Treatment of endogenous progesterone deficiency in the form of menstrual disorders, secondary amenorrhea, anovulatory cycles, premenstrual syndrome, functional uterine bleeding. with artificial insemination, infertility associated with luteal insufficiency, habitual miscarriage and the threat of spontaneous abortion with progesterone deficiency, corpus luteum insufficiency, secondary amenorrhea, prevention of endometrial hypertrophy in women taking estrogens (for example, with hormone replacement therapy - HRT).
Doses of lutein in each case should be set individually, depending on the indications and therapeutic effect.
For menstrual disorders and premenstrual syndrome, 50 mg of progesterone is used 3-4 times a day sublingually. Treatment lasts 3-6 cycles in a row.
For the prevention of endometrial hypertrophy (with HRT), in combination with estrogens, 50 mg of progesterone 3-4 times a day sublingually are most often used. In prolonged intermittent regimens, the preparation is used under the tongue for the last 12-14 days of a 28-day cycle.
With prolonged continuous regimens, progesterone is used daily without interruption.
The dose of progesterone should be dependent on the dose of estrogen so as to protect the endometrium from the proliferative effects of estrogen.
When performing a progesterone test with secondary amenorrhea, progesterone is taken at a dose of 50 mg 3-4 times a day sublingually. Menstruation should appear within 7-10 days after the end of treatment.
In the treatment of functional uterine bleeding, 50 mg of progesterone is used 3-4 times a day sublingually from the 15th to the 25th day of the cycle. Treatment should be continued for 2-3 consecutive months.
With habitual miscarriage and the threat of spontaneous abortion, anovulatory and induced cycles, 100 mg of progesterone is used 3-4 times a day sublingually.
In case of recurrent miscarriage, the use of progesterone should be started during the cycle in which the pregnancy is planned, or earlier (pregravid preparation for 3-4 months). Treatment should be continued continuously until about the 18th to 20th week of pregnancy.
In in vitro (in vitro) fertilization programs, 100-150 mg of progesterone are used 3-4 times a day sublingually.
Hypersensitivity to the components of the preparation. period of breastfeeding. suspected or confirmed neoplasia of the mammary glands or genital organs. bleeding from the genital tract of unknown origin. severe liver dysfunction. cholestatic jaundice. rotor syndrome and cudgel-Johnson syndrome. thromboembolic disease of the veins (deep vein thrombophlebitis, pulmonary embolism). existing or past thromboembolic disorders of the arteries (angina pectoris, myocardial infarction). miscarriages, as well as the presence of residues after a miscarriage in the uterine cavity. porphyria, cerebral hemorrhage.
When using lutein, which contains progesterone, which is identical to the endogenous hormone, side effects have rarely occurred, with the exception of symptoms that develop in case of an overdose.
Violations of the following systems and organs were noted:
from the side of the central nervous system: drowsiness, impaired concentration, fear, depression, headache and dizziness, insomnia.
From the reproductive system: abnormal bleeding from the uterus, dysmenorrhea, spotting, amenorrhea, premenstrual symptoms, intermittent bleeding, mastodynia, changes in libido, discomfort in the mammary glands.
From the skin and its appendages: redness of the skin, acne, allergic reactions, urticaria, itching, alopecia, hirsutism, anaphylactic reactions, chloasma.
From the digestive system: nausea, dry mouth, bleeding from the gums, cholestatic jaundice, gastrointestinal disorders, vomiting, diarrhea, constipation.
From the vascular system: thrombosis, venous thromboembolism, pulmonary embolism.
Other disorders: fluid retention, hyperthermia.
Progesterone can cause fluctuations in body weight.
Drowsiness and / or transient dizziness occurs in case of concomitant hypoestrogenism. Reducing the dose of the preparation or increasing the dose of estrogen immediately eliminates these phenomena without reducing the therapeutic effect.
If the course of treatment begins at the beginning of the monthly cycle, before the 15th day, a reduction in the cycle or bleeding may be noted.
Before starting treatment, it is necessary to conduct a gynecological examination and palpation of the mammary glands. in the case of uterine bleeding, before starting treatment, a diagnosis should be made in order to exclude an organic cause of bleeding. patients who have experienced depression in the past should be under special supervision, since progesterone can cause an increase in depression. in case of development of severe depression, the preparation should be discontinued.
The use of the preparation in patients of premenopausal age can hide the onset of menopause.
In severe violation of liver function, the preparation should not be used. Patients with liver disease should be under the supervision of a physician during treatment with Luteina in the form of sublingual tablets.
In individuals with diabetes mellitus or impaired glucose tolerance, progesterone may reduce glucose tolerance. Lutein does not have a contraceptive effect. In the case of the use of progesterone for other reasons not related to infertility, contraceptives should be used simultaneously. Patients should be warned about the need to be sure to inform the doctor if any changes in the mammary gland are detected.
Especially carefully used in patients after suffering thromboembolic disorders: existing or past arterial or venous thromboembolic disorders, including deep vein thrombophlebitis, pulmonary embolism, angina pectoris, myocardial infarction.
If the course of treatment begins at the beginning of the monthly cycle, there may be a shortening of the cycle or bleeding.
In case of uterine bleeding, do not prescribe the preparation without specifying the cause, in particular when examining the endometrium.
