Progynorm Gesta soft capsules 100 mg blister No. 30

Instructions for use Progynorm Gesta soft capsules 100 mg blister No. 30

Composition

active ingredient: progesterone;

1 soft capsule contains 100 mg or 200 mg of progesterone;

excipients: peanut oil, soy lecithin;

capsule shell: gelatin 150 Bloom, glycerin 99%, titanium dioxide (E 171).

Dosage form

Soft capsules.

Main physicochemical properties: soft, opaque, oval-shaped capsules of almost white color.

Pharmacotherapeutic group

Hormones of the sex glands and drugs used in cases of pathology of the genital sphere. Progestogens. Derivatives of pregnenol (4). Progesterone. ATX code G03D A04.

Pharmacological properties

Pharmacodynamics.

The pharmacological properties of the drug PROGINORM GESTA are due to progesterone - one of the hormones of the corpus luteum, which contributes to the formation of a normal secretory endometrium in women. Causes the transition of the uterine mucosa from the proliferation phase to the secretory phase, and after fertilization promotes its transition to the state necessary for the development of a fertilized egg. Reduces the excitability and contractility of the muscles of the uterus and fallopian tubes. Does not have androgenic activity. Has a blocking effect on the secretion of hypothalamic factors for the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), inhibits the formation of gonadotropic hormones by the pituitary gland and ovulation.

Pharmacokinetics.

Absorption

When applied vaginally, progesterone is rapidly absorbed by the mucous membrane. The increase in the level of progesterone in the blood plasma begins in the first hour, the highest level in the blood plasma is reached 1-3 hours after application. At the average recommended dose (100 mg of progesterone at night) PROGINORM GESTA allows you to achieve and maintain a physiological and stable level of plasma progesterone (on average at 9.7 ng/ml), similar to that in the luteal phase of the menstrual cycle with normal ovulation.

Thus, PROGYNORM GESTA stimulates adequate maturation of the endometrium and promotes embryo implantation.

At higher doses (above 200 mg per day), which are increased gradually, the vaginal route of administration allows achieving a level of progesterone in the blood plasma similar to that during the first trimester of pregnancy.

Metabolism

Metabolites in blood plasma and urine are identical to those found in the physiological secretion of the corpus luteum: in blood plasma, these are mainly 20α-hydroxy, δ4α-pregnanolone and 5α-dihydroprogesterone. Urinary excretion is 95% in the form of glucuronic metabolites, the main component of which is 3α, 5β-pregnanediol (pregnanediol).

Indication

Disorders associated with progesterone deficiency.

Reduced fertility in primary or secondary infertility with partial or complete luteal insufficiency (dysovulation, luteal phase support during preparation for in vitro fertilization, egg donation program). Prevention of habitual miscarriage or threatened spontaneous miscarriage in luteal insufficiency.

Prevention of preterm birth in women with a short cervix or in women with a history of spontaneous preterm birth.

Impossibility or limitation of oral administration of the drug.

Contraindication

Hypersensitivity to any component of the drug.

Severe liver dysfunction.

Suspected or confirmed breast or genital neoplasia.

Undiagnosed vaginal bleeding.

Failed or incomplete abortion.

Thrombophlebitis. Thromboembolic disorders.

Brain hemorrhage.

Porphyria.

Interaction with other medicinal products and other types of interactions

When using estrogen for menopausal hormone therapy, it is strongly recommended to administer progesterone no later than the 12th day of the cycle.

If PROGINORM GESTA is used in combination with beta-adrenomimetics in the treatment of threatened preterm labor, the doses of the latter can be reduced.

Concomitant use of other drugs may alter progesterone metabolism, causing an increase or decrease in progesterone plasma concentrations and, accordingly, altering the drug's action.

Strong inducers of liver enzymes, namely: barbiturates, antiepileptic drugs (phenytoin), rifampicin, phenylbutazone, spironolactone, griseofulvin, cause increased metabolism at the hepatic level.

