Utrozhestan - side effects. Utrozhestan

Registration number No. JIC-000186

TradeName: Utrozhestan ®

International non-proprietary name: progesterone

Dosage form: capsules

Compound for 1 capsule:

Active substance: progesterone micronized 100 or 200 mg.

Excipients: sunflower oil 149 mg/298 mg, soy lecithin 1 mg/2 mg; capsule - gelatin 76.88 mg / 153.76 mg, glycerin 31.45 mg / 62.9 mg, titanium dioxide 1.67 mg / 3.34 mg.

Description: capsules 100 mg - round, capsules 200 mg - oval, soft shiny yellowish gelatin capsules containing an oily whitish homogeneous suspension (no visible phase separation).

Pharmacotherapeutic group: gestagen

The codeATX: G03 DA04

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

The active substance of the drug 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, by 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, 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. Promotes the formation of normal endometrium. Stimulates the development of the terminal elements of the mammary gland and induces lactation.

By stimulating protein lipase, it increases fat reserves; increases the utilization of glucose; 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 the excretion of nitrogen by the kidneys.

Pharmacokinetics

When taken orally

Suction

Micronized progesterone is well absorbed from the gastrointestinal tract (GIT). The concentration of progesterone in the blood plasma gradually increases during the first hour, the maximum concentration in the blood plasma (Cmax) is observed 1-3 hours after ingestion. 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 6 hours later and 1.64 ng/ml 8 hours after ingestion.

Metabolism

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

breeding

It is excreted by the kidneys in the form of metabolites, 95% of which are glucuronconjugated metabolites, mainly 3-alpha, 5-beta-pregnandiol (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

Suction and distribution

Absorption occurs quickly, a high concentration of progesterone in the blood plasma is observed 1 hour after administration. With m ah progesterone in blood plasma is achieved 2-6 hours after administration. With the introduction of 100 mg 2 times a day, the average concentration in blood plasma 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. Communication with plasma proteins - 90%. Progesterone accumulates in the uterus.

Metabolism

It is metabolized with the formation of predominantly 3-alpha, 5-beta-pregnandiol. The concentration of 5-beta-pregnanolone in blood plasma does not increase.

breeding

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

INDICATIONS FOR USE

Progesterone deficiency in women:

For oral administration:

■ threatened abortion or prevention of habitual abortion due to

insufficiency of progesterone;

■ infertility due to luteal insufficiency;

§ premenstrual syndrome;

§ Violations menstrual cycle due to violation of ovulation or anovulation;

§ fibrocystic mastopathy;

§ period of menopausal transition;

§ menopausal (replacement) hormone therapy (MHT) in peri- and postmenopause (in combination with estrogen-containing drugs).

For intravaginal use:

§ MHT in case of progesterone deficiency with non-functioning (absent) ovaries (egg donation);

§ prevention (prevention) of preterm birth in women at risk (with shortening of the cervix and / or the presence of anamnestic data of preterm birth and / or premature rupture of the membranes);

§ support of the luteal phase during preparation for in vitro fertilization;

§ support of the luteal phase in a 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 lack of progesterone.

CONTRAINDICATIONS

Hypersensitivity to progesterone or any of the excipients of the drug; 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 breast and genital organs; severe liver disease (including cholestatic jaundice, hepatitis, Dubin-Johnson syndrome, Rotor syndrome, malignant liver tumors) at present or in history; childhood up to 18 years (efficacy and safety have not been established); breastfeeding period.

CAREFULLY

Diseases of the cardiovascular system, arterial hypertension, chronic kidney failure, diabetes, bronchial asthma, epilepsy, migraine, depression, hyperlipoproteinemia, mild to moderate liver dysfunction; photosensitivity.

The drug should be used with caution in the II and III trimesters of pregnancy.

USE IN PREGNANCY AND DURING BREASTFEEDING

The drug should be used with caution in the II and III trimesters of pregnancy due to the risk of cholestasis.

Progesterone enters breast milk therefore, the use of the drug is contraindicated during breastfeeding.

METHOD OF APPLICATION AND DOSES

oral

The drug is taken orally in the evening before bedtime, washed down 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 bedtime and 100 mg in the morning, if necessary).

§ In threatened abortion or to prevent recurrent abortion due to progesterone deficiency : 200-600 mg per day daily in the I and II 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.

§ With luteal phase deficiency (premenstrual syndrome,

fibrocystic mastopathy, dysmenorrhea, menopausal transition period) the daily dose is 200 or 400 mg taken for 10 days (usually from the 17th to the 26th day of the cycle).

§ At MHT in perimenopause against the background of taking estrogens, the drug Utrozhestan ®

applied at 200 mg per day for 12 days.

§ At MHT in postmenopausal women in continuous mode, the drug Utrozhestan ®

is used at a dose of 100-200 mg from the first day of taking estrogen-containing drugs. Dose selection is carried out individually.

intravaginally

The capsules are inserted deep into the vagina.

§ Prevention (prevention) of preterm birth in women

from the group risk (with short cervix and/or history of preterm labor and/or preterm rupture of membranes): The usual dose is 200 mg at bedtime, from 22 to 34 weeks of gestation.

§ Complete absence of progesterone in women with non-functioning

(absent ) ovaries (egg donation): against the background of estrogen therapy, 100 mg per day on the 13th and 14th days of the cycle, then 100 mg 2 times a day from the 15th to the 25th day of the cycle, from the 26th day, and on if pregnancy is determined, the dose is increased by 100 mg per day every week, reaching a maximum of 600 mg per day, divided into 3 doses. The specified dose can be used for 60 days.

§ Support of the luteal phase during the cycle of extracorporeal

§ Support of the luteal phase in spontaneous or induced menstruation

cycle in infertility associated with dysfunction of the corpus luteum : it is recommended to use 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 be continued.

§ In cases of threatened abortion or to prevent habitual abortion ,

arising against the background of progesterone deficiency: 200-400 mg per day in 2 doses daily in the I and II trimesters of pregnancy.

SIDE EFFECT

The following adverse events noted when administered orally drug, distributed by frequency of occurrence in accordance with the following gradation: often: > 1/100,< 1/10; нечасто: > 1/1000, < 1/100; редко: > 1/10000, < 1/1000; очень редко: < 1/10000.


These adverse reactions are usually the first signs of an overdose. Drowsiness, transient dizziness are possible, as a rule, 1-3 hours after oral administration of 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.

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

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

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

Application in clinical practice

When used in clinical practice, the following adverse events were noted when administered orally progesterone: insomnia; premenstrual syndrome; tension in the mammary glands; vaginal discharge; pain in the joints; hyperthermia; increased sweating at night; fluid retention; change in body weight; acute pancreatitis; alopecia, hirsutism; libido changes; thrombosis and thromboembolic complications (during MHT in combination with estrogen-containing drugs); increase in blood pressure.

The composition of the drug includes soy lecithin, which can cause hypersensitivity reactions (urticaria and anaphylactic shock).

When used vaginally

It was reported about individual cases of the development of reactions of local intolerance to the components of the drug (in particular, soy lecithin) in the form of hyperemia of the vaginal mucosa, burning, itching, oily discharge.

