The tablets covered with a cover of white color, round, biconcave, with bevelled edges, with a risk on one side, with engraving "155" on both sides of the risks.
dydrogesterone 10 mg
Excipients: lactose monohydrate - 111.1 mg, hypromellose - 2.8 mg, corn starch - 14 mg, silicon dioxide colloid - 1.4 mg, magnesium stearate - 700 Ојg.
Composition of the shell: opadray white Y-1-7000 (hypromellose, polyethylene glycol 400, titanium dioxide (E171)) - 4 mg.
20 pcs. - blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
Dydrogesterone in its molecular structure, chemical and pharmacological properties is very close to natural progesterone. Due to the fact that dydrogesterone is not a derivative of testosterone, it does not have the side effects characteristic of most synthetic progestogens, the so-called androgenic progestogens.
Dydrogesterone does not possess estrogenic, androgenic, anabolic, glucocorticoid and thermogenic activity. As a progestogen component of hormone replacement therapy (HRT) in menopause, dydrogesterone helps maintain the beneficial effect of estrogens on the lipid profile of the blood. However, unlike estrogens, which usually negatively affect the blood coagulation system, dydrogesterone does not affect the coagulation indicators. Does not have a negative effect on the metabolism of carbohydrates and liver function.
Dydrogesterone, when administered orally, selectively affects the endometrium, thereby preventing an increased risk of endometrial hyperplasia and / or carcinogenesis in conditions of excess estrogen. It is indicated in all cases of endogenous progesterone deficiency.
The drug has no contraceptive effect.
In the treatment of dydrogesterone therapeutic effect is achieved without suppression of ovulation or menstrual dysfunction. Dydrogesterone makes it possible to conceive and maintain pregnancy during treatment.
After ingestion, dydrogesterone is rapidly absorbed from the digestive tract. C max in plasma is achieved 2 hours after ingestion.
Binding to plasma proteins is 97%.
Dydrogesterone is metabolized in the liver by hydroxylating the ketone groups of the 20th carbon atom. Along with this, hydroxylation of the methyl groups of the 21-carbon atom was also observed, and in a very small volume of 16-? carbon atom.
It is excreted in the urine from 56 to 79%, mainly in the form of conjugates of glucuronic acid. The presence of unchanged substance was not detected. After 24 hours, approximately 85% is output, after 72 hours the elimination process is almost complete.
Pharmacokinetics in special clinical cases
Data on the delay in the body or the increase in the action of dydrogesterone in patients with impaired renal function have not been reported.
Conditions characterized by a deficiency of progesterone:
infertility due to luteal insufficiency;
- Threatening or habitual miscarriage (with progesterone deficiency);
- premenstrual syndrome;
- dysmenorrhea, irregular menstruation;
- Secondary amenorrhea (in complex therapy with estrogens);
- dysfunctional uterine bleeding.
Hormone replacement therapy
- to neutralize the proliferative effect of estrogens on the endometrium within the framework of hormone replacement therapy in women with disorders due to natural or surgical menopause in the intact uterus.
The drug is taken orally.
When endometriosis is prescribed for 10 mg 2-3 times / day from the 5th to the 25th day of the cycle or continuously.
Infertility (due to luteal insufficiency) - 10 mg / day from the 14th to the 25th day of the cycle. Treatment should be continued continuously for at least 6 consecutive cycles. Treatment is recommended to continue in the first months of pregnancy as recommended in the usual abortion.
When threatening abortion, 40 mg once, then 10 mg every 8 hours until the symptoms disappear.
With the usual miscarriage the drug is prescribed for 10 mg 2 times / day until the 20th week of pregnancy, followed by a gradual decrease in the dose.
With premenstrual syndrome - 10 mg 2 times / day from the 11th to the 25th day of the cycle.
With dysmenorrhea - 10 mg 2 times / day from the 5th to the 25th day of the cycle.