Caution should be used in patients with fluid retention (e.g. hypertension, diseases of the cardiovascular system, kidney disease, epilepsy, migraine, asthma), diabetes mellitus, photosensitivity.
Before prescribing the preparation, patients with a family history of neoplasms and with recurrent cholestasis or persistent itching during pregnancy, impaired liver function, heart or kidney failure, fibrocystic mastopathy, epilepsy, asthma, otosclerosis, diabetes mellitus, multiple sclerosis, systemic lupus erythematosus.
Due to the risk of thromboembolic and metabolic complications, which cannot be completely excluded, the preparation should be discontinued if:
visual disturbances such as vision loss, double vision, retinal vascular lesions, ptosis, papilledema;
thromboembolic venous or thrombotic complications, regardless of the site of the lesion;
severe headache, migraine.
In the event of amenorrhea during treatment, pregnancy should be confirmed or excluded, which can cause amenorrhea.
More than half of early spontaneous abortions are caused by genetic complications. In addition, infectious manifestations and mechanical disorders can be the cause of early abortions; the only justification for prescribing progesterone in this case would be to delay the expulsion of the dead fetus. Therefore, the appointment of progesterone on the recommendation of a physician should be considered for cases where the secretion of progesterone is insufficient.
Before starting treatment, the patient should undergo a thorough medical and gynecological examination, including intravaginal and mammological examination, Pap smear, taking into account the history, contraindications and precautions for use. During treatment, it is recommended to undergo regular examinations with a doctor.
In women receiving HRT, the risk/benefit ratio associated with therapy should be carefully assessed.
In patients with postmenopausal symptoms who are receiving or have received HRT, there is a slight to moderate increase in the likelihood of diagnosing breast cancer. This may be due to early diagnosis or the actual benefit of HRT, as well as their combination. The risk of breast cancer increases with increasing duration of treatment and is restored to baseline values 5 years after stopping HRT. Breast cancer diagnosed in patients receiving or recently treated with HRT is less invasive than that occurring in women who have not received HRT. The physician should discuss the higher likelihood of developing breast cancer with patients who will receive long-term hormone therapy, evaluating the benefits of HRT.
The preparation should not be taken with food. The preparation is recommended to be taken at bedtime. Simultaneous food intake increases the bioavailability of the preparation.
Lutein contains lactose, therefore, the preparation should not be used in patients with hereditary forms of galactose intolerance, lactase deficiency (Lapp type) or glucose-galactose malabsorption syndrome.
During pregnancy and breastfeeding. The preparation Lutein can be used in the first trimester of pregnancy. There is evidence of a possible risk of developing hypospadias when using progestogens during pregnancy to prevent recurrent miscarriage or threatened miscarriage due to luteal insufficiency, which the patient should be informed about.
Progesterone passes into breast milk, so the use of the preparation during breastfeeding is contraindicated.
Children. Not recommended for use in children.
The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Special studies of the effect of progesterone on the ability to drive vehicles and work with mechanisms have not been carried out, but given that when using progesterone, dizziness, drowsiness, and impaired concentration are possible in rare cases, the driver or operator working with mechanisms should be warned about this. The use of tablets at bedtime avoids these undesirable effects.
The metabolism of progesterone can be accelerated with the simultaneous use of substances that enhance the activity of the cytochrome p450 enzyme, such as antiepileptic, antibacterial agents, herbal preparations. In vitro studies have shown that preparations that reduce the activity of cytochrome p450 (eg ketoconazole) can slow down the metabolism of progesterone. the clinical significance of this interaction is unknown. the use of progesterone can increase the concentration of cyclosporine in the blood plasma.
Some antibiotics (eg ampicillin, tetracyclines) can cause changes in the intestinal microflora, resulting in a change in the hepatic steroid cycle.
Powerful inducers of liver enzymes, namely barbiturates, antiepileptic preparations (phenytoin), rifampicin, phenylbutazone, spironolactone, griseofulvin, nevirapine, efavirenz, carbamazepine, cause increased metabolism at the hepatic level. Ritonavir and nelfinavir are known to be strong cytochrome inhibitors and exhibit enzyme-inducing properties when used concomitantly with steroid hormones.
All progestins can reduce glucose tolerance, which may require an increase in the daily dose of insulin and other antidiabetic agents in diabetic patients.
The bioavailability of progesterone can be reduced by smoking and increased by alcohol.
Interactions of progesterone with other preparations that would have clinical significance have not been confirmed.
Symptoms of an overdose may be manifested by symptoms of adverse reactions, including drowsiness, dizziness, euphoria, dysmenorrhea, a decrease in the duration of the menstrual cycle, metrorrhagia, and depression.
In some individuals, the usual dose may be excessive due to existing or secondary unstable endogenous secretion of progesterone, hypersensitivity to the preparation, or very low concomitant blood levels of estradiol. In such cases, it is enough:
reduce the dose of progesterone or prescribe progesterone in the evening before bedtime for 10 days per cycle for drowsiness or transient dizziness;
postpone the start of treatment to a later date in the cycle (for example, on the 19th day instead of the 17th) in case of its reduction or spotting;
check whether the level of estradiol is sufficient in a patient receiving HRT in the premenopausal period.
Treatment: Symptoms usually disappear on their own after discontinuation of the preparation.
In case of overdose, stop taking the preparation and apply symptomatic treatment.
In original packaging at a temperature not exceeding 25 ° C.
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