Androderm, AndroGel, Striant, Testim
Andro-Cyp, Depo-Testosterone, Depotest
Delatest, Delatestryl, Malogex
Classifications: hormone; androgen/anabolic steroid; antineoplastic; Therapeutic: antineoplastic; anabolic steroid
Pregnancy Category: X
Controlled Substance: Schedule III
Testosterone 75 mg implantable pellets; 2.5 mg/24 h, 4 mg/24 h, 5 mg/24 h, 6 mg/24 h, transdermal patch; 1% gel; 2.5 g, 5 g gel packets; 30 mg buccal patch;
Testosterone Cypionate 100 mg/mL, 200 mg/mL injection;
Testosterone Enanthate 100 mg/mL, 200 mg/mL injection
Synthetic steroid compound with both androgenic and anabolic activity (1:1). Controls development and maintenance of secondary
sexual characteristics. Androgenic activity: Responsible for the growth spurt of the adolescent and for growth termination by epiphyseal closure. In males and some
females, reduces excretion of phosphorus, nitrogen, potassium, sodium, and chloride. Increases erythropoiesis, possibly by
stimulating production of renal or extrarenal erythropoietin, and promotes vascularization and darkening of skin. Anabolic activity: Increases protein metabolism and decreases its catabolism. Large doses suppress spermatogenesis, thereby causing testicular
Antagonizes effects of estrogen excess on female breast and endometrium. Responsible for the growth spurt of the adolescent
male and onset of puberty.
Androgen replacement therapy, delayed puberty (male), palliation of female mammary cancer (15 y postmenopausal), and
to treat postpartum breast engorgement. Available in fixed combination with estrogens in many preparations.
Hypersensitivity or toxic reactions to androgens; serious cardiac, liver, or kidney disease; hypercalcemia; known or suspected
prostatic or breast cancer in male; benign prostatic hypertrophy with obstruction; patients easily stimulated sexually; older
adults; asthenic males who may react adversely to androgenic overstimulation; conditions aggravated by fluid retention;
hypertension; pregnancy (category X), possibility of virilization of external genitalia of female fetus, lactation.
Cardiac, liver, and kidney disease; prepubertal males; diabetes mellitus; history of MI; CAD; BPH; geriatric patients, acute
Route & Dosage
Adult: IM Cypionate, Enanthate 50400 mg q24wk Topical Start with 6 mg/d system applied daily, if scrotal area inadequate, use 4 mg/d system; Androderm Apply to torso; AndroGel Apply one packet to upper arms, shoulders, or abdomen once daily; Striant Apply one patch to the gum region just above the incisor tooth q12h
Adult: IM Cypionate, Enanthate 50200 mg q24wk
Metastatic Breast Cancer
Adult: IM Cypionate, Enanthate 200400 mg q24wk
- Apply buccal patch to gum just above the incisor tooth.
- Apply transdermal system on clean, dry scrotal skin. Dry shave scrotal hair for optimal skin contact. Do not use chemical
depilatories. Wear patch for 2224 h.
- Apply Androderm patches to abdomen, back, thigh, or upper arm. Alternate application site q24h with ≥7
d between same site.
- Store at 15°30° C (59°86° F).
- Give IM injections deep into gluteal musculature.
- Store IM formulations prepared in oil at room temperature. Warming and shaking vial will redisperse precipitated crystals.
