Pragisan Capsules 100mg N30
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Active ingredients
Progesterone
Release form
Capsules
Composition
Progesterone 100 mg; Excipients: peanut oil - 147.5 mg, soy lecithin - 2.5 mg; Capsule shell composition: sorbitol solution 70% (non-crystallized) - 9 mg, glycerol - 44.89 mg, gelatin - 85.5 mg, titanium dioxide - 1.06 mg , purified water - 84.55 mg.
Pharmacological effect
Progestin, hormone of the corpus luteum. By binding to receptors on the surface of target organ cells, it penetrates into the nucleus, where, by activating DNA, it stimulates RNA synthesis. It promotes the transition of the uterine mucous membrane 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 terminal elements of the mammary gland. , and in large - suppresses the production of pituitary gonadotropic hormones; reduces azotemia, increases the excretion of nitrogen in the urine. It activates the growth of the secretory section of the mammary glands and induces lactation. Promotes the development of normal endometrium.
Pharmacokinetics
When taken by mouth; Absorption; Micronized progesterone is well absorbed in the gastrointestinal tract. The concentration of progesterone in the blood plasma gradually increases during the first hour, Cmax is noted 1-3 h after administration. Metabolism; Metabolized in the liver with the participation of CYP 2C19 isoenzyme. The main metabolites that are determined in the blood plasma are 20-alpha-hydroxy-delta-4-alpha-pregnanolone and 5-alpha-dihydroprogesterone. 95% of them are glucuron-conjugated metabolites, mainly 3-alpha, 5-beta-pregnandiol (pregnandione). These metabolites, which are determined in the blood plasma and in the urine, are similar to substances formed during the physiological secretion of the corpus luteum. When administered vaginally; Absorption; Absorption occurs rapidly; progesterone builds up in the uterus; a high concentration of progesterone in the blood plasma is observed 1 h after injection. Cmax of progesterone in plasma is reached 2-6 hours after administration. With the introduction of the drug in 100 mg 3 times / day, the average concentration is maintained for 24 hours.When administered in doses of more than 200 mg / day, the concentration of progesterone corresponds to the first trimester of pregnancy.; Metabolism; Metabolized with the formation of predominantly 3-alpha, 5-beta-pregnandiol. The concentration of 5-beta-pregnandiol in plasma does not increase.; Excretion; Excreted in the urine as metabolites, the main part is 3-alpha, 5-beta-pregnandiol (pregnandion).
Indications
Disorders associated with progesterone deficiency. Oral route of administration: - infertility due to lutein deficiency; - premenstrual syndrome; - menstrual disorders due to impaired ovulation or anovulation; - fibrocystic mastopathy; - premenopause; - peri- and postmenopausal hormone replacement therapy (in combination with estrogen-containing drugs); vaginal route of administration: - hormone replacement therapy in case of progesterone deficiency in non-functioning (missing) ovaries (egg donation); - support of the luteal phase during preparation for in vitro fertilization; - support of the luteal phase 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 threatening abortion due to progestin deficiency; - prevention of uterine fibroids; - prevention of endometriosis.
Contraindications
For oral and vaginal use; - thrombophlebitis, thromboembolic disorders, intracranial hemorrhage, or a history of these conditions; - bleeding from the genital tract of unknown origin; - incomplete abortion; - porphyria; - identified or suspected malignant neoplasms of the mammary glands or genitals; - Hypersensitivity to the components of the drug, including peanut oil, soy.; For oral use (optional); - severe liver disease now (including cholestatic jaundice, hepatitis, hepatocellular carcinoma, Dubin-Johnson's syndrome, Rotor) or in history, if indicators liver function has not returned to normal values.; with caution should appoint the drug for diseases of the cardiovascular system, hypertension, chronic renal failure, diabetes, bronchial asthma, epilepsy, migraine, depression, hyperlipoprotein missions.
