Description
Tablets are white or almost white, square, scored and engraved "BP" on one side, and "10" on the other, with chamfered and rounded edges. Dosage form Tablets. PHARMACOTHERAPEUTIC GROUP and ATC code: Steroid anabolic, A14A A08. PHARMACOLOGICAL PROPERTIES: Oxandrolone is an 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 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, and promotes the deposition of calcium in the bones. Shows low androgenic activity. INDICATIONS: Protein synthesis disorders, cachexia of various origins, injuries, extensive burns, after infectious diseases and radiation, muscular dystrophy, osteoporosis, negative nitrogen balance during corticosteroid therapy, hypo- and aplastic anemia. METHOD OF APPLICATION AND DOSES: Adults: doses are selected individually. The usual doses for adults are 2.5-20 mg per day, divided into 2-4 doses. Children: The recommended dose is ≤ 0.1 mg/kg/day. The duration of treatment is usually 2-4 weeks. If necessary, the course of treatment can be repeated after 1-2 months. SIDE EFFECTS: In women – symptoms of virilization, acne, menstrual disorders. In men: in the prepubertal period – symptoms of virilization, acne, growth retardation or cessation (calcification of the epiphyseal growth zones of tubular bones), in the postpubertal period – gynecomastia, priapism, inhibition of spermatogenesis. In men and women – the progression of atherosclerosis, peripheral edema, impaired liver function, changes in the leukocyte count, pain in long bones. 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. OVERDOSAGE: No cases of overdose have been reported. PRECAUTIONS AND PECULIARITIES OF APPLICATION: When the first signs of virilization appear in women (coarsening of the voice, hirsutism, acne, clitoromegaly), the intake should be stopped to prevent irreversible changes. Periodically check the level of lipidemia and cholesterolemia. For children, the drug should be prescribed by an experienced specialist in order to prevent premature ossification of the epiphyses of the bones. INTERACTIONS WITH OTHER DRUGS: Enhances the effect of anticoagulants, antiplatelet agents and hypoglycemic agents, as well as the side effects of hepatotoxic drugs. STORAGE CONDITIONS: Store at a temperature of 15-25°C, in a dry, dark place and out of the reach of children. NAME AND ADDRESS of the manufacturer: SC Balkan Pharmaceuticals SRL st. Gradescu, 4 Chisinau, Republic of Moldova
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