Prajisan - instructions for use, reviews, analogs and forms of release (capsules or tablets 100 mg and 200 mg, gel or vaginal cream 8%) drugs to treat infertility, when planning pregnancy, hormone replacement therapy in women. Composition

In this article, you can read the instructions for using the drug Prajisan. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Prajisan in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Prajisan in the presence of existing structural analogs.Use for infertility treatment, in pregnancy planning, hormone replacement therapy in women, as well as in pregnancy and lactation. Composition of the hormonal drug.

Prajisan - Gestagen, the hormone of the yellow body. By binding to receptors on the surface of the cells of target organs, it penetrates into the nucleus, where, by activating DNA, it stimulates the synthesis of RNA. Promotes the transition of the mucous membrane of the uterus from the phase of proliferation caused by the follicular hormone to the secretory phase, and after fertilization - to the condition necessary for the development of a fertilized egg. Reduces excitability and contractility of the muscles of the uterus and fallopian tubes, stimulates the development of the end elements of the breast.

Stimulating proteinolipase, increases protein stores, increases the utilization of glucose, increases the concentration of basal and stimulated insulin, promotes the accumulation of glycogen in the liver, increases the production of aldosterone: in small doses accelerates, and in large doses - suppresses the production of gonadotropic hormones of the pituitary gland; reduces azotemia, increases the excretion of Nitrogen in the urine. Activates the growth of the secretory department of the mammary glands and induces lactation.Promotes the development of normal endometrium.

Composition

Progesterone + auxiliary substances.

Pharmacokinetics

Ingestion

Micronized Progesterone is well absorbed into the digestive tract. The concentration of progesterone in the blood plasma gradually rises during the first hour, Cmax is noted 1-3 hours after admission. Metabolised in the liver with the participation of the isoenzyme CYP 2C19. The main metabolites that are detected in the blood plasma are 20-alpha-hydroxy-delta-4-alpha-pregnanolone and 5-alpha-dihydroprogesterone. It is excreted in the urine in the form of metabolites. 95% of them are glucuron-conjugated metabolites, mainly 3-alpha, 5-beta-pregnanediol (pregnannione). These metabolites, which are determined in the blood plasma and in urine, are similar to substances formed during the physiological secretion of the yellow body.

With vaginal administration

Absorption occurs quickly; progesterone accumulates in the uterus; a high concentration of progesterone in the blood plasma is observed after 1 hour after administration. When the drug is administered 100 mg 3 times a day, the average concentration persists for 24 hours. When administered at doses of more than 200 mg per day, the progesterone concentration corresponds to the 1 trimester of pregnancy. Metabolized with the formation of predominantly 3-alpha, 5-beta-pregnanediol.The concentration of 5-beta-pregnanodiol in plasma does not increase. It is excreted in the urine in the form of metabolites, the main part is 3-alpha, 5-beta-pregnanediol (pregnannione).

Indications

Disorders associated with progesterone deficiency.

Oral route of administration:

• infertility due to luteal insufficiency;
• premenstrual syndrome;
• disorders of the menstrual cycle due to a violation of ovulation or anovulation;
• fibrocystic mastopathy;
• premenopause;
• replacement hormone therapy of peri- and postmenopause (in combination with estrogen-containing drugs).

Vaginal route of administration:

• hormone replacement therapy in case of progesterone deficiency with non-functioning (absent) ovaries (donation of eggs);
• support of the luteal phase during preparation for in vitro fertilization (IVF) and pregnancy planning;
• support of the luteal phase in the spontaneous or induced menstrual cycle;
• premature menopause;
• hormone replacement therapy (in combination with estrogen preparations);
• infertility due to luteal insufficiency;
• prevention of habitual and threatening abortion due to progestin insufficiency;
• prevention of uterine fibroids;
• prevention of endometriosis.

Forms of release

Capsules 100 mg and 200 mg (sometimes mistakenly called pills or vaginal suppositories).

Gel vaginal 8% (sometimes mistakenly called cream or ointment).

Instructions for use and dosing regimen

The duration of treatment is determined by the nature and characteristics of the disease.

Capsules - oral route of administration

The drug is taken orally with water.

In most cases, when progesterone is inadequate, the daily dose of Prajisan is 200-300 mg divided into 2 divided doses (morning and evening).

