Luteina (Progesterone) 100 mg, 30 vaginal tablets

Trade name
of Lutein

the International unlicensed


name Progesterone Dosage Form
of the Tablet vaginal 100 mg and 200 mg

Structure
One tablet contains
active agent - progesterone of 100 mg, 200 mg,
excipients: lactoses monohydrate, starch prezhelatinizirovanny (corn), sodium of a kroskarmelloz, gipromelloz, citric acid monohydrate, magnesium stearate, silicon dioxide colloidal anhydrous.

The description
of the Tablet of round shape, with a biconvex surface, white or almost white color, with an engraving 100 on one party and 22 on other party (for a dosage of 100 mg).
Tablets of round shape, with a biconvex surface, white or almost white color (for a dosage of 200 mg)

Pharmacotherapeutic group
Sex hormones and modulators of a reproductive system. Progestogens. Pregninum derivatives. Progesterone.
ATH G03DA04 code

the Pharmacological

Pharmacodynamics Progesterone properties in Lyutein's drug is synthetic received hormone of a yellow body of an ovary.
The most important effect of progesterone on genital function is implementation of an ovulation by means of strengthening of proteolysis of a wall of Graafovy bubbles, the secretory changes of endometrium giving the chance of implantation of oospore, braking of overgrowth of the endometrium caused by effect of estrogen, cyclic changes in muscles of uterine tubes, a neck of the uterus and vagina. Reduces excitability and contractility of muscles of a uterus and uterine tubes. Has no androgenic activity. Has the blocking effect on secretion of hypothalamic release factors of LG and FSG, education by a hypophysis of gonadotropic hormones oppresses and brakes an ovulation.
The pharmacokinetics
Metabolism
After intravaginalny use of 100 mg of progesterone, hormone reaches the maximum concentration in blood plasma about 6 - 7 hours later from the moment of introduction, and this concentration averages 10.9 +/-4.2 ng/ml. After vaginal introduction of 200 mg of progesterone, hormone reaches the peak of concentration in blood serum in 2-6 hours. Average concentration of progesterone in blood serum after intravaginalny reception of 200 mg of progesterone makes about 9 ng/ml and remains at this level within 24 hours.
Removal
Elimination half-life in an elimination phase makes about 13 h of blood plasma of the progesterone entered intravaginalno. It is generally allocated with kidneys, a small amount of not changed progesterone is removed with bile.
Distribution
After vaginal introduction progesterone is transported directly in uterus endometrium. Penetration of progesterone from a vagina in a uterus can be carried out on the mechanism of direct diffusion in fabric of endometrium, transportation through a neck, transportation with a venous and lymphatic blood-groove or way of the facilitated counterflow diffusion from absorbent and venous vessels to the arterial system of a uterus.

Indications
- support of a lyuteinovy phase at artificial fertilization
- the usual and menacing abortions against the background of deficiency of progesterone

the Route of administration and doses
the Dosage of progesterone has to be established always individually depending on indications and therapeutic effect.
Total absence of progesterone at women with the nonfunctioning (absent) ovaries (donorship of ova): against the background of estrogenic therapy on 100 mg a day on 13 - the 14th day of a cycle, then on 200 mg a day from 15 to the 25th day of a cycle, from the 26th day, in case of pregnancy definition the dose is increased by 100 mg a week to the maximum 600 mg a day, divided into 3 introductions. Such dosage can be applied till 60 in the afternoon, if necessary up to 12 weeks of pregnancy. Support of a lyuteinovy phase during a cycle at artificial fertilization: the dose of 400 - 600 mg a day (in 2-3 introductions), since day of an injection of a chorionic gonadotrophin during the I trimester of pregnancy is recommended.
Support of a lyuteinovy phase in the spontaneous or induced menstrual cycle, in the infertility connected with dysfunction of a yellow body: 200-300 mg a day, since 17th day of a cycle for 10 days are recommended, in case of a delay of periods and diagnostics of pregnancy the treatment has to be continued till 12th week of pregnancy.
In cases of threat of abortion or for prevention of usual abortions. arising against the background of insufficiency of progesterone: 200 – 400 mg a day daily in 2 introductions till 12th week of pregnancy. Need and a possibility of further use of drug the attending physician on the basis of clinical data defines, functions of a placenta and level of progesterone in blood of the pregnant woman.
Uses
of applicator 1. It is necessary to unpack the applicator.
2. It is necessary to insert one tablet of drug of Lutein into the appropriate place on the end of the applicator. The tablet has to adjoin densely to walls of the applicator and should not drop out.






3. The applicator should be entered into a vagina in a comfortable position (standing, sitting, lying on spin with the bent knees).
4. It is necessary to enter the applicator into a vagina until the convex line, notable under a finger, is at one height with vulvar lips.

5. It is necessary to press the applicator piston to release a tablet.







6. Then it is necessary to take out the applicator, to wash out under warm flowing water and to wipe dry soft tissue.
7. The applicator needs to be kept for reuse.

