Perfeclly 400mg Farmaprim vagina is treated for menstrual syndrome (2 blisters x 6 tablets)

Gender hormones and genital transformation agents; Progestogen; Pregnen derivative- (4). ATC code: G03DA04.

progesterone is a natural steroid hormone excreted by ovaries, placenta and adrenal glands. With the full presence of estrogen, the endometrial conversion of endometrial proliferation into endometrials to convert to the period of secretion. The progesterone is necessary to increase the endometrial receptor for embryo transplantation. When the embryo is transplanted, progesterone has the effect of maintaining pregnancy.

Safety and clinical effectiveness

In a clinical study of phase III in premenopausal women, the method of ART and IVF must be used, the rate of pregnancy after the vaginal progesteron (progesteron 400 mg twice daily) is seen as 38.3% (FAS) and 38.1% (PP) after 38 days of supporting the period of the royal period. Clinical pregnancy rate is 34.5% after 70 days of supporting phase.

Dynamic pharmacokinetics

absorption

Progesterone vagina 400mg per 12 hours in healthy women has shown the effectiveness in quickly achieving and maintaining blood progesterone levels at a physiological concentration suitable for the period between the ovarian and early pregnancy. The average cmax after 10 days of multi -dose is 18.4 [ng/ml] and the cran is 10.5 [ng/ml].

distribution

progesterone binds to serum protein approximately 96 - 99%, mainly with serum albumin and corticosteroid bonding globe. (Mainly with albumin (50 - 54%) and globulin mounted cortisoltranscortin (43 - 48%)).

Biological metabolism

Progesterone is converted mainly through the liver into Pregnannediols and Pregnanolon. Pregnanediol and Pre-giaanolon are combined in the liver into glucoronid and sulfate metabolites. The metabolites of progesterone are excreted in bile can be a suitable separation and can be metabolized further in the large intestine by reducing, dehydration, and epime.

excretion

progesterone is excreted through the kidneys and bile.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Progesterone is not indicated in the case of threatening miscarriage. Therapy with progesterone should be stopped in the case of incomplete miscarriage.

progesterone should be stopped if suspected of any of the following conditions: myocardial infarction, cerebrovascular disorders, arterial thrombosis or veins (venous thrombosis or pulmonary disease), intravenous inflammation or retinal thrombosis.

Although the risk of turbulence is associated with estrogen, progestin is still a question. Therefore, in women there are risk factors that are acknowledged in cases of venous thrombosis, such as a prehistoric or family history, therapy with progesterone may increase risk. In these women, the benefits of using Pro-Gesterone should be considered for risk risks. However, it should be noted that pregnancy itself is at risk of venous thrombosis.

Reducing glucose intolerance has been observed in a small number of patients using estrogen-Progestin combinations. The mechanism of this reduction is not known. For this reason, diabetics should be carefully monitored when using progesterone therapy.

progesterone is metabolized in the liver and should be used carefully in patients with liver failure.

progesterone contains hormone progesterone, this hormone is present with significant concentrations in women in the second half of the menstrual cycle and pregnant women. This should be noted when treating patients with hormone sensitivity.

Stop using a sudden use of progesterone can cause anxiety, moody and convulsions.

Treatment of premenstrual syndrome and postpartum depression.

Use rectal sugar if using contraception.

Use the rectal sugar if the patient has a vaginal infection (especially the disease caused by Candida) or cystitis recurrence or near the date of birth.

Use vaginal tract if the patient has colitis or defecation.

progesterone has the same potential toxicity of progestin.

Before starting treatment with progesterone, breast exams and organs in the pelvis must be tested, test papanicolaou (test pap, cervical cell spread).

Progesterone can worsen some water -retaining diseases (such as asthma, epilepsy, migraine, hypertension, kidney dysfunction, heart), and must be monitored carefully.

Be cautious with people with a history of depression.

Need to stop progesterone if depression recurs severely. Can increase the risk of dementia in postmenopausal women.