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

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 at bedtime for 10 days of the menstrual cycle;

In case of shortening of the menstrual cycle or "spotting" 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 MHT in postmenopause, it is necessary to make sure that the concentration of estradiol is optimal.

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

INTERACTION WITH OTHER DRUGS

When administered orally

Progesterone enhances the action of diuretics, hypotensive medicines, immunosuppressants, anticoagulants. Reduces the lactogenic effect of oxytocin. Simultaneous use with drugs-inducers of microsomal liver enzymes CYP3A4, such as barbiturates, antiepileptic drugs (phenytoin, carbamazepine), rifampicin, phenylbutazone, spironolactone, griseofulvin, is accompanied by an acceleration of progesterone metabolism in the liver.

Simultaneous administration of progesterone with certain antibiotics (penicillins, tetracyclines) can lead to a decrease in its effectiveness due to a violation 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 the prediction of the clinical effects of these interactions is difficult.

Ketoconazole may increase the bioavailability of progesterone.

Progesterone can 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 can be reduced in patients who smoke and with excessive alcohol consumption.

For intravaginal use

The interaction of progesterone with other drugs for intravaginal use has not been evaluated. The simultaneous use of other drugs used intravaginally should be avoided in order to avoid impaired release and absorption of progesterone.

SPECIAL INSTRUCTIONS

The drug Utrozhestan ® can not be used for contraception.

The drug should not be taken with food, as 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 diseases, chronic renal failure, epilepsy, migraine, bronchial asthma); in patients with diabetes; impaired liver function of mild and moderate severity; photosensitivity.

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

The composition of the drug Utrozhestan ® includes soy lecithin, which can cause hypersensitivity reactions (urticaria and anaphylactic shock).

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

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

At long-term treatment progesterone, regular medical examinations (including a study of liver function) should be carried out; treatment should be discontinued in the event of abnormal liver function tests or cholestatic jaundice.

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.

In the event of amenorrhea during treatment, it is necessary to exclude the presence of pregnancy.

If the course of treatment is started too early at the beginning of 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 their cause is clarified, including histological examination endometrium.

Patients with a history of chloasma or a tendency to develop it are advised to avoid UV exposure.

More than 50% of cases of spontaneous abortions in early pregnancy are due to 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 fetal 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 the perimenopausal period, it is recommended to use the drug Utrozhestan ® for at least 12 days of the menstrual cycle.

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

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

Due to the risk of developing thromboembolic complications, the use of the drug should be discontinued in the event of: visual disturbances, such as loss of vision, exophthalmos, double vision, vascular lesions of the retina; 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 the drug Utrozhestan ® with estrogen-containing drugs, it is necessary to refer to the instructions for their use regarding the risks of venous thromboembolism.

results clinical trial The Women Health Initiative Study (WHI) shows a small increase in the risk of breast cancer with long-term, more than 5 years, the combined use of estrogen-containing drugs with synthetic progestogens. It is not known whether there is an increased risk of breast cancer in postmenopausal women during MHT with estrogen-containing drugs in combination with progesterone.

The results of the WHI study also found an increased risk of dementia when starting MHT at age 65 or older.

Before starting MHT and regularly during it, a woman should be examined to identify contraindications to its implementation. In the presence of clinical indications, a breast examination and gynecological examination should be carried out.

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

Influence on the ability to drive vehicles and mechanisms

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.

RELEASE FORM

Capsules 100 mg

14 capsules in a PVC / aluminum foil or PVC / PVDC / aluminum foil blister. 2 blisters with instructions for use in a cardboard box (28 capsules in consumer packaging).

Capsules 200 mg

7 capsules in a PVC / aluminum foil or PVC / PVDC / aluminum foil blister. 2 blisters with instructions for use in a cardboard box (14 capsules in consumer packaging).

Many women dream of having children, but not everyone succeeds. Often pregnancy does not occur or it happens, but a miscarriage occurs due to an insufficient amount of progesterone in the body. Produced by the ovaries in sufficient quantities, it helps to preserve the embryo and contributes to its normal development. With a lack of progesterone, doctors prescribe the drug "Utrozhestan", placing high hopes on it. In this case, the woman bears and gives birth to a child without any problems. As evidenced by numerous reviews, "Utrozhestan" during pregnancy is very effective.

Purpose and form of release

"Utrozhestan" is drug, consisting of natural micronized progesterone hormone. Most often, doctors prescribe it during pregnancy so that there is no miscarriage or premature birth. Also use "Utrozhestan" when the feedback on his admission during this period is only positive. In addition, with the help of it, diseases that occur against the background of a lack of progesterone are treated. This is fibrocystic mastopathy, menstrual irregularities. The drug is prescribed to women during menopause to eliminate the climatic syndrome.

"Utrozhestan" is produced in capsules that can be used orally or topically, as vaginal suppositories(therefore, capsules are sometimes called suppositories, in fact, there is only one form of release of the drug). They contain 100 and 200 mg of the active substance, which is micronized natural progesterone, which is well absorbed into the bloodstream. Excipients are peanut butter, gelatin, soy lecithin, titanium dioxide, glycerol. Candles "Utrozhestan" are very effective during pregnancy. Reviews of patients and doctors testify to this.

Indications for use

The use of the drug leads to the following positive aspects:

  • normal endometrium begins to form;
  • increases the concentration of insulin;
  • glycogen in the liver begins to accumulate intensively;
  • the excitability and contractility of the muscles of the uterus and fallopian tubes decreases;
  • the uterine mucosa enters the secretory phase.

"Utrozhestan" is used to treat diseases that have arisen against the background of an insufficient amount of progesterone in the body.

Oral administration is indicated in the following cases:

  • in complex therapy infertility caused by insufficiency;
  • if the menstrual cycle is disturbed;
  • to relieve symptoms during menopause;
  • removal of tension syndrome before the onset of menstruation;
  • for complex treatment fibrocystic mastopathy.
  • with a lack of progesterone;
  • to maintain the luteal phase;
  • as a prevention of the formation of uterine fibroids and endometriosis;
  • so that a miscarriage does not occur;
  • with infertility associated with a lack of lutein;
  • as a result of premature menopause.

Mode of application

When taken orally, if a woman is planning a pregnancy, "Utrozhestan" is taken 2 times a day. In some cases, the doctor may increase the dose to 400 mg per day. For the treatment of fibrocystic mastopathy, as well as premenstrual syndrome, the dosage is 400 mg per day, the duration of treatment is 10 days.

With intravaginal use, if a woman is completely absent of progesterone, the drug is used for at least 3 months. The dosage is selected by the doctor in each individual case. If it exists in the first and second trimester of pregnancy, "Utrozhestan" is used twice a day, injected deep into the vagina.

special instructions

Do not use the drug as a means of contraception, as it does not have a contraceptive effect. When applied in the first half of the menstrual cycle (before ovulation), a shortening of the cycle or bleeding may occur.

If uterine bleeding occurs, then Utrozhestan is not recommended to be taken until the cause of such a pathology is clarified.

