ADAMED #Urogenital_tract #Hormonal #HEALTH_CARE
Indications
Vaginal tablets 100 mg. 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, to prevent endometrial hypertrophy in women taking estrogens (for example, with HRT), for the treatment of endometriosis, in extracorporeal programs fertilization (IVF), with HRT in postmenopausal women with an unremoved uterus to protect the endometrium, for the treatment of luteal phase deficiency in the period before menopause.
Vaginal tablets 200 mg. Recommended in IVF programs.
Application
The dose of lutein in each individual case should be set individually, depending on the indications and therapeutic effect. for more convenient use by patients and regulation of dosing, there are such dosages of lutein, vaginal tablets - 50 mg, 100 mg, 200 mg. vaginal tablets should be inserted into the vagina using the applicator that is included in the package.
For menstrual disorders and premenstrual syndrome, luteal phase insufficiency in the period before menopause, apply vaginally 25–50 mg of progesterone 2 times a day in the 2nd phase of the menstrual cycle (natural or reproducible) for 10–12 days. Apply at the appropriate dosage.
With menstrual irregularities, painful menstruation, premenstrual syndrome, progesterone treatment lasts 3-6 cycles in a row. In case of insufficiency of the luteal phase before menopause, treatment with progesterone should be carried out before the onset of menopause.
In HRT in combination with estrogens, 25–50 mg of progesterone is used vaginally 2 times a day in sequential therapy from the 15th to the 25th day of the cycle or in continuous therapy daily. Apply at the appropriate dosage.
When performing a progesterone test for secondary amenorrhea, progesterone is used vaginally at a dose of 50 mg 2 times a day for 5-7 days. Menstruation should appear within 7-10 days after you stop taking progesterone. Apply at the appropriate dosage.
In the treatment of functional uterine bleeding, 50 mg of progesterone is used vaginally 2 times a day for 5-7 days. Treatment should be continued for 2-3 months in a row, using progesterone at a dose of 25-50 mg 2 times a day vaginally from the 15th to the 25th day of the cycle. Apply at the appropriate dosage.
With endometriosis, 50-100 mg of progesterone is used vaginally 2 times a day in constant therapy for 6 months.
With habitual miscarriage and the threat of miscarriage, anovulatory and induced cycles, 50-150 mg of progesterone is used vaginally 2 times a day. In case of recurrent miscarriage, progesterone should be started in the cycle in which conception is planned. Treatment must be continued continuously until the 18-20th week of pregnancy.
In IVF programs, 150-200 mg of progesterone are used 2 times a day vaginally. Treatment is continued until the 77th day after the transfer (movement) of the embryo. The end of therapy should occur by gradually reducing the dose of the preparation.
Contraindications
Hypersensitivity to the components of the preparation. period of breastfeeding. suspected or confirmed neoplasia of the breast or genitals. unspecified bleeding from the genital tract. severe liver dysfunction. cholestatic jaundice. rotor syndrome and Dabin-Johnson syndrome. thromboembolic diseases of the veins (deep vein thrombophlebitis, pulmonary embolism). existing or past thromboembolic disorders in the arteries (angina pectoris, myocardial infarction). unsuccessful abortions, as well as the presence of residues after a miscarriage in the uterine cavity. porphyria, cerebral hemorrhage.
Side effects
When using lutein, vaginal tablets containing progesterone, identical to the endogenous hormone, side effects occurred sporadically.
In some cases, drowsiness, impaired concentration and attention, fear, depression, headache and dizziness, and insomnia were noted.
From the reproductive system: abnormal bleeding from the uterus, dysmenorrhea, spotting, amenorrhea, premenstrual symptoms, intermittent bleeding, mastodynia, changes in libido, chest discomfort.
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.
special instructions
Progesterone administered intravaginally penetrates directly into the circulatory system without participating in hepatic metabolism. in this regard, there is no need to adjust the dose of the preparation in patients with impaired liver function.
Before starting treatment, a gynecological examination and palpation of the mammary glands should be performed. If the course of treatment is started very early at the beginning of the monthly cycle, especially before the 15th day of the cycle, a decrease (reduction) in the cycle or bleeding may be detected. In case of uterine bleeding, the preparation should not be prescribed without establishing their cause. If amenorrhea occurs, make sure that there is no pregnancy.
