Delatestryl (Testosterone Enanthate)

DELATESTRYL®

Squibb

Testosterone Enanthate

Androgen

Indications And Clinical Uses: Androgen therapy in the male (eunuchism, eunuchoidism, impotence of glandular origin, cryptorchidism, climacteric, senile pruritus), and in the female (menorrhagia, frigidity, palliation of premenopausal mammary carcinoma, inhibition of lactation, postpartum breast engorgement, menopausal syndrome), and in males and females (delayed bone healing, spinal paraplegia, senile osteoporosis, dystrophy, cachexia due to wasting illness).

Contra-Indications: Androgens are contraindicated in male patients with prostatic or breast cancer, in those elderly patients in whom overstimulation is to be avoided, and in those cases of benign prostatic hypertrophy with obstructive symptoms. Androgens are also contraindicated in patients with nephrosis or the nephrotic phase of nephritis.

Pregnancy: Because of the possibility of masculinization of the female fetus, this drug should not be used in the treatment of pregnant women or those who may become pregnant unless in the opinion of the physician the expected benefits outweigh the risks.

Precautions: Premenopausal female patients with breast cancer should receive testosterone enanthate continuously while response is satisfactory to avoid possible acceleration of malignancy. Also, patients must be watched carefully for signs of hypercalcemia, edema, or acceleration of the disease. If any of these signs appear, testosterone therapy should be stopped.

If symptomatic hypercalcemia occurs, discontinue androgen therapy and institute appropriate measures.

Caution is required in administering androgens to patients with cardiac, renal, or hepatic disease. Edema may occur occasionally. Concomitant administration with adrenal steroids or ACTH may add to the edema. Edema may be combatted with a low salt diet and the use of a suitable diuretic; edema of sufficient degree to warrant a reduction of dosage or termination of therapy is rare.

Anabolic steroids may increase sensitivity to anticoagulants. Dosage of the anticoagulant may have to be decreased in order to maintain the prothrombin time at the desired therapeutic level.

Anabolic steroids have been shown to alter glucose tolerance tests. Diabetics should be followed carefully and the insulin or oral hypoglycemic dosage adjusted accordingly.

Serum cholesterol may increase or decrease during therapy. Because of its hypercholesterolemic effects, caution is required when administering this drug to patients with a history of myocardial infarction or coronary artery disease. Serial determinations of serum cholesterol should be made and therapy adjusted accordingly. A cause and effect relationship between myocardial infarction and hypercholesterolemia has not been established.

Inhibition of testicular function and decrease in ejaculatory volume may occur when the drug is administered in doses greater than those used for replacement therapy in hypogonadal males.

Androgens should be used with caution in young boys in order to avoid precocious sexual development and premature closure of the epiphyses.

Use of anabolic steroids by athletes is not recommended. Objective evidence is conflicting and inconclusive as to whether these medications significantly increase athletic performance by increasing muscle strength. Weight gains reported by athletes are due in part to fluid retention, which is a potentially hazardous side effect of anabolic steroid therapy. The risk of other unwanted effects outweigh any possible benefit received from anabolic steroids and make their use in athletes undesirable.

Adverse Reactions: In males, the following post pubertal adverse reactions have occurred: inhibition of testicular function, testicular atrophy and oligospermia, impotence, chronic priapism, gynecomastia, epididymitis, and bladder irritability. In addition, the following reactions are known to occur with anabolic steroids: increased or decreased libido, flushing of the skin, acne, habituation, excitation and sleeplessness, chills, leukopenia, and bleeding in patients on concomitant anticoagulant therapy. In addition, females have exhibited hirsutism, deepening or hoarseness of the voice, enlargement of the clitoris and menstrual irregularities; these phenomena in females appear to be reversible, with the occasional exception of voice changes.

I.M. preparations of anabolic steroids have been associated with urticaria at the injection site, post injection induration, and furunculosis.

Alterations may occur in the following clinical laboratory tests: metyrapone test, fasting blood sugar (FBS) and glucose tolerance test, thyroid function tests[decrease in protein bound iodine (PBI), thyroxine binding capacity, and radioactive iodine uptake, and an increase in T3 uptake by the red blood cells or resin; free thyroxine levels remain normal and the altered tests usually persist for 2 to 3 weeks after stopping anabolic therapy], electrolytes (retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates), blood coagulation tests (increase in clotting factors II, V, VII, and X), and miscellaneous laboratory tests (decreased creatinine and creatine excretion lasting up to 2 weeks after discontinuing therapy and increased 17-ketosteroid excretion).

Dosage And Administration: Care should be taken to inject the preparation deeply into the gluteal muscle following the usual precautions for i.m. administration.

Note: The use of a wet needle or syringe may cause the solution to become cloudy; however, this does not affect the potency of the material.

The following dosages are suggested: In females: For enhancement of libido (frigidity), 100 mg every 4 weeks; use only if uterus is normal in size; not recommended in women with hypertrichosis or acne; discontinue if masculinization occurs.

For mammary cancer (in premenopausal women), 200 to 400 mg every 2 or more weeks; dosage should be adjusted depending upon clinical response; close medical supervision is mandatory; use only in advanced inoperable cases or as an adjunct to surgery or roentgen therapy; hypercalcemia may develop. For dysfunctional uterine bleeding (menorrhagia), 200 to 400 mg to induce endometrial atrophy; 100 to 200 mg every 4 weeks given 1 week before the expected onset of menstruation; a progestogen, then cyclic estrogen-progestogen therapy is generally preferred to androgen. For menopausal syndrome (selected cases), 200 mg every 4 weeks. For prevention of postpartum breast engorgement and inhibition of lactation, 100 to 200 mg at the end of first stage of labor; combining androgen with estrogen therapy is generally preferred.

In males: For hypogonadism, 200 to 400 mg every 4 weeks; androgen therapy is regarded as replacement therapy, being effective only as long as continued; prolonged treatment with chorionic gonadotropin is also recommended. For cryptorchidism, 100 to 200 mg every 4 weeks; chorionic gonadotropin should generally be tried first; use only when no obstructive anatomic lesion exists; if descent has not occurred after 3 or 4 months of therapy, surgical transplantation should be considered. For oligospermia, 100 to 200 mg every 4 to 6 weeks for development and maintenance of testicular tubular function; 200 mg every week for 6 to 12 weeks for suppression of spermatogenesis and rebound stimulation.

In males and females: For anabolic effect, 200 to 400 mg every 4 weeks; combining androgen with estrogen therapy is generally preferred.

In general, total doses of testosterone enanthate above 400 mg per month are not required because of the prolonged action of the preparation. Injections more frequently than every 2 weeks are rarely indicated.

Availability And Storage: Each mL of sterile solution contains: testosterone enanthate 200 mg. Nonmedicinal ingredients: chlorobutanol 0.5% w/v and sesame oil. Vials of 5 mL. Store at room temperature. Low temperatures may result in separation of some crystalline material which redissolves readily on warming.

DELATESTRYL® Squibb Testosterone Enanthate Androgen

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