Inzhesta oxy

General characteristics. Structure:

Active ingredient: 1 ml of solution contains hydroxyprogesterone of a kapronat in terms of 100% substance of 125 mg

excipients: benzyl benzoate, ethyl oleate.

Pharmacological properties:

Pharmacodynamics. Inzhesta Oksi – a synthetic analog of hormone of a yellow body. Drug causes transformation of a mucous membrane of a uterus from a proliferation phase in a secretory phase that is necessary for normal implantation, and after fertilization promotes its transition to a state necessary for development of an oospore. Inzhesta Oksi also reduces excitability and contractility of muscles of a uterus and uterine tubes that provides pregnancy preservation; stimulates development of trailer elements 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.

Inzhesta Oksi more resistant in an organism, than progesterone, acts more slowly and renders the prolonged gestagenny effect. After a single intramuscular injection of Inzhest Oksi his action lasts from 8 to 14 days.

Pharmacokinetics. After an intramuscular injection it is slowly absorbed from an injection site. Therapeutic concentration remains within 7-14 days.

Pharmaceutical characteristics

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

Indications to use:

The pathological processes caused by insufficiency of a yellow body: threat of an abortion; primary and secondary amenorrhea; polymenorrhea; dysfunctional uterine bleedings; hyperplastic processes in an endometria, endometriosis.

Route of administration and doses:

To apply to adult women. To administer the drug intramusculary.                          For the purpose of prevention and treatment of threat of an abortion to enter 125-250 mg (1-2 ml of 12,5% of solution) once a week. To apply Inzhest Oksi only in І a pregnancy trimester.

At an amenorrhea (and secondary) to appoint drug primary directly after phase-out of oestrogenic drugs. To enter 250 mg of Inzhest Oksi once or in two steps.

For the purpose of normalization of a menstrual cycle (at a polymenorrhea, dysfunctional uterine bleedings) Inzhesta Oksi to enter in a dose 62,5-125 mg (0,5-1 ml of 12,5% of solution) for the 20-22nd day of a cycle.

At women with an endometria hyperplasia (in the absence of hormonal active tumors of ovaries) up to 45 years in the I phase of a menstrual cycle to appoint estrogen (ethinylestradiol of 0,05 mg a day from the 5th to the 25th day of a cycle) and Inzhesta Oksi on 1 ml of 12,5% of solution to the 5th, 12th and 19th day of a cycle during 4-5 cycles once a week. To women 45 years are more senior to enter only Inzhest Oksi on 2 ml of 12,5% of solution once a week during 6-8 menstrual cycles.

Features of use:

With care patients need to use drug with arterial hypertension, cardiovascular diseases, a diabetes mellitus, bronchial asthma, epilepsy, migraine.

With care to apply to patients with other diseases promoting a liquid delay, patients 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. It is not necessary to use drug at bleedings from a genital tract which reason is not established, and to patients in whose anamnesis diseases of peripheral arteries were noted. At use of drug 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.

During treatment carrying out regular surveys which frequency and volume are defined individually is recommended.

In the presence of any progestogenzavisimy tumor, for example, meningiomas during pregnancy or the previous hormonal therapy of the patient have to be in the past and/or its progressing under careful observation of the doctor.

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

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

Inzhesta Oksi can cause vision disorders and increased fatigue in this connection it is necessary to refrain from control of motor transport and work with other mechanisms.

Side effects:

From endocrine system: increase in body weight, pain and nagrubaniye of mammary glands, disturbances of a menstrual cycle, irregular uterine bleedings, amenorrhea, oligomenorrhea, symptoms of a premenstrual syndrome, hirsutism, decrease in a libido.

From generative organs: spasms of a uterus, disturbance from external genitals, such as zhzhzheniye, dryness, genital itch, vaginal allocations, vaginal mycosis.

From a nervous system: dizziness, headache, depression, increased fatigue, sleeplessness, drowsiness, paresthesias.

From cardiovascular system: increase in arterial pressure, tachycardia, short wind, blood circulation disturbance, venous thromboembolisms.

From the alimentary system: appetite changes, nausea, vomiting, abdominal distention, abdominal pain, lock, diarrhea, abnormal liver function and changes of functional trials of a liver, cholestatic jaundice.

From a metabolism: hypostases, albuminuria, bad portability of glucose, delay of liquid, change of a lipidic profile of plasma.

From immune system: anaphylactic reactions, hypersensitivity reactions.

From skin and hypodermic fabric: the alopecia, an acne, a yellow nevus pigmentosus on a face   (hloazm), are possible allergic reactions on skin (rashes, an itch, urticaria), a multiformny erythema, a Quincke's disease.

From organs of sight: vision disorder, retina thrombosis, inflammation of optic nerves.

In an injection site: changes in an injection site including pain and a swelling.

General disturbances: fever.

The excess quantity of progesteron can cause virilescence of a female fruit (up to uncertainty of a sex).

Interaction with other medicines:

Inzhesta Oksi 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. Changes effects of gipoglikemiziruyushchy means. Gestagenny activity is reduced by inductors of a microsomal oxidation (carbamazepine, griseofulvin, barbiturates, hydantoins, rifampicin). Combined use of β-adrenomimetik and hydroxyprogesterone of a kapronat for the prevention of premature births promotes reduction of side effects of β-adrenomimetik.

Gidroksiprogesterona капронат oppresses metabolism of a tsiklospornin, leading to increase in concentration of cyclosporine in plasma and to risk of emergence of toxic effects.

Contraindications:

Hypersensitivity to drug components;

abnormal liver function, liver diseases (hepatitis, cirrhosis), a high-quality hyperbilirubinemia, cholestatic jaundice during pregnancy or in the anamnesis;

renal failure;

malignant tumors of a mammary gland and generative organs;

extrauterine pregnancy or the stood pregnancy in the anamnesis, vaginal bleedings of unspecified genesis, a state after abortion;

nervous breakdowns with the depression phenomena, tachycardia;

active venous or arterial thromboembolism, heavy thrombophlebitis or these states in the anamnesis;

porphyria.

Overdose:

At use of the raised drug doses there are side effects described in appropriate section more often. At emergence of gestagenzavisimy side effects treatment needs to be interrupted, and after their disappearance – to renew in the reduced dosage. If necessary to carry out a symptomatic treatment.

Use during pregnancy of an ilikormleniye a breast

To apply Inzhest Oksi only in І a pregnancy trimester at threat of an abortion. 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.

During feeding by a breast use of drug is not recommended.

Children

Children do not have experience of use of drug therefore it cannot be applied in pediatric practice.

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.