Pregnenoldione капронат

General characteristics. Structure:

Active ingredient: hydroxyprogesterone caproate;

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. Pregnenoldione капронат - 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 an oospore razviyotiya. Pregnenoldione капронат also reduces excitability and contractility of muscles of a uterus and uterine tubes that provides pregnancy preservation; stimulates development of trailer elements of moyolochny 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.

Pregnenoldione капронат progesterone is more resistant in an organism, than, works more slowly and renders the prolonged gestagenny effect. After a single vnutrimyyoshechny injection of Pregnenoldione of a kapronat its 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:

Apply at adult women. The drug is administered  vnutrimyyoshechno.

 For the purpose of prevention and treatment of the menacing abortion enter 125-250 mg (1-2 ml of 12,5% of solution) once a week. Pregnenoldione капронат apply only in І a pregnancy trimester.

At an amenorrhea (primary and secondary) drug is naznayochat directly after phase-out of oestrogenic drugs. Enter 250 mg of Pregnenoldione of a kapronat once or in two steps.

For the purpose of normalization менструально­го a cycle (at a polymenorrhea, dysfunctional uterine bleedings) Pregnenoldione капронат enter in a dose 62,5 - 125 mg (0,5 – 1 ml of 12,5% of solution) on 20 - the 22nd day of a cycle.

At women with an endometria hyperplasia (in the absence of hormonal active tumors of ovaries) aged up to 45 years in the I phase of a menstrual cycle appoint estrogen (ethinylestradiol of 0,05 mg a day from the 5th to the 25th day of a cycle) and Pregnenoldione капронат on

1 ml of 12,5% of solution once a week for the 5th, 12th and 19th day of a cycle during 4 – 5 cycles. To women 45 years are more senior enter only Pregnenoldione капронат on 2 ml 12,5% of solution during 6 – 8 menstrual cycles once a week.

Features of use:

With care patients need to use drug with cardiovascular diseases, renal failures, a diabetes mellitus, bronchial asthma, epilepsy, migraine, a depression.

It is not necessary to use drug to patients with rare hereditary diseases, such as intolerance of a galactose, insufficiency of lactase, glucose galactose malabsorption.

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

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

Ability to influence speed of response at control of motor transport or work with other mechanisms. Pregnenoldione капронат 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:

Drug is usually well transferred, the following side effects are in rare instances possible:

from endocrine system: increase in body weight, pain and nagrubaniye of mammary glands, irregular uterine bleedings, oligomenorrhea; seldom at prolonged use – decrease in a libido;

from TsNS: headache, depression, increased fatigue, sleeplessness, paresthesias;

from cardiovascular system: increase in arterial pressure, tachycardia, short wind;

from the alimentary system: nausea, vomiting, abnormal liver function, jaundice;

 from a metabolism: hypostases, albuminuria, bad portability of glucose;

 from skin and hypodermic fabric: acne; allergic reactions on skin – rashes, an itch, urticaria are possible; very seldom - a Quincke's disease;

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

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

Interaction with other medicines:

Pregnenoldione капронат 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 (barbiturates, hydantoins, rifampicin, etc.).

Combined use of β-adrenomimetik and hydroxyprogesterone of a kapronat for the prevention of premature births promotes reduction of side effects of β-adrenomimetik.

Contraindications:

- Hypersensitivity to drug components;

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

- nervous breakdowns with the depression phenomena, tachycardia;

- tendency to a thrombogenesis;

- pregnancy (except for not incubation cases in І a pregnancy trimester);

- feeding period breast.

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 carry out a symptomatic treatment.

Use during pregnancy or feeding by a breast.

Pregnenoldione капронат apply only in І a pregnancy trimester at threat of an abortion. During feeding by a breast the prmeneniye of drug is not recommended.

Children.

There is no experience of use of drug for children therefore it is not applied at 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 the unavailable to children, protected from light place at a temperature from 15 °C to 25 °C. In case of drug hardening the ampoule before use needs to be heated to temperature of 20 °C.

Issue conditions:

According to the recipe

Packaging:

On 1 ml in an ampoule; on 5 or 10 ampoules enclosed in a pack.