Utrogestan, 200 mg capsules 14 pcs

Pharmacotherapeutic group: gestagen

ATX code: G03DA04

Pharmacological Properties

Pharmacodynamics

The active ingredient of Utrogestan® is progesterone, which is identical to the natural hormone of the corpus luteum of the ovary. It binds to receptors on the surface of target cells and penetrates the nucleus where, by activating DNA, it stimulates RNA synthesis. It promotes transition of uterine mucosa from the phase of proliferation caused by the follicular hormone estradiol to the secretory phase, and after fertilization to a state required for development of a fertilized egg.

It reduces the excitability and contractility of uterine muscles and fallopian tubes. Promotes the formation of normal endometrium. Stimulates the development of mammary gland terminal elements and induces lactation.
By stimulating protein lipase, increases fat reserves; increases glucose utilization; by increasing the concentration of basal and stimulated insulin, promotes glycogen accumulation in the liver; increases production of gonadotropic hormones of the pituitary; reduces azotemia, increases nitrogen excretion by the kidneys.

Pharmacokinetics

When taken orally.

Indications

Active ingredient

Composition

for 1 capsule:

Active substance:

Progesterone micronized 100 or 200 mg.

Associates:

Sunflower oil 149 mg/298 mg,

Soybean lecithin 1 mg/2 mg;

The capsule – gelatin 76.88 mg/153.76 mg,

Glycerin 31.45 mg/62.9 mg,

Titanium dioxide 1.67 mg/3.34 mg.

Description:

The 100 mg capsules are round, the 200 mg capsules are oval, soft shiny yellowish gelatin capsules containing an oily whitish homogeneous suspension (no visible phase separation).

How to take, the dosage

Orally

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

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

In threatened abortion or to prevent habitual abortion due to progesterone deficiency: 200-600 mg daily in the first and second trimesters of pregnancy. Further administration of Utrogestan® is possible by prescription of a physician on the basis of the evaluation of the clinical data of a pregnant woman.

In case of luteal phase failure (premenstrual syndrome, cystic fibrosis, dysmenorrhea, menopausal transition) the daily dose is 200 or 400 mg taken for 10 days (usually from the 17th to the 26th day of the cycle).

In MGT in perimenopause against a background of estrogen administration, Utrogestan® is used 200 mg daily for 12 days. At MGT in postmenopause in a continuous regimen Utrogestan® is used in a dose of 100-200 mg from the first day of use of oestrogen-containing drugs. The dose is adjusted individually.

Intravaginal

The capsules are placed deep in the vagina.

Prevention (prevention) of preterm birth in women at risk (with shortened cervix and/or a history of preterm birth and/or premature rupture of 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): on the background of estrogen therapy by 100 mg per day on days 13 and 14 of the cycle, then by 100 mg 2 times a day from day 15 to 25 of the cycle, from day 26, and in case of pregnancy determination the dose increases by 100 mg a day every week, reaching a maximum of 600 mg a day, divided into 3 doses. This dose can be used for up to 60 days.

Luteal phase support during an in vitro fertilization cycle: 200 to 600 mg daily starting on the day of chorionic gonadotropin injection during the first and second trimesters of pregnancy.

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

In cases of threatened abortion or to prevent habitual abortion arising against the background of progesterone insufficiency: 200-400 mg daily in 2 doses daily in I and II trimesters of pregnancy.

Interaction

Special Instructions

Contraindications

Hypersensitivity to progesterone or any of the excipients of the drug; deep vein thrombosis, thrombophlebitis; thromboembolic disorders (pulmonary embolism, myocardial infarction, stroke), intracranial hemorrhage or history of these conditions/diseases; vaginal bleeding of unclear genesis; incomplete abortion; porphyria; established or suspected malignancies of the breast and genital organs; severe liver disease (including cholestatic jaundice, hepatitis, Dubin-Johnson syndrome, Rotor, malignant liver tumors) at present or in anamnesis; childhood age below 18 years (effectiveness and safety not established); period of breast-feeding.

With caution:

Cardiovascular disease, arterial hypertension, chronic renal failure, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression, hyperlipoproteinemia, mild to moderate liver function disorders; photosensitivity.

The drug should be used with caution during the second and third trimesters of pregnancy.

Side effects

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

Genital and mammary gland disorders:often – menstrual irregularities, amenorrhea, acyclic bleeding; infrequent – mastodynia.

Mental side:very rarely – depression.

Nervous system disorders:often – headache; infrequently – drowsiness, transient dizziness.

Gastrointestinal disorders:often – bloating; infrequent – vomiting, diarrhea, constipation; rarely – nausea.

Hepatic and biliary tract disorders: infrequent – cholestatic jaundice.

From the immune system:very rarely – urticaria.

Skin and subcutaneous tissue: infrequently – itching, acne; very rarely – chloasma.

Drowsiness, transient dizziness are possible, usually 1-3 hours after taking the drug. These side effects can be reduced by reducing the dose, using the drug before bedtime, or switching to the vaginal route of administration.

These adverse effects are usually the first signs of an overdose. Drowsiness and/or transient dizziness have been observed, particularly in cases of concomitant hypoestrogenism. Reducing the dose or restoring higher estrogenicity immediately eliminates these phenomena without reducing the therapeutic effect of progesterone.

If treatment begins too early (in the first half of the menstrual cycle, especially before day 15), menstrual cycle shortening or acyclic bleeding may occur.

Recorded menstrual cycle changes, amenorrhea or acyclic bleeding are common with all progestagens.

Application in clinical practice

The following adverse events with oral progesterone have been noted in postmarketing use: Insomnia; premenstrual syndrome; breast tension; vaginal discharge; joint pain; hyperthermia; increased sweating at night; fluid retention; body weight changes; acute pancreatitis; alopecia, hirsutism; changes in libido; thrombosis and thromboembolic complications (if MHT is combined with estrogen-containing medications); increased BP.

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

Vaginal administration There have been reports of individual cases of local intolerance reactions of the drug components (in particular soy lecithin) in the form of hyperemia of the vaginal mucosa, burning, itching, oily discharge.

Systemic adverse effects have not been noted with intravaginal administration at the recommended doses, such as drowsiness or dizziness (observed with oral administration of the drug).

Overdose

Similarities