Instructions for use UTROZHESTAN® (UTROGESTAN)

pharmachologic effect

The active ingredient of Utrozhestan® is progesterone, which is identical to the natural hormone of the corpus luteum of the ovary. By binding to receptors on the surface of cells of target organs, it penetrates into the nucleus, where, activating DNA, it stimulates RNA synthesis.

Promotes the transition of the uterine mucosa from the proliferation phase caused by the follicular hormone estradiol to the secretory phase. After fertilization, it promotes the transition to the state necessary for the development of a fertilized egg. Reduces the excitability and contractility of the muscles of the uterus and fallopian tubes. Promotes the formation of normal endometrium. Stimulates the development of the end elements of the mammary gland, induces lactation.

By stimulating protein lipase, it increases fat reserves and increases glucose utilization. By increasing the concentration of basal and stimulated insulin, it promotes the accumulation of glycogen in the liver and increases the production of gonadotropic hormones of the pituitary gland; reduces azotemia, increases nitrogen excretion in urine.

Utrozhestan

Utrozhestan is a medicine (Belgium), the active component of which is progesterone, identical to the natural hormone of the corpus luteum of the ovary.
When Utrozhestan enters a woman’s body, it provokes the process of transition of the uterine endometrium from the proliferative to the secretory phase. If fertilization has occurred, the medicine promotes the process of implantation and development of the embryo.

The maximum concentration of the active substance in the blood plasma is observed 1–3 hours after use.

Pharmacokinetics

When taken orally

Suction

Micronized progesterone is well absorbed from the gastrointestinal tract. The concentration of progesterone in the blood plasma gradually increases during the first hour, Cmax in the blood plasma is observed 1-3 hours after administration. The concentration of progesterone in the blood plasma increases from 0.13 ng/ml to 4.25 ng/ml after 1 hour, to 11.75 ng/ml after 2 hours and is 8.37 ng/ml after 3 hours, 2 ng/ml after 6 hours and 1.64 ng /ml - 8 hours after administration.

Metabolism

The main metabolites that are detected in blood plasma are 20-alpha-hydroxy-delta-4-alpha-pregnanolone and 5-alpha-dihydroprogesterone.

Removal

It is excreted in the urine in the form of metabolites, 95% of which are glucurone-conjugated metabolites, mainly 3-alpha, 5-beta-pregnanediol (pregnandione). These metabolites, which are determined in blood plasma and urine, are similar to substances formed during the physiological secretion of the corpus luteum.

With intravaginal administration

Suction and distribution

Absorption occurs quickly, a high concentration of progesterone is observed 1 hour after administration. Cmax of progesterone in blood plasma is achieved 2-6 hours after administration. When the drug is administered at a dose of 100 mg 2 times a day, the average concentration remains at the level of 9.7 ng/ml for 24 hours. When administered in doses of more than 200 mg/day, the concentration of progesterone corresponds to the first trimester of pregnancy.

Plasma protein binding is 90%. Progesterone accumulates in the uterus.

Metabolism

Metabolized to form predominantly 3-alpha, 5-beta-pregnanediol. The concentration of 5-beta-pregnanolone in the blood plasma does not increase.

Removal

It is excreted in the urine in the form of metabolites, the main part being 3-alpha, 5-beta-pregnanediol (pregnandione). This is confirmed by a constant increase in its concentration (Cmax 142 ng/ml after 6 hours).

Utrozhestan 200 mg No. 14 caps.