If the following symptoms occur, the drug should be stopped as soon as possible:

  • double vision;
  • damage to the vessels of the retina;
  • unbearable headache;
  • vision loss;
  • thrombosis of veins and arteries;
  • migraine.

In this case, you should immediately consult a doctor.

"Utrozhestan" during pregnancy

The reviews of most women taking this drug during pregnancy are positive, as it contributes to the successful bearing of a child. It is allowed to be taken in the first and second trimester, up to the 27th week. After this period, it should be used with caution and only if there is evidence for this.

The drug helps prevent miscarriage and prevents premature birth, especially if a woman is diagnosed with complete ovarian dysfunction or a lack of progesterone. Moreover, there is a high probability that pregnancy will occur after Utrozhestan. Reviews eloquently testify to this.

Indications for taking the drug if pregnancy is only planned

In what cases should I take "Utrozhestan" when planning a pregnancy? The doctors' comments indicate that the indication for taking the drug is It is characterized by low body temperature in the period following ovulation, and various menstrual irregularities. Such a violation in the work of the body occurs quite often. That is why, in order to prevent a miscarriage, Utrozhestan candles are prescribed during pregnancy. Reviews of women indicate that they are quite effective.

Also an indication for taking artificial progesterone during pregnancy planning is the prevention of endometriosis. In this state of the body, a very strong growth of the uterine mucosa occurs or it begins to penetrate into the deeper layers of the tissue. Most often, endometriosis is observed in women aged 30 to 45 years with a short menstrual cycle, who have impaired metabolism, whose estrogen levels are significantly elevated, and who constantly use intrauterine contraceptives.

Because of this disease, pregnancy can be expected for a very long time, because with endometriosis, cysts begin to form on the wall of the uterus, in the ovaries, inside the fallopian tubes. All this leads to a decrease in the patency of the tubes, the work of the ovaries is disrupted, and the implantation of the embryo into the uterine wall is significantly more difficult. That is why doctors prescribe "Utrozhestan" when planning a pregnancy. Feedback from women on this issue is also positive.

The drug normalizes the menstrual cycle, creates the necessary conditions for the fetal egg to be fixed in the uterus, and in case of a threatened miscarriage, it helps to maintain the pregnancy.

Contraindications and side effects of the drug during planning

A woman who dreams of becoming pregnant should know that although this drug helps to fulfill the dream of having a child, its use is possible only as directed by a doctor. "Utrozhestan" may have the following contraindications:

  • thrombophlebitis;
  • liver disease;
  • malignant tumors;
  • phlebeurysm.

Very rarely, side effects occur when using the drug "Utrozhestan" (candles). Reviews when planning pregnancy about this drug indicate that drowsiness and dizziness may occur, which are of a short duration. But you should be careful while driving, because a small impact on the central nervous system adversely affects the reaction rate when driving.

Indications for taking the drug during pregnancy

As numerous reviews show, "Utrozhestan" during pregnancy is of great benefit. In healthy women, the produced progesterone begins to build up the endometrium, while the uterine mucosa thickens and is enriched with blood vessels, and the embryo receives oxygen and nutrients in abundance.

For women with progesterone deficiency, the drug is prescribed to prevent miscarriage. In addition, it is prescribed if it exists due to an increase in the tone of the uterus. The drug helps to reduce it, allowing a woman to carry a child normally.

Contraindications of the drug during pregnancy

"Utrozhestan" can not be taken in the following cases:

  • vaginal bleeding of unknown origin;
  • porphyria;
  • intolerance or allergic reactions on the components of the drug;
  • incomplete miscarriage;
  • tumors of the genital organs or mammary glands, which are malignant in nature;
  • thromboembolism;
  • tendency to develop blood clots;
  • severe liver disease.

These contraindications are considered absolute, that is, it is strictly forbidden to take the drug if they are present.

With difficulties with conception and the threat of termination of pregnancy, doctors prescribe hormonal drugs. Utrozhestan is a drug with progesterone. Its main task is to help a woman bear a healthy baby.

Compound

The active substance is progesterone. In structure, it is an absolute analogue of the natural hormone of the corpus luteum of the ovary. The metabolism of substances is identical. The medication also contains excipients: peanut or sunflower oil, gelatin, soy lecithin, glycerol and titanium dioxide.

Forms of release of Utrozhestan

The drug is sold in the form of capsules 100 (round) or 200 mg (oval). They are soft to the touch. Inside contains a liquid, and on top - a gelatinous shell. This is a generic dosage form.

The capsules are taken orally or inserted into the vagina.

Mechanism of action

The natural active substance is well absorbed in the intestines, vagina. Through the blood, progesterone enters the tissues. It prepares the uterine mucosa for the introduction of the egg, relaxes its muscles, and promotes the development of the mammary glands.

These processes are necessary for the onset and maintenance of pregnancy.

When taken orally

The concentration of progesterone in the blood rises within an hour after ingestion. After 60-180 minutes, it reaches its maximum performance. Utrozhestan during pregnancy contributes to the fertilization of the egg. Up to 60% of the dose taken orally (metabolic products) is excreted by the kidneys.

For vaginal use

With the introduction of capsules into the vagina, the concentration in the blood is maximum after 2-6 hours. Vaginal use of Utrozhestan during pregnancy reduces the risk of miscarriage. Progesterone stimulates the growth of the endometrium. Up to 95% of the dose is excreted in the urine as metabolic products.

Why is Utrozhestan prescribed for pregnant women

Progesterone, after entering the blood, penetrates to the ovaries and uterus. The hormone promotes the fertilization of the egg, its introduction into the uterine mucosa and further growth. The uterus stops contracting, which helps the embryo to attach firmly. Progesterone helps the body future mother accumulate fat for the safe bearing of a child. The hormone suppresses ovulation, prepares the mammary glands for lactation.

In the early stages

Assign to drink Utrozhestan with the threat of miscarriage in the early stages. It eliminates progesterone deficiency in the first weeks of pregnancy.

The drug is indicated for the treatment of such conditions:

  • uterine hypertonicity;
  • deficiency of progesterone by analysis;
  • the threat of spontaneous abortion;
  • cervical insufficiency;
  • bloody issues;
  • prevention of myoma or cyst;
  • infertility earlier, IVF.

In the last trimesters

The appointment of Utrozhestan during late pregnancy is less common. After 16 weeks, the placenta provides the fetus with progesterone.

Conditions in which Utrozhestan is indicated for pregnant women:

  • The placenta produces little progesterone.
  • Shortening or early softening of the cervix.
  • The patient has a history of miscarriage, premature birth, uterine surgery.
  • The presence of thrombosis.
  • Low position of the fetus.
  • Liver disorder.

How best to take the drug

Only a gynecologist determines the scheme and method of taking Utrogestan by pregnant women. The course of treatment is also selected individually. Sometimes the doctor prescribes a combined use of the drug (vaginally and orally). It is contraindicated for a pregnant woman to drink medication on her own.

Do not spontaneously cancel the medication or reduce / increase the dosage.

Instructions for use

For oral administration, 200-300 mg (1-3 pcs.) Are prescribed per day. As a rule, the capsules are taken at bedtime. At high doses, add the morning dose.