Some antibiotics (ampicillins, tetracyclines) can cause changes in the intestinal microflora, resulting in a change in the enterohepatic steroid cycle.

It is known that such drug interactions are individual and may vary significantly in different patient groups, therefore it is not possible to unequivocally predict any clinical manifestations of such interactions. All progestins may reduce glucose tolerance, which may require an increase in the daily dose of insulin and other antidiabetic agents in patients with diabetes.

Progesterone bioavailability can be reduced by smoking and increased by alcohol.

Application features

If treatment is started too early in the menstrual cycle, especially before day 15 of the cycle, a shortened cycle or bleeding may occur.

In case of uterine bleeding, do not prescribe the drug without clarifying the cause, in particular during endometrial examination.

The drug should be used with caution in patients with fluid retention (e.g., patients with hypertension, cardiovascular disease, kidney disease, epilepsy, migraine, bronchial asthma), with a history of depression, diabetes mellitus, liver dysfunction, and photosensitivity.

Before prescribing the drug, patients with a family history of neoplasms and patients with recurrent cholestasis or persistent itching during pregnancy, liver dysfunction, heart or kidney failure, fibrocystic mastopathy, epilepsy, asthma, otosclerosis, diabetes mellitus, multiple sclerosis, systemic lupus erythematosus should be carefully examined.

Due to the thromboembolic and metabolic risk, which cannot be completely ruled out, the drug should be discontinued in the event of:

visual disturbances, such as vision loss, double vision, retinal vascular lesions, proptosis, optic disc edema;

thromboembolic venous or thrombotic complications, regardless of the site of involvement;

severe headache, migraine.

If amenorrhea occurs during treatment, pregnancy, which may be the cause of amenorrhea, should be confirmed or ruled out.

Oily discharge is possible, which is associated with the dosage form of the drug.

More than half of early spontaneous abortions are caused by genetic complications. Also, infectious manifestations and mechanical disorders can be the cause of early abortions, the only justification for prescribing progesterone in this case would be to delay the expulsion of a dead egg. Therefore, the prescription of progesterone on the recommendation of a doctor should be provided for cases when progesterone secretion is insufficient.

Before starting treatment, the patient should undergo a thorough medical and accurate gynecological examination, including intravaginal and mammological examination, Papanicolaou smear, taking into account the anamnesis, contraindications and precautions for use. Regular check-ups with a doctor are recommended during treatment. Women receiving hormone replacement therapy (HRT) should carefully assess all the risks/benefits associated with therapy.

In patients with postmenopausal symptoms who are receiving or have received HRT, there is a slight to moderate increase in the likelihood of being diagnosed with breast cancer. This may be due to early diagnosis of patients or the actual benefit of HRT, as well as a combination of both. The risk of being diagnosed with breast cancer increases with increasing duration of treatment and returns to baseline values five years after stopping HRT. Breast cancer diagnosed in patients who are receiving or have recently received HRT is less invasive than that occurring in women who have not received HRT. The doctor should discuss the higher risk of developing breast cancer with patients who will receive long-term hormone therapy when assessing the benefits of HRT.

The medicine PROGYNORM HESTA contains peanut oil and soy lecithin. If you are allergic to peanut or soy, you should not use this medicine.

Use during pregnancy or breastfeeding

The use of PROGINORM GESTA is not contraindicated during pregnancy.

During the period of use of the drug, no case of adverse effects of the drug on the fetus was observed.

When using the drug in the II and III trimesters of pregnancy, liver function monitoring is required.

The passage of progesterone into breast milk has not been studied in detail. Therefore, its administration should be avoided during breastfeeding.

There is evidence of the possible development of hypospadias when progestogens are used during pregnancy to prevent spontaneous miscarriage or threatened miscarriage due to luteal insufficiency, which the patient should be informed about.