Instructions for medical use of the drug Utrozhestan® Trade name Utrozhestan® International nonproprietary name Progesterone Dosage form Capsules 100 mg, 200 mg Composition 1 capsule contains the active substance - natural micronized progesterone 100 mg or 200 mg excipients: soy lecithin, sunflower oil, shell composition capsules: gelatin, glycerin, titanium dioxide (E 171) Description Round soft shiny yellowish gelatin capsules containing an oily whitish homogeneous suspension (without visible phase separation) (for a dosage of 100 mg). Oval soft shiny yellowish gelatin capsules containing an oily whitish homogeneous suspension (without visible phase separation) (for a dosage of 200 mg). Pharmacotherapeutic group Sex hormones and modulators of the reproductive system. Progestogens. Derivatives of pregnene. Progesterone. ATC code G03DA04 Pharmacological properties Pharmacokinetics When taken orally, micronized progesterone is absorbed from the gastrointestinal tract. The concentration of progesterone in the blood plasma gradually increases during the first hour, the maximum concentration in the blood (Cmax) is observed 1-3 hours after administration. Communication with plasma proteins - 90%. The concentration of progesterone in the blood plasma increases from 0.13 ng/ml to 4.25 ng/ml after 1 hour, to 11.75 ng/ml after 2 hours and is 8.37 ng/ml after 3 hours, 2 ng/ml after 6 hours and 1.64 ng/ml after 8 hours. The main metabolites that are detected in blood plasma are 20-alpha-hydroxy-delta-4-alpha-pregnanolone and 5-alpha-dihydroprogesterone. Excreted in the urine in the form of metabolites, 95% of them are glucuron-conjugated metabolites, mainly 3-alpha, 5-beta-pregnanediol (pregnandione). These metabolites, which are determined in blood plasma and urine, are similar to substances formed during the physiological secretion of the corpus luteum. When administered vaginally, absorption occurs quickly, progesterone accumulates in the uterus, and a high level of progesterone in the blood plasma is observed 1 hour after administration. Cmax of progesterone in blood plasma is achieved 2-6 hours after administration. When the drug is administered at a dose of 100 mg 2 times a day, the average concentration remains at the level of 9.7 ng/ml for 24 hours. When administered in doses of more than 200 mg/day, the concentration of progesterone corresponds to the 1st trimester of pregnancy. Communication with plasma proteins - 90%. Metabolized to form predominantly 3-alpha, 5-beta-pregnanediol. Plasma 5-beta-pregnanolone levels do not increase. It is excreted in the urine in the form of metabolites, the main part being 3-alpha, 5-beta-pregnanediol (pregnandione). This is confirmed by a constant increase in its concentration (Cmax 142 ng/ml after 6 hours). Pharmacodynamics Gestagen, corpus luteum hormone. By binding to receptors on the surface of cells of target organs, it penetrates into the nucleus, where, activating DNA, it stimulates RNA synthesis. Promotes the transition of the uterine mucosa from the proliferation phase caused by follicular hormone to the secretory phase, and after fertilization - to the state necessary for the development of a fertilized egg. Reduces the excitability and contractility of the muscles of the uterus and fallopian tubes, stimulates the development of the end elements of the mammary gland. By stimulating protein lipase, it increases fat reserves, increases glucose utilization, increasing the concentration of basal and stimulated insulin, promotes the accumulation of glycogen in the liver, increases the production of pituitary gonadotropic hormones; reduces azotemia, increases nitrogen excretion in urine. Activates the growth of the secretory section of the acini of the mammary glands and induces lactation. Promotes the formation of normal endometrium. Indications for use: Progesterone-deficient conditions. Oral route of administration Gynecological: Disorders associated with progesterone deficiency: - premenstrual syndrome - menstrual irregularities with disovulation or anovulation - benign mastopathy - premenopause - menopause therapy (in addition to estrogen therapy) - infertility due to luteal insufficiency. Obstetrics: — Threat of miscarriage or prevention of habitual miscarriages due to established luteal insufficiency. Vaginal route of administration - hypofertility, primary or secondary infertility associated with partial or total luteal insufficiency (disovulation, support of the luteal phase during in vitro fertilization, oocyte donation) - threat of early miscarriage or prevention of habitual abortions associated with luteal insufficiency. Method of administration and dosage The duration of treatment is determined by the nature and characteristics of the disease. Oral route of administration The average dose is 200-300 mg of progesterone per day, divided into 1 or 2 doses, i.e. 200 mg in the evening before bed and 100 mg in the morning, if necessary. For luteal insufficiency (premenstrual syndrome, menstrual irregularities, premenopause, benign mastopathy): treatment should be carried out for 10 days per cycle, usually from the 17th to 26th days inclusive. For menopause therapy: Since estrogen therapy is not recommended alone, progesterone is added in the last two weeks of each therapeutic course, followed by cessation of any replacement treatment for approximately one week, during which abstinence bleeding may occur. If there is a threat of preterm labor: 400 mg of progesterone every 6-8 hours depending on the clinical results obtained during the acute phase, then in a maintenance dosage (for example, 3 times 200 mg per day) until the 36th week of pregnancy. Vaginal route of administration The average dose is 200 mg of progesterone per day (i.e. 1 capsule of 200 mg or two capsules of 100 mg, divided into 2 doses, 1 in the morning and 1 in the evening), which is inserted deep into the vagina, if necessary. using the applicator. The dose may be increased depending on the patient's response. For partial luteal insufficiency (disovulation, menstrual irregularities): treatment should be carried out 10 days per cycle, usually from the 17th to 26th days at the rate of 200 mg of progesterone per day. For infertility with complete luteal phase deficiency (oocyte donation): the dose of progesterone is 100 mg of progesterone on the 13th and 14th days of the transfer cycle, then 100 mg of progesterone in the morning