Testosterone

(teh-STAHS-tuh-RONE)

  Action:
Promotes growth and development of male reproductive organs, maintains secondary sex characteristics, increases protein anabolism, and decreases protein catabolism.

  Indications:

Men: Replacement therapy in primary hypogonadism and hypogonadotropic hypogonadism; stimulation of puberty in delayed puberty; treatment of impotence and male climacteric symptoms.

Women: Ablation of ovaries in metastatic breast cancer; management of postpartum breast pain or engorgement. Unlabeled use(s):Reversible contraception in men.

  Contraindications:
Serious cardiac, hepatic, or renal disease; men with carcinoma of breast or prostate; women who are or may become pregnant; testosterone gel is contraindicated in women.

  Route/Dosage:

Androgen Replacement Therapy

Adults:
IM 25 to 50 mg 2 to 3 times/wk (testosterone, testosterone propionate).
IM 50 to 400 mg q 2 to 4 wk (testosterone enanthate, testosterone cypionate).
SC 150 to 450 mg q 3 to 6 mo.
Transdermal 6 mg/day system applied daily or 4 mg/day system applied daily if scrotal area is small.
Topical Start by applying entire packet of testosterone gel 5 g (delivering 50 mg testosterone systemically) to clean, dry skin of shoulders and upper arms or abdomen. Based on measurements of serum testosterone levels and clinical response 14 days after initiation of therapy, dose may be increased from 5 to 7.5 g and from 7.5 to 10 g.

Delayed Puberty

Adolescents:
IM 40 to 50 mg/m²/dose for 6 mo (testosterone, testosterone propionate) or
IM 50 to 200 mg q 2 to 4 wk for limited duration (testosterone enanthate, testosterone cypionate) or
IM 40 to 50 mg/m²/dose monthly until growth rate falls to prepubertal levels (testosterone, testosterone propionate).
SC 150 to 450 mg q 4 to 6 mo.

Breast Cancer

Adults:
IM 50 to 100 mg 3 times weekly (testosterone, testosterone propionate) or
IM 200 to 400 mg q 2 to 4 wk (testosterone enanthate, testosterone cypionate).

Postpartum Breast Engorgement

Adults:
IM 25 to 50 mg/day for 3 to 4 days (testosterone, testosterone propionate).

  Interactions:

Anticoagulants: May potentiate anticoagulant effects.

Insulin, oral hypoglycemics: May decrease glucose levels and antidiabetic drug requirements.

Oxyphenbutazone: Coadministration may result in elevated serum levels of oxyphenbutazone.

  Lab Test Interferences:

Thyroid function tests: Testosterone may cause decreased levels of thyroid hormones.

Clotting factors II, V, VII, X: Testosterone may suppress expression.

  Adverse Reactions:

CV:

Edema.

CNS:

Depression; headache; increased or decreased libido-anxiety.

DERM:

Acne; hirsutism; male pattern baldness; seborrhea; rash.

GI:

Nausea.

GU:

Gynecomastia, penile erections, decreased ejaculatory volume (men); amenorrhea, virilization (deepening of voice and clitoral enlargement) (women).

HEPA:

Cholestatic jaundice (elevated LFT results).

META:

Increased cholesterol; decreased serum glucose.

OTHER:

Inflammation at injection site; fluid and electrolyte retention.

  Precautions:

Pregnancy: Category X.

Lactation: Undetermined. Testosterone gel is not indicated for women.

Children: Use drug with great caution; may effect bone maturation. Testosterone gel: Safety and efficacy not established.

Elderly: Elderly men may be at increased risk of developing prostatic hypertrophy or carcinoma.

Acute intermittent porphyria: Acute intermittent porphyria has been reported. Use drug with caution in patients known to have this condition.

Athletic performance: Abuse of these agents to enhance athletic performance has potential risk of serious side effects.

Breast cancer and immobilized patients: May cause hypercalcemia.

Edema: Use drug with caution in patients with conditions that might be affected by fluid retention (eg, asthma, cardiac or renal dysfunction, epilepsy).