For intravaginal use, the capsules are inserted deep into the vagina. On average, 1 capsule (200 mg) is prescribed, which is inserted into the vagina at night. Maximum dose for pregnant women - 600 mg / day. For proper insertion, you need to lie on your back, put a roller or pillow under your buttocks. After spreading your legs, insert a pill deep into the vagina.

For complete absorption, it is necessary to lie down for at least 15 minutes.

Cancellation of the drug during pregnancy

It is necessary to stop taking the hormone gradually. Especially important is the slow cancellation of Utrozhestan during pregnancy after the threat of interruption. Rapid cancellation can provoke rejection of the fetal egg.

If the patient drank capsules for the first trimester, the gradual withdrawal of the drug begins at 12-13 weeks. Some women take progesterone until the 20th week, when the hormone is not provided by the formed placenta. If the drug was prescribed in the second trimester, its cancellation begins at 30 weeks.

Completely refuse the use of Utrozhestan in 3-4 weeks.

Possible side effects of Utrozhestan

The influence of Utrozhestan on the fetus has not been revealed by studies.

The drug has the following undesirable effects on a woman:

  • drowsiness, distraction;
  • vomit;
  • dizziness;
  • bleeding from the vagina;
  • urticaria, pruritus;
  • swelling, weight gain;
  • depression.

Contraindications

  • systemic lupus erythematosus;
  • diabetes;
  • venous insufficiency, thrombosis, embolism earlier;
  • neoplasms and suspicion of them;
  • visual impairment;
  • bronchial asthma.

Analogues

Other drugs are available not only in the form of capsules, but also in the form of a vaginal gel. Analogues are selected by the attending physician, taking into account individual characteristics and diseases.

Effective analogues of Utrozhestan:

  • Prajisan.
  • Iprozhin.
  • Duphaston.
  • Crinon.
  • Progestogel.

Price

The cost of Utrozhestan in different cities of Russia differs little. The average price for 100 mg capsules is 370-450 rubles for 28 pieces. Tablets for intravaginal administration of 200 mg will cost more in pharmacies: within 400-470 rubles for 14 pieces.

Video

The drug Utrozhestan is a hormonal drug. It contains the hormone progesterone.

The drug is intended for use in gynecology to normalize the endometrium for the purpose of successful implantation, fixation of a fertilized egg, and further successful pregnancy. The drug is also used to reduce uterine contractility, inhibition of ovulation.

In this article, we will consider why doctors prescribe Utrozhestan, including instructions for use, analogues and prices for this drug in pharmacies. If you have already used Utrozhestan, leave your feedback in the comments.

Composition and form of release

Capsules of 100 mg - 30 pieces in a blister. Capsules of 200 mg - 14 pieces in a blister. Oval-shaped capsules, with a shiny surface, yellowish color. Inside the capsules - a homogeneous oily suspension of white color without visible phase separation. The blister is packed in a cardboard box.

  • The composition of one capsule includes 100 or 200 mg of progesterone extracted from yams (in micronized form), as well as peanut oil (Arachis hypogaea), soy lecithin (Lecithin), glycerin (Glycerol), gelatin (Gelatin), additive E171 (titanium dioxide) .

Clinico-pharmacological group: gestagen.

What is Utrozhestan used for?

The use of candles Utrozhestan contributes to the following positive effects:

  • maintaining the luteal phase in an induced or spontaneous menstrual cycle,
  • maintenance of the luteal phase of the menstrual cycle in preparation for assisted reproductive technologies (in vitro fertilization, egg donation, etc.),
  • in combination with estrogenic drugs, it is prescribed as hormone replacement therapy for menopausal syndrome,
  • hormone replacement therapy in case of premature menopause,
  • infertility due to insufficiency of the corpus luteum of the ovary,
  • prevention of endometriosis, uterine fibroids,
  • preventive treatment for habitual pregnancy loss due to progesterone deficiency,
  • treatment of threatened abortion due to progesterone deficiency.

Utrozhestan tablets for oral administration:

  • infertility due to luteal insufficiency;
  • premenstrual tension syndrome;
  • menstrual disorders due to ovulation or anovulation disorders;
  • fibrocystic mastopathy;
  • hormone replacement therapy of menopause (in combination with estrogenic drugs).

In general, the drug is used for corrective therapy for endogenous progesterone deficiency.

pharmachologic effect

The active substance of utrogestan is progesterone (hormone of the corpus luteum of the ovary).

When introduced into the body, it contributes to normal secretory transformations in the uterine mucosa. Potentiates the transition of the endometrium from the proliferative phase to the secretory. In the case of fertilization of the egg, utrogestan causes changes in the endometrium, which contribute to the implantation and development of the embryo.

During pregnancy, it reduces the contractility and excitability of the myometrium and fallopian tubes, stimulates transformations in the terminal elements of the mammary glands. Due to the normalization of the formation of dihydrotestosterone (the main metabolite), it has antiandrogenic activity. Antialdosterone effect promotes increased urination.

Instructions for use

According to the instructions for use, Utrozhestan suppositories are used intravaginally, they are injected deep into the vagina.

  • Prevention (prevention) of preterm birth in womenfrom the group risk(with short cervix and/or history of preterm labor and/or preterm rupture of membranes): The usual dose is 200 mg at bedtime, from 22 to 34 weeks of gestation.
  • Support of the luteal phase in spontaneous or induced menstruationcycle in infertility associated with dysfunction of the corpus luteum: it is recommended to use 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 be continued.
  • Support of the luteal phase during the cycle of extracorporealfertilization: it is recommended to use from 200 to 600 mg per day, starting from the day of injection of human chorionic gonadotropin during the I and II trimester of pregnancy.
  • In cases of threatened abortion or to prevent habitual abortion arising against the background of progesterone deficiency: 200-400 mg per day in 2 doses daily in the I and II trimesters of pregnancy.
  • Complete absence of progesterone in women with non-functioning(absent) ovaries(egg donation): against the background of estrogen therapy, 100 mg per day on the 13th and 14th days of the cycle, then 100 mg 2 times a day from the 15th to the 25th day of the cycle, from the 26th day, and on if pregnancy is determined, the dose is increased by 100 mg per day every week, reaching a maximum of 600 mg per day, divided into 3 doses. The specified dose can be used for 60 days.

Instructions for tablets

Take orally in the evening before going to 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 bedtime and 100 mg in the morning, if necessary).

  • With luteal phase deficiency(premenstrual syndrome, fibrocystic breast disease, dysmenorrhea, menopausal transition period) the daily dose is 200 or 400 mg taken for 10 days (usually from the 17th to the 26th day of the cycle).
  • With MHT in perimenopause against the background of taking estrogen, 200 mg per day is used for 12 days.
  • For postmenopausal MHT in continuous mode, it is used at a dose of 100-200 mg from the first day of taking estrogen-containing drugs. Dose selection is carried out individually.
  • In threatened abortion or to prevent recurrent abortion due to progesterone deficiency: 200-600 mg per day daily in the I and II trimesters of pregnancy. Further use is possible as prescribed by the attending physician, based on an assessment of the clinical data of a pregnant woman.

