Instructions for Femoston 2 (Estradiol, Dydrogesterone) 28 pills
Release form
A set of film-coated tablets
Description:
A set of tablets covered with film sheath of two kinds.
The tablets, covered with a film shell of white color, round, double-convex, with an engraving "379" on one side; view of tablets on a cross section: white, rough surface (14 pieces in blister).
1 tab.
estradiol hemihydrate 2.06 mg,
which corresponds to estradiol content 2 mg
Auxiliary substances: lactose monohydrate - 119.1 mg, hypromellose (HPMC 2910) - 2.8 mg, cornstarch - 15 mg, silicon dioxide colloidal - 1.4 mg, magnesium stearate - 0.7 mg.
Film sheath composition:
Opadray® Y-1-7000 is white (hypromellose (HPMC 2910) - 62.5%, titanium dioxide (E171) - 31.25%, macrogol 400 - 6.25%) - 4 mg.
The tablets, covered with a film shell of gray, round, double-convex, with an engraving "379" on one side; view of tablets on a cross section: white, rough surface (14 pieces in blister).
1 tab.
estradiol hemihydrate 1.03 mg,
which corresponds to estradiol content 1 mg
didrogesteron 10 mg
Auxiliary substances:
lactose monohydrate - 110.2 mg, hypromellose (HPMC 2910) - 2.8 mg, corn starch - 13.9 mg, silicon dioxide colloidal - 1.4 mg, magnesium stearate - 0.7 mg.
Film sheath composition:
Opadray® II 85F27664 grey (polyvinyl alcohol - 40%, titanium dioxide (E171) - 23.2%, macrogol 3350 - 20.2%, talc - 14.8%, iron oxide black (E172) - 1.8%) - 4 mg.
ATC Codes
G03FB08 Dydrogesterone and Estrogen
Clinical and pharmacological groups / Group affiliation
Antimenopausal drug
Active ingredient
dydrogesterone
Estradiol
Pharmaco-therapeutic group
Antimenopausal agent combined (estrogen + gestagen)
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 30 ° C.
Shelf life
Shelf life - 3 years. Do not use after the expiration date.
Testimony:
hormone replacement therapy for estrogen deficiency disorders in perimenopausal women (not earlier than 6 months after the last menstruation) or postmenopausal women;
Prevention of postmenopausal osteoporosis in women at high risk of fractures due to intolerance or contraindications to other drugs.
Method of use, course and dosage:
The drug is taken daily, in continuous mode one tablet per day (preferably at the same time of day), regardless of the meal.
Each package is designed for a 28-day dose of the drug. In the first 14 days, 1 white tablet (half of the pack with the arrow marked "1") containing 1 mg of estradiol is taken daily, and in the remaining 14 days, 1 gray tablet (half of the pack with the arrow marked "2") containing 1 mg of estradiol and 10 mg of didrogesterone is taken daily.
Taking the drug should continue without interruption, immediately after the end of the 28-day cycle should begin the next cycle of taking the drug.
For the beginning and continuation of GST treatment of estrogen deficiency disorders, the combination of estradiol and didrogesteron + estradiol should be used at the lowest effective dose and for the shortest period of time: Continuous and consistent use of this combination should begin with the drug Femoston® 1; depending on the clinical response, the dose of hormones can be adjusted in the future according to the individual need; if estrogen deficiency complaints persist, the dose of active substances can be increased and Phemoston® 2 can be administered.
When switching from another continuous sequential or cyclic mode of the drug intake, it is necessary to finish the current cycle, and then go to the drug Femoston® 1.
For women who have not previously received a DHT or who have switched from another continuous combined DHT regimen, Femoston® 1 should be administered on any given day.
If the patient has missed the next dose, the pill must be taken within 12 hours after the usual time of administration. If more than 12 hours have passed, you should not take the tablet, and the next day you should take the tablet at normal time. Skipping the drug can increase the likelihood of "breakthrough" uterine bleeding or "smearing" blood secretions.
Application for kidney disorders
Use with caution in patients with kidney failure.
Use in liver disorders
The invention is contraindicated for acute or chronic liver diseases at present or in anamnesis (prior to normalisation of liver functional samples), including malignant liver tumors.
Terms of Sale
The drug is prescription.
Application in elderly patients
The experience of using the drug in women over 65 years is limited.
- Nosology (ICD codes)
- M80.0
- Postmenopausal osteoporosis with pathological fracture
- M80.1
- Osteoporosis with pathological fracture after ovarian removal
- M81.0
- Postmenopausal osteoporosis
- M81.1
- Osteoporosis after ovarian removal
- N95.1
- Menopause and Menopause in Women
- N95.3
- Conditions associated with artificially induced menopause
Pharmacological effect:
Estradiol, which is part of the drug Femoston® 1, is identical to human endogenous estradiol, which is the most active estrogen.
Estradiol makes up for estrogen deficiency in the female body in perimenopause (at the start of therapy not earlier than six months after the last menstruation) and in postmenopause, and reduces the clinical manifestations of postmenopause during the first weeks of treatment.
Hormone replacement therapy (SGT) with Femoston® 1 prevents bone loss in the postmenopausal period or after ovarioectomy.
Didrogesterone is a progestagen that is effective at ingestion and has similar activity to parenterally administered progesterone.
During GST, the inclusion of didrogesterone ensures a full secretory endometrial transformation, thereby reducing the risk of endometrial hyperplasia increased by the action of estrogen.
