Oxymetholone

Package leaflet (information for patients)

Tradename
Oxymetholone

Dosage form
Tablets 50 mg.

Description
Round, flat, beveled to the edge white tablets with an imprint in the form of the brand name "V" on one side.

Composition
Active ingredient: Oxymetholone 50 mg.
Excipients: microcrystalline cellulose 102, calcium stearate, aerosil ® 200 (hydrophilic pyrogenic silicon dioxide).

Pharmacotherapeutic group
Anabolic / androgenic steroids.

Pharmacological properties
Oxymetholone promotes body tissue building processes and reverses catabolic processes; improves nitrogen balance when adequate calorie and protein intake is provided. Anemia caused by bone marrow failure: Increases the production of erythropoietin. Anemia due to poor production of red blood cells: Stimulates erythropoiesis. Anemias associated with kidney disease: increases the volume of hemoglobin and red blood cells. A prophylactic agent for angioedema (hereditary): increases the serum concentration of esterase inhibitors C1 and C4.

Indications for use
In the treatment of anemia due to bone marrow failure and anemia due to poor production of red blood cells. Congenital and acquired aplastic anemias, myelofibrosis and hypoplastic anemias caused by myelotoxic drugs, which often respond to oxymetholone ; it is also used for the prevention and treatment of hereditary angioedema and alcoholic hepatitis with encephalopathy.

Method of administration and dosage
Film-coated tablets should be swallowed whole with plenty of water. The drug should not be taken on an empty stomach.
Oxymetholone should be taken for at least 3–6 months, as the reaction does not always appear immediately. Adults: 1 to 5 mg per kg of body weight per day. The usual effective dose is 1 to 2 mg per kg of body weight per day, but some patients may require higher doses.
Children: Infants and premature babies : 0.1 to 75 mg per kg of body weight per day. Infants and Children: See Adult Dosage. It is important not to take more than the prescribed dosage ; otherwise, it may increase the chance of side effects.

Side effects
Nausea, vomiting, constipation, diarrhea, bladder irritability, jaundice and edema. In women: acne or oily skin, hirsutism, hoarseness or low voice, clitoral hypertrophy, decreased or increased libido, unnatural hair growth, and unusual hair loss; these manifestations are irreversible even after rapid discontinuation of treatment. Concomitant use of estrogens does not prevent virilization in women. In men: Prepubertal period: premature epiphysis closure, acne, priapism, phallic growth, body and facial hair growth. Postpubertal period: testicular hypertrophy, oligospermia, decreased ejaculation, impotence, gynecomastia, epididymitis.

Contraindication
- Mr. ipertrofiya prostate gland obstruction.
- M The men's prostate and breast cancer.
- Severe impairment of liver or kidney function.
It should be used with caution in children before puberty, in patients with diabetes or coronary artery disease, in people taking ACTH, corticosteroids, or anticoagulants.

Overdose
Symptoms: hepatotoxicity and intoxication. During intoxication, sweating, nausea, and vomiting may occur. These symptoms can be eliminated by reducing the dose.
Treatment: in case of signs of poisoning, induce vomiting or gastric lavage, prescribe activated charcoal and a laxative, and consult a doctor.
Intoxication and hepatotoxicity are more likely in elderly patients and especially in young children (therapeutic overdose or accidental intoxication can be very dangerous for them). Monitor your liver function.

Precautions
- Pregnancy: May cause virilization in female fetuses.
- Breastfeeding: It is not known how anabolic steroids are excreted in breast milk. In accordance with the adverse reactions that may occur in infants, it is necessary to decide whether to stop breastfeeding or stop taking the drug.
The risk-benefit ratio should be assessed in the following clinical situations: cardiac, hepatic, or renal dysfunction; ischemic heart disease, myocardial infarction and diabetes mellitus. Oxymetholone should be used with caution in prepubertal children due to possible premature closure of the pineal gland, early sexual development in men and virilization in women; in male geriatric patients, it may increase the risk of prostate hypertrophy or prostate carcinoma. In children, this treatment should be started after completion of x-rays of the wrist bones to determine the level of bone maturation. During treatment, bone maturation may progress faster than linear growth; dosage will be intermittent and X-rays will be taken periodically. The growth of the pineal gland can continue 6 months after stopping treatment. It is important to follow a diet rich in protein and calories to maximize the therapeutic effect of this medication.

Interaction with other medicinal products
Anabolic steroids can enhance the effect of oral anticoagulants: the dosage can be reduced to maintain prothrombin time. In diabetics, taking anabolic steroids may increase the need for insulin and oral hypoglycemic agents. Adrenocorticoids or ACTH can increase edema when used in combination with anabolic steroids. Methandienone lowers fasting blood glucose levels in both normal people and people with diabetes.

Special instructions
Peliosis of hepatitis can occur in patients receiving anabolic steroids. These cysts can be present with minimal liver dysfunction, but they are associated with a liver defect. Symptoms are often not recognized until a life-threatening liver problem or intra-abdominal bleeding develops. Discontinuation of anabolic steroid treatment usually results in complete resolution of the lesions. Tumors in liver cells have also been reported. Many of these tumors are benign and estrogen-dependent, but fatal malignant tumors have also been reported; discontinuation of the drug may lead to regression or cessation of tumor development. Even though androgen-related or anabolic steroid-associated liver tumors, they are much more vascular than other liver tumors and may not manifest until life-threatening intra-abdominal hemorrhage develops. Changes in blood lipids associated with an increased risk of arteriosclerosis in patients taking androgens and anabolic steroids. These changes include a decrease in high density lipoprotein changes and sometimes an increase in low density lipoprotein. The changes can be very noticeable and should seriously affect the risk of changes in blood lipids associated with an increased risk of arteriosclerosis in patients taking androgens and anabolic steroids

Pregnancy and elbowing
This drug should not be used during pregnancy and lactation.
During pregnancy, the drug can cause virilization in female fetuses.
During breastfeeding, it is not known how anabolic steroids are excreted in breast milk. In accordance with the adverse reactions that may occur in infants, it is necessary to decide whether to stop breastfeeding or stop taking the drug.

Influence on the ability to drive vehicles and work with mechanisms
Does not affect

Storage conditions
Store in a dry, dark place at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life
3 years. Do not use after the expiration date printed on the package.

Vacation conditions
On prescription.

Packaging
Oxymetalone 50 mg Tablets. There are 25 tablets in a blister. 4 blisters are packed in a cardboard box together with an enclosed leaflet.