Iprozhin

The drug Iprozhin cannot be used for the purpose of contraception.
The drug should not be taken with food, since food intake increases the bioavailability of progesterone.

The use of the drug Iprozhin after the first trimester of pregnancy can cause the development of cholestasis. The drug 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 concomitant cardiovascular diseases or a history of them should be periodically observed by a doctor.

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

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

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.

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 Iprozhin in these cases can only lead to a delay in rejection and evacuation of a non-viable fertilized egg. The use of the drug Iprozhin to prevent habitual abortion is justified only in cases of progesterone deficiency.

When carrying out HRT with estrogen-containing drugs during perimenopause, it is recommended to use the drug Iprozhin for at least 12 days of the menstrual cycle.

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

When carrying out HRT, the risk of developing venous thromboembolism (deep vein thrombosis or pulmonary embolism), the risk of ischemic stroke, and coronary heart disease increases.

Due to the risk of developing thromboembolic complications, you should stop using the drug if: visual disturbances such as vision loss, 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 Iprozhin with estrogen-containing drugs, you must refer to the instructions for their use regarding the risks of venous thromboembolism. Results from the Women Health Initiative Study (WHI) indicate a small increase in the risk of breast cancer over a long period of more than 5 years. combined use of estrogen-containing drugs with gestagens. Regarding the use of estrogen-containing drugs in combination with progesterone as part of HRT, there is no evidence of an increased risk of breast cancer.

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

Before starting HRT and regularly during it, a woman should be examined to identify contraindications to her behavior. If clinically indicated, a breast examination and gynecological examination should be performed.

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

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

Iprozhin caps for vaginal or internal use 200 mg N 15

Release form

capsules

Package

15 pcs.

pharmachologic effect

Iprozhin is a gestagen, a 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 aldosterone; in small doses it accelerates, and in large doses it suppresses 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 development of normal endometrium.

Pharmacokinetics

When taken orally, it is well absorbed from the gastrointestinal tract, the time to reach Cmax is 1-3 hours. After taking 200 mg, the concentration of progesterone in plasma increases from 0.13 ng/ml to 4.25 ng/ml after 1 hour and is 11.75 ng/ml after 2 hours, 8.37 ng/ml - after 3 hours, 2 ng/ml - after 6 hours, 1.64 ng/ml - after 8 hours.

When administered intravaginally, it is rapidly absorbed, a high concentration of progesterone in plasma is observed after 1 hour. The time to reach Cmax is 2-6 hours. When administered 100 mg 2 times a day, the average concentration is 9.7 mg/ml for 24 hours. When administered more than 200 mg progesterone concentration corresponds to the first trimester of pregnancy. Communication with plasma proteins - 90%.

Metabolized in the liver with the participation of the CYP2C19 enzyme system. The main metabolites are 20-alpha-hydroxy-delta-4-alpha-pregnanolone and 5-alpha-dihydroprogesterone. Excreted by the kidneys - 50-60%.

Indications

For oral administration:

premenstrual syndrome;
fibrocystic mastopathy;
premenopause;
as a gestagenic component of hormone replacement therapy in postmenopause (in combination with estrogens);

Intravaginally:

hormone replacement therapy with non-functioning (absent) ovaries in case of complete lack of progesterone (egg donation);
luteal phase support during preparation for IVF;
luteal phase support in spontaneous or induced menstrual cycle;
premature menopause, postmenopause (in combination with estrogens);
prevention of habitual and threatened miscarriage due to gestagenic insufficiency;
endocrine infertility;
prevention of uterine fibroids;
endometriosis.

Contraindications

Hypersensitivity to any of the ingredients of the drug, tendency to thrombosis, acute forms of phlebitis or thromboembolic diseases;
bleeding from the vagina 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.

Use during pregnancy and breastfeeding

Use with caution during pregnancy due to the risk of liver dysfunction.

With caution - during lactation.

special instructions

The drug Iprozhin cannot be used for the purpose of contraception; Use with caution during pregnancy due to the risk of liver dysfunction; 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.

Compound

1 capsule contains:

Active substance: micronized progesterone 100 mg.

Directions for use and doses

Follow the recommended dosage strictly unless otherwise directed by your doctor.

Orally: in the evening before bed (not recommended to take before, after or during meals). For premenstrual syndrome, fibrocystic mastopathy, dysmenorrhea, premenopause - 200-300 mg for 10 days (from 17 to 26 days of the cycle); with hormone replacement therapy in postmenopause while taking estrogen - 200 mg/day, for 10-12 days.

