Instructions for Femoston 1 (Estradiol, Dydrogesterone) 28 pills
English Product Name
Femoston® 1
Dosage form:
Set of film-coated tablets
Description:
A set of film-coated tablets of two types.
Film-coated tablets of white color, round, biconcave, engraved "379" on one side; type of tablets on a cross-section: white, rough surface (14 pcs. in a blister).
1 tab.
estradiol hemihydrate 1.03 mg,
which corresponds to the content of estradiol 1 mg
Excipients:
lactose monohydrate - 119.1 mg, hypromellose (HPMC 2910) - 2.8 mg, corn starch - 15 mg, silicon dioxide colloidal - 1.4 mg, magnesium stearate - 0.7 mg.
Composition Femoston of the film shell:
Opadrai® Y-1-7000 white (hypromellose (HPMC 2910) - 62.5%, titanium dioxide (E171) - 31.25%, macrogol 400 - 6.25%) - 4 mg.
Film-coated tablets of gray color, round, biconcave, engraved "379" on one side; type of tablets on a cross-section: white, rough surface (14 pcs. in a blister).
estradiol hemihydrate 1.03 mg,
which corresponds to the content of estradiol 1 mg
Dydrogesterone 10 mg
Excipients:
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.
Composition of the film shell:
Opadrai® II 85F27664 gray (polyvinyl alcohol - 40%,
titanium dioxide (E171) - 23.2%,
macrogol 3350 - 20.2%,
talc - 14.8%,
iron oxide black dye (E172) - 1.8%) - 4 mg.
ATC Codes
G03FB08 Dydrogesterone and Estrogen
Clinical and pharmacological groups / Group affiliation
Antimenopausal drug
Active ingredient Femoston
dydrogesterone
Estradiol
Pharmaco-therapeutic group:
Antimenopausal agent combined (estrogen + gestagen)
Storage conditions Femoston:
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 Femoston:
The drug is taken daily, in a continuous mode of 1 tabb. / 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.
Use in renal dysfunction
With caution, the drug should be taken in patients with renal insufficiency.
Use in case of impaired liver function
Contraindicated in acute or chronic liver diseases at present or in a history (until the normalization of liver function tests), incl. malignant liver tumors.
Terms of implementation Femoston
The drug is dispensed by prescription.
Use in elderly patients
The experience of using the drug in women over 65 years of age is limited.
- Nosology (ICD codes)
- M80.0
- Postmenopausal osteoporosis with pathological fracture
- M80.1
- Osteoporosis with pathological fracture after removal of the ovaries
- 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
Estradiol, which is part of the drug Femoston® 1, is identical to endogenous human estradiol, which is the most active estrogen.
Estradiol replenishes the deficiency of estrogens in the female body in perimenopause (at the beginning of therapy no earlier than 6 months after the last menstruation) and in postmenopause, and reduces the severity of clinical manifestations of postmenopause during the first weeks of treatment.
Hormone replacement therapy (HRT) with Femoston® 1 prevents bone loss in the postmenopausal period or after ovarioectomy.
Dydrogesterone is a progestogen that is effective when taken orally and has activity similar to parenterally administered progesterone.
