Progesterone is a naturally occurring steroid secreted by the ovaries, placenta and adrenal glands. In the presence of an appropriate estrogen, progesterone changes the proliferative endometrium into secretion endometrium. Progesterone is necessary to increase the susceptibility of the endometrium to the implantation of the embryo. After implantation, the embryo works to support pregnancy. After repeated administration of a 25 mg dose daily by subcutaneous injection, steady state concentrations are achieved within approximately 2 days of treatment. 96-99% of progesterone is bound to plasma proteins such as albumin (50-54%), transcortin (43-48%), and the remainder is free in plasma. Progesterone passes from the bloodstream to the target cell by passive diffusion due to its ability to dissolve in lipids. It is primarily metabolised in the liver mainly for pregnandiols and pregnanolones that are conjugated in the liver to glucuronide and sulphate metabolites. Progesterone biliary metabolites can deconjugate and be re-metabolized in the intestine by reduction, dehydroxylation and epimerisation. Progesterone is excreted through the kidneys and bile.
Contraindications:
Hypersensitivity to progesterone or any of the excipients. Bleeding from the genital tract of unknown cause. Fixed abortion or ectopic pregnancy. Severe liver dysfunction or liver disease. Diagnosed cancer or suspected breast cancer or genital tract. Thromboembolic or severe thrombophlebitis, both active and past history. Porphyria. Idiopathic jaundice, severe pruritus or pregnant pemphigoid found in the interview.
Precautions:
The preparation should be discontinued if one of the following clinical conditions is suspected: myocardial infarction, cerebral circulation disorders, arterial or vein thrombosis, phlebitis or retinal thrombosis. Caution should be exercised in patients with mild to moderate hepatic insufficiency. Patients with a history of depression should be closely monitored. Discontinue treatment if symptoms worsen. Because progesterone can cause fluid retention in the body, patients with conditions that can be affected by fluid retention (eg epilepsy, migraine, asthma, heart or kidney problems) require careful observation. In a small number of patients using complex estrogen-progesterone drugs, a decrease in insulin sensitivity and thus a decrease in Glucose tolerance were observed. Patients with diabetes should be monitored closely when using progesterone therapy. The use of sex hormones may increase the risk of vascular changes in the retina. To counteract this later complication, caution should be exercised in patients over the age of 35 years, smokers and patients at an increased risk of atherosclerosis. The preparation should be discontinued in case of transient ischemic attacks, sudden severe headaches or visual disturbances related to the swelling of the optic disc or retinal bleeding. Abrupt discontinuation of progesterone may result in increased feelings of anxiety, mood swings and an increased tendency to epileptic seizures. Before starting treatment with the preparation, a detailed assessment of the type of infertility in a given couple should be made and the patient should be examined for contraindications to pregnancy. There are no data on the use of the preparation of patients over 65 years and in patients with impaired liver or kidney function. The safety and efficacy of the preparation in children (0-18 years) has not been established.
Pregnancy and lactation:
There are limited and inconclusive data on the risk of congenital malformations, including sexual dysfunction in male or female infants, after intrauterine exposure during pregnancy. Indicators of congenital defects, spontaneous abortions and ectopic pregnancy observed during clinical trials were comparable to their prevalence in the general population, although the total exposure is too low to allow conclusions. Progesterone is excreted in human milk - the preparation should not be used during breastfeeding.
Side effects:
Very common: uterine contractions, vaginal bleeding, injection site reactions (irritation, pain, pruritus and edema). Common: headache, bloating, abdominal pain, nausea, vomiting, constipation, breast hypersensitivity, breast pain, vaginal discharge, vulval and vaginal itching, discomfort within the vulva and vagina, vulvovaginal inflammation, ovarian hyperstimulation syndrome, hematoma in at the injection site, multiple at the injection site, fatigue. Uncommon: mood disorders, dizziness, drowsiness, gastrointestinal disturbances, pruritus, rash, breast disorders, feeling hot, feeling unwell, pain. The following disorders have not been described in clinical studies for Prolutex, but for other preparations of this group of drugs: depression, insomnia, jaundice, menstrual disorders, symptoms resembling premenstrual syndrome, urticaria, acne, hirsutism, alopecia, weight gain, reactions Anaphylactic.
Dosage:
Subcutaneously or intramuscularly. Adults: 1 injection of 25 mg daily from the day of release of oocytes from the ovaries, usually up to 12 weeks of confirmed pregnancy. Treatment with the preparation should be started under the supervision of a physician experienced in the treatment of infertility. Intramuscular administration - in the quadriceps of the left or right thigh. Subcutaneous use - forward thigh or lower abdomen. The product should be injected slowly.
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