Estrocad suppositories 0.5mg, No. 10
Russian Pharmacy name:
Эстрокад суппозитории 0,5мг, №10
hormone replacement therapy (HRT) for the treatment of atrophy of the mucous membrane of the lower urinary tract associated with estrogen deficiency;
pre- and postoperative therapy in postmenopausal women with surgical interventions by vaginal access;
for diagnostic purposes with unclear results of a vaginal smear against the background of atrophic changes.
The drug should be used at 1 supp. / Day (the dose cannot be exceeded) The suppository is inserted deep into the vagina in the evening before bedtime.
Atrophy of the mucous membrane of the lower parts of the urogenital tract - 0.5 mg / day (1 suppository) daily for the first 2-3 weeks, then gradually reduce the dose, based on symptoms, to 0.5 mg / day (1 suppository) 2 times a week.
Pre- and postoperative therapy in postmenopausal women - 0.5 mg / day (1 suppository) for 2 weeks before and after surgery.
As a diagnostic tool - 0.5 mg / day (1 suppository) every other day for a week before taking the next smear.
Active substance:
Estriol - 500 mcg
Excipients:
witepsol S 51: solid fat,
macrogol cetostearyl ether,
glyceryl monodiricinoleate.
.estrogen-dependent malignant neoplasms of the uterus or mammary glands or suspicion of them;
vaginal bleeding of unknown etiology;
thrombophlebitis or thromboembolic diseases in the active phase;
untreated endometrial hyperplasia;
previous idiopathic or currently present venous thromboembolism (deep vein thrombosis, pulmonary embolism);
active or recent arterial thromboembolism (including angina pectoris, myocardial infarction);
a history of acute liver disease or a history of liver disease until liver function tests return to normal;
porphyria;
pregnancy;
lactation period;
hypersensitivity to estriol or other components of the drug.
The drug should be used with caution in thrombophlebitis, thrombosis or thromboembolism with a history of estrogen use; familial hyperlipoproteinemia, pancreatitis, endometriosis, a history of gallbladder disease (especially cholelithiasis), severe liver failure, jaundice (including a history of previous pregnancy), leiomyoma, a history of thromboembolism, or risk factors for its development tumors, incl. 1 degree of heredity of breast cancer, arterial hypertension, liver disease (including adenoma), diabetes mellitus with or without vascular involvement, migraine or severe headache, systemic lupus erythematosus, a history of endometrial hyperplasia, epilepsy, bronchial asthma, otosclerosis ...
Dosage form:
Vaginal suppositories
Description:
Vaginal suppositories, white, homogeneous, odorless.
Composition:
Active substance:
Estriol - 500 mcg
Excipients:
witepsol S 51: solid fat,
macrogol cetostearyl ether,
glyceryl monodiricinoleate.
Clinical and pharmacological group: Estrogen drug
Pharmaco-therapeutic group: Estrogen
pharmachologic effect
Estriol is an estrogen synthesized in the human body. Once in the bloodstream, it forms a complex with specific receptors (in the uterus, vagina, urethra, mammary gland, liver, hypothalamus, pituitary gland), stimulates the synthesis of DNA and proteins.
It has a selective effect, mainly on the cervix, vagina, vulva, causes an increase in the proliferation of the epithelium of the vagina and cervix, stimulates its blood supply, promotes the restoration of the epithelium during its atrophic changes during premenopause and menopause, normalizes the pH of the vaginal environment, vaginal microflora, increases its resistance epithelium to infectious and inflammatory processes, affects the quality and quantity of cervical mucus. The effect on the endometrium is negligible (low risk of uterine bleeding).
It has a hypolipidemic effect, slightly increases the concentration of beta-lipoproteins in the blood, increases sensitivity to the action of insulin, improves glucose utilization, stimulates the liver's production of globulins that bind sex hormones, renin, HDL and blood coagulation factors.
Due to its participation in the implementation of positive and negative feedback in the hypothalamic-pituitary-ovarian system, estriol is able to cause moderately pronounced central effects; stimulates parasympathomimetic reactions.
Pharmacokinetics
Absorption and distribution
Cmax in blood plasma with intravaginal application is achieved after 1-2 hours. Plasma protein binding is 90%.
Metabolism and excretion
Excretion is carried out mainly in the urine in the form of metabolites (a few hours after application and lasts up to 18 hours), 2% is excreted in the feces unchanged.
Indications
hormone replacement therapy (HRT) for the treatment of atrophy of the mucous membrane of the lower urinary tract associated with estrogen deficiency;
pre- and postoperative therapy in postmenopausal women with surgical interventions by vaginal access;
for diagnostic purposes with unclear results of a vaginal smear against the background of atrophic changes.