It is necessary to warn the earliest signs and symptoms of myocardial infarction, brain vascular disorders, thrombosis (such as intravenous thrombosis, pulmonary disease), thrombophlebitis or retinal thrombosis. The drug must be stopped immediately when suspected or there are any of the above disorders.

Do not use progesterone in combination with cardiovascular prevent or dementia. Using proges-tin in combination with estrogen can increase the risk of breast cancer, dementia, myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis in postmenopausal women. Stop using progestin in combination with estrogen at least 4-6 weeks before performing surgery increases the risk of thrombosis or in the prolonged immobile phase. Using progestin in combination with estrogen in the shortest possible time, suitable for the treatment destination. Periodically assess the risk/ benefits when taking the drug.

If there is a phenomenon of loss or loss of vision occurs suddenly or slowly, unexplained, protruding eyes, but thorny gai, retinal blood vessel damage or migraine, progesterone stops and immediately conduct diagnostic and treatment methods.

If there is abnormal vaginal bleeding while being treated with progesterone, must be examined to find the cause.

Regularly check blood pressure, test pap, breast exams, breast x-rays. In all cases of abnormal vaginal bleeding for unknown reasons, to fully diagnose, it is recommended to take the uterine mucosa to eliminate malignant ability. Monitor the signs and symptoms of vasoconstriction, visual changes.

The effect of the drug on driving and operating machinery

There is no evidence of the effect of the drug on the ability to drive and operate machinery.

Use drugs for women during pregnancy and lactation

Pregnant women:

The drug should not be used during pregnancy except for the prescribed cases in the early stages of pregnancy as part of the ART method. Progesterone is a natural hormone, used to support embryos and maintain pregnancy in reproductive support techniques (Art) in infertile women, increasing the rate of pregnancy.

Restricted and unconvincing data about the risk of birth defects, including genital defects in male or female infants, after the uterus during pregnancy.

The rate of birth defects, spontaneous miscarriage and ectopic pregnancy has been observed in clinical trials that can be compared to the percentage of these cases observed on common population, but the total exposure is too low to allow conclusions.

breastfeeding women:

progesterone is excreted in human milk and drugs should not be used during breastfeeding.

Drug interaction

The effect of simultaneous use of vaginal lines on progesterone exposure from progesterone has not been evaluated and therefore is not recommended.

The drugs are known to cause the liver's liver's Cytochrom P450-3A4 system (such as rifampicin, carbamazepin or phenytoin) that may increase the speed of clearance and thus reduce the bioavailability of the progesterone.

Avoid simultaneous use of progesterone with dabigatran ether, rivaroxaban, Silodosin, topotecan.

Increased effects/toxicity: Progesterone can increase the effects of dabigatran ether, p-glyco-protein substrates, rivaroxaban, silodosin, topotecan, colchicin.

Herbs with active progestogen may increase the effect, ADR/ toxicity of progestin.

Ciclosporin metabolism can inhibit the metabolism that leads to an increase in ciclosporin concentration, resulting in an increase in plasma ciclosporin concentrations and a risk of ciclosporin poisoning.

Reduce effects: Aminoglutethimid, CYP2C19, CYP3A4 (Carbamazepin, Gris-Eofulvin, Phenobarbital, Phenytoin, Phenytoin, Rifampicin, which can increase the clearance of Progesterone and Pro-Gestogen), Deferasirox, Peginterferon Alpha-2B, can reduce Alpha-2B use of progesterone.

Interaction with alcohol, nutrition, herbs:

Food reduces the oral bioavailability of Pro-Gesterone.

Preparations from female trees, Hypericum Perforatum (St John’s Wort) can reduce progesterone levels.

progesterone and other progestogen may affect blood glucose control in diabetes, may need to adjust the dose of anti -diabetic drugs.

Progestin combination with estrogen can cause the results of thyroid test, liver function, blood clotting, endocrine function and Metyrapon test. This combination also reduces Pregnanediol's excretion.