The ability to influence the reaction speed when driving or working with other mechanisms

Taking PROGYNORM GESTA has a minor effect on the ability to drive vehicles and use machines.

Method of administration and doses

The duration of treatment depends on the nature of the disease.

The capsules should be inserted deep into the vagina while lying on your back.

Before each use of the drug, it is necessary to wash your hands thoroughly so that no detergent remains on your hands.

The average dose is 200 mg of progesterone per day (1 capsule of 200 mg or 2 capsules of 100 mg, divided into 2 doses, morning and evening, which are inserted deep into the vagina, if necessary using an applicator). The dose can be increased depending on the patient's response.

In case of complete luteal phase deficiency [complete absence of progesterone in women with non-functioning (absent) ovaries (egg donation)]: the dose of progesterone is 100 mg on the 13th and 14th days of the transfer cycle. From the 15th to the 25th day of the cycle, the dose of progesterone is 200 mg, divided into 2 doses (morning and evening). Starting from the 26th day, in case of early diagnosis of pregnancy, the dose is increased gradually (every week) by 100 mg of progesterone per day, reaching a maximum of 600 mg of progesterone per day, divided into 3 doses. This dosage should be followed until the 60th day.

Luteal phase support during an in vitro fertilization cycle: treatment is carried out starting from the evening of the embryo transfer day, at the rate of 600 mg per day in 3 doses (200 mg once every 8 hours).

In case of threatened miscarriage or for the prevention of habitual miscarriages due to luteal insufficiency: 200-400 mg per day (100-200 mg per dose every 12 hours) up to 12 weeks of pregnancy.

Prevention of preterm birth in women with a short cervix or in women with a history of spontaneous preterm birth: the dose is 200 mg per day and is administered in the evening before bedtime from the 22nd to the 36th week of pregnancy.

Children.

The drug is not intended for use in pediatric practice.

Overdose

Symptoms of overdose may manifest as symptoms of adverse reactions, including drowsiness, dizziness, euphoria, dysmenorrhea, decreased cycle length, and metrorrhagia.

In some individuals, the usual dose may be excessive due to existing or secondary unstable endogenous progesterone secretion, hypersensitivity to the drug, or very low concomitant blood estradiol levels.

In such cases, it is sufficient to:

reduce the dose of progesterone or prescribe progesterone in the evening before bedtime for 10 days per cycle in case of drowsiness or dizziness that quickly passes;

postpone the start of treatment to a later date in the cycle (for example, day 19 instead of day 17) in case of its shortening or bleeding;

to check whether the estradiol level is sufficient in a premenopausal patient receiving HRT.

Side effects

The following adverse reactions have been observed with oral administration:

Adverse reactions such as changes in libido, breast discomfort, premenstrual symptoms, hyperthermia, insomnia, alopecia, hirsutism, venous thromboembolism, pulmonary embolism, fluid retention, weight changes, gastrointestinal disorders, and anaphylactic reactions may also occur.

Drowsiness and/or a brief feeling of dizziness are observed, especially in the case of concomitant hypoestrogenism. Reducing the dose of the drug or increasing the dose of estrogen immediately eliminates these phenomena, without reducing the therapeutic effect.

If treatment is started too early in the menstrual cycle, especially before day 15, there may be a shortening of the cycle or spotting.

With vaginal use of progesterone, hypersensitivity reactions are possible, including burning, itching, hyperemia, as well as the appearance of oily discharge.

Expiration date

3 years.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging

15 soft capsules in a blister; 2 blisters in a pack.

Vacation category

According to the recipe.

Producer

LABORATORIOS LEON PHARMA S.A.

Location of the manufacturer and address of its place of business.

Poligono Industrial Navatechera, Calle La Vallina b/n, Villaquilambre, 24193 Leon, Spain.

Applicant

CJSC "Farmlyga" / UAB "Farmlyga".

Location of the applicant.

Antakalnio g. 48A-304, Vilnius, Republic of Lithuania.