Contraindications

You can not use the drug in such cases:

  1. Deep vein thrombosis, thrombophlebitis;
  2. Bleeding from the vagina of unknown origin;
  3. incomplete abortion;
  4. Porfiria;
  5. The period of breastfeeding;
  6. Children under 18 years of age (efficacy and safety have not been established);
  7. Hypersensitivity to progesterone or any of the excipients of the drug;
  8. Established or suspected malignant neoplasms of the breast and genital organs;
  9. Severe liver disease (including cholestatic jaundice, hepatitis, Dubin-Johnson syndrome, Rotor syndrome, malignant liver tumors) at present or in history;
  10. Thromboembolic disorders (pulmonary embolism, myocardial infarction, stroke), intracranial hemorrhage or a history of these conditions / diseases.

Use with caution in such cases: diseases of the cardiovascular system, arterial hypertension, epilepsy, migraine, depression, hyperlipoproteinemia, chronic renal failure, diabetes mellitus, bronchial asthma, mild to moderate liver dysfunction; photosensitivity.

The drug should be used with caution in the II and III trimesters of pregnancy.

Side effects

The following adverse events noted when administered orally drug, distributed by frequency of occurrence in accordance with the following gradation: often: > 1/100,< 1/10; нечасто: > 1/1000, < 1/100; редко: > 1/10000, < 1/1000; очень редко: < 1/10000.

Organ system Adverse events
often infrequently rarely very rarely
Genital and breast disorders Menstrual irregularities
amenorrhea
acyclic bleeding
Mammalgia
Psychiatric disorders Depression
Nervous System Disorders Headache Drowsiness
transient dizziness
Gastrointestinal disorders Bloating Vomit
Diarrhea
Constipation
Nausea
Liver and biliary tract disorders cholestatic jaundice
Immune System Disorders Hives
Skin and subcutaneous tissue disorders Itching
acne
Chloasma

Drowsiness, transient dizziness are possible, as a rule, 1-3 hours after oral administration of 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 adverse reactions 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 estrogen levels immediately reverses these effects without reducing the therapeutic effect of progesterone.

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

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

When used vaginally

It was reported about individual cases of the development of reactions of local intolerance to the components of the drug (in particular, soy lecithin) in the form of hyperemia of the vaginal mucosa, burning, itching, oily discharge.

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

Application in clinical practice

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

The composition of the drug includes soy lecithin, which can cause hypersensitivity reactions (urticaria and anaphylactic shock).

Overdose

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.

Overdose treatment:

  • in case of drowsiness or dizziness, it is necessary to reduce the daily dose or prescribe the drug at bedtime for 10 days of the menstrual cycle;
  • in case of shortening of the menstrual cycle or “spotting” 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 MHT in postmenopause, it is necessary to make sure that the concentration of estradiol is optimal.

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


Pregnancy and lactation

During pregnancy, the drug can only be used intravaginally. The drug should be used with caution in the II and III trimesters of pregnancy due to the risk of cholestasis.

Progesterone passes into breast milk, so the use of the drug is contraindicated during breastfeeding.

special instructions

When using the drug, you need to pay attention to the following points:

  1. The drug Utrozhestan can not be used for contraception.
  2. The drug should not be taken with food, as food intake increases the bioavailability of progesterone.
  3. Patients with a history of depression should be observed, and if severe depression develops, the drug should be discontinued.
  4. The composition includes soy lecithin, which can cause hypersensitivity reactions (urticaria and anaphylactic shock).
  5. It 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; impaired liver function of mild and moderate severity; photosensitivity.
  6. Patients with concomitant cardiovascular diseases or their history should also be periodically observed by a doctor.
  7. Application after the first trimester of pregnancy may cause the development of cholestasis.
  8. With prolonged treatment with progesterone, regular medical examinations (including a study of liver function) should be carried out; treatment should be discontinued in the event of abnormal liver function tests or cholestatic jaundice.
  9. 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.
  10. In the event of amenorrhea during treatment, it is necessary to exclude the presence of pregnancy.
  11. Patients with a history of chloasma or a tendency to develop it are advised to avoid UV exposure.
  12. If the course of treatment is started too early at the beginning of the menstrual cycle, especially before the 15th day of the cycle, shortening of the cycle and / or acyclic bleeding is possible. In the case of acyclic bleeding, the drug should not be used until their cause is clarified, including a histological examination of the endometrium.
  13. More than 50% of cases of spontaneous abortions in early pregnancy are due to genetic disorders. In addition, the cause of spontaneous abortions in early pregnancy can be infectious processes and mechanical damage. Application in these cases can only lead to a delay in rejection and evacuation of a non-viable fetal egg. Use to prevent threatened abortion is justified only in cases of progesterone deficiency.
  14. When conducting MHT with estrogens during the perimenopausal period, it is recommended to use for at least 12 days of the menstrual cycle.
  15. With a continuous regimen of MHT in postmenopausal women, it is recommended to use the drug from the first day of taking estrogens.
  16. When conducting MHT, the risk of developing venous thromboembolism (deep vein thrombosis or pulmonary embolism), the risk of ischemic stroke, coronary heart disease increases.
  17. Due to the risk of developing thromboembolic complications, the use of the drug should be discontinued in the event of: visual disturbances, such as loss of vision, exophthalmos, double vision, vascular lesions of the retina; migraine; venous thromboembolism or thrombotic complications, regardless of their location.
  18. If there is a history of thrombophlebitis, the patient should be closely monitored.
  19. When used with estrogen-containing drugs, refer to the instructions for use regarding the risks of venous thromboembolism.
  20. The results of the Women Health Initiative Study (WHI) clinical study indicate a slight increase in the risk of breast cancer with prolonged, more than 5 years, the combined use of estrogen-containing drugs with synthetic progestogens. It is not known whether there is an increased risk of breast cancer in postmenopausal women during MHT with estrogen-containing drugs in combination with progesterone.
  21. The results of the WHI study also found an increased risk of dementia when starting MHT at age 65 or older.
  22. Before starting MHT and regularly during it, a woman should be examined to identify contraindications to its implementation. In the presence of clinical indications, a breast examination and gynecological examination should be carried out.
  23. The use of progesterone may affect the results of some laboratory tests, including indicators of liver function, thyroid gland; coagulation parameters; concentration of pregnandiol.

Influence on the ability to manage transport

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.

Utrozhestan or Duphaston - which is better?

Duphaston, like its analogue, is used to compensate for the deficiency of endogenous progesterone. The main difference between the drugs is that the first is a synthetic analogue of progesterone, and the second is the only progesterone to date, which is obtained from plant materials.

The effectiveness of Duphaston and Utrozhestan in planning pregnancy and in pregnant women is comparable. The advantages of Duphaston are the absence of a sedative effect, which, when using Utrozhestan, is manifested by drowsiness and lethargy, as well as a long experience of use.

The advantages of Utrozhestan are the ability to influence androgen metabolism and suppress the effects of oxytocin, thus improving the course of pregnancy.

Analogues

Structural analogues of Utrozhestan: Iprozhin, Crinon, Progestogel, Progesterone, Prajisan.