and evening from the 15th to 25th days of the cycle. In the case of the initial stage of pregnancy, starting from the 26th day, the dose is increased from 100 mg of progesterone per day to a maximum of 600 mg of progesterone per day, divided into three doses. This dosage should be maintained until the 60th day. When supporting the luteal phase during in vitro fertilization, treatment should be carried out starting in the evening of the day of transfer, at the rate of 600 mg of progesterone in three doses - morning, afternoon and evening. If there is a threat of miscarriage or to prevent a habitual miscarriage due to luteal insufficiency, the average dosage is 200-400 mg of progesterone per day in two doses until the 12th week of pregnancy. The capsule should be inserted deep into the vagina. Side effects Often >l/100; <1/10: - menstrual irregularities - amenorrhea - intermenstrual bleeding - headaches Not often >l/1000; <1/100: - mastodynia - drowsiness - transient feeling of dizziness - vomiting - diarrhea - constipation - cholestatic jaundice - itching - acne Rarely >l/10000; <1/1000: - nausea Very rare <1/10000: - depression - urticaria - chloasma Contraindications - hypersensitivity to the active or auxiliary components of the drug - tendency to thrombosis, acute forms of phlebitis or thromboembolic diseases - bleeding from the genital tract of unknown origin - incomplete abortion - porphyria - established or suspected malignant neoplasms of the mammary glands and genital organs - impaired liver function With caution - diseases of the cardiovascular system - arterial hypertension - chronic renal failure - diabetes mellitus - bronchial asthma - epilepsy - migraine - depression - hyperlipoproteinemia - pregnancy II and III trimesters - lactation period Drug interactions During hormonal therapy of menopause with estrogen, it is necessary to prescribe progesterone for at least 12 days per cycle. Combined use with other drugs may cause increased metabolism of progesterone and a change in the effect of the drug. This happens in the cases of: - inducers of liver enzymes, such as barbiturates, antiepileptic drugs (phenytoin), rifampicin, phenylbutazone, spironolactone and griseofulvin (these drugs cause increased metabolism at the hepatic level) - some antibiotics (ampicillins, tetracyclines) cause changes in the intestinal tract microflora, the consequence of which is a change in the enterohepatic steroid cycle. Progestogens can cause a decrease in glucose tolerance, as a result of which it is necessary to increase the need for insulin or other antidiabetic drugs in a diabetic patient. The bioavailability of progesterone may be reduced in patients who smoke and with excessive alcohol consumption. Special instructions THIS IS NOT A CONTRACEPTIVE. Treatment must be carried out in accordance with existing recommendations. If treatment is started too early in the menstrual cycle, especially before the 15th day of the cycle, a shortening of the cycle or bleeding may occur. In case of uterine bleeding, the drug should not be prescribed until the cause is determined (for example, examination of the uterine cavity). Due to thromboembolic and metabolic risks that cannot be completely excluded, use should be discontinued if: - visual disturbances (such as loss of vision, double vision, retinal vascular lesions) - thromboembolic venous or thrombotic complications (regardless of their location) - severe headaches. If there is a history of thrombophlebia, the patient should be closely monitored. If amenorrhea occurs during treatment, you must make sure that you are not talking about pregnancy. More than 50% of early spontaneous abortions are caused by genetic complications. Prescription of progesterone on the recommendation of a doctor is indicated in case of insufficiency of secretion of the corpus luteum. Utrogestan® contains soy lecithin and may cause hypersensitivity reactions (urticaria and anaphylactic shock). Pregnancy and lactation Should be used with caution in the second and third trimester of pregnancy due to the risk of liver dysfunction. The entry of progesterone into milk has not been sufficiently studied. It is advisable not to use progesterone during breastfeeding. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous machinery Drivers and persons working with machinery should be alerted to the risk of drowsiness and/or dizziness associated with the oral use of this drug. Taking capsules before bed helps avoid these consequences. Care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Overdose Symptoms: increased side effects indicate an overdose. They disappear spontaneously when the dose of the drug is reduced. In some patients with unstable endogenous secretion in anamnesis, the usual dose of progesterone may be excessive and manifest itself in special sensitivity to the drug or too low concomitant estradiolemia. Treatment: dose reduction or administration of progesterone IN THE EVENING BEFORE BED for ten days. In case of drowsiness or a short-lived feeling of dizziness, it is necessary to postpone the start of treatment to a later date in the cycle (for example, the 19th day instead of the 17th). In case of shortening of the cycle or spotting, it is necessary to check that estradiolemia is sufficient in premenopause and during menopausal hormone replacement therapy. Release form: 14 capsules in a blister pack made of PVC/aluminum foil or PVC/PVDC/aluminum foil. 2 blister packs together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard pack (for a dosage of 100 mg). 7 capsules per blister pack made of PVC/aluminum foil or PVC/PVDC/aluminum foil. 2 blister packs together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard pack (for a dosage of 200 mg). Storage conditions Store at a temperature not exceeding 25° C. Keep out of the reach of children! Shelf life: 3 years Do not use after the expiration date indicated on the package. Conditions for dispensing from pharmacies By prescription Name and country of the manufacturing organization OLIC (Thailand) Limited, Thailand Name and country of the owner of the registration certificate BEZEN HELSCEA SA, BELGIUM Name and country of the packaging organization OLIC (Thailand) Limited, Thailand Address of the receiving organization in the territory of the Republic Kazakhstan claims on product quality 123557 Moscow, Russia, Sredny Tishinsky lane, 28 tel.; fax (495) 98010 68

