. Or, 40 mg (four actuations of Fortesta topical gel) applied to clean, intact skin of thighs once daily in morning, adjusted to 10 mg (one pump actuation) or up to 70 mg (seven pump actuations) based on total serum testosterone level 2 hours after applying gel at approximately 14 days after starting treatment or following dosage adjustment. Or, 50 mg testosterone gel (AndroGel 1%) daily applied topically, adjusted up to 75 mg daily within 14 days, with subsequent dosages up to 100 mg daily. Or, 30 mg (buccal system) to gum region b.i.d. Or, 50 to 400 mg I.M. (cypionate) q 2 to 4 weeks.

Delayed puberty

Adult males: 50 to 200 mg I.M. (enanthate only) q 2 to 4 weeks for limited duration (4 to 6 months); or 150 to 450 mg subcutaneously (pellets) q 3 to 6 months

Inoperable breast cancer in women 1 to 5 years after menopause

Adults: 200 to 400 mg I.M. (enanthate) q 2 to 4 weeks

Contraindications

• Hypersensitivity to drug, its components, or tartrazine

• Males with breast cancer or suspected prostate cancer

• Females (buccal or transdermal systems or gel)

• Pregnancy or breastfeeding

Precautions

Use cautiously in:

• diabetes mellitus; edema associated with serious cardiac, hepatic, or renal disease; sleep apnea; hypercalcemia

• children younger than age 18 (safety and efficacy not established).

Administration

• Evaluate elderly patients and patients at increased risk for prostate cancer for presence of prostate cancer before starting testosterone replacement therapy.

• Inspect aqueous solution for injection. If crystals are visible, warm bottle and shake contents to dissolve crystals.

• Rotate I.M. injection sites within upper outer quadrant of gluteus maximus. Inject deeply into muscle.

• Apply gel once daily to clean, dry, intact skin on shoulder, upper arm, or abdomen.

• Place buccal system just above incisor tooth. Have patient hold it in place for 30 seconds to ensure adhesion. Rotate to other side of mouth with each application.

Adverse reactions

CNS: headache, depression, emotional lability, nervousness, anxiety, asthenia, memory loss, dizziness, vertigo, cerebrovascular accident

CV: edema, peripheral edema, deepvein phlebitis, heart failure

GI: bleeding

GU: hematuria, urinary tract infection, impaired urination, scrotal cellulitis, benign prostatic hyperplasia, scrotal papilloma (with transdermal use), prostatitis, libido changes, breast pain or tenderness, gynecomastia, virilization in females, excessive hormonal effects in males

Hematologic: polycythemia, leukopenia, suppressed clotting factors

Hepatic: hepatic adenoma (with long-term enanthate use)

Metabolic: hyperphosphatemia, hypernatremia, hypercalcemia, hypoglycemia, hyperkalemia

Musculoskeletal: myalgia

Respiratory: sleep apnea

Skin: acne; rash, itching, burning, discomfort, irritation, burn-like blister, erythema (with transdermal use); pain, local edema, and induration at injection site (with I.M. or subcutaneous use)

Other: accidental injury, flulike symptoms, hypersensitivity reaction

Interactions

Drug-drug. Corticosteroids: increased risk of edema

Hepatotoxic drugs: increased risk of hepatotoxicity

Insulin, oral hypoglycemics: decreased blood glucose level

Oral anticoagulants: increased anticoagulant effect

Oxyphenbutazone: increased oxyphenbutazone blood level

Propranolol: increased propranolol clearance

Drug-diagnostic tests. Bilirubin, liver function tests: abnormal results

Calcium, cholesterol, hematocrit, hemoglobin, phosphate, prostate-specific antigen (with topical use), sodium: increased levels

Clotting factors, creatine excretion, glucose, serum creatinine, thyroxine, thyroxine-binding globulin: decreased levels

Urine creatine and creatinine: decreased excretion

Urine 17-ketosteroids: increased excretion

Drug-herbs. Chaparral, comfrey, germander, jin bu huan, kava, pennyroyal: increased risk of hepatotoxicity

Patient monitoring

• Monitor electrolyte levels, liver function tests, blood and urine calcium levels, lipid panels, CBC with white cell differential, and semen studies.

• Assess diabetic patient carefully for hypoglycemia.

• Closely monitor neurologic status. Stay alert for sleep apnea.

• Assess for early signs of excessive hormonal effects in females (virilization). If these occur, drug withdrawal may be indicated.

Patient teaching

Instruct patient to immediately report signs and symptoms of liver problems, including nausea, vomiting, yellowing of skin or eyes, and ankle swelling.

• Teach prepubertal male about signs and symptoms of excessive hormonal effects, such as acne, priapism, increased body and facial hair, and penile enlargement.

• Teach postpubertal male about signs and symptoms of excessive adverse hormonal effects, such as erectile dysfunction, gynecomastia, epididymitis, testicular atrophy, and infertility.

Tell female patient to immediately report signs of masculinization, such as excessive body or facial hair, deepening of voice, clitoral enlargement, and menstrual irregularities.

• Advise female of childbearing age to use barrier contraceptives. Caution her not to breastfeed.

• Tell patient which transdermal patches can be applied to scrotum. Instruct him to apply patch daily to clean, dry skin after removing protective liner to expose drug-containing film. To prevent irritation, instruct him to apply each patch to a different site, waiting at least 1 week before reusing same site.

• Advise patient to apply topical gel once daily to clean, dry skin on shoulder, upper arm, or abdomen. Tell him that after opening packet, he should squeeze entire contents into palm and apply immediately. Instruct him to wait until gel dries before getting dressed.

• Teach patient to place buccal system in comfortable position just above incisor tooth and hold it in place for about 30 seconds to ensure adhesion. Tell him to use opposite side of mouth with each application. Caution him not to dislodge buccal system, especially when eating, drinking, brushing teeth, or using mouthwash. If system doesn't properly adhere or falls out during 12hour dosing interval, tell him to discard it and apply new system. If it falls out within 4 hours of next dose, tell him to apply new system and keep it in place until next regularly scheduled dose.

• Instruct patient to apply topical solution to clean, dry, intact skin of axilla area only and to allow application site to dry completely before dressing. Advise patient to wash axilla with soap and water to remove any testosterone residue if direct skin-to-skin contact with another person is anticipated.

• Tell patient drug shouldn't be used to enhance athletic performance or physique.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

Andropatch

A brand name for TESTOSTERONE formulated in a transdermal patch.