Use during pregnancy and lactation
The use of the drug during pregnancy is not contraindicated.However, there is a potential risk to the fetus (especially male) when using progesterone in the first 4 months of pregnancy. The use of micronized progesterone in the II-III trimesters of pregnancy can lead to the development of liver disease in pregnant women. Numerous epidemiological studies have revealed no cases of fetal development abnormalities when using progesterone during pregnancy. Progesterone passes into breast milk Data on the use of the drug during lactation is not enough to assess the potential risk to the infant.
Dosage 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 deficient, the daily dose of Pragisan is 200-300 mg, divided into 2 doses (morning and evening) .; luteal phase (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) .; monotherapy in peri-and postmenopausal therapy with estrogen intake Pragisan is used at 200 mg / day for 10–12 days.; Vaginal route of administration; Capsules are injected deep into the vagina; oocytes): against the background of estrogen therapy, 200 mg / day on the 13th and 14th days of the cycle, then 100 mg 2 times / day from the 15th to the 25th day of the cycle, from the 26th day, and if established pregnancy dose increases by 100 mg / day every week, reaching a maximum of 600 mg / day, divided into 3 reception. This dose can be used for 60 days.; Support for the luteal phase during preparation for in vitro fertilization: it is recommended to take from 200 to 600 mg / day, starting from the day of injection of chorionic gonadotropin during the I and II trimester of pregnancy.; Support the luteal phase in the spontaneous or induced menstrual cycle, with infertility associated with dysfunction of the corpus luteum, it is recommended to take 200-300 mg / day, starting from the 17th day of the cycle for 10 days, in case of delayed menstruation and diagnosis The treatment should be continued. In cases of threatened abortion or in order to prevent habitual abortions occurring against the background of progesterone deficiency: 200-400 mg daily in 2 doses in the I and II 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 h after administration), nausea. These side effects can be reduced by lowering the dose, changing the mode of taking the drug, or switching to a vaginal route of administration. These effects are usually the first signs of an overdose.; Fatigue, migraine, headache, skin rash, itching, jaundice, fluid retention.; Oral and vaginal routes of administration; Allergic reactions (urticaria, anaphylactic shock).
Overdose
Symptoms: drowsiness, transient dizziness, shortening of the normal menstrual cycle. Treatment: dose reduction or correction reception mode, for example, in the case of drowsiness and dizziness - 200 mg taken before bedtime from the 12th to the 14th day of the cycle or go to the vaginal route introduction: in case of shortening of the menstrual cycle - start treatment later in the cycle, for example, from the 19th day, instead of the 17th. If necessary, carry out symptomatic treatment.
Interaction with other drugs
Oral use; With long-term simultaneous use of barbiturates, carbamazepine, hydantoin or rifampicin may decrease the effectiveness of progesterone.; Despite limited data, it is assumed that activated carbon and griseofulvin may also reduce the effectiveness of the drug.; Progesterone may increase the therapeutic, pharmacological or toxic effects of cyclosporin , theophylline and troleandomitsina.; When vaginal application; Interaction with intravaginal application has not been evaluated. The simultaneous administration of other intravaginal drugs should be avoided to avoid disrupting the release and absorption of progesterone.
special instructions
The drug can not be used for contraception.; With long-term treatment with progesterone, it is necessary to periodically conduct medical examinations (including liver function tests); treatment should be canceled if there are abnormalities in diagnostic tests for liver function or cholestatic jaundice.When using estrogen and / or progestogen-containing drugs, there were cases of chloasma, especially in patients with a history of chloasma during previous pregnancy. In women with a tendency to develop chloasma, exposure of the skin to natural or artificial UV radiation can cause or aggravate the course of chloasma. Patients with a history of depression should be monitored, and if severe depression develops, the drug should be discontinued. Patients with concomitant cardiovascular diseases or their history should also be observed periodically by a doctor. During treatment with progesterone, fluid retention may occur, which can affect the course of epilepsy, migraine, bronchial asthma, cardiac or renal failure; such patients should be carefully monitored.; Impact on the ability to drive vehicles and control mechanisms; When taking orally, care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and psychomotor reactions.