Treatment of anorexia or weight loss due to neoplastic disease or acquired immunodeficiency syndrome (AIDS).
Composition:
1 ml of suspension contains 40 mg of megestrol acetate in micronized form. The suspension contains sucrose.
Action:
Megestrol acetate is a synthetic steroid with strong progestational, antiestrogenic and anti-gonadotropic properties. The mechanism of action may be to suppress the production of gonadotrophins by the pituitary gland. The concentration of the drug in the blood depends on the intestinal process and hepatic inactivation of the drug, which may be influenced by: intestinal motility, intestinal bacterial flora, simultaneous administration of antibiotics, body weight, diet and liver function. Metabolites account for 5-8% of the administered dose of megestrol acetate. The drug is excreted mainly in the urine (approximately 66%) and in the faeces (approximately 20%). The remaining part of the administered dose can be excreted through the respiratory system and accumulated in adipose tissue.
Contraindications:
Hypersensitivity to megestrol acetate or other ingredients of the preparation. Pregnancy and breastfeeding.
Precautions:
The preparation should be used with caution in patients with a history of thrombophlebitis and in patients with diabetes (possibility of an increased need for insulin). In the event of a sudden discontinuation of the drug should be carefully observed patient, especially in the direction of such symptoms as: hypotension, nausea, vomiting, dizziness, weakness. In patients using the drug or interrupting chronic treatment with the preparation, there is a risk of mild adrenal suppression. The drug is not recommended for use in children. The product contains sucrose - should not be used by patients with rare hereditary fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption syndrome.
Pregnancy and lactation:
The preparation is contraindicated in pregnancy and breast-feeding. During the use of the preparation, women of childbearing age should be advised to use effective contraception.
Side effects:
The following may occur: palpitations, cardiomyopathy, hypertension, thrombophlebitis, pulmonary embolism, diarrhea, nausea, bloating, vomiting, constipation, dry mouth, enlarged liver, indigestion, mood changes, weakness, insomnia, neuropathy, confusion , convulsions, paresthesia, coma, depression, headache, urinary tract infections, proteinuria, incontinence, intermenstrual bleeding, decreased libido, oval face "moonlike" with symptoms of congestion (hyperlobium), hyperglycemia, hypercalcemia, edema, generalized edema, dyspnea , cough, pneumonia, pharyngitis, anemia, leukopenia, rash, alopecia, herpes, pruritus, sweating, urticaria, carpal tunnel syndrome, amblyopia, pain, candidosis, sarcomas, hot flushes. In patients with advanced non-hormone-dependent type of cancer who received the drug due to lack of appetite and weight loss, there were usually such activities as: shortness of breath, nausea, edema, pain, coma and diarrhea; rarely: urticaria, thrombophlebitis, thrombophlebitis and pulmonary embolism including (in some cases fatal). In clinical studies in patients with acquired immune deficiency syndrome, there were no statistically significant differences in the severity of adverse reactions between the group of patients receiving the drug and the group receiving placebo. The following side effects are described: diarrhea, impotence, rash, bloating, weakness and pain. In addition to impotence, all these symptoms were more frequent in the placebo group. Patients taking high doses of the drug also had constipation and pollakiuria. Mild adrenal suppression has been reported in patients who have been discontinued. In case of a sudden discontinuation of the drug, the patient should be closely monitored.
Dosage:
Orally. Adults and the elderly: 400-800 mg once daily. Treatment is recommended for at least 2 months.