Utrozhestan capsules 200 mg 14 pcs ➤ instructions for use

Pharmacological properties of the drug Utrozhestan

Pharmacodynamics. The pharmacological properties of the drug are due to progesterone, one of the hormones of the corpus luteum, which promotes the formation of normal secretory endometrium in women. Causes a transition of the uterine mucosa from the proliferation phase to the secretory phase, and after fertilization contributes to its 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. Does not have androgenic activity. It has a blocking effect on the secretion of hypothalamic factors for the release of LH and FSH, inhibits ovulation and the secretion of gonadotropic hormones by the pituitary gland. Pharmacokinetics. Oral administration. An increase in the level of progesterone in the blood plasma is observed from the first hour after oral administration. The maximum concentration of progesterone in the blood plasma is observed 1–3 hours after administration (after 1 hour it averages 4.25 ng/ml, after 2 hours - 11.75 ng/ml, after 4 hours - 8.37 ng/ml , after 6 hours - 2 ng/ml, after 8 hours - 1.64 ng/ml). The main metabolites of progesterone detected in blood plasma are 20α-hydroxy,d4α-pregnanolone and 5α-dihydroprogesterone. The drug is excreted in the urine in the form of glucuronic metabolites, the main of which is 3α,5β-pregnanediol (pregnanediol). These metabolites are identical to the metabolites that are formed during physiological secretion of the corpus luteum. Intravaginally. When administered intravaginally, progesterone is quickly absorbed by the mucous membrane. The maximum concentration in blood plasma is observed 2–6 hours after intravaginal administration and remains for 24 hours at an average level of 9.7 ng/ml after application of 100 mg in the morning and evening. This indicator is identical to the concentration of progesterone, which is noted during the luteal phase. When used in doses above 200 mg/day, the concentration of progesterone is similar to its concentration in the first trimester of pregnancy. The drug is excreted in the urine, mainly in the form of pregnanediol. The metabolites that are detected in urine and blood plasma are similar to the metabolites that appear during the physiological secretion of the corpus luteum.

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.

Indications for use of the drug Utrozhestan

Disorders caused by progesterone deficiency. Oral administration: premenstrual syndrome, menstrual irregularities (disovulation, anovulation), fibrocystic mastopathy, premenopausal period, menopause (in combination with estrogen therapy), infertility with luteal insufficiency, prevention of recurrent miscarriage or threatened miscarriage due to luteal insufficiency, threat of premature childbirth Intravaginal use: Reducing the possibility of fertilization in case of primary or secondary infertility with partial or complete luteal insufficiency (disovulation, support of the luteal phase during preparation for in vitro fertilization, egg donation program); prevention of recurrent miscarriage or threatened miscarriage due to luteal insufficiency.

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.

Use of the drug Utrozhestan

The duration of use depends on the nature of the disease. Oral administration In most cases, the average daily dose is 200–300 mg in 2 divided doses (200 mg in the evening, before bedtime and 100 mg in the morning, if necessary). In case of luteal phase deficiency (premenstrual syndrome, fibrocystic mastopathy, menstrual irregularities, premenopause), take for 10 days (from the 17th to the 26th day of the cycle). With hormone replacement therapy during menopause , due to the fact that estrogen therapy is not recommended separately, progesterone is used as an addition to the latter in the last 2 weeks of each course of therapy, which occurs after one week of replacement therapy, during which withdrawal bleeding is possible. If there is a threat of premature birth, 400 mg of Utrozhestan is prescribed every 6–8 hours until symptoms disappear. The effective dose and frequency of use are determined individually depending on the clinical manifestations of the threat of premature birth. After the symptoms disappear, the dose of Utrozhestan is gradually reduced to a maintenance dose of 200 mg 3 times a day. At this dose, the drug can be used up to 36 weeks of pregnancy. Intravaginal administration: Insert capsules deep into the vagina. The average dose is 200 mg of progesterone per day (1 capsule of 200 mg or 2 capsules of 100 mg, in 2 doses, morning and evening, which are injected deep into the vagina, if necessary using an applicator). The dose may be increased depending on the patient's response. In case of partial insufficiency of the luteal phase (disovulation, menstrual irregularities), the daily dose is 200 mg for 10 days (from the 17th to the 26th day of the cycle). In case of complete insufficiency of the luteal phase: Complete absence of progesterone in women with non-functioning (absent) ovaries (egg donation): the dose of progesterone is 100 mg in the morning and evening from the 15th to the 25th day of the cycle. Starting from the 26th day, in case of early diagnosis of pregnancy, the dose is increased by 100 mg of progesterone per day, reaching a maximum of 600 mg per day, in 3 doses. This dosage must be observed until the 60th day. Support of the luteal phase during an in vitro fertilization cycle: 600 mg 3 times a day (200 mg once every 8 hours). In case of threatened miscarriage or for the prevention of recurrent miscarriage due to progesterone deficiency: prescribe 200–400 mg/day (100–200 mg every 12 hours) until 12 weeks of pregnancy.