Indications for the drug Utrozhestan®

Progesterone deficiency conditions in women:

oral route of administration:

• threatened abortion or prevention of habitual abortion due to progesterone deficiency;
• infertility due to luteal insufficiency;
• premenstrual syndrome;
• menstrual irregularities due to ovulation or anovulation disorders;
• fibrocystic mastopathy;
• period of menopausal transition;
• menopausal (replacement) hormone therapy (MHT) in peri- and postmenopause (in combination with estrogen-containing drugs).

vaginal route of administration:

• MHT in case of progesterone deficiency with non-functioning (absent) ovaries (egg donation);
• prevention (prophylaxis) of premature birth in women at risk (with shortening of the cervix and/or anamnestic data of premature birth and/or premature rupture of membranes);
• luteal phase support during preparation for in vitro fertilization;
• luteal phase support in spontaneous or induced menstrual cycle;
• premature menopause;
• MHT (in combination with estrogen-containing drugs);
• infertility due to luteal insufficiency;
• threatened abortion or prevention of habitual abortion due to progesterone deficiency.

Popular questions about Utrozhestan

Why is the drug Utrozhestan prescribed?

Utrozhestan is recommended as a corrective hormonal therapy for progesterone deficiency.

Why is Utrozhestan prescribed during pregnancy?

Utrozhestan during pregnancy should be taken if there is a threat of abortion due to progesterone deficiency.

What is the best way to take Utrozhestan if you have menstrual irregularities?

In case of menstrual irregularities, the medication is taken from the 17th to the 26th day of the cycle.

How to drink Utrozhestan correctly?

When taken orally, Utrozhestan should be taken with a sufficient amount of water, preferably before bedtime. You should not combine taking the medication with eating food, as food increases the bioavailability of the medication.

Dosage regimen

Oral route of administration

The drug is taken orally, in the evening before bed, with water.

In most cases, with progesterone deficiency, the daily dose of Utrozhestan® is 200-300 mg, divided into 2 doses (200 mg in the evening before bed and 100 mg in the morning, if necessary).

In case of threatened abortion or to prevent habitual abortion due to progesterone deficiency, 200-600 mg/day is prescribed daily in the first and second trimesters of pregnancy. Further use of the drug Utrozhestan® is possible as prescribed by the attending physician based on an assessment of the clinical data of the pregnant woman.

In case of luteal phase insufficiency (premenstrual syndrome, fibrocystic mastopathy, dysmenorrhea, menopausal transition), the daily dose of the drug is 200 or 400 mg for 10 days (usually from the 17th to the 26th day of the cycle).

For MHT in perimenopause while taking estrogen, Utrozhestan® is prescribed at 200 mg/day for 12 days.

For MHT in postmenopause in a continuous mode, the drug Utrozhestan® is used in a dose of 100-200 mg from the first day of taking estrogen. Dose selection is carried out individually.

Vaginal route of administration

Capsules are inserted deep into the vagina.

Prevention (prophylaxis) of preterm birth in women at risk (with shortening of the cervix and/or history of preterm labor and/or premature rupture of membranes): the usual dose is 200 mg at bedtime, from the 22nd to the 34th week pregnancy.

Complete absence of progesterone in women with non-functioning (absent) ovaries (egg donation): against the background of estrogen therapy, 100 mg/day on the 13th and 14th days of the cycle, then 100 mg 2 times/day from the 15th to On the 25th day of the cycle, from the 26th day and if pregnancy is detected, the dose increases by 100 mg/day every week, reaching a maximum of 600 mg/day, divided into 3 doses. The indicated dose is usually used for 60 days.

Support of the luteal phase during the in vitro fertilization cycle: it is recommended to use from 200 to 600 mg/day, starting from the day of human chorionic gonadotropin injection during the first and second trimesters of pregnancy.

Support of the luteal phase in a spontaneous or induced menstrual cycle, in case of infertility associated with dysfunction of the corpus luteum: it is recommended to use 200-300 mg/day, starting from the 17th day of the cycle for 10 days, in case of delayed menstruation and diagnosis of pregnancy, treatment should to be continued.

In cases of threatened abortion or in order to prevent habitual abortion occurring against the background of progesterone deficiency: 200-400 mg/day in 2 divided doses daily in the first and second trimesters of pregnancy.

Utrozhestan capsules 200 mg No. 7x2

Writing

Utrozhestan.

Release forms

Capsules.

INN

Progesterone.

FTG

Progestogen.

Composition (per 1 capsule)

Active ingredient: progesterone (natural micronized progesterone) 100 or 200 mg. Excipients: sunflower oil, soy lecithin, gelatin, glycerin, titanium dioxide.

Description

100 mg capsules are round, 200 mg capsules are oval, soft, shiny, yellowish gelatin capsules containing an oily, whitish homogeneous suspension (without visible phase separation).

Pharmacotherapeutic group

Gestagen. ATX code: G03DA04

Pharmacological properties

Progestin, hormone of the corpus luteum. By binding to receptors on the surface of cells of target organs, it penetrates into the nucleus, where, activating DNA, it stimulates RNA synthesis. Promotes the transition of the uterine mucosa from the proliferation phase caused by follicular hormone to the secretory phase, and after fertilization - to the state necessary for the development of a fertilized egg. Reduces the excitability and contractility of the muscles of the uterus and fallopian tubes, stimulates the development of the end elements of the mammary gland. By stimulating protein lipase, it increases fat reserves; increases glucose utilization; increasing the concentration of basal and stimulated insulin, promotes the accumulation of glycogen in the liver; increases the production of gonadotropic hormones of the pituitary gland; reduces azotemia, increases nitrogen excretion in urine. Activates the growth of the secretory section of the acini of the mammary glands and induces lactation. Promotes the formation of normal endometrium.

