Agesta

Agesta – antigestagenny synthetic steroid drug.

Form of release and structure

Dosage form – tablets (on 1 or 2 pieces in polymeric banks, in a cardboard pack of 1 bank; on 1 or 2 pieces in a blister strip packaging, in a cardboard pack 1 packaging).

Active ingredient of Agesta – mifepristone, in 1 tablet – 10 mg.

Indications to use

• Interruption of a uterine pregnancy on early terms (in the absence of periods up to 42 days);
• Induction of patrimonial activity at the full-term pregnancy;
• Emergency contraception, one-time prevention of undesirable pregnancy after the unprotected sexual intercourse;
• Leiomyoma of a uterus which size does not exceed 12 weeks of pregnancy.

Contraindications

• Acute and chronic form of a renal and/or liver failure;
• Adrenal insufficiency, long therapy by glucocorticosteroids;
• Porphyria;
• Diseases of a female reproductive system of an inflammatory etiology;
• Existence of a hem on a uterus;
• Severe forms of extragenital pathologies (without preliminary consultation of the therapist);
• Anemia;
• Disturbance of a hemostasis (including against the background of the previous use of anticoagulants);
• Smoking at patients is aged more senior than 35 years;
• Individual intolerance of drug.

Besides, Agesta cannot be applied by separate types of clinical indications in the presence of the following pathologies:

• Abortion: suspicion on an extrauterine pregnancy, the pregnancy period more than 42 days from the moment of the termination of periods, the pregnancy which is not confirmed with clinical trials, the pregnancy which occurred after cancellation of hormonal contraception or against the background of use of intrauterine contraceptives, a hysteromyoma;
• Preparation and induction of childbirth: premature or postmature pregnancy, gestosis of heavy degree, hysteromyoma, eclampsia, preeclampsia;
• Treatment of a leiomyoma of a uterus: a hyperplasia of an endometria and/or a tumor of ovaries, submucous localization of myomatous nodes, the period of pregnancy and breastfeeding, and also if the size of a leiomyoma exceeds 12 weeks of pregnancy.

Route of administration and dosage

Pill is taken inside.

The dose and the mode of reception are appointed by the doctor depending on clinical indications.

The recommended dosing:

• Medicamentous abortion: 600 mg once, washing down 100 ml of water (in 1-1,5 hours after food). For strengthening of effect at the same time appoint 400 mg of a mizoprostol. The procedure is carried out in the presence of the doctor and it is necessary to provide control of a condition of the patient within 2 hours after administration of drugs. 36-48 hours later performing control ultrasonography (ultrasonography) is required. For confirmation of a spontaneous abortion in 1-2 weeks it is necessary to determine the level of a chorionic gonadotrophin, to repeatedly conduct ultrasonography and clinical examination;
• Preparation and induction of childbirth: under observation of the doctor – 200 mg once, then in 24 hours it is necessary to repeat reception of 200 mg. Assessment of a condition of patrimonial ways is carried out in 48-72 hours, if necessary purpose of prostaglandins or oxytocin is possible;
• Post-coital contraception (irrespective of a phase of a menstrual cycle): 10 mg once, in 2 hours prior to or in 2 hours after food during the next few 72 hours after the unprotected sexual intercourse;
• Treatment of a leiomyoma of a uterus: on 50 mg of 1 times a day within 12 weeks.

Side effects

The general undesirable phenomena against the background of Agesta's use can become: a hyperthermia, weakness, discomfort in the bottom of a stomach, a headache, nausea, vomiting, dizziness, diarrhea, an enanthesis.

Besides, in addition drug can cause the side effects connected with reception according to separate indications:

• Abortion: pain in the bottom of a stomach, bleeding, an exacerbation of infectious pathologies of urinary tract and a uterus, an inflammation of a uterus and appendages; at co-administration of a mizoprostol (in addition) – sleeplessness, dyspepsia, a vaginitis, unconscious states, an adynamy, concern, anemia, a scelalgia, bleach, insignificant lowering of the level of hemoglobin;
• Emergency contraception: bloody allocations, disturbance of a menstrual cycle;
• Treatment of a leiomyoma: amenorrhea, disturbance of a menstrual cycle.

Special instructions

Agesta's use for abortion and preparation of childbirth is made only in the conditions of a hospital, in the presence of the resuscitation equipment, in the presence of the highly skilled doctor.

Effect of drug can cause the plentiful uterine bleeding demanding immediate surgical intervention. It is necessary to be careful at purpose of synthetic prostaglandins.

Before administration of drug for the purpose of abortion the patient has to be informed that in case of inefficiency of medicamentous therapy operational abortion will be required. At incomplete abortion or the continuing pregnancy for the 14th day after Agesta's reception carry out vacuum aspiration with the subsequent careful histologic research of aspirate. Drug appoint after holding all actions accompanying abortion, including the prevention a Rhesus factor-alloimmunizatsii.

Breastfeeding is contraindicated within 14 days after mifepristone use.

At an infectious endocarditis and to women with artificial heart valves administration of drug should be accompanied with preventive antibacterial therapy.

It is not recommended to apply Agesta as regular planned contraception. Drug does not protect from sexually transmitted diseases, including HIV infection.

Medicinal interaction

It is necessary to raise a dose of glucocorticosteroids at simultaneous use with Agesta.

Terms and storage conditions

To protect from children.

To store at a temperature up to 25 °C in the place protected from light and moisture.

Period of validity – 2 years.