With irregular menstruation - 10 mg 2 times / day from the 11th to the 25th day of the cycle.
In amenorrhea, estrogens are prescribed 1 time / day from the 1st to the 25th day of the cycle together with Dufaston - 10 mg 2 times / day from the 11th to the 25th day of the cycle.
To stop dysfunctional uterine bleeding appoint Dufaston В® 10 mg 2 times / day for 5-7 days.
To prevent dysfunctional uterine bleeding appoint Dufaston В® 10 mg 2 times / day from the 11th to the 25th day of the cycle.
With hormone replacement therapy in combination with continuous estrogen therapy, Dufaston В® is prescribed 10 mg once a day for 14 days within a 28-day cycle.With a cyclic regimen of estrogen administration, Duphaston В® is given at a dose of 10 mg 1 time / day during the last 12-14 days of estrogen administration.
If a biopsy or ultrasound testifies to an inadequate response to a progestagenic drug, the daily dose should be increased to 20 mg.
From the hemopoietic system: in isolated cases - hemolytic anemia.
From the immune system: in very rare cases - hypersensitivity reactions.
From the side of the central nervous system: headache, migraine.
From the hepatobiliary system: rarely - minor violations of the liver, sometimes accompanied by weakness or malaise, jaundice or pain in the abdominal region.
On the part of the reproductive system: in rare cases - breakthrough uterine bleeding (which can be prevented by increasing the dose); hypersensitivity of mammary glands.
From the skin and subcutaneous tissue: allergic reactions, such as skin rash, itching, urticaria; very rarely - Quincke's edema.
Other: very rarely - peripheral edema.
- hypersensitivity to dydrogesterone or other components of the drug.
Caution should be given to the drug with a history of skin pruritus during an earlier pregnancy.
PREGNANCY AND LACTATION
It is possible to use Dufaston during pregnancy according to the indications.
Dydrogesterone is excreted in breast milk. Breastfeeding during the drug is not recommended.
APPLICATION FOR FUNCTIONS OF THE LIVER
At present, there is no evidence of a negative effect of dydrogesterone in chronic renal failure.
Some patients may experience breakthrough bleeding, which can be prevented by increasing the dose of the drug.
In the case of the appointment of dydrogesterone in combination with estrogens (for example, for HRT), contraindications and warnings associated with the use of estrogens should be taken into account.
Before starting HRT, a complete history should be collected. During treatment it is recommended to periodically monitor the individual tolerability of HRT. The patient should be informed about what changes in the mammary gland she should inform the doctor. Studies involving mammography should be conducted in accordance with the generally accepted screening of patients.
When HRT is carried out, an accurate assessment of the risk and benefit is determined over time.
Sometimes, during the first months of treatment, there may be breakthrough uterine bleeding. If breakthrough bleeding occurs after a certain period of taking the drug or continues after the course of treatment, the cause should be studied, an endometrial biopsy should be done to exclude malignant changes in the endometrium.
A thorough clinical examination is required if a history of a progesterone-dependent tumor (eg, meningioma) is indicated, as well as in case of its progression during pregnancy or during previous hormonal therapy.
Do not prescribe Dufaston В® to patients with genetically determined galactose intolerance, lactase deficiency or malabsorption syndrome.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the ability to drive vehicles and control mechanisms.
To date, cases of overdose of Dufaston В® have not been reported.
Treatment: with occasional administration in a dose significantly higher than therapeutic, gastric lavage is recommended; if necessary, conduct symptomatic therapy.There is no specific antidote.
With simultaneous use with Dufaston inducers of microsomal liver enzymes (such as phenobarbital, rifampicin) can accelerate the metabolism of dydrogesterone and reduce the effectiveness of the drug.
Cases of incompatibility with other medicinal products are unknown.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored in a dry place inaccessible to children, in the original packaging at a temperature of no higher than 30 В° C. Shelf life - 5 years.
The information is provided for your information, do not self-medicate, it is dangerous for your health.