Pharmacokinetics

When taken orally Absorption Micronized progesterone is absorbed from the gastrointestinal tract. The concentration of progesterone in the blood plasma gradually increases during the first hour, the maximum concentration in the blood () is observed 1-3 hours after administration. The concentration of progesterone in the blood plasma increases from 0.13 ng/ml to 4.25 ng/ml after 1 hour, to 11.75 ng/ml after 2 hours and is 8.37 ng/ml after 3 hours, 2 ng/ml after 6 hours and 1.64 ng/ml after 8 hours after administration. Metabolism The main metabolites that are detected in blood plasma are 20-alpha-hydroxy-delta-4-alpha-pregnanolone and 5-alpha-dihydroprogesterone. Excretion Excreted in the urine in the form of metabolites, 95% of which are glucurone-conjugated metabolites, mainly 3-alpha, 5-beta-pregnanediol (pregnandione). These metabolites, which are determined in blood plasma and urine, are similar to Cmax substances formed during the physiological secretion of the corpus luteum. With vaginal administration Absorption Absorption occurs quickly, progesterone accumulates in the uterus, a high level of progesterone in the blood plasma is observed 1 hour after administration. Cmax of progesterone in blood plasma is achieved 2-6 hours after administration. When the drug is administered at a dose of 100 mg 2 times a day, the average concentration remains at the level of 9.7 ng/ml for 24 hours. When administered in doses of more than 200 mg/day, the concentration of progesterone corresponds to the 1st trimester of pregnancy. Metabolism Metabolized to form predominantly 3-alpha, 5-beta-pregnanediol. Plasma 5-beta-pregnanolone levels do not increase. Excretion Excreted in the urine in the form of metabolites, the main part being 3-alpha, 5-beta-pregnanediol (pregnandione). This is confirmed by a constant increase in its concentration (Cmax 142 ng/ml after 6 hours).

Indications

Progesterone deficiency conditions in women. Oral route of administration: threat of spontaneous abortion or prevention of habitual miscarriage due to established luteal insufficiency threat of premature birth infertility due to luteal insufficiency premenstrual syndrome of menstrual irregularities due to ovulation or anovulation disorders fibrocystic mastopathy premenopause hormone replacement therapy peri- and postmenopause (in combination with estrogen drugs) . Vaginal route of administration: hormone replacement therapy in case of progesterone deficiency with non-functioning (absent) ovaries (egg donation) luteal phase support during preparation for in vitro fertilization luteal phase support in a spontaneous or induced menstrual cycle premature menopause hormone replacement therapy (in combination with estrogen drugs) infertility due to luteal insufficiency, prevention of habitual and threatened abortion due to progestin insufficiency.

Contraindications

Hypersensitivity to the components of the drug, tendency to thrombosis, acute forms of phlebitis or thromboembolic diseases; bleeding from the genital tract of unknown origin; incomplete abortion, porphyria. Established or suspected malignant neoplasms of the mammary glands and genital organs. Oral route of administration - for severe liver dysfunction. With caution: Diseases of the cardiovascular system, arterial hypertension, chronic renal failure, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression; hyperlipoproteinemia, lactation period.

Directions for use and doses

The duration of treatment is determined by the nature and characteristics of the disease. Oral route of administration The drug is taken orally with water. In most cases, with progesterone deficiency, the daily dose of Utrozhestan is 200-300 mg, divided into 2 doses (morning and evening). If there is a threat of spontaneous abortion and premature birth or to prevent recurrent miscarriage: 200-600 mg per day daily until the 16th week of pregnancy. Further use of the drug is possible as prescribed by the attending physician based on an assessment of clinical data, placental function and the level of progesterone in the blood of a pregnant woman. For luteal phase deficiency (premenstrual syndrome, fibrocystic mastopathy, dysmenorrhea, premenopause), the daily dose is 200 or 400 mg, taken for 10 days (usually from the 17th to the 26th day of the cycle). For hormone replacement therapy in peri- and postmenopause while taking estrogen, Utrozhestan is used at a dose of 200 mg per day for 10-12 days. Vaginal route of administration Capsules are inserted deep into the vagina. Complete absence of progesterone in women with non-functioning (absent) ovaries (egg donation): against the background of estrogen therapy, 200 mg per day on the 13th and 14th days of the cycle, then 100 mg 2 times a day from the 15th to 25th day of the cycle, from the 26th day, and if pregnancy is detected, the dose increases by 100 mg per day every week, reaching a maximum of 600 mg per day, divided into 3 doses. This dosage can be used for 60 days. Luteal phase support during an in vitro fertilization cycle: it is recommended to take from 200 to 600 mg per day, starting from the day of human chorionic gonadotropin injection during the first and second trimesters of pregnancy. Support of the luteal phase in the spontaneous or induced menstrual cycle, in case of infertility associated with dysfunction of the corpus luteum, it is recommended to take 200-300 mg per day, starting from the 17th day of the cycle for 10 days, in case of delayed menstruation and diagnosis of pregnancy, treatment should to be continued. In cases of threatened abortion or for the purpose of preventing habitual abortions that occur due to progesterone deficiency: 200-400 mg per day daily in 2 divided doses until the 16th week of pregnancy. Further use of the drug is possible as prescribed by the attending physician based on an assessment of clinical data, placental function and the level of progesterone in the blood of a pregnant woman.