  1. Oleg

    My wife had spotting at the beginning of pregnancy, the doctor quickly diagnosed a lack of the hormone progesterone - he prescribed Utrozhestan. At first he prescribed them in tablets, but his wife could not drink them, since toxicosis tormented her, the tablets immediately came back. As a result, the doctor recommended vaginal administration, then everything was fine, and there was no nausea and the discharge stopped from the first application. Of the minuses - the high cost.

    It turned out that a pack was enough for 10 days, and a pack cost about 500 rubles. Of course, nothing is a pity for the health of the child, but the first three months of pregnancy did not hit the pocket so weakly. Then Utrozhestan was canceled for us, we needed other medicines, there were all sorts of vitamins, etc. Now our healthy son Sasha is growing up.

  2. Nastya

    I am 21 years old! There were no pregnancies and was not planned, the cycle was broken with an interval of 45 days and pain in the right breast, and I decided to consult a doctor, because I want to have a child in the future!

    Upon arrival at the gynecologist, I underwent an ultrasound scan, passed tests for hormones (not a cheap procedure) and all together showed progesterone deficiency! The doctor prescribed me Utrozhestan 200 mg and Mastodinon! Drinking Utrozhestan was not possible, my head was spinning, I didn’t understand what they were saying to me, and where I was at all! I work day / night 48! And it was not very convenient to take it, but I drank the course!

    While taking weight, I didn’t gain weight, my periods were regular, but as soon as I stopped menstruating there were no three months, and I began to feel pain in the lower abdomen! The guy forced me to see a doctor! Having done an ultrasound again, they found an ovarian cyst! Is it possible because of utrogestan? But they attributed it to me again! But now I don’t drink it, but put it like candles! So it’s a little easier to endure its side effects! I can say one thing, we are poor women! Are we risking our health without knowing whether it will be better or worse?

  3. Arina

    Hormonal drugs should only be used on the advice of a doctor. Mastiol edas 127 effectively helps with mastopathy. But it is used in a course.

One capsule contains 100 or 200 mg of yam extract progesterone (in micronized form), as well as peanut butter (Arachis hypogaea), (Lecithin) soy , (Glycerol), gelatin (Gelatin) additive E171 (titanium dioxide).

Release form

  • Capsules Utrozhestan 100 mg, package No. 30;
  • capsules Utrozhestan 200 mg, package No. 14.

pharmachologic effect

Progestogenic.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

The effects of Utrozhestan are due to the properties of the progesterone , which is analogous to the natural biological progesterone produced by the corpus luteum of the ovaries after ovulation, and also - in pregnant women - by the placenta.

Under the influence progesterone the mucosa lining the uterine cavity thickens and becomes secretory, which contributes to the fixation of a fertilized egg in it and normal development in the future.

In pregnant women progesterone reduces contractility and excitability of the muscles of the uterus and fallopian tubes.

It blocks the secretion of regulating the release of FSH and LH from the pituitary gland, inhibits ovulation and the production of gonadotropins by the pituitary gland. Androgenic properties are not found.

Pharmacokinetics when taken orally

Plasma concentration progesterone begins to rise from the first hour after taking the capsules and reaches maximum values ​​after 1-3 hours. An hour later, this figure is 4.25, after two hours - 11.75, after four hours - 8.37, after six hours - 2, and after eight hours - 1.64 ng / ml.

two thirds of the dose progesterone metabolized in the liver. Mainly found in urine pregnenolone and pregnandiol (metabolites are identical to those formed during physiological secretion).

Specified derivatives progesterone play an important role in the education and exchange of others steroid hormones . From 15 to 60% of metabolic products are excreted by the kidneys, a little less than a third - with faeces.

Pharmacokinetics with intravaginal application

Progesterone when administered parenterally, it is absorbed in the mucosa. Absorption is fast. Plasma concentration begins to rise from the first hour after the use of the drug. Its level reaches its highest values ​​in 1-3 hours.

The use of Utrozhestan 100 mg capsules at night allows you to achieve and maintain a stable and physiological concentration progesterone in plasma, which corresponds to that in the corpus luteum phase (luteal phase) of the cycle in women with normal ovulation.

Thus, the drug stimulates adequate maturation of the internal lining of the uterus and contributes to the normal implantation of the embryo.

The use of a dose exceeding 200 mg / day, intravaginal use of Utrozhestan does not allow reaching plasma levels progesterone , which would be identical to that in the first 3 months of pregnancy.

About 95% of the dose is excreted as (basic - pregnandiol ) with urine.

Indications for use

Utrozhestan: why is it taken orally?

And obstetric practice Utrozhestan is used for threat warnings or ordinary miscarriage against the background of luteal phase insufficiency (NLF), as well as for prevention of the threat of preterm birth .

Also, oral administration of the drug is indicated for those associated with deficiency progesterone gynecological disorders, including PMS, menstrual irregularities (dys- or anovulation), FCD of the mammary glands, premenopausal conditions; , the cause of which is luteal insufficiency; HRT in women with menopausal disorders (in combination with containing drugs).

Indications for the use of Utrozhestan vaginally

As candles, Utrozhestan is used:

  • in hormone replacement therapy for non-functioning ovaries as part of the program oocyte donation ;
  • with IVF (to maintain the phase of the corpus luteum at the stage of preparation for fertilization of the egg);
  • to maintain the corpus luteum phase in an induced/spontaneous cycle;
  • for the prevention of progestogen insufficiency spontaneous / habitual miscarriage ;
  • at endocrine infertility ;
  • at ;
  • at ;
  • if there are restrictions for oral use of the drug or if it is impossible.

Contraindications

Contraindications to the use of Utrozhestan:

  • severe violations of the liver;
  • vaginal bleeding of unknown nature;
  • incomplete/unsuccessful ;
  • hemorrhage in the brain;
  • thromboembolic disorders;
  • neoplasia of the genital organs / mammary glands (confirmed or suspected);
  • porphyria;
  • hypersensitivity to any of the substances contained in the capsules.

Side effects of Utrozhestan

Side effects of Utrozhestan when administered orally are most often manifested in the form of:

  • changes in the cycle of menstrual bleeding;
  • bleeding beginning in the middle of the cycle;

Less common are:

  • transient;
  • mammalgia ;
  • vomit;
  • cholestatic jaundice.

In rare cases, nausea may occur.

Also, the possibility of a change in libido, the appearance of discomfort in the chest and / or symptoms characteristic of PMS, hyperthermia, , hirsutism , , venous thromboembolism , changes in body weight, gastrointestinal disorders, fluid retention, anaphylactic-type hypersensitivity reactions.

Transient dizziness and / or drowsiness is especially pronounced with concomitant hypoestrogenism . To eliminate these phenomena (without reducing the therapeutic effect), it is usually sufficient to increase the dosage estrogen or reduce the dose of the drug.

If treatment is started before the 15th day of the cycle, it is possible to shorten the cycle. Occasional bleeding may also occur.

If Utrozhestan tablets are inserted into the vagina, side effects are expressed in the form of hypersensitivity reactions (hyperemia, itching, burning) and the appearance of oily discharge.