Dosage regimen
The drug should be used at 1 supp. / Day (the dose cannot be exceeded) The suppository is inserted deep into the vagina in the evening before bedtime.
Atrophy of the mucous membrane of the lower parts of the urogenital tract - 0.5 mg / day (1 suppository) daily for the first 2-3 weeks, then gradually reduce the dose, based on symptoms, to 0.5 mg / day (1 suppository) 2 times a week.
Pre- and postoperative therapy in postmenopausal women - 0.5 mg / day (1 suppository) for 2 weeks before and after surgery.
As a diagnostic tool - 0.5 mg / day (1 suppository) every other day for a week before taking the next smear.
Side effect
From the endocrine system: sometimes - at the beginning of treatment, intermenstrual smearing vaginal discharge, soreness, sensitivity and an increase in the size of the mammary glands, hypersecretion of cervical mucus, vaginal discharge, temporary increase in body weight due to fluid retention are possible.
From the digestive system: sometimes - intestinal or biliary colic, jaundice, nausea, flatulence, anorexia, diarrhea.
Local reactions: sometimes - irritation in the vaginal area, accompanied by itching, burning, feeling of heat and redness.
Others: rarely - migraine-like headache; very rarely - a feeling of heaviness in the legs, cramps of the calf muscles.
Side effects associated with the endocrine system may indicate an overdose of the drug and, as a result, usually disappear after a dose reduction.
Contraindications
estrogen-dependent malignant neoplasms of the uterus or mammary glands or suspicion of them;
vaginal bleeding of unknown etiology;
thrombophlebitis or thromboembolic diseases in the active phase;
untreated endometrial hyperplasia;
previous idiopathic or currently present venous thromboembolism (deep vein thrombosis, pulmonary embolism);
active or recent arterial thromboembolism (including angina pectoris, myocardial infarction);
a history of acute liver disease or a history of liver disease until liver function tests return to normal;
porphyria;
pregnancy;
lactation period;
hypersensitivity to estriol or other components of the drug.
The drug should be used with caution in thrombophlebitis, thrombosis or thromboembolism with a history of estrogen use; familial hyperlipoproteinemia, pancreatitis, endometriosis, a history of gallbladder disease (especially cholelithiasis), severe liver failure, jaundice (including a history of previous pregnancy), leiomyoma, a history of thromboembolism, or risk factors for its development tumors, incl. 1 degree of heredity of breast cancer, arterial hypertension, liver disease (including adenoma), diabetes mellitus with or without vascular involvement, migraine or severe headache, systemic lupus erythematosus, a history of endometrial hyperplasia, epilepsy, bronchial asthma, otosclerosis ...
Application during pregnancy and lactation
The use of the drug during pregnancy and during breastfeeding is contraindicated.
Application for violations of liver function
The drug should be used with caution in case of a history of gallbladder disease (especially cholelithiasis), severe hepatic failure, jaundice (including a history of a previous pregnancy), hepatic porphyria.
special instructions
The use of EstrocadЃ vaginal suppositories should be carried out exclusively under the regular supervision of a physician. Before starting admission and every 6 months of treatment, a thorough general medical and gynecological examination, including examination of the mammary glands, is recommended.
It is necessary to cancel the use of the drug EstrocadЃ when a migraine-like headache appears for the first time or with repeated unusually severe headaches, the first signs of phlebitis or thromboembolic symptoms, such as local redness, swelling and pain, with the onset of jaundice, increased blood pressure and acute visual impairment, and consult a doctor.
Overdose
Overdose is unlikely.
Symptoms (if accidentally ingested): nausea, vomiting, withdrawal bleeding.
Treatment: symptomatic. There is no specific antidote.
Drug interactions
With the simultaneous use of Estrocad with barbiturates, antiepileptic drugs (including carbamazepine, phenytoin), the metabolism of steroid hormones increases, which can lead to a decrease in the effectiveness of estriol.
With the simultaneous use of Estrocad with antibiotics (including ampicillin, rifampicin), drugs for general anesthesia, opioid analgesics, anxiolytics, some antihypertensive drugs, ethanol, the effectiveness of estriol decreases.
With the simultaneous use of estriol enhances the effect of lipid-lowering drugs.
With the simultaneous use of estriol weakens the effects of male sex hormones, anticoagulants, antidepressants, diuretic, antihypertensive and hypoglycemic drugs.
With the simultaneous use of folic acid and thyroid preparations increase the effect of estriol.
Storage conditions
The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25 ? C.
Shelf life
Shelf life is 3 years.
Terms of sale
The drug is approved for use as a means of OTC.