Prajisan - instructions for use, doses, side effects, contraindications

capsule shell: 70% sorbitol solution (uncrystallized) 9.00 mg / 12.80 mg, glycerol 44.89 mg / 63.84 mg, gelatin 85.50 mg / 121.60 mg, titanium dioxide 1.06 mg / 1.50 mg , purified water 84.55 ml / 120.26 ml.

Description:Soft gelatin capsules oval in shape, light yellow color, containing an oily suspension of almost white color.

Pharmacotherapeutic group:gestagen

ATX: & nbsp

G.03.D.A Derivative derivatives

G.03.D.A.04 Progesterone

Pharmacodynamics:

The gestagen, the hormone of the yellow body, binds to the receptors on the surface of the cells of target organs, penetrates into the nucleus, where, by activating DNA, 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 fat stores, increases the utilization of glucose, increasing 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 - 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.

Pharmacokinetics:

Ingestion

Suction

Micronized progesterone well absorbed in the gastrointestinal tract (GIT). The concentration of progesterone in the blood plasma gradually increases during the first hour, the maximum concentration in the blood (FROM_mOh) is noted 1-3 hours after administration.

Metabolism

Metabolized in the liver with the participation of isoenzyme CYP2C19. The main metabolites that are detected in the blood plasma are 20-alpha-hydroxy-delta-4-alpha-pregnanolone and 5-alpha-dihydroprogesterone.

Excretion

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

Suction

Absorption occurs quickly; progesterone accumulates in the uterus; a high concentration of progesterone in the blood plasma is observed after 1 hour after administration. The progesterone progesterone in the blood plasma is reached 2-6 hours after the injection. 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 / day, the progesterone concentration corresponds to the I trimester of pregnancy.

Metabolism

Metabolized with the formation of predominantly 3-alpha, 5-beta-pregnanediol. The concentration of 5-beta-pregnanodiol in plasma does not increase.

Excretion

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;

- 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.

Contraindications:

For oral and vaginal application ^

- hypersensitivity, incl. to peanut oil, soy;

- 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 neoplasm of the mammary glands or genitals.

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.

Carefully:

With diseases of the cardiovascular system, arterial hypertension, chronic renal failure, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression, and iprolipoproteinemia.

Pregnancy and lactation:

The use of the drug during pregnancy is not contraindicated. However, there is a potential risk to the fetus (especially males) when using progesterone in the first 4 months of pregnancy. The use of micronized progesterone in II-III trimester of pregnancy can lead to the development of liver diseases in pregnant women. Numerous epidemiological studies have not revealed cases of fetal abnormalities in the use of progesterone during 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.

Dosing and Administration:

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

In case of luteal insufficiency phase (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 applied at 200 mg per day for 10-12 days.

Vaginal route of administration

Capsules are injected deep into the vagina.

Absolute deficiency of progesterone in women with non-functioning (absent) ovaries (egg donation): against the background of estrogen therapy at 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 of the cycle, from the 26th day, and if the pregnancy is determined, the dose increases at 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 first and second trimester of pregnancy.

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

In cases of threatened abortion or for the prevention of habitual abortions, Progesterone deficiency: 200-400 mg daily in 2 divided doses in the first and second trimesters of pregnancy.

Side effects:

With the oral route of administration

Bleeding "breakthrough" or shortening of the normal menstrual cycle, tension of the mammary glands (usually in the first month of treatment).

Drowsiness, transient dizziness (usually 1-3 hours after admission), nausea. These side effects can be reduced by reducing the dose, changing the regimen of the drug, or switching to a vaginal route of administration. These effects are usually the first signs of an overdose.

Feeling of fatigue, migraine, headache, skin rash, itching, jaundice, fluid retention.

With the oral and vaginal route of administration

Allergic reactions (hives, anaphylactic shock).

Overdose:

Symptoms: drowsiness, transient dizziness, shortening of normal menstrual cycle.

Treatment: dose reduction or correction of the regimen, for example, in case of drowsiness and dizziness - 200 mg taken at bedtime from the 12th to the 14th day of the cycle or switched to the vaginal route of administration; in the case of a shortening of the menstrual cycle, start treatment later in the cycle, for example from the 19th day, instead of the 17th day. If necessary, perform symptomatic treatment.

Interaction:

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 assumed that Activated carbon and griseofulvin can also reduce the effectiveness of the drug.

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

With intravaginal 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.

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. Patients with concomitant cardiovascular diseases or having them in a history should also be observed periodically by a doctor.

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.

Effect on the ability to drive transp. cf. and fur:

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.

Form release / dosage:Capsules, 100 and 200 mg.

Packaging:

10 capsules per blister, made of PVC and aluminum foil.

For 1, 2 or 3 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

In dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-000698

Date of registration:28.09.2011

The owner of the registration certificate:San Pharmaceutical Industries Co., Ltd.San Pharmaceutical Industries Co., Ltd. India

Manufacturer: & nbsp

Sun Pharmaceutical Industries, Ltd. India

Representation: & nbspSAN PHARMACEUTICAL INDUSTRIES LTD. SAN PHARMACEUTICAL INDUSTRIES LTD. India

Information update date: & nbsp01.09.2015

Illustrated instructions

Instructions

Prajisan (Pragisan)