Reviews of the side effects of Utrozhestan (including during pregnancy) allow us to conclude that the greatest number of unpleasant phenomena occurs after taking the capsules inside. To reduce their severity, the capsules should be taken at bedtime or switched to an intravaginal route of administration.

Capsules Utrozhestan: instructions for use

The method of administration, as well as instructions on how best to take Utrozhestan, how long to continue treatment and how to stop the drug, depend on the indications for use and clinical manifestations pathology.

Instructions for use Utrozhestan inside

Inside, as a rule, the drug is prescribed to be taken at a dose of 200-300 mg / day. The main dose (in the evening, before bedtime) is 200 mg, in the morning (if necessary) another 100 mg are taken.

At luteal insufficiency (PMS, FKB, premenopause, cycle failures) tablets are taken in ten-day courses, starting from the 17th day of the cycle.

With HRT in menopause due to the fact that a separate therapy estrogen containing preparations is not recommended, Utrozhestan is used as an adjunct to the main treatment.

Start taking the drug should be 7 days after the start of each course of HRT. Duration of application - 2 weeks. It should be remembered that withdrawal bleeding is possible during HRT.

To prevent preterm labor (PR), the drug is taken 3-4 rubles / day, at regular intervals. Single dose - 400 mg. After the disappearance of the clinical manifestations of the threat of PR, the dose is gradually reduced to a maintenance dose of 600 mg / day: the capsules continue to be taken one 3 times a day.

Regarding until which week to take the drug, the following recommendations are given in the instructions: intake during pregnancy at a dose of 600 mg / day. available up to 36 weeks.

Apply progesterone beyond 36 weeks is not recommended.

How to administer Utrozhestan capsules intravaginally?

The capsules are inserted into the vagina as deeply as possible. The average daily dose of the drug for intravaginal use is 200 mg (1 capsule 200 mg 1 r./day or 2 capsules 100 mg 2 r./day). If necessary, for greater convenience, you can use the applicator.

Depending on the woman's response to the prescribed treatment, the dose may be increased.

With partial NLF (“ovulation syndrome”, cycle failures), Utrozhestan is used for 10 days at a dose of 200 mg / day. Treatment begins on the 17th day of the cycle.

With complete NLF in women with absent (non-functioning) ovaries ( oocyte donation ) appoint 100 mg of progesterone in the morning and evening from 15 to 25 days of the menstrual cycle.

If pregnancy is confirmed on the 26th day of the cycle, from that moment the dose is gradually increased by 100 mg / day, bringing it to a maximum of 600 mg / day. (one capsule of 200 mg for each dose).

In this dosage, Utrozhestan suppositories continue to be used up to 60 days.

During the IVF cycle, 1 capsule of 200 mg is administered once every 8 hours.

During pregnancy, when there is a possibility of its termination, as well as to prevent a habitual miscarriage associated with a progesterone deficiency, a woman should be administered 100 or 200 mg of progesterone every 12 hours until the 12th week.

It is very important to correctly insert the capsules into the vagina, especially when the drug is prescribed for hormonal support in IVF. Before you enter the capsule, you should lie on the bed, while putting a pillow under the buttocks and lower back, spread your legs wide and place the pill as deep as possible into the vagina.

After that, in order to active substance the drug managed to be absorbed into the mucous membrane in the right amount, it is recommended to stay in bed in the same position for another 15 minutes to an hour.

Overdose

Symptoms of an overdose may be manifested by symptoms of side effects of the drug: drowsiness, euphoria, dizziness, metrorrhagia , shortening the cycle time, .

For some women, the standard dose may be too high due to existing or secondary endogenous secretion. progesterone , hypersensitivity to Utrozhestan or a concomitant reduced level of c.

With the appearance of transient dizziness or drowsiness, it is enough to reduce the dose progesterone or prescribe the drug in the evening hours (before going to bed).

By shortening the cycle and metrorrhagia the start of treatment is postponed to a later day of the cycle (for example, from day 17 to day 19).

In patients receiving premenopausal HRT, it is necessary to control the level of estradiol.

Interaction

Women undergoing treatment during menopause estrogen-containing drugs , it is recommended to start taking no later than the 12th day of the cycle progesterone .

If, in the treatment of the threat of PR, the drug is combined with β-agonists , the latter can be used at a lower dose.

Concomitant use of other medicinal products may interfere with pharmacokinetics progesterone , causing an increase or, conversely, a decrease in its concentration in plasma and, thus, leading to a change in the action of the drug.

Drugs that potently induce the liver ( antiepileptic drugs , barbiturates , Phenylbutazone , , , ) contribute to strengthening progesterone in the liver.

Smoking contributes to a decrease in bioavailability progesterone , alcohol - its increase.

Terms of sale

On prescription.

Storage conditions

Capsules should be stored at a temperature not exceeding 25°C.

Best before date

Three years.

special instructions

Due to the likelihood of metabolic disorders and thromboembolic complications it is necessary to cancel the drug when:

  • visual disturbances, including vision loss, double vision, retinal vascular lesions , optic disc , proptosis ;
  • thrombotic or thromboembolic venous complications (regardless of which area is affected);
  • high intensity headache, .

Patients with thrombophlebitis history should be under constant medical supervision.

The absence of menstruation during treatment with Utrozhestan requires tests to confirm or exclude pregnancy, which may be the cause amenorrhea .

More than 50% of spontaneous abortions in early pregnancy are due to genetic complications. In addition, the cause of abortion can be mechanical disorders and infectious diseases . In such cases, the use of drugs progesterone justified only in cases where there is a delay in the expulsion of the fetal egg.

Based on this, the appointment of Utrozhestan on the recommendation of a gynecologist should be provided for cases where a woman's body produces an insufficient amount progesterone .

The capsules should not be taken with food. The best time to take it is before bed. The simultaneous use of food increases the bioavailability of Utrozhestan.

Some women are interested in whether the drug affects the level of hCG. Doctors say that Utrozhestan does not change the results.

Utrozhestan flows out - what to do?

All patients note that the drug leaks when administered intravaginally. The manufacturer and doctors say that such a phenomenon is the norm. The appearance of oily secretions is associated with dosage form Utrozhestan and its composition, in which fatty substances are present - vegetable oil and soy lecithin.

Some women worry that this may reduce the effectiveness of Utrozhestan. However, doctors are in a hurry to reassure here, assuring that it is not the active substance that is leaking, but only the capsule shell.

In some cases, when the drug is used several times a day, the doctor may recommend intravaginal administration of only 1 rub / day - before bedtime, and at other times - in the morning and afternoon - oral capsules.

Utrozhestan and menstruation

Utrozhestan is prescribed to correct cycle disorders caused by endogenous progesterone deficiency , as well as for the correction of disorders caused by excessive production estrogen .

A delay in menstruation against the background of the use of the drug may indicate pregnancy. In this case, a woman must definitely donate blood to determine the level of hCG or do it.

The situation when there is no menstruation after taking the drug can also be the result of “blind” support of the 2nd phase of the cycle, when the time of ovulation is not taken into account.

For women planning a pregnancy, doctors recommend taking Utrozhestan not from the 16th day, but one day after ovulation.