If the luteal phase is insufficient (premenstrual syndrome, fibro-cystic mastopathy, dysmenorrhea, premenopause), the daily dose is 200 or 400 mg taken within 10 days (usually from the 17th to the 26th day of the cycle).

With hormone replacement therapy in peri- and post-menopause, when taking estrogens, the preparation Prajisan is administered at 200 mg per day for 10-12 days.

Capsules - the vaginal route of administration

Capsules are injected deep into the vagina.

Absolute deficiency of progesterone in women with non-functioning ovaries (donation): against estrogen therapy 200 mg per day on the 13th and 14th days of the cycle, then 100 mg twice a day from the 15th to the 25th day cycle,from the 26th day, and in case of pregnancy, the dose increases by 100 mg per day every week, reaching a maximum of 600 mg per day, divided into 3 doses. This dose can be applied for 60 days.

Support of the luteal phase during preparation for in vitro fertilization: it is recommended to take 200 to 600 mg per day, starting from the day of injection of the chorionic gonadotropin during the 1st and 2nd trimester of pregnancy.

Support for the luteal phase in the spontaneous or induced menstrual cycle, infertility associated with a violation of the function of the yellow body is recommended to take 200-300 mg per day, starting from the 17th day of the cycle for 10 days, in the case of delay in menstruation and pregnancy diagnosis treatment should be continued.

In cases of threatened abortion or in order to prevent habitual abortions that occur against the background of progesterone deficiency: 200-400 mg daily in 2 divided doses in 1 and 2 trimesters of pregnancy.

Vaginal gel

In the treatment of infertility due to luteal insufficiency, 90 mg of progesterone (1 applicator) is administered daily intravaginally, from the day of confirmed ovulation or from 18 to 21 day of the cycle for 10 days.

To maintain the luteal phase during the use of assisted reproductive technologies (ART): from the day of embryo transfer, the gel is used in a dose of 90 mg of progesterone (1 applicator) and administered daily intravaginally. When pregnancy occurs, the drug is continued for 12 weeks or for 10-12 weeks from the date of pregnancy confirmation.

Secondary amenorrhea, dysfunctional uterine bleeding due to a deficiency of progesterone: 90 mg of progesterone (1 applicator) is administered intravaginally every other day from the 15th to the 25th day of the cycle. If necessary, the dose may be decreased or increased.

Replacement hormone therapy in postmenopause (in combination with estrogen preparations): 90 mg of progesterone (1 applicator) is administered 2 times a week.

Rules for the independent use of the drug Prajisan

Prajisan is introduced into the vagina. For hygienic reasons and for ease of use, Prajisan is packaged in a disposable applicator that is discarded after use:

1. It is necessary to open the package with the applicator and pull the applicator out of it.
2. Unscrew the cap.
3. It is necessary to hold the applicator firmly between the thumb and middle finger and the index finger over the piston.
4. You should lie on your back with slightly bent knees.Carefully insert the applicator into the vagina.
5. Strongly press the index finger on the applicator piston to get the gel from the applicator into the vagina.

Note

Despite the fact that some amount of gel remains in the applicator, the patient receives all the necessary dose. Progesterone will be absorbed slowly and for a long time. Now you can throw the applicator with the remaining gel.

Side effect

• breakthrough bleeding;
• shortening of the normal menstrual cycle;
• tension of mammary glands (usually in the first month of treatment);
• drowsiness;
• transient dizziness (usually 1-3 h after administration);
• nausea;
• stomach ache;
• feeling tired;
• migraine;
• headache;
• allergic reactions (skin rash, itching, hives, anaphylactic shock);
• jaundice;
• fluid retention;
• irritation of the mucous membrane of the vagina at the place of application (for the gel).

Contraindications

For oral and vaginal administration

• thrombophlebitis, thromboembolic disorders, intracranial hemorrhage or the presence of these conditions in the anamnesis;
• bleeding from the genital tract of unknown origin;
• incomplete abortion;
• porphyria;
• established or suspected malignant neoplasms of the mammary glands or genitals;
• Hypersensitivity to the components of the drug, incl. to peanut butter, soy.

For oral administration (optional):

• severe liver diseases at present (including cholestatic jaundice, hepatitis, hepatic cell carcinoma, Dubin-Johnson syndromes, Rotor syndrome) or in an anamnesis if the liver function indices did not return to normal values.

