Primary Information
The Latin name of the product Djufaston z
Duphaston Z
ATX
G03DB01 Dydrogesterone
Pharmacological group
Estrogens, progestins, and their homologues and antagonists
Nosological classification (ICD-10)
N80 Endometriosis
N91 Absence of menstruations, scarce and rare menstruation
N93 Other abnormal bleeding from the uterus and vagina
N94.3 Syndrome premenstrual tension
N94.6 Dysmenorrhea unspecified
N95.1 menopausal and menopausal the status of women
N96 Habitual abortion
N97 Female infertility
O20.0 Threatened abortion
Composition and form of issue
Tablets, film-coated 1 tab.
10 mg dydrogesterone
excipients: lactose monohydrate; hypromellose; corn starch; colloidal silicon dioxide; magnesium stearate.
shell: Opadry white Y-1-7000 (hypromellose, polyethylene glycol 400, titanium dioxide (E171)
blistere in 20 pcs.; in a cardboard box one blister.
A description of the dosage form
Round, convexoconvex tablets white, with bevelled edges, film-coated, with the engraving "S" on the sign of the "6" on one side of the tablet, scored and the mark "155" on both sides of the risks on the other.
Pharmacological action
The drugs - progestin.
The Pharmacokinetics Of
After intake of dydrogesterone is rapidly absorbed from the digestive TRACT, Cmax in plasma achieved in two hours. Linking plasma protein is 97%. Metabolism in the liver occurs by gidrauxilirovania ketone groups of the 20-th of the carbon atom. Along with this, there has also been a hydroxylation of methyl groups of the 21st carbon atom and in a very small volume - 16-α carbon atom. With urine output from 56 to 79%; within 24 hours to return approximately 85% in 72 hours the process of removing virtually ends. Information about the delay or strengthening actions dydrogesterone with limited kidney function today is not reported. Metabolites found in the urine mainly in the form of kongugatov glukuronova acid. Presence in the urine unchanged substance is not found.
Pharmacodynamics
Djufaston z (dydrogesterone) is a progestogen, active by ingestion. Dydrogesterone by their molecular structure, chemical and pharmacological properties very similar to the natural progesterone. In connection with the fact that dydrogesterone is not a derivative of testosterone, it has no side-effects, characteristic for the majority of synthetic progestogen, the so-called. "Androgenic" progestagens. Dydrogesterone has no estrogenic, androgenic and anabolic, glukokortikoidna and thermogenic activity. Acting in the role of progestagen component of hormone replacement therapy (HRT) in postmenopausal, dydrogesterone contributes to preservation of the favorable effect of estrogen on the lipid profile blood. However, unlike estrogen, which usually have a negative influence on blood coagulation system, dydrogesterone has no effect on parameters of coagulation. Not have a negative impact on carbohydrate metabolism and function of the liver. Dydrogesterone for peroral use of selective effect on the endometrium, thereby preventing an increased risk of endometrial hyperplasia and / or carcinogenesis in conditions of excess estrogen. It is shown in all cases, the endogenous progesterone deficiency. The drug has no contraceptive effect. In the treatment of dydrogesterone therapeutic effect is achieved without the suppression of ovulation or impaired menstrual function. Dydrogesterone makes possible the conception and the preservation of pregnancy during treatment.
Indications of the drug Djufaston z
Progesterone insufficiency: endometriosis; infertility due to luteal insufficiency; the usual and threatening miscarriage in the background of the established deficiency of progesterone, premenstrual syndrome, dysmenorrhea, irregular menstruation, secondary amenorrhea (in combination with estrogen therapy), dysfunctional uterine bleeding.
HRT: to neutralize the proliferative action of estrogen on the endometrium in the framework of HRT in women with disorders caused by natural or surgical menopause with intact uterus.
Contraindications
Hypersensitivity to dydrogesterone or other components of the preparation.
With care - skin itch during the previous pregnancy.
At the present time there are no data about negative effect of dydrogesterone in patients with chronic renal insufficiency.
