Universal reference book for medicines
Product name: MEGACE (MEGACE)

Active substance: megestrol

Type: Gestagen.
Antitumor preparation
Manufacturer: BRISTOL-MYERS SQUIBB AUSTRALIA (Australia)
Composition, form of production and packaging
Tablets
1 tab.

megestrol 160 mg

30 pcs.
- bottles (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Megase (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 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 is the excretion of the kidneys (on average around 66%) and the intestine (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.

DOSING MODE

Inside.
To determine the effectiveness of the drug should be at least 2 months of continuous treatment.
Breast cancer: 160 mg / day (once or several times).

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

Anorexia or weight loss: a single daily dose is 400-300 mg.

Elderly patients: dose adjustments are not required.

SIDE EFFECT

The increase in body weight is a frequent effect when using Megeis in patients with breast or endometrial cancer and is a consequence of increased appetite.

Thromboembolism: reported cases of thromboembolism, including thrombophlebitis and pulmonary embolism.

Other side effects: nausea, vomiting, swelling and discharge from the uterus that are not associated with menstruation are noted in approximately 1-2% of patients;
the presence of dyspnea, pain, heart failure, arterial 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.
The development of pathological conditions associated with impaired functioning of the pituitary - adrenal system was reported : 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 the discontinuation of treatment with Megeis, 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 GCS may be indicated as a substitute therapy.
CONTRAINDICATIONS

- as a diagnostic test for pregnancy;

- pregnancy and the period of breastfeeding;

- age under 18 years (effectiveness and safety not established);

- Hypersensitivity to megestrol or any other substance that is part of the drug.

With caution, Megesis should be used in patients with a history of thrombophlebitis.

PREGNANCY AND LACTATION

Contraindication: pregnancy and the period of breastfeeding.

APPLICATION FOR CHILDREN

Contraindication: age under 18 years (efficacy and safety not established).

APPLICATION IN ELDERLY PATIENTS

Elderly patients: dose adjustments are not required.

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.
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.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Keep out of the reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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