Capsules "Utrozhestan ^® " are used at indications which are provided below.

Disturbance, connected with deficiency of progesterone.

Oral administration

Gynecologic:

• violation, connected with deficiency of progesterone, namely:
  • premenstrual syndrome;
  • violation of a menstrual cycle (dizovulyation, anovulation);
  • fibrous and cystous mastopathy;
  • preklimakterichesky period;
• replaceable hormonal therapy in a menopause (in combination with estrogenic therapy);
• infertility at lyuteinovy insufficiency;

Obstetric:

• prevention of a usual abortion or threat of an abortion against the background of lyuteinovy insufficiency;
• threat of premature births.

Intravaginalny application

• decline in the ability to fertilization at primary or secondary infertility at partial or full lyuteinovy insufficiency (a dizovulyation, support of a lyuteinovy phase in preparation time to in vitro fertilization, the program of donation of ova); prevention of a usual abortion or threat of a spontaneous abortion at lyuteinovy insufficiency;
• prevention of premature births at women with a short neck of the uterus or at women with existence of premature spontaneous births in the anamnesis;
• impossibility or restriction of intake of medicine.

Structure

Acting substance - progesterone (one capsule contains the progesterone micronized 100 mg).

Excipients: sunflower oil, lecithin soy, gelatin, glycerin, the titan dioxide (E 171), the water purified.

Contraindication

• hypersensitivity to medicine components;
• heavy violations of functions of a liver;
suspect or is confirmed to
• a neoplasia of a breast or genitals;
• not diagnosed vaginal bleedings;
• unsuccessful or incomplete abortion;
• thrombophlebitis;
• thromboembolic violations;
• cerebral hemorrhage;
• porphyria.

Route of administration

Duration of treatment depends on the nature of a disease.

Oral administration

In most cases the average daily dose makes 200-300 mg in 1 or 2 receptions (200 mg in the evening, before going to bed, and 100 mg in the morning if there is such need).

At insufficiency of a lyuteinovy phase (a premenstrual syndrome, violations of a menstrual cycle, a premenopause, fibrous and cystous mastopathy): accept within 10 days (usually from the 17th to the twenty sixth day of a cycle inclusive).

At replaceable hormonal therapy of a menopause: as separately the estrogenoterapiya is not recommended, progesterone it is necessary to apply as addition to it the last 2 weeks of each course which come behind one-week support of any replacement therapy during which cancellation bleeding can be observed.

At threat of premature births: accept 400 mg of the medicine "Utrozhestan®" every 6-8 hours before disappearance of symptoms. The effective dose and frequency rate of application are selected individually depending on clinical manifestations of threat of premature births. After disappearance of symptoms a medicine dose "Utrozhestan ^® " gradually reduce to supporting (for example 200 mg 3 times a day). In this dose medicament can be used up to 36 weeks of pregnancy.

Use of progesterone after 36 weeks of pregnancy is not recommended to

.

Intravaginalny application

Capsule to enter

deeply into a vagina in a dorsal decubitus.

Before each use of medicine needs to wash up carefully hands that there is no detergent left on hands.

dose averages 200 mg of progesterone a day (one capsule on 200 mg or two capsules on 100 mg, in 2 receptions, in the morning and in the evening which enter deeply into a vagina, if necessary by means of the applicator). The dose can be increased depending on reaction of the patient.

At partial insufficiency of a lyuteinovy phase (dizovulyation, violation of a menstrual cycle) the daily dose makes 200 mg within 10 days (usually from the 17th to the twenty sixth day of a cycle).

At full insufficiency of a lyuteinovy phase (total absence of progesterone at women with the nonfunctioning (absent) ovaries (donation of ova)): the dose of progesterone makes 100 mg for the thirteenth and fourteenth day of a cycle of transfer. From the 15th in twenty fifth day a cycle the dose of progesterone makes 200 mg divided into two receptions (in the morning and in the evening). Since 26th day, in case of early diagnostics of pregnancy, the dose increases, gradually (every week) by 100 mg of progesterone a day, reaching a maximum of 600 mg of progesterone a day divided into three receptions. This dosing should be observed till 60th day.

Support of a lyuteinovy phase during a cycle of in vitro fertilization: treatment is carried out, since evening of day of transfer of an embryo, from calculation for 600 mg a day to 3 receptions (200 mg once every 8 hours).

in case of threat of an abortion or for prevention usual vikidyshy because of lyuteinovy insufficiency: 200-400 mg a day (100-200 mg on one reception every 12 hours) up to 12 weeks of pregnancy.

Prevention of premature births at women with a short neck of the uterus or at women with existence of premature spontaneous births in the anamnesis: the dose makes 200 mg a day and is applied in the evening before going to bed from the 22nd to the thirty sixth week of pregnancy.

to

Pregnant

to

medicine Use "Utrozhestan ^® " is not contraindicated to

Feature of application

at pregnancy, including in the first weeks. During use of medicine any case of adverse effect of medicine on a fruit was not observed. At use of medicine in the second and third trimesters of pregnancy the control of function of a liver is necessary.

Intake of progesterone in breast milk in detail was not studied by

. Therefore, its appointment should be avoided during feeding by a breast.

hypospadias given about possible development, at use of progestogens during pregnancy for prevention of a usual abortion or threat of an abortion against the background of lyuteinovy insufficiency what the patient has to be informed on Exists.

Children

Clinical data on use of medicine to children are absent.

Drivers

to Drivers of transport and operators of cars: the drowsiness and dizziness connected with administration of medicament internally are possible. Use of capsules before going to bed allows to avoid these unpleasant consequences. Cases of drowsiness and dizziness were observed only at oral administration of medicine.

Overdose

Symptoms of overdose can be shown by symptomatology of side reactions, including drowsiness, dizziness, euphoria, a dysmenorrhea, reduction of duration of a cycle, a metrorrhagia.

usual dose can be

At some persons excessive because of the existing or secondary emergence of unstable endogenous secretion of progesterone, hypersensitivity to medicament or very low accompanying oestradiol level in blood.

is enough

In such cases:

• to reduce a dose of progesterone or to appoint intake of progesterone in the evening before going to bed within 10 days for a cycle in case of drowsiness or fleeting dizziness;
• to transfer an initiation of treatment to later term in a cycle in case of its reduction or blood discharges;
to check
• whether oestradiol level at the patient who receives the substituted hormonal therapy in a premenopauza is sufficient.

Side effects

Frequent (> 1/100; <1/10) by-effects which were observed at oral administration:

• frustration of a reproductive system and mammary glands: change of periods, amenorrheas, the alternating bleedings;
• violation of the central nervous system: headaches.

At vaginal use of medicine reactions of hypersensitivity, including burning, an itch, hyperaemia and also emergence of oily discharges are possible

.

Storage conditions

to Store

at a temperature not above 25 °C, out of children's reach.

Expiration date - 3 years.