STANOZOLOL

FORMULA

Each ml contains
Stanozolol………………………………………………………………………. 50 mg
Excipients ………………………………………………………………………. Q.s.

THERAPEUTIC ACTION:

Anabolic hormone that promotes the processess of reconstruction of body tissues and reverses body catabolism. It is used therapeutically to treat hereditary angioedema, the cryofibrinogenemia decreasing the severity and frequency of seizures and increasing muscle mass in athletes.

MECHANISM OF ACTION AND PHARMACOKINETICS

Stanozolol is a synthetic steroid derived from testosterone that enhances muscular development. However, it also has the androgenic properties of the sexual male hormones (testosterone). As with all other anabolic steroids, stanozolol suppresses the pituitary gonadotropic function and can exert a direct effect on testicles. Stanozolol increases plasma levels of the LDL and reduces the levels of HDL, eventhough total cholesterol or triglycerides are not modified. When administration is discontinued, this levels turn back to normal. Elimination is through the kidneys, a small part is eliminated through feces, because of the enterohepatic incubation.

INDICATIONS

Treatment of hereditary angioedema: oral administration
– Adults: Initially, 2 mg orally three times a day. Once the angioedema seizures have decreased, doses can be reduced to intervals of 1 to 3 months until reaching the maintenance dose of 2 mg once every other day.
– Children: Safety and efficacy of stanozolol in children with hereditary angioedema have not been determined. A risk/benefit evaluation of the use of Stanozolol should be done in children and monitor skeletal maturation. Long-term treatment is not recommended (risks increase with chronic use).

Treatment of cryofibrinogenemia: Oral administration
– Adults: Doses of 2 mg twice a day for 5 months have been used. Lesions start to disappear after two weeks to one month of treatment.

Increase of muscular mass in athletes:

Doses used in some clinical studies to determine scientifically the increase of muscular mass and strength have ranged from 6 to 8 mg/day for periods no longer than 2 or 3 weeks. However, once the drug is discontinued, its effects dissipate in 6 to 10 weeks. With the use of this drug an adequate support of calories and proteins is important to maintain a positive nitrogen balance.

DOSAGE AND USE:

STANOZOLAND DEPOT injectable intramuscular.

– Adults: 1 ml every 2 – 3 weeks
– Children: Up to 2 years: 0,5 ml, every 2 – 3 weeks.
From 2 – 6 years: from 0,5 to 1 ml, every 2-3 weeks, according to the doctor’s criterion.

STANOZOLAND DEPOT is an aqueous suspension particularly studied for a long-term absorption free of local irritant effects. Its use is preferred provided the doctor deems appropriate parenteral administrations spaced in time. It is important to supplement the treatment with a rich and equilibrated diet.

CONTRAINDICATIONS:

Use of stanozolol is contraindicated in male patients with breast carcinoma or with suspected or latent prostate carcinoma. In women, stanozolol is contraindicated in breast cancer with hypercalcemia. Androgenic steroids can stimulate the osteolytic bone resorption.

Anabolic steroids, including stanozolol belong to the category X of risk during pregnancy. Animal studies have shown that these drugs produce fetal masculinization. The potential risk of theses drugs clearly outweighs the theoretical therapeutic benefit. So, the use of this drug in pregnant women is contradindicated. It is not known if stanozolol is excreted in significant amounts in human milk. Because of the possibility of severe adverse reactions in the infant, it is recommended to discontinue breastfeeding or to avoid the administration of this drug.

Hepatic peliosis, a condition in which hepatic tissue and sometimes the spleen are replaced by blood-filled cysts has been ocasionally observed in subjects treated with androgenic anabolics. These cysts usually present with minimal hepatic dysfunction. But in other cases they can be associated with hepatic failure. Besides, these cysts are not evident until severe hepatic failure occurs or until abdominal bleeding takes place. Usually, withdrawal of the drug results in complete disappearance of the lesions.

Tumors of the hepatic cells have also been reported, most of them benign and androgen-dependent, eventhough there can be some malignancies. Discontinuation of treatment produces, usually regression of tumors and stops its progression. However, tumors associated with androgens or anabolic steroids are highly vascularized and can be asymptomatic until an intra-abdominal bleeding occurs that can be fatal.

Anabolic steroids cause lipid abnormalities that increase the risk of arterosclerosis. These changes consist of an increase of LDLs and a decrease of HDLs that can reach significant levels with a corresponding increase in the risk of coronary heart disease. As all other steroids, stanozolol is contraindicated in diabetes mellitus, in nephrotic phase of nephritis and in the presence of convulsive disorders.

Anabolic steroids should be used with caution in children and adolescents because it can cause an early closure of the epiphysis, precocious sexual development in males and masculinization in female. Epiphysis maturation may be faster than the growth and continue 6 months after discontinuation of the medication.

PRECAUTIONS AND WARNINGS:

Anabolic steroids should be used with caution in children and adolescents because it can cause an early closure of the epiphysis, precocious sexual development in males and masculinization in female. Epiphysis maturation may be faster than the growth and continue 6 months after discontinuation of the medication.

DRUG INTERACTIONS

Effects of heparin and oral anticoagulants may be increased by androgens, including stanozolol.

Antidiabetics (insulin): there are studies in which a potentiation of the hypoglycemic effect has been shown, with toxicity risk. The mechanism has not been established, but it has been suggested that with the increase of metabolic activity by anabolics and increasing the glucose consumption, the effect of the hypoglycemic can be increased.

RESTRICTIONS IN USE:

Do not use in cases of hypersensitivity to any of the components, pregnancy or lactancy.

ADVERSE REACTIONS:

Adverse effects of stanozolol are, in general, frequent, moderately important and irreversible in some cases. During therapy with stanozolol adverse reactions in the liver have been described (hepatic peliosis and hepatic tumors) and cholestatic jaundice. In most cases, these effects disappear when treatment is discontinued. There have also been described cases of diarrhea, nausea/vomits, agitation, insomnia, virilization, hirsutism, clitorial hypertrophy, acne, inhibition of testicular function with oligospermia and sodium, potassium, chloride and water retention.

When stanozolol is used by athletes and gymnasts, adverse reactions have been described in up to 40% of men and 50% of women. Most frequent side effects experienced by men are increased sexual urges, acne, hirsutism, irritability, fluid retention, hypertension, insomnia, depression, increased appetite, hair loss and gynecomastia. In women, adverse reactions most frequently observed are virilization, acne and fluid retention.

Use of stanozolol in adolescents interferes with height growth.

When used in super therapeutic doses there is a decrease in quantity and quality of semen in men, producing, within a few months, sterility. The exact time required to get back to normal is not known although some authors estimate 5 to 6 months after withdrawal of the drug. Long-term administration of stanozolol produces hypogonadism with testicular atrophy and azoospermia.

OVERDOSE (signs, symptoms, and treatment behavior):
No acute toxicity has been reported to therapeutic indicated doses. In case of an overdose go to the Medical Emergency Center Dr. Manuel Giagni, Toxicology Department (Gral. Santos and Teodoro S. Mongelós, phone: 204800-206203).

PACKAGING:

Box with 100 tablets
Box with 3 ampoules x 1 ml
Box with 1 ampoule x 15 ml
Box with 1 ampoule x 30 ml

Keep at a temperature below 25º C in a dry place.
Keep out of reach of children.