Inzhesta

General characteristics. Structure:

Active ingredient: progesterone;

1 ml of solution contains progesterone in terms of 100% substance of 10 mg or 25 mg;

excipients: 2,5% solution – benzyl benzoate, ethyl oleate; 1% solution – ethyl oleate.

Pharmacological properties:

Pharmacodynamics. Progesterone is hormone of a yellow body. Drug causes transformation of a phase of proliferation of a mucous membrane of a uterus in a secretory phase that is necessary for normal implantation of an oospore, and after fertilization promotes its development. Progesterone also reduces excitability and contractility of muscles of a uterus and uterine tubes that provides pregnancy preservation; stimulates development of mammary glands. Stimulates in small doses, and in big – suppresses secretion of gonadotropic hormones. Slows down action of Aldosteronum that leads to strengthening of secretion of sodium and chlorine with urine. Possesses a catabolic and immunodepressive effect.

Pharmacokinetics. After an intramuscular or subcutaneous injection it is quickly and well absorbed from an injection site. Metabolism of progesterone proceeds in a liver, an insignificant part it collects in a hypodermic fatty tissue. The main transmutation product of progesterone is biologically active pregnandiol. Pregnandiol after conjugation with glucuronic acid gets from a liver to blood, and then – to urine. The smaller share of progesterone will be transformed in прегнанолол and прегнандион. All metabolites of progesterone which are allocated with urine are inactive.

Pharmaceutical characteristics

Main physical and chemical properties: oily liquid of light green or light yellow color with a specific smell.

Indications to use:

Amenorrhea, dysfunctional (anovulatory) uterine bleedings; the endocrine infertility including caused by insufficiency of a yellow body; pregnancy not incubation, an oligomenorrhea, альгодисменорея (against the background of a hypogonadism).

Route of administration and doses:

To administer the drug intramusculary or subcutaneously. At dysfunctional uterine bleedings to appoint drug on 5-15 mg daily within 6-8 days. If the scraping of a mucous membrane of a uterus was preposted, to begin injections 18-20 days later. If it is impossible to make a scraping, to enter Inzhesta even into a bleeding time. At Inzhesta's use in a bleeding time strengthening in this connection patients with anemia of moderate and heavy degree are recommended to prepost hemotransfusion (200-250 ml) can be observed its temporary (for 3-5 days). At the stopped bleeding it is not necessary to interrupt treatment before 6 days. If bleeding did not stop after 6-8 days of treatment, further introduction of Inzhesta is inexpedient.

At a hypogonadism and an amenorrhea to begin treatment with use of oestrogenic drugs with the purpose to reach sufficient proliferation of an endometria. Directly upon termination of use of oestrogenic drugs to appoint Inzhesta on 5 mg daily or on 10 mg every other day within 6-8 days.

At algodismenory treatment by Inzhesta to begin in 6-8 days prior to periods. To administer the drug daily on 5-10 mg within 6-8 days. The course of treatment can be repeated several times.

For prevention and elimination of threat of an abortion to enter 10-25 mg of Inzhesta daily or every other day before full-his disappearance of symptoms of threat of an abortion. At a usual abortion to administer the drug till IV month of pregnancy.

The highest single and daily dose for adults at intramuscular introduction makes     25 mg (2,5 ml of 1% of solution or 1 ml of 2,5% of solution).

Features of use:

Patients whose condition can become complicated at a liquid delay (asthma, migraine, heart failure) should apply Inzhesta with care and under careful control.

Inzhesta also should be applied with care the patient with mental disturbances in the anamnesis, drug needs to be cancelled at emergence of the first symptoms of a depression.

At patients with a diabetes mellitus it is necessary to control carefully glucose indicators in blood.

At Inzhesta's use it is necessary to be attentive to precursory symptoms and symptoms of a thromboembolism, and in case of their emergence therapy by drug needs to be stopped.

As metabolism of steroid hormones happens in a liver, Inzhesta should not be applied to patients with abnormal liver functions.

At prolonged use of high doses of Inzhesta the termination of periods is possible.

Ability to influence speed of response at control of motor transport or work with other mechanisms

 

Drug can cause dizziness and drowsiness in this connection the patients applying Inzhesta are recommended to abstain from control of motor transport and works with other mechanisms.

Side effects:

Drug is usually well transferred, in isolated cases manifestations of such side reactions are possible:

from cardiovascular system: increase in arterial pressure, venous thromboembolisms;

neurologic disturbances: headache, dizziness, drowsiness, sleeplessness, depression;

from reproductive system and mammary glands: swelling, hypersensitivity and pain of mammary glands, disturbances from external genitals, such as burning, dryness, genital itch, vaginal allocations, bleedings, vaginal mycosis, premenstrual syndrome, disturbances of a menstrual cycle, acyclic bloody allocations, amenorrhea, oligomenorrhea, hirsutism, decrease in a libido, uterus spasms;

from a digestive tract: abdominal distention, abdominal pain, nausea, vomiting, lock, diarrhea;

from gepatobiliarny system: cholestatic jaundice;

metabolic and alimentary disturbances: increase or loss of body weight, hypostases, albuminuria;

from skin and soft tissues: allergic manifestations on skin, a multiformny erythema, an itch, a small tortoiseshell, rash, an acne, a hloazma, an alopecia;

general disturbances and condition of the place of an injection: increased fatigue, fever, hypersensitivity reactions, including anaphylactic reactions, pain and a swelling in the place of an injection.

Interaction with other medicines:

Inzhesta weakens effect of the drugs stimulating reduction of a myometrium (oxytocin, Pituitrinum), anabolic steroids (retabolil, Nerobolum), gonadotropic hormones of a hypophysis. At interaction with oxytocin the lactogenic effect decreases. Strengthens effect of diuretics, hypotensive drugs, immunodepressants, a bromkriptin and system coagulants. Reduces efficiency of anticoagulants.

Contraindications:

Liver diseases, liver and renal failure, hepatitis, tendency to thromboses, active venous or arterial thrombembolia, heavy thrombophlebitis or these states in the anamnesis, nervous breakdowns with the depression phenomena, a porphyria. Malignant tumors of a mammary gland and generative organs. An extrauterine pregnancy or the stood pregnancy in the anamnesis, vaginal bleedings of an unspecified origin, a state after abortion.

Overdose:

At use of the raised drug doses there are side effects described in appropriate section more often. At emergence of side effects treatment by drug needs to be stopped, and after their disappearance to continue in smaller doses. If necessary to carry out a symptomatic treatment.

Use during pregnancy or feeding by a breast

During pregnancy to use drug only for prevention and treatment of the menacing abortion. After the 36th week of pregnancy use of drug is contraindicated. Not to use drug to the women planning pregnancy in the nearest future. The risk of congenital anomalies, including sexual anomalies at children of both floors, connected with effect of exogenous progesterone during pregnancy, completely is not established.

Progesterone gets into breast milk therefore during feeding by a breast drug should not be used.

Children

Efficiency and safety of use to children is not investigated therefore not to appoint drug to patients of this age category.

Storage conditions:

Period of validity. 2 years. Not to use drug after the termination of the period of validity specified on packaging. To store in original packaging at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 1 ml in an ampoule. On 5 or 10 ampoules in a pack. On 5 ampoules in the blister. On 1 or 2 blisters in a pack.