Patients with a history of depression should be under special supervision, since progesterone can cause an increase in depression.
The use in accordance with the recommended doses 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. It is necessary to warn patients about the mandatory informing the doctor if changes in the mammary gland are detected.
The use of the preparation in patients of premenopausal age can hide the onset of menopause.
The preparation should not be used in patients with severe hepatic impairment.
Patients with liver disease should be under medical supervision during treatment.
Use with particular caution in patients after previous thromboembolic disorders: existing or past arterial or venous thromboembolic disorders, including deep vein thrombophlebitis, pulmonary embolism, angina pectoris, myocardial infarction.
Caution should be given to patients with fluid retention (for example, due to hypertension, diseases of the cardiovascular system, kidneys, as well as patients with 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.
Before starting treatment, the patient should undergo a thorough medical and thorough 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.
Women who receive HRT should carefully evaluate the risk/benefit ratio associated with therapy.
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 identification of patients 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 its original 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 not treated with 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 contains lactose, so it should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
The use of the preparation in patients of premenopausal age can hide the onset of menopause.
The preparation contains lactose, so it should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
Due to thromboembolic and metabolic risk, which cannot be completely excluded, it is necessary to stop taking the preparation in the event of:
visual disturbances such as vision loss, double vision, retinal vascular lesions;
thromboembolic venous or thrombotic complications, regardless of the site of the lesion;
severe headache.
In the case of a thrombophlebitis history, the patient should be under strict supervision.
More than half of early involuntary abortions are caused by genetic complications. In addition, infectious manifestations and mechanical disorders can be the cause of early abortions; the only reasonable use of progesterone would then be to delay the expulsion of a dead egg. Thus, the appointment of progesterone on the advice of a physician should be considered for cases where the secretion of progesterone is insufficient.
Use during pregnancy and lactation. Progesterone can be used in the first trimester of pregnancy. It does not have masculinizing, virilizing, corticoid and anabolic effects. Clinical information on the use of progesterone in the II and III trimester of pregnancy is not enough. The use of progesterone during breastfeeding is contraindicated due to the penetration of the hormone into breast milk.
There is evidence of a possible risk of hypospadias when using progestogens during pregnancy to prevent recurrent miscarriage or threatened miscarriage due to luteal insufficiency, which should be informed to the patient.
Children. There is no data.
Influence on the ability to drive vehicles and work with complex mechanisms. In connection with the possible occurrence of drowsiness and impaired concentration, it is necessary to refrain from driving vehicles and working with other mechanisms. When using progesterone, dizziness, drowsiness, impaired concentration and attention are possible in rare cases, about which the patient should be warned. The use of tablets at bedtime avoids these unpleasant consequences.
Interactions
No clinically significant interactions with other preparations were noted. In vitro studies have shown that preparations that reduce the activity of cytochrome p450 (for example, ketoconazole) can slow down the metabolism of progesterone. the clinical significance of this effect is unknown.
The introduction of high doses of progesterone can temporarily lead to an increase in the excretion of sodium and chlorides from the body.
Progestins reduce glucose tolerance, which may lead to an increase in the daily dose of insulin or other antidiabetic preparations in diabetic patients.
The use of progesterone may increase the concentration of cyclosporine in the blood plasma. Some antibiotics (eg ampicillin, tetracycline) 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, increase metabolism at the hepatic level. Ritonavir and nelfinavir are known to be potent inhibitors of cytochrome enzymes and exhibit enzyme-inducing properties when used concomitantly with non-steroidal hormones.
Overdose
Symptoms of side effects, as a rule, occur due to an overdose.
The most common symptoms are drowsiness, dizziness, and depression.
Symptoms usually disappear on their own after the dose is reduced.
For some patients, the recommended dose may be high due to hypersensitivity to the preparation or low concomitant blood levels of estradiol, or the existing or secondary appearance of unstable endogenous secretion of progesterone.
In such cases, you should:
- reduce the dose of the preparation or use it in the evening before bedtime for 10 days of the cycle in case of drowsiness or short-term 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 the occurrence of spotting;
- check the level of estradiol in a patient receiving HRT in the premenopausal period.
Storage conditions
In a dry place protected from light at a temperature not exceeding 25 ° C.
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