Compound

It consists of female sex hormones, and its main active ingredient is progesterone. It also consists of peanut butter, soy lecithin, gelatin, glycerin and titanium dioxide (E171). This is a thyroid hormone that is involved in a woman's ovarian cycle. It also ensures that the uterus is in perfect condition to receive a fertilized egg.

This hormone can also regulate irregular or heavy bleeding cycles.

These drugs come in several forms:

• Pack of 15 capsules of 200 mg active ingredient: Utrozhestan 200 mg
• Pack of 30 capsules progesterone 100 mg: Utrogestan 100 mg

Side effects of the drug Utrozhestan

When administered orally, the following side effects are observed:

Drowsiness and/or dizziness are observed in case of concomitant hypoestrogenism. Reducing the dose of the drug or increasing the dose of estrogen eliminates these phenomena without reducing the therapeutic effect. If the course of treatment begins at the beginning of the monthly cycle, before the 15th day, a shortening of the cycle or occasional bleeding occurs. In general, changes in menstruation, amenorrhea, or mid-cycle bleeding occur when taking progestins. For intravaginal use: no side effects.

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.

Special instructions for the use of the drug Utrozhestan

Treatment in recommended doses does not have a contraceptive effect. If treatment is started very early in the menstrual cycle, especially before the 15th day of the cycle, shortening of the cycle or bleeding may occur. In case of uterine bleeding, the drug should not be prescribed without specifying its cause, in particular when examining the endometrium. Due to the risk of thromboembolic complications and metabolic disorders, you should stop taking the drug if:

• visual disturbances (vision loss, diplopia, vascular lesions of the retina);
• thromboembolic venous or thrombotic complications, regardless of the site of the lesion;
• severe headache.

If there is a history of thrombophlebitis, the patient should be under strict medical supervision. If amenorrhea occurs during treatment, pregnancy must be excluded. Use during pregnancy or breastfeeding. In clinical studies during the period of use of the drug, no adverse effects on the fetus were observed. In the second and third trimesters of pregnancy, monitoring of liver function is necessary. The penetration of progesterone into breast milk has not been studied in detail, so its administration should be avoided during breastfeeding. The ability to influence the reaction rate when driving a vehicle or working with other mechanisms. Drowsiness and dizziness associated with taking the drug orally are possible.

Contraindications

Utrozhestan should not be taken in any of the following cases:

• Allergy to progesterone.
• Suffering from thromboembolism.
• Prolonged vaginal bleeding.
• Suffering from liver problems.

Because this drug may cause drowsiness, special attention should be taken when driving or using heavy machinery. For this reason, it is recommended to take the dose at night, that is, before going to bed.

Progesterone passes through breast milk. For this reason, it is not recommended to take during breastfeeding. Regarding pregnancy, since progesterone is a hormone that increases during pregnancy, taking it during pregnancy may not have side effects.

Interactions of the drug Utrozhestan

When treating the threat of premature birth, Utrozhestan is combined with β-adrenergic agonists, the dosage of the latter can be reduced. When used simultaneously with liver enzyme inducers (barbiturates, phenytoin, rifampicin, phenylbutazone, spironolactone, griseofulvin) or antibiotics (ampicillins, tetracyclines), an increase or decrease in the concentration of progesterone in the blood plasma is possible. Progestins reduce glucose tolerance, and it may be necessary to increase the daily dose of insulin and other antidiabetic agents in patients with diabetes.

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.

Overdose of the drug Utrozhestan, symptoms and treatment

The side effects symptoms described above usually appear as a result of an overdose. They disappear spontaneously when the dose is reduced. In some individuals, the usual dose may be too high due to the existing or secondary appearance of unstable endogenous secretion of progesterone, increased sensitivity to the drug, or a very low concomitant level of estradiol in the blood; in such cases, it is enough to: reduce the dose of progesterone or prescribe progesterone in the evening before bed for 10 days of the cycle in case of drowsiness or dizziness; postpone the start of treatment to a later period of the cycle (for example, the 19th day instead of the 17th) in case of its contraction or bleeding; It is necessary to check whether the level of estradiol is sufficient in a patient who is receiving premenopausal hormone replacement therapy.

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.