Pragisan capsules 100mg №30

Indications

Progesterone deficiency disorders.

Oral route of administration:

- infertility due to luteal insufficiency;

- 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 with non-functioning (absent) 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.

Dosage and administration

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

Oral administration route

The drug is taken orally with water.

In most cases, with progesterone deficiency, the daily dose of Pragisan is 200-300 mg, divided into 2 doses (in the morning and evening).

At luteal phase deficiency (premenstrual syndrome, fibrocystic 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).

At hormone replacement therapy in peri-and postmenopause with estrogen therapy, Pragisan is used at 200 mg / day for 10-12 days.

Vaginal route of administration

The capsules are inserted deep into the vagina.

Absolute progesterone deficiency in women with non-functioning (missing) ovaries (egg donation): against 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 pregnancy is established, the dose increases on 100 mg / day every week, reaching a maximum of 600 mg / day, divided into 3 doses. This dose can be applied 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 of the luteal phase in a 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 the case of delayed menstruation and diagnosis of pregnancy, treatment should be continued.

In cases of threatened abortion or in order to prevent habitual abortions, arising on the background of progesterone deficiency: 200-400 mg daily in 2 doses in the I and II trimesters of pregnancy.

Adverse effects

When administered orally

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

Drowsiness, transient dizziness (usually 1-3 h after ingestion), 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.

Feeling tired, migraine, headache, skin rash, itching, jaundice, fluid retention.

For oral and vaginal routes of administration

Allergic reactions (urticaria, anaphylactic shock).

Contraindications

For oral and vaginal use

- thrombophlebitis, thromboembolic disorders, intracranial hemorrhage or the presence of these conditions in history;

- 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 to peanut butter, soy.

For oral administration (optional)

- Severe liver disease at the present time (includingcholestatic jaundice, hepatitis, hepatocellular carcinoma, Dubin-Johnson, Rotor syndromes) or in history, if the liver function indicators did not return to normal values.

WITH caution the drug should be prescribed for diseases of the cardiovascular system, arterial hypertension, chronic renal failure, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression, hyperlipoproteinemia.

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 developmental 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.

Application for violations of the liver

Oral administration is contraindicated in severe liver diseases at the present time (including cholestatic jaundice, hepatitis, hepatocellular carcinoma, Dubin-Johnson, Rotor syndromes) or in history if liver function indicators have not returned to normal values.

Application for violations of kidney function

WITH caution It should appoint a drug for chronic renal failure.

Special notes

The drug can not be used for contraception.

With prolonged treatment with progesterone, it is necessary to periodically conduct medical examinations (including the study of the liver); 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 physician.

With progesterone treatment, fluid retention may occur, which can affect the course of epilepsy, migraine, asthma, heart or kidney failure; such patients should be carefully monitored.

Influence on ability to drive motor transport and control mechanisms

When taking orally, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed.

Overdosage

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

Treatment: dose reduction or correction of the regimen, 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 switch to the vaginal route of administration: 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.

Drug interaction

Oral administration

With prolonged simultaneous use of barbiturates, Carbamazepine , hydantoin, or rifampicin can reduce the effectiveness of progesterone.

Despite 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 troleandomycin.

With vaginal application

Interaction with intravaginal use was not evaluated. The simultaneous administration of other intravaginal drugs should be avoided to avoid disrupting the release and absorption of progesterone.

Terms and conditions of storage

The drug should be stored in a dry, protected from light, out of reach of children at a temperature not exceeding 25 ° C.