Side effect

The following effects may occur with oral administration: Organ system class Frequent adverse events≥1/100; ≤1/10 Uncommon adverse events ≥1/1000; ≤1/100 Rare adverse events ≥1/10000; ≤1/1000 Very rare adverse events ≤1/10000 Diseases of the reproductive system and mammary glands Changes in menstruation Amenorrhea Intermenstrual bleeding • Mastodynia Diseases of the central nervous system • Headaches Drowsiness Short-lived feeling of dizziness • Depression Diseases of the gastrointestinal tract Vomiting Diarrhea Constipation • Nausea Hepatic diseases biliary system • Cholestatic jaundice Diseases immune system • Urticaria Diseases of the skin and subcutaneous tissues Itching Acne • Chloasma Drowsiness and/or a transient feeling of dizziness are observed, in particular, in the case of concomitant hypoestrogenism. Reducing the dose or restoring higher estrogenization immediately eliminates these effects without reducing the therapeutic effect. If treatment is started too early in the monthly cycle, especially before the 15th day, shortening of the cycle or occasional bleeding may occur. Recorded changes in the menstrual cycle, amenorrhea or intermenstrual bleeding are characteristic of the use of progestogens in general. For vaginal use: Local irritation such as burning, itching or oily discharge may occur as a local individual intolerance (in particular to soy lecithin),

Overdose

Although no cases of overdose have been reported to date, the undesirable effects listed above most often indicate an overdose. They disappear spontaneously when the dose of the drug is reduced. In some patients, the average therapeutic dose may be excessive due to existing or emerging unstable endogenous secretion of progestone, special sensitivity to the drug, or too low estradiol levels. In this case, it is enough: in case of drowsiness or a short-lived feeling of dizziness, reduce the daily dose of Utrozhestan or prescribe it in the evening before bed for 10 days of the menstrual cycle; in case of a shortened menstrual cycle or spotting, move the start of treatment to a later day of the cycle (for example, on the 19th instead of the 17th); in perimenopause and hormone replacement therapy in menopause, ensure that estradiol levels are optimal.

Interaction with other drugs

Enhances the effect of diuretics, antihypertensive drugs, immunosuppressants, anticoagulants. Reduces the lactogenic effect of oxytocin. The combined use of Utrozhestan with barbiturates, phenytoin, rifampicin, phenylbutazone, spironolactone, griseofulvin, ampicillin, tetracycline may lead to a change in the effect of the drug. When using estrogen hormone replacement therapy during menopause, the use of progesterone for at least 12 days per cycle is strongly recommended. Combination with the following drugs may be accompanied by an acceleration of progesterone metabolism and a change in the therapeutic effect: simultaneous use with powerful enzymatic inducers, such as barbiturates, antiepileptic drugs (pheniton), rifampicin, phenylbutazone, spironolactone, griseofulvin, is accompanied by accelerated metabolism of progesterone by the liver. antibiotics (ampicillins, tetracyclines) cause disturbances in the intestinal microflora, which is accompanied by changes in the enterohepatic steroid cycle. The severity of these interactions can vary greatly between patients, so predicting the clinical effects of these interactions is difficult. Progestogens may cause a decrease in glucose tolerance and may increase the need for insulin or other antidiabetic drugs in diabetics. The bioavailability of progesterone may be reduced in patients who smoke and with excessive alcohol consumption.

special instructions

The drug cannot be used for contraception; Use orally with caution during pregnancy in patients with impaired liver function; If treatment is started too early in the monthly cycle, especially before the 15th day of the cycle, shortening of the cycle and/or bleeding may occur. In case of uterine bleeding, do not prescribe the drug until the cause is clarified, including examination of the endometrium. Due to thromboembolic and metabolic risks that cannot be completely excluded, use of the drug Utrozhestan should be discontinued if: visual disturbances such as loss of vision, double vision, vascular lesions of the retina occur; venous thromboembolism or thrombotic complications, regardless of their location; severe headaches. If there is a history of thrombophlevitis, the patient should be closely monitored. If amenorrhea occurs during treatment, make sure that it is not a pregnancy. More than 50% of early spontaneous abortions are caused by genetic complications. In addition, infectious processes and mechanical damage can cause abortions in early pregnancy. The use of progesterone in these cases can only lead to a delay in rejection and evacuation of a non-viable fertilized egg. Therefore, the prescription of progesterone on the advice of a physician should be reserved for cases where the secretion of the corpus luteum is insufficient. Utrozhestan contains soy lecithin and may cause hypersensitivity reactions (urticaria and anaphylactic shock).

Fertility, pregnancy and breastfeeding

Pregnancy The use of Utrozhestan is not contraindicated during pregnancy, including in the first weeks. Breastfeeding The entry of progesterone into breast milk has not been studied with precision. Therefore, its use should be avoided during breastfeeding.

Use in children

Not shown.

Use in the elderly (over 65 years of age)

No clinical data available.

Use in patients with impaired liver function

No clinical data available.

Use in patients with impaired renal function

No clinical data available.

