Hypersensitivity to progesterone or any of the excipients of the drug; deep vein thrombosis, thrombophlebitis; thromboembolic disorders (pulmonary embolism, myocardial infarction, stroke), intracranial hemorrhage or a history of these conditions / diseases; bleeding from the vagina of unknown origin; incomplete abortion; porphyria; established or suspected malignant neoplasms of the breast and genital organs; severe liver disease (including cholestatic jaundice, hepatitis, Dubin-Johnson syndrome, Rotor syndrome, malignant liver tumors) at present or in history; children under 18 years of age (efficacy and safety have not been established); breastfeeding period.
Diseases of the cardiovascular system, arterial hypertension, chronic renal failure, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression, hyperlipoproteinemia, mild to moderate liver dysfunction; photosensitivity.
The drug should be used with caution in the II and III trimesters of pregnancy.
The following adverse events noted with the oral method of administration of the drug are distributed by frequency of occurrence according to the following gradation: often >1/100, < 1/10; infrequently >1/1000, < 1/100; rarely >1/10000, < 1/1000; very rarely < 1/10000.
From the genitals and breast: often — menstrual disorders, amenorrhea, acyclic bleeding; infrequently — mastodynia.
From the side of the psyche: very rarely — depression.
From the nervous system: often — headache; infrequently — drowsiness, transient dizziness.
From the gastrointestinal tract: often — bloating; infrequently — vomiting, diarrhea, constipation; rarely — nausea.
From the liver and biliary tract: infrequently — cholestatic jaundice.
From the immune system: very rarely — urticaria.
From the skin and subcutaneous tissues: infrequently — itching, acne; very rarely — chloasma.
Drowsiness, transient dizziness are possible, as a rule, 1-3 hours after taking the drug. These side effects can be reduced by reducing the dose, using the drug before bedtime or switching to the vaginal route of administration.
These undesirable effects are usually the first signs of an overdose. Drowsiness and/or transient dizziness are observed, in particular, in the case of concomitant hypoestrogenism. Reducing the dose or restoring higher estrogenization immediately eliminates these phenomena without reducing the therapeutic effect of progesterone.
If the course of treatment begins too early (in the first half of the menstrual cycle, especially before the 15th day), a shortening of the menstrual cycle or acyclic bleeding is possible.
Recorded changes in the menstrual cycle, amenorrhea or acyclic bleeding are characteristic of all progestogens.
How to take, course of administration and dosage
The drug is taken orally in the evening before bedtime, washed down with water.
In most cases, with progesterone deficiency, the daily dose of Utrozhestan® is 200-300 mg, divided into 2 doses (200 mg in the evening before bedtime and 100 mg in the morning, if necessary).
With threatened abortion or to prevent habitual abortion due to progesterone deficiency: 200-600 mg per day daily in the first and second trimesters of pregnancy. Further use of the drug Utrozhestan® is possible as prescribed by the attending physician, based on an assessment of the clinical data of the pregnant woman.
In case of insufficiency of the luteal phase (premenstrual syndrome, fibrocystic mastopathy, dysmenorrhea, menopausal transition period), the daily dose is 200 or 400 mg taken for 10 days (usually from the 17th to the 26th day of the cycle).
With MHT in perimenopause while taking estrogen, Utrozhestan® is used at a dose of 200 mg per day for 12 days. With MHT in postmenopausal women in continuous mode, the drug Utrozhestan® is used at a dose of 100-200 mg from the first day of taking estrogen-containing drugs. Dose selection is carried out individually.
The capsules are inserted deep into the vagina.
Prevention (prevention) of preterm labor in women at risk (with a short cervix and/or a history of preterm labor and/or preterm rupture of membranes): the usual dose is 200 mg at bedtime, from the 22nd to the 34th week pregnancy.
Complete absence of progesterone in women with non-functioning (absent) ovaries (egg donation): against the background of estrogen therapy, 100 mg per day on the 13th and 14th days of the cycle, then 100 mg 2 times a day from the 15th to the 25th day of the cycle, from the 26th day, and in case of pregnancy, the dose is increased by 100 mg per day every week, reaching a maximum of 600 mg per day, divided into 3 doses. The specified dose can be used for 60 days.
Support of the luteal phase during the in vitro fertilization cycle: it is recommended to use from 200 to 600 mg per day, starting from the day of injection of human chorionic gonadotropin during the first and second trimesters of pregnancy.
Support of the luteal phase in a spontaneous or induced menstrual cycle in case of infertility associated with impaired function of the corpus luteum: it is recommended to use 200-300 mg per day, starting from the 17th day of the cycle for 10 days, in case of delayed menstruation and diagnosis of pregnancy, treatment should be continued.
In cases of threatened abortion or in order to prevent habitual abortion that occurs against the background of progesterone deficiency: 200-400 mg per day in 2 doses daily in the I and II trimesters of pregnancy.