Methandienone

Package leaflet (information for patients)

Tradename
Methandienone

Dosage form
Tablets 10 mg.

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

Structure
Active ingredient: Methandienone 10 mg.
Excipients: microcrystalline cellulose 102, calcium stearate, aerosil ® 200 (hydrophilic pyrogenic silicon dioxide).

Pharmacotherapeutic group
Anabolic / androgenic steroids.

Pharmacological properties
Anabolic steroid. Penetrating into the cell nucleus, it activates the genetic apparatus of the cell, which leads to an increase in the synthesis of DNA, RNA and structural proteins, the activation of enzymes of the tissue respiration chain and increased tissue respiration, oxidative phosphorylation, ATP synthesis and the accumulation of macroergs inside the cell. Stimulates anabolic and suppresses catabolic processes caused by GCS. Leads to an increase in muscle mass, a decrease in fat deposits and a negative nitrogen balance. Hematopoietic action is associated with an increase in the synthesis of erythropoietin. The anti-allergic effect is due to an increase in the concentration of the inhibitor of the C-1 complement fraction and a decrease in the content of the C-2 and C-4 complement fractions. The presence of androgenic activity can contribute to the development of secondary sexual characteristics in the male pattern. Duration of action - up to 14 hours.

Indications for use
Cachexia, impaired protein metabolism (after severe injuries, operations, burns, radiation therapy); severe infectious diseases accompanied by protein loss; progressive muscular dystrophy, glucocorticoid-induced myopathy; diabetic angiopathy; the need to accelerate regeneration in case of fractures, injuries; retarded growth of children (Shereshevsky-Turner syndrome, pituitary dwarfism); delayed puberty (sexual infantilism) and physical development in boys; encephalopathy against the background of alcoholic hepatitis.

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.
Senile and postmenopausal osteoporosis: Adults: Initially, 5 mg orally per day. Supportive care: 2.5 to 5 mg daily.
Anabolic effect: Adults: 5-10 mg orally per day.
Severe depletion: Adults: 10-20 mg orally daily for 3 weeks. Thereafter, reduce to 5-10 mg per day for a maintenance regimen.
Severe maturation delay, when growth hormone ACTH is not produced in the required volume. Children (post-pubertal period): up to 0.05 mg / kg orally per day. Intermittent therapy is recommended for long-term use.

Side effects
Progression of atherosclerosis (an increase in LDL concentration and a decrease in HDL concentration), iron deficiency anemia, peripheral edema, dyspeptic symptoms (epigastric pain, abdominal pain, nausea, vomiting), impaired liver function with jaundice, leukemoid syndrome (leukemia, pain in long tubular bones), hypocoagulation with a tendency to bleeding; with long-term therapy - hepatonecrosis (dark feces, vomiting with blood, headache, discomfort, respiratory failure), hepatocellular carcinoma, hepatic purpura (dark urine, discoloration of feces, urticaria, punctate or macular hemorrhagic mucous membranes on the skin and skin and or tonsillitis), cholestatic hepatitis (yellow discoloration of the sclera and skin, pain in the right hypochondrium, dark urine, discolored feces), increased secretion of the sebaceous glands, chills, increased or decreased libido, diarrhea, feeling of fullness in the stomach, flatulence, convulsions, disturbance sleep.
In women: the phenomenon of virilism (enlargement of the clitoris, coarseness or hoarseness of the voice, dys- and amenorrhea, hirsutism, steroid acne, oily skin), hypercalcemia (depression of the central nervous system, nausea, vomiting, fatigue).
In men: in the prepubertal period - virilism (acne, enlarged penis, priapism, formation of secondary sexual characteristics), idiopathic hyperpigmentation of the skin, slowing or stopping growth (calcification of the epiphyseal growth zones of tubular bones); in the postpubertal period - irritation of the bladder (increased frequency of urge), mastodynia, gynecomastia, priapism, decreased sexual function; old age - hyperplasia and / or carcinoma of the prostate gland.

Contraindication
Hypersensitivity to the components of the drug, prostate cancer, breast cancer (in men), breast cancer (in women with hypercalcemia), hypercalcemia, severe liver failure, nephrosis, glomerulonephritis (nephrotic stage), pregnancy.
With care. CHF, coronary atherosclerosis, myocardial infarction (including history), diabetes mellitus, prostatic hyperplasia, liver failure, renal failure, lactation period (there is no data on the drug penetration into breast milk), old age.
Childhood and adolescence (risk of premature closure of the epiphyseal growth zones, early puberty in boys and virilization in girls). Acceleration of the epiphyseal growth of tubular bones can be observed in children both during treatment and within 6 months after its termination.

Overdose
Symptoms: hepatotoxicity and intoxication. During intoxication, sweating, nausea, and vomiting may occur. A TED symptoms can be avoided by dose reduction.
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).

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.
- Pediatrics: The use of anabolic steroids can have serious consequences, the benefits of which should be assessed before starting therapy. Anabolic steroids can accelerate the maturation of the pineal gland in children faster than linear growth, and the effect can last for up to 6 months after stopping the drug. In any case, therapy should be monitored by X-ray studies at intervals of 3 to 6 months, and the drug should be discontinued before bone age reaches the norm for chronological age, in order to avoid the risk of deterioration in adult growth.
- Hepatotoxicity: including jaundice with or without itching. This may be associated with acute hepatitis, accompanied by pain in the right upper quadrant. The incidence of hepatocellular carcinoma has been observed with long-term treatment with high doses of androgens.
- Geriatrics: Geriatric patients taking anabolic steroids may have an increased risk of developing prostate hypertrophy and prostate carcinoma. This may be associated with acute hepatitis, accompanied by pain in the right upper quadrant. The incidence of hepatocellular carcinoma has been observed with long-term treatment with high doses of androgens.

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 may 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 leads to complete disappearance 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 n ri temperature not higher than 25 ° C, the reach of children.

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

Vacation conditions
On prescription.

Packaging
Methandienone 10 mg, Tablets. There are 25 tablets in a blister. 4 blisters are packed in a cardboard box together with an enclosed leaflet.