The effect of using the drug on driving vehicles and working with machinery

When taken orally, caution must be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form

Capsules 100 mg, 14 capsules in a blister, 2 blisters in a cardboard box along with instructions for use. Capsules 200 mg, 7 capsules in a blister, 2 blisters in a cardboard box along with instructions for use.

Best before date

3 years. Do not use after the expiration date indicated on the package.

Storage conditions

At a temperature not exceeding 25 ° C, out of the reach of children.

Conditions for dispensing from pharmacies

On prescription.

Buy Utrozhestan caps. 200 mg in blister pack No. 7x2 in the pharmacy

Price for Utrozhestan caps. 200 mg in blister pack No. 7x2

Instructions for use for Utrozhestan caps. 200 mg in blister pack No. 7x2

Side effect

The following adverse events noted during oral administration of the drug are distributed according to the frequency of occurrence in accordance with the following gradation: often (>1/100, 1/1000, 1/10,000,

Drowsiness and transient dizziness are possible, as a rule, 1-3 hours after taking the drug. These adverse reactions can be reduced by reducing the dose, using the drug at bedtime, or switching to the vaginal route of administration.

These unwanted effects are usually the first signs of an overdose.

Drowsiness and/or transient dizziness are observed, in particular, in the case of concomitant hypoestrogenism. Reducing the dose or restoring higher estrogenization immediately eliminates these effects without reducing the therapeutic effect of progesterone.

If the course of treatment begins too early (in the first half of the menstrual cycle, especially before the 15th day), a shortening of the menstrual cycle or acyclic bleeding is possible.

Recorded changes in the menstrual cycle, amenorrhea or acyclic bleeding are characteristic of all progestogens.

Application in clinical practice

When used in clinical practice, the following adverse events have been noted with oral use of progesterone: insomnia, premenstrual syndrome, tension in the mammary glands, vaginal discharge, joint pain, hyperthermia, increased sweating at night, fluid retention, changes in body weight, acute pancreatitis, alopecia, hirsutism, changes in libido, thrombosis and thromboembolic complications (when performing MHT in combination with estrogen-containing drugs), increased blood pressure.

The drug contains soy lecithin, which can cause hypersensitivity reactions (urticaria and anaphylactic shock).

For vaginal use

Isolated cases of local intolerance reactions to the components of the drug (in particular, soy lecithin) have been reported in the form of hyperemia of the vaginal mucosa, burning, itching, and oily discharge.

Systemic side effects with intravaginal use of the drug in recommended doses, in particular drowsiness or dizziness (observed with oral administration of the drug), were not observed.

Contraindications for use

• deep vein thrombosis, thrombophlebitis;
• thromboembolic disorders (pulmonary embolism, myocardial infarction, stroke), intracranial hemorrhage or a history of these conditions/diseases;
• bleeding from the vagina of unknown origin;
• incomplete abortion;
• porphyria;
• established or suspected malignant neoplasms of the mammary glands and genital organs;
• severe liver diseases (including cholestatic jaundice, hepatitis, Dubin-Johnson syndrome, Rotor syndrome, malignant liver tumors) currently or in history;
• age under 18 years (efficacy and safety have not been established);
• breastfeeding period;
• hypersensitivity to progesterone or any of the auxiliary components of the drug.

With caution: diseases of the cardiovascular system, arterial hypertension, chronic renal failure, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression, hyperlipoproteinemia, mild to moderate liver dysfunction, photosensitivity; II and III trimesters of pregnancy.

special instructions

Utrozhestan® should not be used for contraception.

The drug should not be taken with food, because food intake increases the bioavailability of progesterone.

The drug Utrozhestan® should be taken with caution in patients with diseases and conditions that may be aggravated by fluid retention (arterial hypertension, cardiovascular disease, chronic renal failure, epilepsy, migraine, bronchial asthma); in patients with diabetes mellitus; liver dysfunction of mild to moderate severity; photosensitivity.

Patients with a history of depression should be monitored, and if severe depression develops, the drug should be discontinued.

Patients with concomitant cardiovascular diseases or a history of them should also be periodically observed by a doctor.

The use of Utrozhestan® after the first trimester of pregnancy may cause the development of cholestasis.

During long-term treatment with progesterone, regular medical examinations (including liver function tests) are necessary; Treatment should be discontinued if abnormal liver function tests or cholestatic jaundice occur.

When using progesterone, it is possible to reduce glucose tolerance and increase the need for insulin and other hypoglycemic drugs in patients with diabetes mellitus.

If amenorrhea occurs during treatment, pregnancy must be excluded.

If the course of treatment begins too early in the menstrual cycle, especially before the 15th day of the cycle, shortening of the cycle and/or acyclic bleeding is possible. In case of acyclic bleeding, the drug should not be used until the cause is determined, including a histological examination of the endometrium.

If there is a history of chloasma or a tendency to develop it, patients are advised to avoid UV irradiation.

More than 50% of spontaneous abortions in early pregnancy are caused by genetic disorders. In addition, the cause of spontaneous abortions in early pregnancy can be infectious processes and mechanical damage. The use of the drug Utrozhestan® in these cases can only lead to a delay in rejection and evacuation of a non-viable fertilized egg.

The use of the drug Utrozhestan® to prevent threatened abortion is justified only in cases of progesterone deficiency.