Gynecomastia: Frequently occurs and may persist. Use drug with caution in patients with preexisting gynecomastia.

Hepatic effects: Prolonged use of high doses of androgens may result in potentially life threatening hepatitis, hepatic neoplasms, or hepatocellular carcinoma.

Oligospermia and reduced ejaculatory volume: May occur after prolonged use.

Product interchange: Do not interchange products because of their differences in duration of action, especially testosterone cypionate and testosterone propionate.

Serum cholesterol: Levels may increase with androgen use; use drug with caution in patients with history of MI or coronary artery disease.

  Administration/Storage:

• Administer IM injections deep in gluteal muscle. Rotate sites.
• Shake vial well before withdrawing solution. Warming and shaking vial dissolves crystals that may have formed.
• Using wet needle or syringe may cause solution to become cloudy; however, this does not affect potency of drug.
• The number of pellets to be implanted depends upon the minimum daily requirement of testosterone propionate required weekly. Usual ratio is as follows: Implant 2 pellets for each 25 mg testosterone propionate required weekly. So when a patient requires injections of 75 mg/wk, it is usually necessary to implant 450 mg (6 pellets). With injection of 50 mg/wk, implantation of 300 mg (4 pellets) may suffice for 3 mo. With lower requirements by injection, correspondingly lower amounts may be implanted.
• Ascertain whether health care provider desires aqueous suspension or oil-based testosterone. Do not interchange products. Different salt forms have different duration of action.
• Wear gloves while handling transdermal patches. Apply patches to clean, dry, and shaved scrotal skin. Patch should be worn 22 to 24 hr/day. Fold used patches with adhesive edges together. Discard patches so that they cannot be handled.
• Store IM preparation at room temperature.
• Store pellets in a cool place.

  Assessment/Interventions:

• Obtain patient history, including drug history and any known allergies.
• Determine if patient has serious cardiac, hepatic, or renal disease, carcinoma of breast or prostate, clotting problems, epilepsy, or migraine headaches.
• Monitor and record I&O. Notify health care provider of fluid retention.
• Report jaundice or inflamed injection site to health care provider.
• Monitor serum cholesterol and report to health care provider if total cholesterol has increased and is > 200 mg/dL.
• In male adolescents being treated for delayed puberty, monitor bone maturation by assessing bone age of the wrist and hand q 6 mo by x-ray evaluation.
• Perform periodic LFTs.
• Observe for hypercalcemia, especially in breast cancer patients and immobilized patients.
• Monitor for signs of virilization in women.
• Report frequent, persistent erections, nausea, vomiting, changes in skin color, or ankle swelling.

  Patient/Family Education:

• Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible. Advise patient to use reliable form of birth control while taking this drug.
• Advise patient to consult with health care provider before taking otc or prescription drugs.
• Instruct patient to remain as active as possible. Hypercalcemia may result if patient is inactive and therapy will have to be discontinued.
• Advise patient to report these symptoms to health care provider: depression, headache, nausea, yellow skin or yellowing of whites of eyes, swelling of ankles, painful or difficult urination, severe acne, painful or prolonged penile erections.
• Inform patient of potential side effects: increased facial or body hair and loss of scalp hair (in both men and women); breast enlargement and decreased ejaculatory volume (in men); deep voice, enlarged clitoris, and cessation of menses (in women).
• Warn patients being treated for hypogonadism that gynecomastia caused by testosterone therapy may persist.
• Caution patient not to take this drug without prescription and not to increase prescribed dosage in an effort to increase athletic performance. Side effects can be very serious.
• Instruct patient not to accept brands, types, or forms of drug different from one originally prescribed.
• Advise patient using transdermal patches to wear briefs instead of boxer shorts underwear to keep the patch from falling off.
• Instruct patient using the transdermal scrotal patch to shave scrotum with dry disposable razor about once a week. Apply patch to dry scrotum. Patch should be temporarily removed while bathing or swimming. Patch is adhesive-free and clings to skin by an electrostatic effect.
• Male patients should have bone development checked q 6 mo if receiving treatment for delayed puberty.

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