Application of pregnancy and breastfeeding
The drug may be used during pregnancy (see box, "Submissions"). Dydrogesterone excreted in human milk; therefore breast-feeding during a drug is not recommended.
Side effects of the drug Djufaston z
From the hematopoietic system: in a few cases, hemolytic anemia.
On the part of the immune system: in very rare cases, hypersensitivity reactions.
CNS: headache / migraine.
From the side of the hepatobiliary system: rarely - minor violations of the liver, sometimes accompanied by weakness and malaise, jaundice, pain in the abdomen.
On the part of the reproductive system: in rare cases, you may experience breakthrough bleeding, which can prevent an increase in the dose; hypersensitivity of the mammary glands.
Of the skin and subcutaneous tissue: seldom - skin rash, itching, urticaria; rarely - angioedema.
General disorders: very rarely - peripheral edema.
Interaction
Induktora mikrosomaionah liver enzymes (phenobarbital, rifampicin) may accelerate the metabolism of dydrogesterone and to reduce the effect.
Overdose
Messages about the symptoms of the overdose have not been registered. Casual admission to the dose of, much higher than the therapeutic, gastric lavage is recommended.
Treatment: symptomatic. Specific antidote exists.
Way of application and dosage
Inside. Endometriosis: 10 mg 2-3 times a day, from 5 to 25 day of the cycle or continuous.
Infertility (due to luteal insufficiency): 10 mg / day, from the 14th to the 25th day of the cycle, the course of conduct continuously for a period of six consecutive cycles and more; it is recommended to continue treatment in the first months of pregnancy (as in habitual abortion).
Threatened abortion: 40 mg once, and then on the 10 mg every eight hours before the disappearance of symptoms.
Habitual abortion: 10 mg twice a day up to 20 weeks of pregnancy, followed by a gradual decrease in dose.
Premenstrual syndrome: 10 mg twice a day from the 11th to the 25th day of the cycle.
Dysmenorrhea: 10 mg twice a day from 5 to 25 day of the cycle.
Irregular menstruation: 10 mg twice a day from the 11th to the 25th day of the cycle.
Amenorrhea: estrogen - one time per day from 1 to 25 of the day, Djufaston z-10 mg twice a day from the 11th to the 25th day of the cycle.
Dysfunctional uterine bleeding: to stop the bleeding - to 10 mg twice a day for 5-7 days; for the prevention of bleeding - to 10 mg twice a day from the 11th to the 25th day of the cycle.
HRT in conjunction with estrogens: with the continuous scheme of receiving estrogen - 10 mg Djufastona z 1 once a day for 14 days in the framework of the 28-day cycle. During cyclic scheme of reception of estrogen: Djufaston z-10 mg once a day in the last 12 to 14 days of receiving estrogens. If the biopsy or ULTRASOUND are indicative of a lack of reaction to progestogenic the drug, dydrogesterone daily dose should be increased to 20 mg.
Special instructions
Some patients may experience breakthrough bleeding, which prevent by increasing the dose of the drug. In the case of the appointment of dydrogesterone in combination with estrogen (for example, for HRT) should carefully read the contraindications and warnings related to the use of estrogen. Before the beginning of a combination of dydrogesterone and estrogen (HRT) should be collected the complete history. During the treatment it is recommended to periodically carry out the control of individual tolerance of HRT. The patient should be informed of any changes in the mammary glands she should inform the doctor or the nurse. Investigations, including mammography, should be carried out in accordance with the generally accepted screening of patients. For women receiving HRT, a precise assessment of risks and benefits is assessed over time. Sometimes during the first months of treatment you may experience breakthrough bleeding. If breakthrough bleeding occur after a certain period of reception of a preparation or continue after the course of treatment, should examine the cause, to make endometrial biopsy to exclude malignant changes in the uterine lining.
Conditions under which must be observed: patients should be carefully examined in the presence of the history of progesteronzavisimoy tumors (such as meningiomas), and also in case of its progression during pregnancy or during the preceding hormonal therapy.
Other conditions: patients with a genetically determined galactose intolerance, lactase deficiency syndrome or malabsorption should not take this drug.
The drug does not affect the ability to control the car and other mechanisms.
