Utrozhestan capsules 200 mg 14 pcs ➤ instructions for use

Utrozhestan is the only hormonal drug based on plant-based progesterone. Without this hormone, the process of ovulation, conception and a healthy pregnancy are not possible, therefore, before a planned conception, an analysis is required to determine the level of this steroid compound.

The main indication for the use of this drug is a lack of the hormone progesterone in case of hormonal infertility, after a miscarriage caused by a decrease in the level of progesterone in the blood, as well as in case of an unreasonable decrease in the concentration of the hormone.

The level of progesterone changes depending on the day of the menstrual cycle, the highest concentration is observed in the second phase: it is then that laboratory tests should be carried out to determine its level in the blood, it is also important to take this fact into account when taking the drug.

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.

What effect does micronized progesterone have?

1. In case of threatened abortion
, prevention of habitual abortion due to progesterone deficiency, as well as prevention of premature birth in women at risk, the drug of micronized progesterone has:

— progestational and immunomodulatory effect

, preventing immune conflict between the organisms of the mother and fetus;

— tocolytic (relaxing) effect

, reducing the excitability and contraction of the muscles of the uterus and fallopian tubes;

— antimineralocorticoid effect

, regulating water metabolism and preventing excess fluid retention;

— anxiolytic (anti-anxiety) and sedative (calming) effect

, acting with the help of allopregnanolone - a metabolite of progesterone - on certain receptors in the brain.

has a beneficial effect not only on the course of pregnancy, but also on the development of the child’s nervous system: the progesterone metabolite allopregnanolone affects the development of cells responsible for the myelination (insulation) of nerve fibers. A lack of progesterone can lead to a decrease in the speed of impulse transmission and disturbances in the process of formation of the nervous system, which can cause future neurological diseases.

2. For menstrual irregularities
and in preparation for pregnancy
.

The micronized progesterone preparation provides a full second (luteal) phase of the cycle, causes secretory transformation of the endometrium - changes in the uterine mucosa, which are necessary for the onset and maintenance of pregnancy.

3. With hormone replacement therapy

in women during menopause.

While taking estrogen, a woman experiences active growth of the endometrium. The drug micronized progesterone corrects (restrains) its growth, preventing uterine bleeding and possible neoplastic changes in the endometrium. In addition, the drug affects the central nervous system, having a calming and relaxing effect, reducing irritability and normalizing sleep.

Method of use and dosage of the micronized progesterone preparation

The duration of treatment with the drug depends on the characteristics and nature of the disease. There are two options for taking the drug: oral (taking the capsule orally with water) and intravaginal (inserting the capsule into the vagina).

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.

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 effects

When using the drug Utrozhestan, a number of side effects may occur: menstrual cycle failure, breast pathologies, amenorrhea, depression, drowsiness, dizziness, acyclic bleeding, headache, nausea, bloating, diarrhea, vomiting, jaundice, urticaria, acne, itching, chloasma .

When using capsules vaginally, local reactions may occur: oily discharge, burning, itching.

If side effects not listed in the instructions occur, you should consult a doctor.

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

• Susceptibility to the active components of the drug Utrozhestan.
• Bleeding of unknown origin.
• Incomplete abortion.
• Oncological diseases of the mammary glands and reproductive organs.
• Porphyria.
• Thromboembolic disorders (pulmonary embolism, stroke, heart attack).
• Liver dysfunction (internal use).
• Children under 18 years of age.
• If Utrozhestan therapy is started before the 15th day of the cycle, bleeding or a shortening of the menstrual cycle may occur.
• Utrozhestan is allowed during pregnancy, but in the third trimester the drug should be used with caution due to an increased risk of liver failure.

During lactation, the drug Utrozhestan should be used with caution.

Utrozhestan cannot be used as a contraceptive.

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.

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.