Intravaginally:

For egg donation (against the background of estrogen therapy): 100 mg/day on days 13 and 14 of the cycle, then 100 mg 2 times a day, from days 15 to 25 of the cycle; from day 26 and if pregnancy is detected, the dose increases by 100 mg/day every week, reaching a maximum of 600 mg in 3 doses (over 60 days).

To support the luteal phase during an IVF cycle - 400-600 mg/day, starting from the day of hCG injection until 12 weeks of pregnancy.

To support the luteal phase in a spontaneous or induced menstrual cycle, in case of infertility associated with dysfunction of the corpus luteum - 200-300 mg/day, starting from the 17th day of the cycle for 10 days; in case of delayed menstruation and diagnosis of pregnancy, treatment should be continued. If there is a threat or prevention of abortion - 100-200 mg 2 times a day daily, up to 12 weeks of pregnancy.

The duration of treatment is determined by the nature and characteristics of the patient’s condition.

Side effects

Allergic reactions, drowsiness, transient dizziness (1-3 hours after using the drug), shortening of the menstrual cycle, intermenstrual bleeding.

Drug interactions

Enhances the effect of diuretics, antihypertensive drugs, immunosuppressants, anticoagulants. Reduces the lactogenic effect of oxytocin.

Overdose

The undesirable effects listed above are possible, but disappear when the dose of the drug is reduced.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 ºС.

Iprozhin capsules for oral or intravaginal administration 200 mg No. 15

Iprozhin (Iprozhin) instructions for medical use of the drug Active ingredient: Progesterone (Progesterone) Release form and composition: Dosage form - capsules: almost white or white, ovoid, with a soft structure; inside the capsules there is a white or almost white thin suspension (dosage 100 mg: 30 pcs in a blister, 1 or 3 blisters in a cardboard pack, 15 pcs in a blister, 2 or 6 blisters in a cardboard pack; dosage 200 mg: 15 pcs in a blister ., in a cardboard box 1 or 3 blisters). 1 capsule contains: active ingredient: micronized progesterone – 100 mg or 200 mg; auxiliary components: soy lecithin, peanut oil; capsule shell: glycerol, titanium dioxide, gelatin. Pharmacological properties Pharmacodynamics Gestagen is a hormone of the corpus luteum. Penetrating into the nucleus, after binding to receptors on the surface of cells of target organs, it activates DNA (deoxyribonucleic acid) and stimulates the synthesis of RNA (ribonucleic acid). Promotes the transformation of the uterine mucosa from the proliferation phase caused by follicular hormone to the secretory phase, then, after fertilization, the transition to the state necessary for the further development of the zygote. Progesterone 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. Stimulation of protein lipase increases fat reserves, glucose utilization, stimulated and basal insulin concentrations, causes accumulation of glycogen in the liver, and increases aldosterone production. Low doses of gestagen accelerate the production of gonadotropic hormones of the pituitary gland, and high doses suppress it. The drug increases the excretion of nitrogen in the urine, reducing azotemia. While taking it, the endometrium develops normally, the growth of the secretory section of the acini of the mammary glands and lactation are activated. Pharmacokinetics The drug is well absorbed into the gastrointestinal tract after oral administration, the maximum concentration in the blood is reached after 1-3 hours. After taking Iprozhin 200 mg, the concentration of progesterone in plasma increases from 0.13 ng/ml: after 1 hour - to 4.25 ng/ml, after 2 hours - to 11.75 ng/ml, after 3 hours it is 8.37 ng/ml, after 6 hours – 2 ng/ml, after 8 hours – 1.64 ng/ml. When administered intravaginally, it is absorbed quickly; after 1 hour, a high concentration of progesterone is observed in the plasma, which reaches its maximum after 2–6 hours. When Iprozhin is administered 200 mg per day (twice 100 mg), the average concentration over 24 hours is 9.7 mg per 1 ml. Administration of a dose of more than 200 mg provides a level of progesterone concentration corresponding to the first trimester of pregnancy. Communication with plasma proteins – 90%. Progesterone metabolism occurs in the liver with the participation of the CYP2C19 enzyme system. The main metabolites are 20-alpha-hydroxy-delta-4-alpha-pregnanolone and 5-alpha-dihydroprogesterone. Approximately 50–60% of Iprozhin is excreted through the kidneys.

