Luteina vaginal tablets 200 mg. №30 without applicator

Description

Luteina vaginal tablets 200 mg composition
active substance: progesterone;
1 tablet contains micronized progesterone 200 mg;
Excipients: lactose monohydrate, pregelatinized corn starch, croscarmellose sodium, hypromellose, citric acid monohydrate, magnesium stearate, colloidal anhydrous silica.

Dosage form
Vaginal tablets.

Pharmacological properties
The progesterone in Luteina vaginal tablets 200 mg, a vaginal tablet, is synthetically derived, identical to the natural corpus luteum hormone of the ovary.
The most important effects of progesterone on the reproductive organs are: the possibility of ovulation by increasing proteolysis of the wall of the graph bubble; secretory change of the endometrium, which makes it possible to implant a fertilized egg; inhibition of excessive endometrial hypertrophy under the influence of estrogen; cyclic changes in the epithelium of the fallopian tubes, cervix and vagina. Progesterone acts synergistically with estrogen on the breast, stimulating the growth of glandular vesicles and duct epithelium, as well as participating in the expression of receptors necessary for lactation. Progesterone is a hormone necessary for the maintenance of pregnancy throughout its term: it inhibits the immune response of the uterus to fetal antigens, is a substrate for the formation of glucocorticoids and mineralocorticoids of the fetus. Progesterone inhibits the spontaneous contractile activity of the pregnant uterus, and is also necessary to trigger the mechanisms that initiate childbirth.

Indication
Luteina vaginal tablets 100 mg. Decreased ability to fertilize in primary or secondary infertility in partial or complete luteal insufficiency (disovulation, maintenance of the luteal phase during preparation for in vitro fertilization, egg donation program). Prevention of habitual miscarriage or threat of miscarriage in lutein deficiency. Prevention of premature birth in women with a short cervix or in women with a history of premature birth. Impossibility or restriction of oral administration of the drug.
Luteina vaginal tablets 200 mg. Recommended in IVF programs.

Contraindication
Hypersensitivity to any of the components of the drug. Suspected or confirmed neoplasia of the breast or genitals. Indeterminate bleeding from the genital tract, frozen pregnancy, ectopic pregnancy.
Severe dysfunction or liver disease. Severe renal failure. Thromboembolic disorders or severe thrombophlebitis in the active phase or in the anamnesis. Porphyria, the active phase of arterial or venous thromboembolism, as well as these conditions in the anamnesis.

Children
Not recommended for children.

Use during pregnancy or breastfeeding
Luteina vaginal tablets 200 mg can be used in the first trimester of pregnancy. There are insufficient clinical data on the use of progesterone in the II and III trimesters of pregnancy.
There are data on the possible risk of developing hypospadias when using progestogens during pregnancy to prevent habitual miscarriage or the risk of miscarriage due to lutein deficiency, about which the patient should be informed.
Progesterone passes into breast milk, so the use of the drug during breastfeeding is contraindicated.

Method of application and dosage
Doses of Luteina vaginal tablets 200 mg in each case should be set individually, depending on the indications and therapeutic effect. For more convenient use by patients and dose adjustment, there are the following dosages of Luteina, vaginal tablets: 50 mg, 100 mg, 200 mg. Vaginal tablets should be inserted into the vagina using an applicator, which is included in the package.

• With partial insufficiency of the luteal phase (disovulation, menstrual irregularities), the daily dose is 200 mg for 10 days (usually from the 17th to the 26th day of the cycle).
• With complete insufficiency of the luteal phase [complete absence of progesterone in women with dysfunctional (absent) ovaries (egg donation)]: the dose of progesterone is 100 mg on the 13th and 14th day of the transfer cycle. From the 15th to the 25th day of the cycle, the dose of progesterone is 200 mg, divided into two doses (morning and evening). From the 26th day, in the case of early diagnosis of pregnancy, the dose is increased, gradually (every week) by 100 mg of progesterone per day, reaching a maximum of 600 mg of progesterone per day, divided into three doses. This dosage should be followed until the 60th day.
• Maintenance of the luteal phase during the cycle of in vitro fertilization: treatment is carried out starting in the evening of the day of embryo transfer, at the rate of 600 mg per day in 3 doses (200 mg once every 8 hours).
• In case of risk of miscarriage or for the prevention of habitual miscarriages due to lutein deficiency: 200-400 mg per day (100-200 mg per dose every 12 hours) up to 12 weeks of pregnancy.
• Prevention of premature birth in women with a short cervix or in women with a history of premature spontaneous birth: the dose is 200 mg per day and is used in the evening before bedtime from the 22nd to the 36th week of pregnancy.
• In IVF programs to use 150 – 200 mg of progesterone 2 times a day vaginally. Treatment is continued until 77 days after embryo transfer. Completion of therapy should occur by gradually reducing the dose of the drug.

Overdose
The most common symptoms of progesterone overdose are: drowsiness, dizziness, depression. After reducing the dose of the drug, these symptoms disappear by themselves. In some cases, it may be necessary to discontinue the drug and initiate appropriate symptomatic and supportive treatment.

Side effects
When using Luteina containing progesterone, identical to the endogenous hormone, side effects were observed sporadically.

• Violations by the following systems and organs were noted.
• From the nervous system: drowsiness, impaired concentration and attention, fear, depression, headache and dizziness, insomnia.
• From the reproductive system: vaginal reactions (irritation, itching, discharge), ovarian hyperstimulation syndrome, uterine muscle spasms (during IVF), vulvovaginal discomfort, vaginal burning, vulvovaginal dryness, vaginal bleeding (during IVF), vaginal mycosis, pain, tenderness and swelling of the mammary glands.
• From the gastrointestinal tract: bloating, abdominal pain, nausea, diarrhea, constipation, vomiting.
• Other disorders: fatigue, urinary tract infections, peripheral edema, hypersensitivity reactions, including urticaria, rash.

Expiration date
36 months.

Storage conditions
Store below 30 ºC. Keep out of reach of children.