Composition, form of production and packaging
Tablets, film-coated 1 tab.
Estradiol 2 mg
norethisterone acetate 1 mg
28 pcs. - packings of cellular contour (1) - packs cardboard.
28 pcs. - packings cellular planimetric (3) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2005.
PHARMACHOLOGIC EFFECT
Monophasic drug for hormone replacement therapy. Pausogest is a combination of estrogen and progestogen. The drug replenishes the lack of female sex hormones during the postmenopause. Pazogeste suppresses vegetative-vascular, psychoemotional and other climacteric estrogen-dependent symptoms during the postmenopause, prevents the development of hyperplastic endometrial processes, prevents the reduction of bone mass and osteoporosis.
PHARMACOKINETICS
Suction
Estradiol and norethisterone acetate are absorbed from the digestive tract.
Metabolism
Metabolised in the liver.
Excretion
Isolate with urine in the form of metabolites and in small amounts - unchanged with feces.
INDICATIONS
- hormone replacement therapy in the post-menopausal period;
- prevention of postmenopausal osteoporosis.
DOSING MODE
Each package is designed for 28 days of admission. Treatment is carried out continuously, starting taking the tablets from the next package immediately after the completion of the previous one. Assign 1 tablet / day.
The duration of therapy with Pausogest is determined by the attending physician depending on the clinical situation. Therapy should be started no earlier than one year after the onset of menopause.
SIDE EFFECT
On the part of the endocrine and reproductive systems: in the first few months of treatment - menstrual bleeding; engorgement of the mammary glands, nausea, headache, peripheral edema.
From the cardiovascular system: rarely - thrombosis, thromboembolism (with prolonged admission).
Other: visual impairment, skin reactions, breast diseases.
CONTRAINDICATIONS
pregnancy or suspected pregnancy;
- Malignant breast tumors (or suspected of them) or their presence in the anamnesis;
- an estrogen-dependent tumor (eg, endometrial carcinoma) or suspected of it;
- acute or chronic liver disease or a history of liver disease;
- kidney disease;
- deep vein thrombosis of the lower extremities, thromboembolic diseases;
- cerebrovascular disorders or the presence of these diseases in the anamnesis;
- abnormal vaginal bleeding of unknown etiology;
- hemoglobinopathy;
- porphyria;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in diseases of the kidneys.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in acute or chronic liver disease or in the presence of a history of liver disease.
SPECIAL INSTRUCTIONS
Before starting treatment, it is necessary to collect a family history and conduct a thorough medical examination, including measurement of blood pressure, examination of mammary glands and abdominal cavity, gynecological examination.
Patients who received previous therapy with estrogens should be carefully screened for the purpose of identifying endometrial hyperplasia.
With prolonged use of the drug, the examination should be carried out at least once a year.
In the first months of taking the drug, transient menstrual bleeding may appear. If these bleedings last a long time, it is necessary to perform diagnostic scraping or aspiration biopsy to exclude a possible malignant process of the endometrium.
Immediately discontinue therapy if the following side effects occur:
deep vein thrombosis, incl. thromboembolic complications;
-development of jaundice;
-appearance of migraine-like headache;
-Sudden deterioration or visual impairment;
-expressive increase in blood pressure.
Long-term therapy for the prevention of osteoporosis should be performed in those women who have a high risk of bone fracture. In patients who receive antihypertensive therapy in combination with hormonal therapy, it is necessary to regularly monitor blood pressure.
Patients with epilepsy, migraine, diabetes mellitus, bronchial asthma or cardiovascular diseases should be observed with great care, because Estrogens can worsen the course of these diseases.
4-6 weeks before surgery, discontinue therapy with the drug.
OVERDOSE
With proper use of the drug, an overdose is impossible.
Symptoms: nausea, vomiting, uterine bleeding are possible.
Treatment: there is no specific antidote. If necessary, conduct symptomatic therapy.
DRUG INTERACTION
When used simultaneously with inducers of hepatic enzymes, estrogen metabolism increases and the effectiveness of Pausogest decreases.
Means for anesthesia, opioid analgesics, some antihypertensives, ethanol reduce the effectiveness of the drug.
With a simultaneous appointment, you may need to adjust the dosage of hypoglycemic drugs.
The drug interaction is proven by the joint use of the drug Pausogest with barbiturates, phenytoin, rifampicin and carbamazepine.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored at a temperature of 15 В° to 30 В° C out of the reach of children. Shelf life - 3 years.
Conditions of leave from pharmacies
The drug is released prescription.