When conducting MHT with estrogens during perimenopause, it is recommended to use the drug Utrozhestan® for at least 12 days of the menstrual cycle.

With a continuous MHT regimen in postmenopause, it is recommended to use the drug from the first day of taking estrogen.

When conducting MHT, the risk of developing venous thromboembolism (deep vein thrombosis or pulmonary embolism), the risk of developing ischemic stroke, and coronary artery disease increases.

Due to the risk of developing thromboembolic complications, the use of the drug should be discontinued if: visual disturbances such as loss of vision, exophthalmos, double vision, vascular lesions of the retina occur; migraine; venous thromboembolism or thrombotic complications, regardless of their location.

If there is a history of thrombophlebitis, the patient should be closely monitored.

When using Utrozhestan® with estrogen-containing drugs, you must refer to the instructions for their use regarding the risks of venous thromboembolism.

The results of the Women Health Initiative Study (WHI) clinical study indicate a slight increase in the risk of breast cancer with long-term, more than 5 years, combined use of estrogen-containing drugs with synthetic gestagens. It is unknown whether there is an increased risk of breast cancer in postmenopausal women when undergoing MHT with estrogen-containing drugs in combination with progesterone.

The WHI study also found an increased risk of dementia when starting MHT after age 65 years.

Before starting MHT and regularly during it, a woman should be examined to identify contraindications to its implementation. If clinically indicated, a breast examination and gynecological examination should be performed.

The use of progesterone may affect the results of some laboratory tests, including liver and thyroid function tests; coagulation parameters; pregnanediol concentration.

Impact on the ability to drive vehicles and operate machinery

When using the drug orally, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Specialists

Makatsaria Alexander Davidovich

Obstetrician-gynecologist, famous scientist, founder of clinical hemostasiology.
It will help you plan and maintain your pregnancy if you have had cases of fetal loss, thrombosis, obstetric complications or blood coagulation disorders. You can also contact your doctor for a transcript of hemostasis tests.

Akinshina Svetlana Vladimirovna

Obstetrician-gynecologist, hemostasiologist with an academic degree.
Pregnancy management S.V. Akinshina will help avoid severe complications: gestosis, placental insufficiency, fetal loss syndrome.

The doctor's expertise includes hemostasis disorders and immunological infertility.

Margiani Fatima Abdurashidovna

Doctor of Medical Sciences, qualified diagnostician of female infertility factors.
Provides competent support for late, multiple or problematic pregnancies. A consultation and examination with Fatima Abdurashidovna will help determine the cause of failure to conceive a child or recurrent miscarriage.

Petreykov Evgeniy Rafailovich

If you are planning a pregnancy, IVF, or have a history of fetal failure in the first trimester, contact Dr. Petreikov.
A gynecologist of the highest category, Candidate of Sciences, will help determine the risk and cause of obstetric complications, and also prescribe supportive treatment for a genetic predisposition to thrombosis.

Overdose

Symptoms: drowsiness, transient dizziness, euphoria, shortening of the menstrual cycle, dysmenorrhea.

In some patients, the average therapeutic dose may be excessive due to existing or emerging unstable endogenous secretion of progesterone, special sensitivity to the drug, or too low concentration of estradiol.

Treatment:

• in case of drowsiness or dizziness, it is necessary to reduce the daily dose or prescribe the drug before bedtime for 10 days of the menstrual cycle;
• in case of a shortening of the menstrual cycle or spotting, it is recommended to postpone the start of treatment to a later day of the cycle (for example, on the 19th instead of the 17th);
• in perimenopause and with postmenopausal MHT, it is necessary to ensure that the concentration of estradiol is optimal.

In case of overdose, symptomatic treatment is carried out if necessary.

Drug interactions

When administered orally

Progesterone enhances the effect of diuretics, antihypertensive drugs, immunosuppressants, and anticoagulants.

Reduces the lactogenic effect of oxytocin.

Concomitant use with drugs that induce microsomal liver enzymes CYP3A4, such as barbiturates, antiepileptic drugs (phenytoin), rifampicin, phenylbutazone, spironolactone, griseofulvin, is accompanied by an acceleration of progesterone metabolism in the liver.

Simultaneous use of progesterone with some antibiotics (penicillins, tetracyclines) can lead to a decrease in its effectiveness due to disruption of the enterohepatic recirculation of sex hormones due to changes in the intestinal microflora.

The severity of these interactions may vary in different patients, so predicting the clinical effects of these interactions is difficult.

Ketoconazole may increase the bioavailability of progesterone.

Progesterone may increase the concentration of ketoconazole and cyclosporine.

Progesterone may reduce the effectiveness of bromocriptine.

Progesterone can cause a decrease in glucose tolerance, resulting in an increase in the need for insulin or other hypoglycemic drugs in patients with diabetes.

The bioavailability of progesterone may be reduced in patients who smoke and with excessive alcohol consumption.

For intravaginal use

The interaction of progesterone with other drugs when administered intravaginally has not been assessed. The simultaneous use of other drugs used intravaginally should be avoided to avoid interfering with the release and absorption of progesterone.

Note!

The description of the drug Utrozhestan on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.