Application in pregnancy and lactation

The use of Prajisan during pregnancy is not contraindicated. However, there is a potential risk to the fetus (especially the male) when using progesterone in the first 4 months of pregnancy. The use of micronized progesterone in 2-3 trimesters of pregnancy can lead to the development of liver diseases in pregnant women. Numerous epidemiological studies have not revealed cases of fetal abnormality in the use of progesterone in pregnancy.

Progesterone penetrates into breast milk. Data on the use of the drug during lactation is not enough to assess the potential risk to the baby.

Use in children

Not used.

special instructions

The drug can not be used for contraception.

Prolonged treatment with progesterone requires periodic medical examinations (including liver function tests); treatment should be canceled if there are abnormalities in diagnostic tests of liver function or the occurrence of cholestatic jaundice. When using estrogen and / or progestogen-containing drugs, there have been cases of development of chloasma, especially in patients with a history of chloasma during an earlier pregnancy. In women with a tendency to develop chloasma, exposure of the skin to natural or artificial UV irradiation can cause or aggravate the course of chloasma.

It is necessary to observe patients with depression in the anamnesis, and in case of development of a depression of a serious degree, it is necessary to cancel the drug.

Caution should be prescribed medication Prajisan for diseases of the cardiovascular system, arterial hypertension, chronic kidney failure, diabetes, bronchial asthma, epilepsy, migraine, hyperlipoproteinemia.

The composition of the preparation Prajisan gel vaginal is sorbic acid, which can cause a local skin reaction (contact dermatitis).

With sudden bleeding, as well as in the case of irregular vaginal bleeding, organic pathology should be ruled out. If there is a vaginal bleeding of an unclear etiology, an appropriate examination should be carried out.

In the treatment with progesterone, fluid retention may occur, which can affect the course of epilepsy, migraine, bronchial asthma, cardiac or renal insufficiency; such patients should be carefully observed.

Impact on the ability to drive vehicles and manage mechanisms

With oral intake, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions.

Drug Interactions

When administered orally

With prolonged simultaneous use of barbiturates, carbamazepine, hydantoin or rifampicin may reduce the effectiveness of progesterone.

Despite the limited data, it is suggested that activated charcoal and Griseofulvin also can reduce the effectiveness of Prajisan.

Progesterone may increase the therapeutic, pharmacological or toxic effects of cyclosporine, theophylline and trolleandomycin.

With vaginal application

Interaction with intravaginal application was not evaluated.

Simultaneous administration of other intravaginal drugs should be avoided in order to avoid disturbance of the release and absorption of progesterone.

Analogues of the medicine Prajisan

Structural analogs for the active substance:

• Iprozhin;
• Krajonon;
• Progesterone;
• Projest;
• Utrozhestan.

Analogues for the pharmacological group (estrogens, gestagens):

• Angelique;
• Belara;
• Bonade;
• Byzanne;
• Gestodene;
• Ginepristone;
• Gynestrel;
• Gynodian Depot;
• Gynoflor E;
• Desogestrel;
• Depot Provera;
• Jess;
• Jess Plus;
• Diane 35;
• The Divigel;
• Divina;
• Dimia;
• Duphaston;
• Evra;
• Janine;
• Wife;
• Zoeli;
• Implanon;
• Clira;
• Climadinone;
• Climadinon Uno;
• Climara;
• Klimodien;
• Clinonorm;
• Clomiphene;
• Clostilbite;
• Krajonon;
• Lactineth;
• Lindineth 20;
• Lyndyneth 30;
• Logest;
• Marvelon;
• Mersilon;
• Microinon;
• Microlus;
• Miropristone;
• Mifegin;
• Mifepristone;
• NovaRing;
• Novinet;
• Norplant;
• Pausogest;
• Postinor;
• Provera;
• Proginova;
• Rigevidone;
• Silhouettes;
• Tamoxifen;
• Triogynal;
• Femoden;
• Femoston;
• Femoston continuum;
• Femoston mini;
• Charozette;
• Exemestane;
• Erica 35;
• Escapel;
• Estriol;
• Estrogele;
• Ethinylestradiol;
• Yarina;
• Yarina Plus.

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