Side effects
Perhaps:
- drowsiness, disturbances of concentration and attention, sensation of fear, depressions, headaches and dizziness
- allergic reactions (rash, an itching), yellowness of skin and scleras
- intermenstrual bleeding, reduction of a menstrual cycle, hypersensitivity, pain and swelling of mammary glands, disturbances from external genitals such as dryness, burning, genital itching, the profound vaginitis, vaginal mycosis
- disorders of vision and speeches
- peripheral hypostases, hypostases under eyes
- gastrocnemius muscle pains, feeling of numbness
- change of body weight
- paroxysmal short wind, thorax pains, cough with blood discharge
- nausea, vomiting, an abdominal distension, an abdominal pain, a constipation,

Contraindication diarrhea
- hypersensitivity to drug components, including to peanut butter, soy
- tendency to thromboses, acute phlebitis or a thrombembolia
- a cerebral hemorrhage
- bleeding of not clear etiology from a genital tract
- incomplete abortion
- a porphyria
- children's and teenage age up to 18 years
- the profound abnormal liver function
- the established or suspected malignant new growths of mammary glands and genitals
- hereditary intolerance of fructose, deficiency of LAPP enzyme – lactase, glucose galactose malabsorption.
With care it is necessary to use drug in diseases of a cardiovascular system, arterial hypertension, chronic kidney disease, diabetes, bronchial asthma, epilepsy, migraine, a depression, a giperlipoproteinemiya, the lactation period.

Medicinal interactions
At combined use of drug are strengthened by effect of diuretics, hypotensive medicines, immunodepressants, anticoagulants. Reduces lactogenic effect of oxytocin.
Can change effect of Bromocriptinum, increase concentration in cyclosporine plasma. Drug can affect results of laboratory researches of function of a liver and/or endocrine organs. Metabolism of drug accelerates Rifamycinum. Metabolism of progesterone in microsomes of a liver of the person is suppressed ketokonazoly as ketokonazol is inhibitor of P 450 3A4 cytochrome, povmozhno increase in bioavailability of progesterone.

The special
instructions Progesterone at intravaginalny introduction gets directly into the blood circulatory system, passing metabolism in a liver. In this regard, at moderate disturbance of work of a liver there is no need for change of a dose of the progesterone accepted in the vaginal way.
Before an initiation of treatment it is necessary to collect the detailed medical and family anamnesis, to perform gynecologic examination and inspection of mammary glands. The patients using drugs of replacement hormonal therapy have data on some increase in risk of developing a breast cancer and thromboembolic diseases (deep vein thrombosis, an embolism of a pulmonary artery).
Drug is not used for the purpose of contraception and for treatment of premature births. Lutein drug use after the I trimester of pregnancy can become the cholestasia reason. At emergence of symptoms of a disorder of vision (partial or total loss of sight, an exophthalmos, doubling in eyes, vascular disorders in an eye retina, a papilledema), migraine attacks, use of drug it is necessary to stop and carry out necessary treatment. Patients with a depression have to be under special control as strengthening of symptoms of a disease is possible. Drug of Lutein needs to be used with care in diseases of a cardiovascular system, arterial hypertension, chronic kidney disease, diabetes, bronchial asthma, epilepsy, migraine, photosensitivity, a giperlipoproteinemiya, a slight and moderate liver failure, in the lactation period.
The period of pregnancy and a lactation
Progesterone can be applied safely only in the first trimester of pregnancy. Does not render the masculinizing, virilizing, kortikoidny and anabolic effects. There are no clinical data on safety of use of Progesterone in the second and third trimester of pregnancy. Breastfeeding is restriction to drug use.
Features of influence on ability to run the vehicle or potentially dangerous mechanisms
Considering a possibility of development of such side effects as dizziness, it is necessary to be careful at control of vehicles and work with moving mechanisms.

Overdose
Symptoms: drowsiness, dizziness, depression.
Treatment: reduction of a dose or drug withdrawal, after reduction of a dose of drug these symptoms completely independently disappear.

The form of release and packing
On 15 tablets place in blister strip packaging from polyvinylchloride / 90/polyvinyldichloride
(PVH/90/PVDH) of a film and aluminum foil for a dosage of 100 mg.
On 10 tablets place in blister strip packaging from polyvinylchloride / 90/polyvinyldichloride (PVH/90/PVDH) of a film and aluminum foil for a dosage of 200 mg.
On 2 planimetric packs together with applicator 100 with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
On 3 planimetric packs together with applicator 200 with the instruction for medical use in the state and Russian languages place in a pack from cardboard for a dosage 200 mg.




To Store storage conditions at a temperature not over 25 of 0C
to Store out of children's reach!


2 years
not to use a period of storage after an expiration date.




The Applicant
of Adamed Limited Liability Company
to Develop prescription status According to the prescription