Lutein is a hormonal agent containing progesterone (an exogenous analogue of the hormone of the corpus luteum), which contributes to the formation of normal endometrium in women and the transition of the uterine mucosa from the proliferative phase to the secretory, and during fertilization, creating the conditions necessary for the favorable development of a fertilized egg.
Release form and composition
- Vaginal tablets (15 pieces in a contour packaging, 2 packs in a cardboard box);
- Sublingual tablets (30 pieces in plastic bottles, 1 bottle in a carton).
1 tablet (both vaginal and sublingual) contains:
- Active ingredient: progesterone micronized - 50 mg;
- Auxiliary components, incl. lactose monohydrate.
Indications for use
Lutein is intended for the treatment of conditions characterized by a deficiency of endogenous progesterone, such as menstrual disorders, premenstrual syndrome, dysmenorrhea, anovulatory cycles, endometriosis of the uterus.
Also, the drug is used in the following cases:
- Treatment of threatening and habitual abortions;
- Therapy of infertility caused by the lack of progesterone production by the corpus luteum;
- Hormone replacement therapy (in combination with etrogens);
- In artificial insemination schemes;
- Correction of hormonal background in premenopausal women with a luteal phase deficiency.
The use of Luteins is strictly contraindicated in the following cases:
- Malignant neoplasms (including breast cancer) and other hormone-dependent tumors;
- Vaginal bleeding of unknown origin;
- Lactase deficiency, glucose-galactose malabsorption syndrome and galactosemia;
- Jaundice with cholestasis, severe liver dysfunction, Dubin-Johnson and Rotor syndromes (for sublingual tablets);
- Lactation period;
- Individual sensitivity to exogenous progesterone.
After a thorough benefit / risk ratio, and only under the strict supervision of a physician, Lutein can be used for deep vein thrombophlebitis, pulmonary embolism, myocardial infarction, and angina pectoris.
After miscarriage, the use of the drug is possible only after a thorough cleaning of the uterus.
With amenorrhea, Lutein can be used only after pregnancy is excluded.
With extreme caution prescribed drug in patients with depression or depressive states in history.
Dosing and Administration
Vaginal tablets are inserted deep into the vagina. For a more comfortable administration just before use, the tablet can be slightly moistened with water.
Recommended treatment regimens:
- Algodysmenorrhea, premenstrual syndrome, menstrual irregularities and insufficiency of the luteal phase in the premenopausal period: 25-50 mg 2 times a day starting from the second phase of the natural or reproduced cycle for 10-12 days. It is recommended to conduct 3-6 courses (respectively, 3-6 cycles) in a row. In the premenopausal period, the drug should be used before the onset of menopause;
- Replacement therapy (in combination with estrogens): 25-50 mg 2 times a day, Lutein should be used from the 15th to the 25th day of the cycle or 1 time in 2-3 days (depending on the replacement therapy regimen prescribed by the doctor) ;
- Secondary amenorrhea: 50 mg 2 times a day for 5-7 days (bleeding should begin 7-10 days after progesterone is discontinued);
- Dysfunctional uterine bleeding: 50 mg 2 times a day for 5-7 days. In the future, the drug is used from the 15th to the 25th day of the cycle, 25-50 mg 2 times a day, for another 2-3 cycles in a row;
- Endometriosis: 50-100 mg 2 times a day. The course of treatment is 6 months;
- Anovulatory and induced cycles, as well as habitual and threatening miscarriages: 50-150 mg 2 times a day. It is necessary to begin treatment during that cycle when pregnancy is planned, or earlier. It is recommended to continue using progesterone until 18–20 weeks of pregnancy;
- Artificial insemination: 150-200 mg 2 times a day. Treatment continues up to 77 days after the embryo is moved, after which the dose of progesterone is gradually reduced, until the drug is completely discontinued.
Lutein sublingual tablets should be kept under the tongue until completely dissolved. Within 10-15 minutes after ingestion should not drink and eat food.
Recommended treatment regimens:
- Premenstrual syndrome and menstrual disorders: 50 mg 3 times a day. The course of treatment is 3-6 cycles;
- Replacement therapy (in combination with estrogen): 50 mg 3-4 times a day from the 14th to the 16th to the 28th day of the cycle (with a full 28-day cycle);
- Secondary amenorrhea: 50 mg 3-4 times a day (bleeding usually begins 7-10 days after the end of the drug);
- Dysfunctional uterine bleeding: 50 mg 3-4 times a day from the 15th to the 25th day of the cycle for 2-3 cycles in a row;
- Habitual abortions, induced and anovulatory cycles, artificial insemination: 100-150 mg 3-4 times a day. Treatment should begin several cycles before the planned pregnancy and continue until 18-20 weeks of pregnancy.
Basically, Lutein is well tolerated. In some cases, drowsiness, weakness, fatigue, decreased concentration and memory, headache, dizziness, depressive states, unreasonable fear, changes in body weight are noted.
There are isolated cases of intermenstrual bleeding, amenorrhea, dysmenorrhea, acne, hyperemia of the skin, thrombosis, disorders of bile outflow, allergic reactions. In case of early onset of the drug (up to the 15th day of the cycle), the menstrual cycle may be reduced or bleeding may develop.
When taking Luteins in the form of sublingual tablets, some patients complain of dryness of the oral mucosa and bleeding gums.
In premenopausal women, progesterone can hide the onset of menopause.
With the use of the drug in high doses, there is a likelihood of hypochloremia and hyponatremia.
To identify possible contraindications to Lutein, before starting treatment, the patient should undergo a gynecological examination and examination (palpation) of the mammary glands.
In case of insufficient production of progesterone by the corpus luteum, the drug can be used in the first trimester of pregnancy. Experience with the use of exogenous progesterone in the II and III trimesters not.
During treatment, it is recommended to refrain from driving and working with potentially dangerous machinery.
In the event of a severe headache, visual impairment or thrombotic complications, Lutein should be immediately canceled.
Preparations inhibiting the cytochrome P450 system may slightly alter the plasma concentration of progesterone.
Terms and conditions of storage
Store at temperatures up to 25 ºС.
The shelf life of vaginal tablets is 2 years, sublingual tablets are 3 years.