Hereditary Angioedema. Stanozolol is indicated prophylactically to decrease the frequency and severity of attacks of angioedema.

DOSAGE AND ADMINISTRATION

The use of anabolic steroids may be associated with serious adverse reactions, many of which are dose related; therefore, patients should be placed on the lowest possible effective dose.

Hereditary Angioedema. The dosage requirements for continuous treatment of hereditary angioedema with Stanosim 10mg should be individualized on the basis of the clinical response of the patient. It is recommended that the patient be started on 2 mg, three times a day. After a favorable initial response is obtained in terms of prevention of episodes of edematous attacks, the proper continuing dosage should be determined by decreasing the dosage at intervals of one to three months to a maintenance dosage of 2 mg a day. Some patients may be successfully managed on a 2 mg alternate day schedule. During the dose adjusting phase, close monitoring of the patient's response is indicated, particularly if the patient has a history of airway involvement.

The prophylactic dose of Stanozolol, to be used prior to dental extraction, or other traumatic or stressful situations has not been established and may be substantially larger.

Attacks of hereditary angioedema are generally infrequent in childhood and the risks from stanozolol administration are substantially increased. Therefore, long-term prophylactic therapy with this drug is generally not recommended in children, and should only be undertaken with due consideration of the benefits and risks involved (see PRECAUTIONS, Pediatric Use ).

HOW SUPPLIED

Stanosim 10mg tablets for oral administration are white, round tablets scored on one side with "Stanosim" and on the other side "NOVOCRINE"

SIDE EFFECTS

Cholestatic hepatitis and jaundice occur with 17-alpha-alkylated androgens at relatively low doses. If cholestatic hepatitis with jaundice appears, the anabolic steroid should be discontinued. If liver function tests become abnormal, the patient should be monitored closely and the etiology determined. Generally, the anabolic steroid should be discontinued although in cases of mild abnormalities, the physician may elect to follow the patient carefully at a reduced drug dosage.

In patients with breast cancer, anabolic steroid therapy may cause hypercalcemia by stimulating osteolysis. In this case, the drug should be discontinued.

Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. Concomitant administration of adrenal cortical steroids or ACTH may add to the edema.

Geriatric male patients treated with androgenic anabolic steroids may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma.

In children, anabolic steroid treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child, the greater the risk of compromising final mature height. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every six months.

Anabolic steroids have not been shown to enhance athletic ability.

PRECAUTIONS

General

Anabolic steroids may cause suppression of clotting factors II, V, VII, and X, and an increase in prothrombin time.

Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, and clitoromegaly). To prevent irreversible change, drug therapy must be discontinued, or the dosage significantly reduced when mild virilism is first detected. Such virilization is usual following androgenic anabolic steroid use at high doses. Some virilizing changes in women are irreversible even after prompt discontinuance of therapy and are not prevented by concomitant use of estrogens. Menstrual irregularities may also occur.

The insulin or oral hypoglycemic dosage may need adjustment in diabetic patients who receive anabolic steroids.

Information for the Patient. The physician should instruct patients to report any of the following side effects of androgens:

Adult or Adolescent Males. Too frequent or persistent erections of the penis, appearance or aggravation of acne.

Women. Hoarseness, acne, changes in menstrual periods, or more hair on the face.

All Patients. Any nausea, vomiting, changes in skin color, or ankle swelling.

Laboratory Tests. Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of androgenic anabolic steroid therapy (see WARNINGS).

Because of the hepatotoxicity associated with the use of 17-alpha-alkylated androgens, liver function tests should be obtained periodically.

Periodic (every 6 months) x-ray examinations of bone age should be made during treatment of prepubertal patients to determine the rate of bone maturation and the effects of androgenic anabolic steroid therapy on the epiphyseal centers.

In common with other anabolic steroids, WINSTROL has been reported to lower the level of high-density lipoproteins and raise the level of low-density lipoproteins. These changes usually revert to normal on discontinuation of treatment. Increased low-density lipoproteins and decreased high-density lipoproteins are considered cardiovascular risk factors. Serum lipids and high-density lipoprotein cholesterol should be determined periodically.

Hemoglobin and hematocrit should be checked periodically for polycythemia in patients who are receiving high doses of anabolic steroids.

Drug Interaction. Anabolic steroids may increase sensitivity to anticoagulants; therefore, dosage of an anticoagulant may have to be decreased in order to maintain the prothrombin time at the desired therapeutic level.

Drug/Laboratory Test Interferences. Therapy with androgenic anabolic steroids may decrease levels of thyroxine-binding globulin resulting in decreased total T ₄ serum levels and increase resin uptake of T ₃ and T ₄ . Free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction.

Carcinogenesis, Mutagenesis, Impairment of Fertility.

Animal data: Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically-induced carcinomas of the liver in rats.

Human data: There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.

Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

This compound has not been tested for mutagenic potential. However, as noted above, carcinogenic effects have been attributed to treatment with androgenic hormones. The potential carcinogenic effects likely occur through a hormonal mechanism rather than by a direct chemical interaction mechanism.

Impairment of fertility was not tested directly in animal species. However, as noted below under ADVERSE REACTIONS, oligospermia in males and amenorrhea in females are potential adverse effects of treatment with WINSTROL Tablets. Therefore, impairment of fertility is a possible outcome of treatment with WINSTROL.

Pregnancy Category X. See CONTRAINDICATIONS section.

Nursing Mothers. It is not known whether anabolic steroids are excreted in human milk. Many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from WINSTROL, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use. Anabolic agents may accelerate epiphyseal maturation more rapidly than linear growth in children, and the effect may continue for 6 months after the drug has been stopped. Therefore, therapy should be monitored by x-ray studies at 6 month intervals in order to avoid the risk of compromising the adult height. The safety and efficacy of WINSTROL in children with hereditary angioedema have not been established.

No Information Provided.

The use of WINSTROL is contraindicated in the following: 

1. Male patients with carcinoma of the breast, or with known or suspected carcinoma of the prostate.
2. Carcinoma of the breast in females with hypercalcemia; androgenic anabolic steroids may stimulate osteolytic resorption of bone.
3. Nephrosis or the nephrotic phase of nephritis.
4. WINSTROL can cause fetal harm when administered to a pregnant woman.

WINSTROL is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

CLINICAL PHARMACOLOGY