Utrozhestan capsules 200 mg 14 pcs ➤ instructions for use

Utrozhestan

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

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

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

Indications

Corrective hormonal therapy for progesterone deficiency.

Utrozhestan capsules are prescribed orally for:

• infertility, which arose as a result of insufficiency of the corpus luteum of the ovary;
• premenstrual syndrome;
• ovulation and menstrual cycle disorders;
• fibrocystic mastopathy.

In combination with estrogen-containing drugs, Utrozhestan is recommended for use as hormone replacement therapy (HRT) for menopausal syndrome.

Intravaginal Utrozhestan is recommended for use in:

• infertility due to insufficiency of the corpus luteum;
• preventing abortion and pregnancy loss due to progesterone deficiency;
• preventive therapy for uterine fibroids and endometriosis;
• premature menopause and during the postmenopausal period as part of HRT;
• maintaining the luteal phase of the menstrual cycle and preparing for assisted reproductive technologies such as egg donation or fertilization.

Utrozhestan capsules 200 mg No. 7x2

Writing

Utrozhestan.

Release forms

Capsules.

INN

Progesterone.

FTG

Progestogen.

Composition (per 1 capsule)

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

Description

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

Pharmacotherapeutic group

Gestagen. ATX code: G03DA04

Pharmacological properties

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

Pharmacokinetics

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

Indications

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

Contraindications

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

Directions for use and doses

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

Side effect

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

Overdose

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

Interaction with other drugs

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

special instructions

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

Fertility, pregnancy and breastfeeding

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

Use in children

Not shown.

Use in the elderly (over 65 years of age)

No clinical data available.

Use in patients with impaired liver function

No clinical data available.

Use in patients with impaired renal function

No clinical data available.

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

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

Release form

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

Best before date

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

Storage conditions

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

Conditions for dispensing from pharmacies

On prescription.

Buy Utrozhestan capsules 200 mg No. 7x2 in the pharmacy

Price for Utrozhestan capsules 200 mg No. 7x2

Instructions for use for Utrozhestan capsules 200 mg No. 7x2

Application

When using Utrozhestan internally, it is recommended to drink capsules before bedtime with a sufficient amount of water. You should not combine the dose with food, as food increases the bioavailability of the medicine.

The recommended dosage of the drug for progesterone deficiency is 200–300 mg/day, divided into two doses, morning and evening (200 mg in the morning, 100 mg in the evening).

In case of insufficiency of the corpus luteum of the ovary, the drug is taken from the 16th day of the cycle to the 25th day (10–12 days).

Dosage for HRT together with estrogens in case of premenopause - 200 mg/day in the second phase of the cycle for 10-12 days, during menopause - 100 mg/day, without interrupting use.

When administered intravaginally, Utrogestan capsules should be inserted deep into the vagina. The duration of therapy is determined by the doctor and depends on the clinical data of the patient.

In combination with estrogens, capsules are inserted into the vagina at a dose of 100 mg/day before bedtime on the 13th to 14th day of the cycle. From the 15th to the 25th day the dose is increased to 200 mg/day. From the 26th day of the cycle, increase the dosage by 100 mg every 7 days. If pregnancy occurs, the dose can be increased to 800 mg/day in three doses. The 800 mg dosage must be used over the next 60 days.

To maintain the luteal phase during in vitro fertilization, the recommended dosage is 400–800 mg/day. Capsules should be administered intravaginally on the day of human chorionic gonadotropin injection and administration should continue until the 8th week of pregnancy.

For infertility, the recommended dosage is 200–300 mg/day from the 17th day of the menstrual cycle for 10 days.

In case of threatened abortion, Utrozhestan is prescribed at 400–800 mg/day. The dose should be divided into two doses.

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.

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.

Popular questions about Utrozhestan

Why is the drug Utrozhestan prescribed?

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

Why is Utrozhestan prescribed during pregnancy?

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

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

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

How to drink Utrozhestan correctly?

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

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.

Note!

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