Description
Commercial name of the drug
Danabol
Mn active substance
Methandienonum
COMPOSITION OF THE DOSAGE FORM
1 tablet contains:
active substance: methandienone – 10 mg or 50 mg,
excipients: magnesium stearate, FD&C Red No. 40, ludipress (lactose, povidone, crospovidone).
PRODUCT DESCRIPTION
Tablets of light pink and pink color, respectively, for doses of 10 mg and 50 mg, square, flat on both sides and chamfered, with a risk and engraving "BP" on one of the sides, and on the other – "10" and "50" , respectively for doses of 10 mg and 50 mg, with rounded edges.
Dosage form
Tablets.
PHARMACOTHERAPEUTIC GROUP and ATC code
Anabolic. A14A A03.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics.
Methandienone is a steroid anabolic. 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 tissue respiration chain enzymes and an increase in tissue respiration, oxidative phosphorylation, ATP synthesis and the accumulation of macroergs inside the cell. Stimulates anabolic and suppresses catabolic processes caused by glucocorticoids. It leads to an increase in muscle mass, a decrease in fat deposits, improves tissue trophism, promotes the deposition of calcium in the bones, retains nitrogen, phosphorus, sulfur, potassium, sodium and water in the body. Hematopoietic action is associated with an increase in the synthesis of erythropoietin. Androgenic activity (low) can contribute to the development of male secondary sexual characteristics.
Pharmacokinetics.
Quickly and completely absorbed in the gastrointestinal tract, low bioavailability due to the presence of the effect of "first pass" through the liver. In the blood, 90% binds to specific carrier globulins. Undergoes final biotransformation in the liver with the formation of inactive metabolites. Excreted by the kidneys. Duration of action – up to 14 hours.
INDICATIONS
Protein synthesis disorders, cachexia of various origins, injuries, burns, pre- and postoperative periods, after infectious diseases and radiation, renal and adrenal insufficiency, toxic goiter, muscular dystrophy, osteoporosis, negative nitrogen balance during corticosteroid therapy, hypo- and aplastic anemia. Auxiliary agent in the treatment of tuberculosis, osteomyelitis, bronchial asthma, hepatitis.
METHOD OF APPLICATION AND DOSES
For adults, the initial dose is 10-20 mg/day. The maintenance dose is 5-10 mg/day. The highest dose is 50 mg / day.
Children: up to 2 years – 0.04 mg / kg, from 2 to 6 years – 0.05 mg / kg, from 6 to 14 years – 1 mg / kg in 1-2 doses. Course – up to 4 weeks. Repeated course – after 6-8 weeks.
SIDE EFFECTS
In women, symptoms of virilization, ovarian depression, menstrual disorders, hypercalcemia.
In men: in the prepubertal period – symptoms of virilization, idiopathic hyperpigmentation of the skin, slowdown or cessation of growth (calcification of the epiphyseal growth zones of tubular bones), in the postpubertal period – bladder irritation, gynecomastia, priapism, in old age – hypertrophy and / or carcinoma of the prostate gland .
In men and women – the progression of atherosclerosis, peripheral edema, dyspeptic disorders, impaired liver function with jaundice, changes in the leukocyte formula, pain in long bones, hypocoagulation with a tendency to bleeding.
CONTRAINDICATIONS
Hypersensitivity to the drug, prostate cancer, breast cancer in men, breast carcinoma in women with hypercalcemia, ischemic heart disease, severe atherosclerosis, liver and kidney failure, acute and chronic prostatitis, pregnancy, breastfeeding.
OVERDOSE
Cases of overdose are not registered.
PRECAUTIONS AND APPLICATIONS
After a month of taking the drug, children are recommended a 1-2-month break.
When the first signs of virilization appear in women (coarsening of the voice, hirsutism, acne, clitoromegaly), the reception should be stopped in order to prevent the irreversibility of the changes. Periodically check the level of lipidemia and cholesterolemia.
INTERACTIONS WITH OTHER DRUGS
Enhances the effect of anticoagulants, antiplatelet agents and hypoglycemic agents, as well as side effects of hepatotoxic drugs.
Release form
, PACKAGE
Tablets 10 mg and 50 mg.
10 or 20 tablets in a blister pack.
5, 15, 25, 50, 100, 500 tablets in packs.
5, 15, 25, 50, 100 tablets in vials.
STORAGE CONDITIONS
Store at a temperature of 15-25 ° C, in a dry, dark place and out of the reach of children.
BEST BEFORE DATE
3 years
.
Do not use after the expiry date stated on the package.
HOLIDAY CONDITIONS
Released by prescription.
DATE OF LAST REVISION OF THE TEXT
July 2009
NAME AND ADDRESS OF THE MANUFACTURER
SC Balkan Pharmaceuticals SRL
st. Gradescu, 4
Chisinau,
The Republic of Moldova
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