Luteina sublingual tablets 50 mg. №30

Description

Luteina sublingual tablets composition
active substance: micronized progesterone;
1 tablet contains micronized progesterone 50 mg;
Excipients: lactose monohydrate, potato starch, polyvinylpyrrolidone, ethylcellulose, talc, vanillin, magnesium stearate.

Dosage form
Sublingual tablets.

Pharmacological properties
The progesterone in Luteina sublingual tablets, 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
Treatment of endogenous progesterone deficiency in the form of menstrual disorders, secondary amenorrhea, anovulatory cycles, premenstrual syndrome, functional uterine bleeding. In artificial insemination, infertility associated with luteal insufficiency, habitual miscarriage and the threat of miscarriage in progesterone deficiency, corpus luteum insufficiency, secondary amenorrhea, to prevent endometrial hypertrophy in women taking estrogen (eg, hormone therapy).

Contraindication
Hypersensitivity to the components of the drug. Breastfeeding period. Suspected or confirmed neoplasia of the breast or genitals. Indeterminate bleeding from the genital tract.
Severe liver dysfunction. Cholestatic jaundice. Rotor syndrome and Dabin ̶ Johnson syndrome. Thromboembolic venous disease (deep vein thrombophlebitis, pulmonary embolism). Existing or transferred thromboembolic disorders in the arteries (angina, myocardial infarction). Miscarriages, as well as the presence of residues after miscarriage in the uterine cavity. Porphyria, hemorrhage into the brain.

Children
Not recommended for children.

Use during pregnancy or breastfeeding
Luteina sublingual tablets can be used in the first trimester of pregnancy. The drug has no masculinizing, virilizing, corticosteroid and anabolic effects. There are insufficient data on the use of progesterone in the second and third 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 penetrates into breast milk, so the use of the drug during breastfeeding is contraindicated.

Method of application and dosage
Doses of Luteina sublingual tablets in each case should be set individually for each patient depending on the indications and therapeutic effect.

• In menstrual disorders and premenstrual syndrome, apply 50 mg of progesterone 3-4 times a day sublingually. The treatment lasts 3-6 cycles in a row.
• To prevent endometrial hypertrophy (with hormone replacement therapy) in combination with estrogen should often be used 50 mg of progesterone 3-4 times a day sublingually. In case of prolonged intermittent regimens, the drug should be applied under the tongue during the last 12-14 days of the 28-day cycle.
• At the prolonged continuous schemes to apply progesterone daily without breaks.
  The dose of progesterone should depend on the dose of estrogen so as to protect the endometrium from the proliferative action of estrogen.

When performing a progesterone test for secondary amenorrhea, apply progesterone 50 mg 3-4 times a day sublingually. Menstruation should begin within 7-10 days after treatment.

• In the treatment of functional uterine bleeding use 50 mg of progesterone 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.
• In case of habitual miscarriage and threat of miscarriage, anovulatory and induced cycles, apply 100 mg of progesterone 3-4 times a day sublingually.
• In case of habitual miscarriage, progesterone should be started during the cycle in which the pregnancy is planned, even earlier (pre-pregnancy training in 3-4 months). Treatment should be continued continuously until about 18-20 weeks of pregnancy.
• In in vitro fertilization programs (in vitro) apply 100-150 mg of progesterone 3-4 times a day sublingually.

Overdose
The most common symptoms of overdose may be: drowsiness, dizziness, nausea, depression.
Symptoms usually stop on their own after reducing the dose of the drug.
In case of overdose, the drug should be discontinued and symptomatic treatment instituted.

Side effects:

• From the nervous system: uncommon: drowsiness, headache and dizziness.
• From the psyche: infrequently: impaired concentration and attention, fear, depression.
• From the reproductive system: rare: abnormal uterine bleeding, dysmenorrhea, hemorrhage.
• From the skin and subcutaneous tissue: rare: anaphylactic reactions, redness of the skin, acne, allergic reactions.
• From the vascular system: rare: bleeding gums, thrombosis, venous thromboembolism, pulmonary embolism
• From the gastrointestinal tract: uncommon: nausea; rare: dry mouth, gastrointestinal upset, vomiting, diarrhea, constipation
• Liver and biliary tract disorders: rare cholestatic jaundice.
• Metabolism and digestion disorders: rare: body weight fluctuations.
• Other disorders: fluid retention, hyperthermia.

Expiration date
3 years.

Storage conditions
Store in the original package at a temperature below 25 ºC. Keep out of reach of children.