Indications for use Iprozhin is indicated for the treatment of the following pathologies: premenstrual syndrome; premenopause; fibrocystic mastopathy; Hormone replacement therapy in postmenopause - as a gestagenic component in complex therapy with estrogens.

Intravaginal capsules are prescribed in the following cases: the period of preparation for in vitro fertilization (IVF) to support the luteal phase; endocrine infertility; complete absence of progesterone (egg donation) – as hormone replacement therapy for non-functioning (absent) ovaries; prevention of uterine fibroids; luteal phase support in spontaneous or induced menstrual cycle; premature menopause, postmenopause (in combination with estrogens); endometriosis; prevention of habitual and threatened miscarriage due to gestational insufficiency. Vaginal bleeding of unknown origin is contraindicated ; acute forms of thromboembolic diseases or phlebitis; predisposition to thrombosis; incomplete abortion; malignant neoplasms of the genital organs and mammary glands, including if they are suspected; porphyria; hypersensitivity to the components of the drug. Caution should be exercised when prescribing Iprozhin to women with arterial hypertension, diseases of the cardiovascular system, chronic renal failure, bronchial asthma, diabetes mellitus, epilepsy, depression, migraine, hyperlipoproteinemia and during breastfeeding. Capsules should be taken orally with caution in patients with severe liver dysfunction. Directions for use Capsules are intended for oral and intravaginal use. The drug is taken orally once a day, in the evening, just before going to bed. Do not take before, during or after meals. Recommended dosage : premenstrual syndrome, premenopause, fibrocystic mastopathy, dysmenorrhea: from 17 to 26 days of the menstrual cycle - 200–300 mg; hormone replacement therapy in postmenopause in combination with estrogens: 200 mg, course duration 10–12 days. The clinical effect depends on strict adherence to the specified dosage regimen, unless it contradicts the individual doctor’s prescription. Recommended dosage for intravaginal use of the drug: hormone replacement therapy for non-functioning (absent) ovaries (egg donation) in combination with estrogen therapy: on days 13 and 14 of the cycle - 100 mg per day, from days 15 to 25 of the cycle - 100 mg 2 times per day, from the 26th day and when pregnancy is determined - the dose is increased every week by 100 mg per day, after reaching the maximum dose of 600 mg, it is taken 3 times a day for 60 days;

luteal phase support during an IVF cycle: from the day of injection of human chorionic gonadotropin (CG) - 400–600 mg per day, throughout the entire period up to the 12th week of pregnancy;

support of the luteal phase in a spontaneous or induced menstrual cycle and in case of infertility associated with dysfunction of the corpus luteum: from the 17th day of the menstrual cycle - 200-300 mg per day for 10 days. Treatment should be continued if menstruation is delayed and pregnancy is detected;

threat or prevention of abortion: daily – 100–200 mg 2 times a day until the 12th week of pregnancy.

The duration of use depends on the nature and characteristics of the patient’s condition. Side effects 1–3 hours after using Iprozhin, transient dizziness is possible. In addition, the drug can cause the development of allergic reactions, drowsiness, shortening of the menstrual cycle, and breakthrough bleeding. Overdose Symptoms of overdose are: drowsiness, dizziness, breakthrough bleeding. To treat the condition, it is necessary to reduce the dose of the drug. Special instructions The drug is not a contraceptive, so it cannot be used for contraception. Effect on the ability to drive vehicles and complex mechanisms During the period of taking capsules orally, care must be taken when performing types of work associated with the risk of increased injury, including driving vehicles and other mechanisms, since during therapy a decrease in concentration and speed is possible psychomotor reactions. Use during pregnancy and lactation Due to the risk of liver dysfunction during pregnancy, the drug should be used with caution. During lactation, Iprozhin is prescribed with caution. In case of liver dysfunction, it is recommended to use the capsules orally with caution in women with severe liver dysfunction.

Drug interactions With simultaneous use of Iprozhin: diuretics, antihypertensives, anticoagulants, immunosuppressants - enhance their effect; Oxytocin – reduces the lactogenic effect. Terms and conditions of storage Keep away from children. Store at temperatures up to 25 °C, protected from moisture and light. Shelf life – 3 years. Conditions for dispensing from pharmacies Dispensed by prescription. Manufacturer : ITALFARMACO SpA (Italy)
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