Preparations progesterone can be used to call menstruation. Menstrual bleeding is due to the effect of the withdrawal of Utrozhestan. The onset of menstruation usually occurs 2-10 days after stopping the capsules.

Analogues of Utrozhestan

Coincidence in the ATX code of the 4th level:

Analogues with a similar mechanism of action: Oxyprogesterone capronate , Medroxyprogesterone-LANS .

Prajisan and Utrozhestan - the difference?

Prajisan belongs to the group of drugs progesterone and is a generic of Utrozhestan. Therefore, the difference between these means is small.

Prajisan , unlike its structural counterpart, is available not only in the form of capsules for oral and intravaginal use, but also in the form of a gel that is inserted into the vagina using a disposable applicator.

Which is better - Kraynon or Utrozhestan?

A drug Crinon is a vaginal gel produced by the manufacturer in disposable applicators. Active substance - progesterone , which is contained in the drug at a concentration of 90 mg / dose (1 dose \u003d 1.125 g of gel).

A feature of the drug is that the gel is placed in a polymer delivery system, which provides a high degree binding to the vaginal mucosa and continuous release active substance for at least three days.

Iprozhin or Utrozhestan - which is better?

Iprozhin are capsules containing 100 or 200 mg progesterone (micronized). The main difference between the drug and Utrozhestan is that when applied intravaginally, it practically does not flow out of the vagina, which, according to many women, is more convenient.

In the annotation to Iprozhina it is indicated that it can enhance the effect immunosuppressants , diuretics , anticoagulants and antihypertensive drugs , as well as reduce the lactogenic effect .

Alcohol compatibility

Alcohol increases the bioavailability of the drug.

Utrozhestan during pregnancy

Does Utrozhestan help to get pregnant?

Utrozhestan when planning pregnancy is necessary when, during the tests, insufficiency of the 2nd phase of the cycle is detected.

The use of the drug stimulates the formation of a secretory type of endometrium, promotes the transition of the uterine mucosa from the proliferative to the secretory phase, and then, when fertilization occurs, its transition to the optimal state for the development of a fertilized egg.

The endometrium, which swells under the influence of Utrozhestan, becomes loose, making it easier for the egg to attach to the wall of the uterus.

Also, Wikipedia states that progestins also help to reduce the excitability and contractility of the muscles of the uterus and fallopian tubes, prevent an increase in concentration estrogen in the 2nd phase of the cycle and promote nervous relaxation, thus creating conditions favorable not only for conception, but also for maintaining the normal course of pregnancy.

Analyzing reviews of those who helped get pregnant Utrozhestan, we can conclude that the drug is effective in situations where the cause of infertility is a low level endogenous progesterone . If there are no other obstacles to conception, pregnancy against the background of the use of the drug occurs quite quickly.

How to take the drug when planning a pregnancy?

As a rule, when trying to get pregnant, the drug is taken for ten days in each cycle, starting from day 16. On the 25-26th day, you should do a pregnancy test or donate blood to determine the level of hCG.

If pregnancy is not confirmed, the drug is stopped and resumed in a new cycle, following the same regimen.

If there is reason to suspect pregnancy, you cannot stop taking Utrozhestan - abrupt cancellation during pregnancy can cause it to spontaneously terminate. If the test gave a positive result, the use of the drug is continued up to 12-16 weeks.

Women whose ovaries do not produce at all progesterone , Utrozhestan is prescribed intravaginally according to the following scheme:

  • 100 mg/day on the 13th and 14th days of the cycle;
  • 200 mg / day, divided into 2 doses, from 15 to 25 days;
  • from 200 to 800 mg / day. (the dose is increased daily by 100 mg to the maximum) - from the 26th day (provided that the pregnancy is confirmed).

How to take Utrozhestan during pregnancy?

The use of Utrozhestan during pregnancy does not adversely affect the fetus. If it is necessary to use after the third month of pregnancy, it is necessary to control the functional state of the liver.

There is evidence that the use progestogens in pregnant women in order to prevent habitual / spontaneous miscarriage against the background of NFL can lead to the development hypospadias .

In the early stages, with the threat of miscarriage, the drug is recommended to be used vaginally, since with this method healing effect develops faster, and the load on the liver is minimal. It is also recommended to prescribe candles to women who suffer from severe .

The treatment regimen and dosage for each individual patient are selected by the doctor individually.

When it comes to maintaining a pregnancy, the initial dose is usually 400 to 600 mg. Subsequently, the woman is transferred to maintenance treatment at a dose of 200 mg / day. up to 600 mg / day. With the ineffectiveness of therapy, the dose can be increased to 0.8-1 g / day. Treatment usually lasts up to 18-20 weeks.

In the 2nd and 3rd trimester, the use of Utrozhestan is advisable when the clinic of the threat of abortion is resumed, and also, in a situation where a woman develops ICI ( isthmic-cervical insufficiency ).

The method of administration at this time does not play a role. Reviews of doctors and their patients allow us to conclude that the use of the drug in daily dose up to 300 mg up to 36 weeks inclusive, it is equally effective both when taking capsules orally and when they are introduced into the vagina.

Up to 34-36 weeks, until the uterine tone is removed, the capsules are taken orally 1 every 8 hours. Then the woman is prescribed maintenance treatment at a dose of 200 mg.

Side effects of the drug

The most common side effects of Utrozhestan are manifested in the form of drowsiness, lethargy and dizziness. However, these unpleasant symptoms occur only when the capsules are taken orally.

Since Utrozhestan is a hormonal remedy, the question naturally arises - is it possible to recover from it? Doctors say that taking the capsules does not cause a change in body weight. This is due to the fact that the drug does not affect carbohydrates and lipids, and also does not retain fluid in the body.

Discharge during pregnancy after the drug (with the intravaginal method of use) is not a side effect if there are no bloody impurities in them - it's just a melted capsule shell. The appearance of bleeding requires dose adjustment.

How much to take Utrozhestan during pregnancy?

Only a doctor can say exactly how long to take Utrozhestan during pregnancy in a particular case. If pregnancy occurs during treatment progesterone , capsules continue to be taken for an average of 2 months, starting from the 26th day of the cycle in which conception occurred.

How to cancel the medicine during pregnancy?

During pregnancy, Utrozhestan is canceled by gradually reducing the dose, since an abrupt cessation of treatment is fraught with spontaneous abortion.

The withdrawal regimen may include a dose reduction of 50 mg every three days or a weekly reduction of 100 mg.

Which is better - Duphaston or Utrozhestan during pregnancy?

Like its counterpart, it is used to compensate for the deficit endogenous progesterone .

The main difference between the drugs is that the first is a synthetic analogue progesterone , and the second is the only one to date progesterone , which is obtained from plant materials.

Efficiency Duphaston and Utrozhestan when planning pregnancy and in pregnant women is comparable.

The advantages of Duphaston are the absence of a sedative effect, which, when using Utrozhestan, is manifested by drowsiness and lethargy, as well as a long experience of use.

The advantages of Utrozhestan are the ability to influence androgen metabolism and suppress the effects oxytocin thus improving the course of pregnancy.

Application for lactation

Ability progesterone pass into breast milk has not been studied, and therefore should avoid the use of the drug during the period.