Duphaston Z
ATX
G03DB01 Dydrogesterone
Pharmacological group
Estrogens, progestins, and their homologues and antagonists
Nosological classification (ICD-10)
N80 Endometriosis
N91 Absence of menstruations, scarce and rare menstruation
N93 Other abnormal bleeding from the uterus and vagina
N94.3 Syndrome premenstrual tension
N94.6 Dysmenorrhea unspecified
N95.1 menopausal and menopausal the status of women
N96 Habitual abortion
N97 Female infertility
O20.0 Threatened abortion
Composition and form of issue
Tablets, film-coated 1 tab.
10 mg dydrogesterone
excipients: lactose monohydrate; hypromellose; corn starch; colloidal silicon dioxide; magnesium stearate.
shell: Opadry white Y-1-7000 (hypromellose, polyethylene glycol 400, titanium dioxide (E171)
blistere in 20 pcs.; in a cardboard box one blister.
A description of the dosage form
Round, convexoconvex tablets white, with bevelled edges, film-coated, with the engraving "S" on the sign of the "6" on one side of the tablet, scored and the mark "155" on both sides of the risks on the other.
Pharmacological action
The drugs - progestin.
The Pharmacokinetics Of
After intake of dydrogesterone is rapidly absorbed from the digestive TRACT, Cmax in plasma achieved in two hours. Linking plasma protein is 97%. Metabolism in the liver occurs by gidrauxilirovania ketone groups of the 20-th of the carbon atom. Along with this, there has also been a hydroxylation of methyl groups of the 21st carbon atom and in a very small volume - 16-α carbon atom. With urine output from 56 to 79%; within 24 hours to return approximately 85% in 72 hours the process of removing virtually ends. Information about the delay or strengthening actions dydrogesterone with limited kidney function today is not reported. Metabolites found in the urine mainly in the form of kongugatov glukuronova acid. Presence in the urine unchanged substance is not found.
Pharmacodynamics
Djufaston z (dydrogesterone) is a progestogen, active by ingestion. Dydrogesterone by their molecular structure, chemical and pharmacological properties very similar to the natural progesterone. In connection with the fact that dydrogesterone is not a derivative of testosterone, it has no side-effects, characteristic for the majority of synthetic progestogen, the so-called. "Androgenic" progestagens. Dydrogesterone has no estrogenic, androgenic and anabolic, glukokortikoidna and thermogenic activity. Acting in the role of progestagen component of hormone replacement therapy (HRT) in postmenopausal, dydrogesterone contributes to preservation of the favorable effect of estrogen on the lipid profile blood. However, unlike estrogen, which usually have a negative influence on blood coagulation system, dydrogesterone has no effect on parameters of coagulation. Not have a negative impact on carbohydrate metabolism and function of the liver. Dydrogesterone for peroral use of selective effect on the endometrium, thereby preventing an increased risk of endometrial hyperplasia and / or carcinogenesis in conditions of excess estrogen. It is shown in all cases, the endogenous progesterone deficiency. The drug has no contraceptive effect. In the treatment of dydrogesterone therapeutic effect is achieved without the suppression of ovulation or impaired menstrual function. Dydrogesterone makes possible the conception and the preservation of pregnancy during treatment.
Indications of the drug Djufaston z
Progesterone insufficiency: endometriosis; infertility due to luteal insufficiency; the usual and threatening miscarriage in the background of the established deficiency of progesterone, premenstrual syndrome, dysmenorrhea, irregular menstruation, secondary amenorrhea (in combination with estrogen therapy), dysfunctional uterine bleeding.
HRT: to neutralize the proliferative action of estrogen on the endometrium in the framework of HRT in women with disorders caused by natural or surgical menopause with intact uterus.
Contraindications
Hypersensitivity to dydrogesterone or other components of the preparation.
With care - skin itch during the previous pregnancy.
At the present time there are no data about negative effect of dydrogesterone in patients with chronic renal insufficiency.
Application of pregnancy and breastfeeding
The drug may be used during pregnancy (see box, "Submissions"). Dydrogesterone excreted in human milk; therefore breast-feeding during a drug is not recommended.
