Prajisan capsules 200mg, No. 10

Progesterone deficiency disorders.

Oral route of administration:

• infertility due to luteal insufficiency;

• premenstrual syndrome;

• menstrual irregularities due to impaired ovulation or anovulation;

• fibrocystic breast disease;

• premenopause;

• hormone replacement therapy for peri- and postmenopause (in combination with estrogen-containing drugs).

Vaginal route of administration:

• hormone replacement therapy in case of progesterone deficiency with non-functioning (absent) ovaries (egg donation);

• prevention (prophylaxis) of premature birth in women at risk (with shortening of the cervix and / or the presence of anamnestic data of premature birth and / or premature rupture of the membranes);

• support of the luteal phase during preparation for in vitro fertilization;

• support of the luteal phase in a spontaneous or induced menstrual cycle;

• premature menopause;

• hormone replacement therapy (in combination with estrogen drugs);

• infertility due to luteal insufficiency;

• prevention of habitual and threatening abortion due to progestin deficiency.

The duration of treatment is determined by the nature and characteristics of the disease.

Oral route of administration

The drug is taken orally after meals with water.

In most cases, with progesterone deficiency, the daily dose of PrajisanЃ is 200-300 mg, divided into 2 doses (morning and evening).

In case of insufficiency of the luteal phase (premenstrual syndrome, fibrocystic breast disease, dysmenorrhea, premenopause), the daily dose is 200 or 400 mg, taken for 10 days (usually from the 17th to the 26th day of the cycle).

With hormone replacement therapy in perimenopause while taking estrogens, PrajisanЃ is used at 200 mg / day for 12 days.

In continuous postmenopausal hormone replacement therapy, PrajisanЃ is used at a dose of 100-200 mg from the first day of estrogen intake.

Dose selection is carried out individually.

Vaginal route of administration

The capsules are inserted deep into the vagina.

Absolute progesterone deficiency in women with non-functioning (absent) ovaries (egg donation): against the background of estrogen therapy, 200 mg / day on days 13 and 14 of the cycle, then 100 mg 2 times / day from 15 to 25 day of the cycle, from the 26th day, and in case of pregnancy, the dose increases by 100 mg / day every week, reaching a maximum of 600 mg / day, divided into 3 doses. This dose can be applied for 60 days.

Prevention (prophylaxis) of premature birth in women at risk (with shortening of the cervix and / or the presence of anamnestic data of premature birth and / or premature rupture of membranes): the usual dose is 200 mg at bedtime, from 22 to 34 weeks pregnancy.

Luteal phase support during preparation for in vitro fertilization: it is recommended to take from 200 to 600 mg / day, starting from the day of injection of chorionic gonadotropin during the I and II trimester of pregnancy.

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

In cases of threat of abortion or in order to prevent habitual abortions occurring against a background of progesterone deficiency: 200-400 mg daily in 2 doses in the first and second trimesters of pregnancy.

Soft gelatin capsules, oval, light yellow; the contents of the capsules are an oily suspension of almost white color.

1 caps. progesterone (micronized)

Excipients: peanut oil, soy lecithin.

For oral and vaginal use

• deep vein thrombosis, thrombophlebitis;

• thromboembolic disorders (pulmonary embolism, myocardial infarction, stroke), intracranial hemorrhage, or a history of these conditions / diseases;

• vaginal bleeding of unknown origin;

• incomplete abortion;

• porphyria;

• established or suspected malignant neoplasms of the mammary glands and genitals;

• age up to 18 years (efficacy and safety have not been established);

• lactation period (breastfeeding);

• hypersensitivity to progesterone or any of the auxiliary components of the drug.

For oral administration (optional)

• severe liver disease (including cholestatic jaundice, hepatitis, Dubin-Johnson, Rotor syndromes, malignant liver tumors) currently or in history;

The drug should be used with caution in diseases of the cardiovascular system, arterial hypertension, chronic renal failure, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression, in the II trimester of pregnancy.

Pharmaco-therapeutic group: Gestagen

Side effect

With the oral route of administration

The following adverse events noted with oral administration of the drug are distributed according to the frequency of occurrence in accordance with the following gradation: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10 000, <1/1000), very rare (<1/10 000).

From the genitals and mammary gland: often - amenorrhea, menstrual irregularities, acyclic bleeding; infrequently - mastodynia.

From the side of the psyche: very rarely - depression.

From the nervous system: often - headache; infrequently - drowsiness, transient dizziness.

From the gastrointestinal tract: often - bloating; infrequently - vomiting, diarrhea, constipation; rarely - nausea.

From the liver and biliary tract: infrequently - cholestatic jaundice.

From the immune system: very rarely - urticaria.

On the part of the skin and subcutaneous tissues: infrequently - itching, acne; very rarely - chloasma.

Drowsiness, transient dizziness are possible, as a rule, 1-3 hours after taking the drug. These side effects can be reduced by lowering the dose, using the drug at bedtime, or switching to the intravaginal route of administration.

These unwanted effects are usually the first signs of an overdose. Drowsiness and / or transient dizziness is observed, in particular, in the case of concomitant hypoestrogenism. Reducing the dose or restoring a higher estrogenation immediately eliminates these phenomena without diminishing the therapeutic effect of progesterone.

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

Recorded changes in the menstrual cycle, amenorrhea or acyclic bleeding are characteristic of all progestogens.

Application in clinical practice

With post-marketing use, the following adverse events have been reported with oral progesterone: insomnia; premenstrual syndrome, breast tension, vaginal discharge; joint pain; hyperthermia; increased sweating at night; fluid retention; change in body weight; acute pancreatitis; alopecia, hirsutism; changes in libido; thrombosis and thromboembolic complications (when HRT is performed in combination with estrogen-containing drugs); increased blood pressure.

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

With the vaginal route of administration

It was reported about individual cases of the 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 recommended doses, in particular, drowsiness or dizziness (observed with oral administration of the drug), were not observed.