Active substanceMegestrolMegestrol
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  • MEGEIS®
    pills inwards 
    VALEANT, LLC     Russia
  • Dosage form: & nbspPills.
    Composition:

    One tablet contains:

    active substance: megestrol acetate 160 mg;

    Excipients: lactose, microcrystalline cellulose, povidone, silicon dioxide colloid, carboxymethyl starch sodium, magnesium stearate.

    Description:Oval biconvex tablets from white to almost white with a risk on one side and labeling "160" on the other side.
    Pharmacotherapeutic group:Antitumour agent, progestogen
    ATX: & nbsp

    L.02.A.B.01   Megestrol

    L.02.A.B   Progestogens

    Pharmacodynamics:

    Megeis (megestrol) is a synthetic progestogen. The precise mechanism of the antitumor effect of the Megeis preparation in endometrial carcinoma remains unknown. It is believed that the action is associated with the presence of an antileutinizing effect, which is realized through the pituitary gland. There is an indication of the local effect of megestrol, obtained by the direct administration of progestogens into the uterine cavity.

    The antitumor effect of the drug in breast cancer and the mechanism by which the drug is effective in anorexia and cachexia are also unknown. The increase in body weight when taking megestrol acetate is associated with an increase in appetite and an increase in the mass of adipose tissue and the body as a whole.

    Pharmacokinetics:

    Concentrations in the plasma depend on the degree of inactivation of the drug in the digestive tract and in the liver, which can be affected by motility of the intestinal tract, intestinal microflora, simultaneous use of antibiotics, body weight, diet and functional state of the liver.

    Only about 5-8% of the administered dose of megestrol acetate is metabolites. The main ways of isolating the drug from the human body are kidneys (on average about 66%) and the intestines (an average of about 20% of the administered dose). That portion of the administered dose, which is not found in urine and feces, can be released through the respiratory system and accumulate in adipose tissue.

    Indications:

    - Palliative treatment of advanced breast cancer or endometrial cancer;

    - treatment of anorexia or weight loss in malignant neoplasms or acquired immunodeficiency syndrome.

    Contraindications:

    - Hypersensitivity to megestrol or any other substance in the formulation;

    - as a diagnostic test for pregnancy;

    - pregnancy and the period of breastfeeding;

    - age under 18 years (efficiency and safety not established).

    Carefully:Megesis should be used in patients with a history of thrombophlebitis.
    Dosing and Administration:

    Inside. To determine the effectiveness of the drug should be at least two months of continuous treatment.

    Mammary cancer: 160 mg per day (once or several times).

    Endometrial cancer: 80-320 mg per day (once or several times).

    Anorexia or weight loss: a single daily dose is 400-800 mg.

    Elderly patients: no dose adjustment is required.

    Side effects:

    Weight gain is a frequent effect when using Megeis in patients with breast or endometrial cancer and is a consequence of increased appetite.

    Thromboembolism. There have been reports of thromboembolism, including thrombophlebitis and pulmonary embolism.

    Other side effects. Nausea, vomiting, swelling and blood discharge from the uterine cavity, not associated with menstruation, are noted in approximately 1-2% of patients. It has been reported that patients have shortness of breath, pain, heart failure, hypertension, hot flashes, mood changes, Cushingoid features on the face, temporary activation of tumor development (in the absence or presence of hypercalcemia), hyperglycemia, alopecia, carpal tunnel syndrome, diarrhea, lethargy, skin rashes.

    It was reported on the development of pathological conditions associated with impaired functioning of the pituitary-adrenal system: glucose intolerance, the onset of diabetes mellitus and exacerbation of existing diabetes mellitus with a decrease in glucose tolerance and Cushing's syndrome. In rare cases, patients soon after discontinuing treatment with MEGAIS, clinical signs of adrenal insufficiency were observed. It should be borne in mind the possibility of suppressing the function of the adrenal glands in all patients taking the drug for a long time, as well as after discontinuing the drug. In such cases, shock doses of glucocorticoids may be indicated as a substitution therapy.

    Overdose:

    In clinical trials, the drug was used in doses up to 1600 mg / day for 6 months or more. There were no acute toxic effects.

    In case of an overdose, treatment should be symptomatic.

    Special instructions:

    Treatment with Megasic should be performed under the supervision of a specialist with experience in the use of chemotherapy treatment.

    On the background of Megaeus therapy and at least 3 months after it is necessary to use reliable methods of contraception.

    Form release / dosage:Tablets of 160 mg.
    Packaging:For 30 tablets in a glass bottle of a dark stack, sealed with a polypropylene lid. 1 bottle with instructions for use, placed under the label of the bottle, in a pack of cardboard.
    Storage conditions:Store at a temperature of 15-25 ° C. Keep out of the reach of children.
    Shelf life:

    3 years.

    Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013296 / 01
    Date of registration:28.05.2010 / 30.10.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspVALEANT LLC VALEANT LLC Russia
    Information update date: & nbsp26.04.2018
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