Side effects of the drug Djufaston z
From the hematopoietic system: in a few cases, hemolytic anemia.
On the part of the immune system: in very rare cases, hypersensitivity reactions.
CNS: headache / migraine.
From the side of the hepatobiliary system: rarely - minor violations of the liver, sometimes accompanied by weakness and malaise, jaundice, pain in the abdomen.
On the part of the reproductive system: in rare cases, you may experience breakthrough bleeding, which can prevent an increase in the dose; hypersensitivity of the mammary glands.
Of the skin and subcutaneous tissue: seldom - skin rash, itching, urticaria; rarely - angioedema.
General disorders: very rarely - peripheral edema.
Interaction
Induktora mikrosomaionah liver enzymes (phenobarbital, rifampicin) may accelerate the metabolism of dydrogesterone and to reduce the effect.
Overdose
Messages about the symptoms of the overdose have not been registered. Casual admission to the dose of, much higher than the therapeutic, gastric lavage is recommended.
Treatment: symptomatic. Specific antidote exists.
Way of application and dosage
Inside. Endometriosis: 10 mg 2-3 times a day, from 5 to 25 day of the cycle or continuous.
Infertility (due to luteal insufficiency): 10 mg / day, from the 14th to the 25th day of the cycle, the course of conduct continuously for a period of six consecutive cycles and more; it is recommended to continue treatment in the first months of pregnancy (as in habitual abortion).
Threatened abortion: 40 mg once, and then on the 10 mg every eight hours before the disappearance of symptoms.
Habitual abortion: 10 mg twice a day up to 20 weeks of pregnancy, followed by a gradual decrease in dose.
Premenstrual syndrome: 10 mg twice a day from the 11th to the 25th day of the cycle.
Dysmenorrhea: 10 mg twice a day from 5 to 25 day of the cycle.
Irregular menstruation: 10 mg twice a day from the 11th to the 25th day of the cycle.
Amenorrhea: estrogen - one time per day from 1 to 25 of the day, Djufaston z-10 mg twice a day from the 11th to the 25th day of the cycle.
Dysfunctional uterine bleeding: to stop the bleeding - to 10 mg twice a day for 5-7 days; for the prevention of bleeding - to 10 mg twice a day from the 11th to the 25th day of the cycle.
HRT in conjunction with estrogens: with the continuous scheme of receiving estrogen - 10 mg Djufastona z 1 once a day for 14 days in the framework of the 28-day cycle. During cyclic scheme of reception of estrogen: Djufaston z-10 mg once a day in the last 12 to 14 days of receiving estrogens. If the biopsy or ULTRASOUND are indicative of a lack of reaction to progestogenic the drug, dydrogesterone daily dose should be increased to 20 mg.
Special instructions
Some patients may experience breakthrough bleeding, which prevent by increasing the dose of the drug. In the case of the appointment of dydrogesterone in combination with estrogen (for example, for HRT) should carefully read the contraindications and warnings related to the use of estrogen. Before the beginning of a combination of dydrogesterone and estrogen (HRT) should be collected the complete history. During the treatment it is recommended to periodically carry out the control of individual tolerance of HRT. The patient should be informed of any changes in the mammary glands she should inform the doctor or the nurse. Investigations, including mammography, should be carried out in accordance with the generally accepted screening of patients. For women receiving HRT, a precise assessment of risks and benefits is assessed over time. Sometimes during the first months of treatment you may experience breakthrough bleeding. If breakthrough bleeding occur after a certain period of reception of a preparation or continue after the course of treatment, should examine the cause, to make endometrial biopsy to exclude malignant changes in the uterine lining.
Conditions under which must be observed: patients should be carefully examined in the presence of the history of progesteronzavisimoy tumors (such as meningiomas), and also in case of its progression during pregnancy or during the preceding hormonal therapy.
Other conditions: patients with a genetically determined galactose intolerance, lactase deficiency syndrome or malabsorption should not take this drug.
The drug does not affect the ability to control the car and other mechanisms.
