Progesterone

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Progesterone

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Orally

The drug is taken orally in the evening before bedtime, drinking water.

In most cases, with progesterone deficiency, the daily dose of Utrogestan® is 200-300 mg, divided into 2 doses (200 mg in the evening before bedtime and 100 mg in the morning, if necessary).

With threatened abortion or to prevent habitual abortion due to progesterone deficiency: 200-600 mg per day daily in the first and second trimesters of pregnancy. Further use of the drug Utrogestan® may be prescribed by the attending physician on the basis of an assessment of the clinical data of a pregnant woman.

In case of insufficiency of the luteal phase (premenstrual syndrome,

fibrocystic mastopathy, dysmenorrhea, menopausal transition period) the daily dose is 200 or 400 mg taken within 10 days (usually from the 17th to the 26th day of the cycle).

With MGT in perimenopause with estrogen therapy, the drug Utrogestan®

applied at 200 mg per day for 12 days.

When MGT in postmenopause in continuous mode drug Utrogestan®

used in a dose of 100-200 mg from the first day of estrogen preparations. Selection of the dose is carried out individually.

Intravaginal

Capsules are inserted deep into the vagina.

Prevention (prevention) of premature birth in women

from the risk group (with shortening of the cervix of the uterus and / or availability of anamnestic data of preterm labor and / or premature rupture of the membranes): the usual dose is 200 mg before bedtime, from the 22nd to the 34th week of pregnancy.

The complete absence of progesterone in women with non-functioning

(absent) ovaries (egg donation): during estrogen therapy, 100 mg per day on the 13th and 14th days of the cycle, then 100 mg twice a day from the 15th to the 25th day of the cycle, from the 26th day, and in the case of determining the pregnancy dose increases by 100 mg per day every week, reaching a maximum of 600 mg per day, divided into 3 doses. This dose may be applied for 60 days.

Support of the luteal phase during the extracorporal cycle

fertilization: it is recommended to use from 200 to 600 mg per day, starting from the day of injection of chorionic gonadotropin during the first and second trimester of pregnancy.

Support of the luteal phase in spontaneous or induced menstrual

cycle for infertility associated with dysfunction of the corpus luteum: it is recommended to use 200-300 mg per day, starting from the 17th day of the cycle for 10 days, in case of delayed menstruation and pregnancy diagnosis, treatment should be continued.

In cases of threatened abortion or to prevent habitual abortion,

arising on the background of progesterone deficiency: 200-400 mg per day in 2 divided doses daily in the first and second trimesters of pregnancy.

Adverse reactions

The adverse events listed below, noted during oral administration of the drug, are distributed according to the frequency of occurrence according to the following gradation: often:> 1/100, <1/10; infrequently:> 1/1000, <1/100; rarely:> 1/10000, <1/1000; very rarely: <1/10000.

System	Undesirable effects
bodies	often	infrequently	seldom	very rarely
Disorders of the genitals and breast	Violations menstrual cycle Amenorrhea Acyclic bleeding	Mammalgia
Mental Disorders				Depression
Nervous system disorders	Headache	Drowsiness Transient dizziness
Disorders of the gastrointestinal tract	Bloating	Vomiting Diarrhea Constipation	Nausea
Disorders of the liver and biliary tract		Cholestatic jaundice
Immune system disorders				Hives
Violations of the skin and subcutaneous tissue		Itching Acne		Chloasma

Drowsiness, transient dizziness are possible, as a rule, 1-3 h after oral administration of the drug. These adverse reactions can be reduced by reducing the dose, using the drug at bedtime or switching to a vaginal route of administration.

These unwanted reactions are usually the first signs of an overdose.

Drowsiness and / or transient dizziness are observed, in particular, in the case of concomitant hypoestrogenism.Reducing the dose or restoring higher estrogenation immediately eliminates these phenomena, without reducing the therapeutic effect of progesterone.

If the treatment starts too early (in the first half of the menstrual cycle, especially before the 15th day), shortening of the menstrual cycle or acyclic bleeding is possible.

Registered changes in the menstrual cycle, amenorrhea or acyclic bleeding are characteristic of all gestagens.

Application in clinical practice

When used in clinical practice, the following adverse events were noted with oral progesterone administration: insomnia; premenstrual syndrome; tension in the mammary glands; vaginal discharge; joint pain; hyperthermia; excessive sweating at night; fluid retention; change in body weight; acute pancreatitis; alopecia, hirsutism; libido changes; thrombosis and thromboembolic complications (when MHT is performed in combination with estrogen preparations); increase blood pressure.

The drug contains soy lecithin, which can cause hypersensitivity reactions (urticaria and anaphylactic shock).

When vaginal application

It was reported about individual cases of development of reactions of local intolerance to the components of the drug (in particular, soy lecithin) in the form of hyperemia of the vaginal mucosa, burning, itching, oily discharge.

Systemic side effects with intravaginal use of the drug in the recommended doses, in particular, drowsiness or dizziness (observed with oral administration of the drug), were not observed.

Hypersensitivity to progesterone or any of the excipients of the drug; deep vein thrombosis, thrombophlebitis; thromboembolic disorders (thromboembolism of the pulmonary artery, myocardial infarction, stroke), intracranial hemorrhage, or a history of these conditions / diseases; bleeding from the vagina of unknown origin; incomplete abortion; porphyria; established or suspected malignant neoplasms of the mammary gland and genitals; severe liver disease (including cholestatic jaundice, hepatitis, Dubin-Johnson's syndrome, Rotor, malignant liver tumors) currently or in history; children's age up to 18 years (efficiency and safety are not established); breastfeeding period.

CAREFULLY

Cardiovascular diseases, arterial hypertension, chronic renal failure, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression, hyperlipoproteinemia, dysfunction of the liver of mild and moderate severity; photosensitivity.

The drug should be used with caution in the II and III trimesters of pregnancy.

Drug interactions

Oral administration

Progesterone enhances the action of diuretics, antihypertensive drugs, immunosuppressants, anticoagulants. Reduces the lactogenic effect of oxytocin. Simultaneous use of CYP3A4 liver microsomal enzymes with inducer drugs, such as barbiturates, antiepileptic drugs (phenytoin, carbamazepine), rifampicin, phenylbutazone, spironolactone, griseofulvin, is accompanied by an acceleration of progesterone metabolism in the liver.

Simultaneous administration of progesterone with certain antibiotics (penicillins, tetracyclines) can lead to a decrease in its effectiveness due to a violation of the enterohepatic recirculation of sex hormones due to changes in the intestinal microflora.

The severity of these interactions can vary in different patients, so the prognosis of the clinical effects of these interactions is difficult.

Ketoconazole may increase the bioavailability of progesterone.

Progesterone can increase the concentration of ketoconazole and cyclosporine.

Progesterone may decrease the effectiveness of bromocriptine.

Progesterone can cause a decrease in glucose tolerance, as a result of which - to increase the need for insulin or other hypoglycemic drugs in patients with diabetes mellitus.

Bioavailability of progesterone can be reduced in patients who smoke and with excessive use of alcohol.

With intravaginal use

The interaction of progesterone with other drugs with intravaginal use was not evaluated. It is necessary to avoid the simultaneous use of other drugs used intravaginally, in order to avoid impaired release and absorption of progesterone.

Pregnancy and Lactation

Special instructions

Overdosage