Adverse Effects (≥1%)CNS:
Skin flushing and vascularization. GI:
Nausea, vomiting, anorexia, diarrhea
, gastric pain, jaundice
. Hematologic: Leukopenia
Hypercalcemia, hypercholesterolemia, sodium and water retention (especially in older adults) with edema. Renal: Renal
calculi (especially in the immobilized patient), bladder irritability. Urogenital: Increased libido. Skin: Acne,
injection site irritation and sloughing. Body as a Whole:
Hypersensitivity to testosterone, anaphylactoid reactions
Precipitation of acute intermittent porphyria. Endocrine:
Femalesuppression of ovulation, lactation, or menstruation; hoarseness or deepening of voice (often irreversible);
hirsutism; oily skin; clitoral enlargement; regression of breasts; male-pattern baldness (in disseminated
flushing, sweating; vaginitis
with pruritus, drying, bleeding; menstrual irregularities. Maleprepubertal-premature
epiphyseal closure, phallic enlargement, priapism. Postpubertaltesticular atrophy, decreased ejaculatory volume, azoospermia,
oligospermia (after prolonged administration
or excessive dosage), impotence, epididymitis, priapism, gynecomastia.
Diagnostic Test Interference
Testosterone alters glucose tolerance tests; decreases thyroxine-binding globulin concentration (resulting in decreased total T4 serum levels and increased resin of T3 and T4 ). Increases creatinine and creatinine excretion (lasting up to 2 wk after therapy is discontinued) and alters response to metyrapone test. It suppresses clotting factors II, V, VII, X and decreases excretion of 17-ketosteroids. May increase or decrease serum cholesterol.
InteractionsDrug: oral anticoagulants
may potentiate hypoprothrombinemia. May decrease insulin
are slowly absorbed from lipid tissue
24 wk cypionate
and enanthate. Distribution:
98% bound to sex hormone-binding globulin. Metabolism:
Primarily in liver. Elimination:
90% in urine, 6% in feces. Half-Life:
Assessment & Drug Effects
- Therapeutic response from testosterone therapy is slow; breast cancer, usually apparent within 3 mo after regimen begins.
Terminate therapy if signs of disease progression appear.
- Check I&O and weigh patient daily during dose adjustment period. Weight gain (due to sodium and water retention) suggests
need for decreased dosage. When dosage is stabilized, urge patient to check weight at least twice weekly and to report increases,
particularly if accompanied by edema in dependent areas. Dose adjustment and diuretic therapy may be started.
- Lab tests: Periodic serum cholesterol, serum electrolytes as well as liver function tests throughout therapy.
- Monitor serum calcium closely. Androgenic therapy is usually terminated if serum calcium rises above 14 mg/dL.
- Report S&S of hypercalcemia (see Appendix F) promptly. The immobilized patient is particularly prone to develop hypercalcemia,
which indicates progression of bone metastasis in patients with metastatic breast cancer. Treatment includes withdrawing
testosterone and checking calcium, phosphate, and BUN levels daily.
- Instruct diabetic to report sweating, tremor, anxiety, vertigo. Testosterone-induced anabolic action enhances hypoglycemia
(hyperinsulinism). Dosage adjustment of antidiabetic agent may be required.
- Observe patients on concomitant anticoagulant treatment for signs of overdosage (e.g., ecchymoses, petechiae). Report promptly
to physician; anticoagulant dose may need to be reduced.
- Monitor prepubertal or adolescent males throughout therapy to avoid precocious sexual development and premature epiphyseal
closure. Skeletal stimulation may continue 6 mo beyond termination of therapy.
Patient & Family Education
- Review directions for application of transdermal patches.
- Report soreness at injection site, because postinjection furunculosis may be an associated adverse reaction.
- Report priapism (sustained and often painful erections occurring especially in early replacement therapy), reduced ejaculatory
volume, and gynecomastia to physician. Symptoms indicate necessity for temporary withdrawal or discontinuation of testosterone
- Notify physician promptly if pregnancy is suspected or planned. Masculinization of the fetus is most likely to occur if
testosterone (androgen) therapy is provided during first trimester of pregnancy.
- Androgens may cause virilism in women at dosage required to treat carcinoma. Report increase in libido (early sign of toxicity),
growth of facial hair, deepening of voice, male-pattern baldness. The onset of hoarseness can easily be overlooked unless
its significance as an early and possibly irreversible sign of virilism is appreciated. Reevaluation of treatment plan is