Hydroxyprogesterone capronate

Pharmacological properties

ingesta oxy is a synthetic analogue of the hormone of the corpus luteum. the drug causes the transformation of the uterine mucosa from the proliferation phase to the secretory phase, which is necessary for normal implantation, and after fertilization it contributes to its transition to the state required for the development of a fertilized egg. ingesta oxy also reduces the excitability and contractility of the muscles of the uterus and fallopian tubes, which ensures the preservation of pregnancy; stimulates the development of terminal elements of the mammary glands. in low doses it stimulates, and in high - inhibits the secretion of gonadotropic hormones. inhibits the effect of aldosterone, which leads to increased secretion of sodium and chlorine in the urine. has a catabolic and immunosuppressive effect.

Ingesta Oxy is more persistent in the body than progesterone, it acts more slowly and has a prolonged gestagenic effect. After a single IM injection of Injest Oxy, its effect lasts from 8 to 14 days.

Pharmacokinetics After i / m injection, it is slowly absorbed at the injection site. The therapeutic concentration lasts for 7-14 days.

Indications

Pathological processes caused by insufficiency of the corpus luteum: the threat of miscarriage; primary and secondary amenorrhea; polymenorrhea; dysfunctional uterine bleeding; hyperplastic processes in the endometrium, endometriosis.

Application

Used in adult women. the drug is administered in / m. in order to prevent and treat the threat of miscarriage, 125–250 mg (1-2 ml of 12.5% ​​solution) are administered once a week. Ingesta oxy is used only in the first trimester of pregnancy.

With amenorrhea (primary and secondary), they are prescribed immediately after stopping the administration of estrogen drugs. 250 mg of Ingesta Oxy are administered once or in two divided doses.

In order to normalize the menstrual cycle (with polymenorrhea, dysfunctional uterine bleeding), Ingesta Oxy is administered at a dose of 62.5–125 mg (0.5–1 ml of 12.5% ​​solution) on the 20th – 22nd day of the cycle.

In women with endometrial hyperplasia (in the absence of hormonally active ovarian tumors) under the age of 45 years, estrogens (ethinyl estradiol 0.05 mg / day from the 5th to the 25th day of the cycle) and 1 ml of Ingest Oxy are prescribed in the first phase of the menstrual cycle) 12.5% ​​of the solution once a week on the 5th, 12th and 19th day of the cycle for 4-5 cycles. For women over the age of 45 years, only Ingesta Oxy is administered 2 ml of 12.5% ​​solution once a week for 6-8 menstrual cycles.

Contraindications

Hypersensitivity to the components of the drug; impaired liver function, liver disease (hepatitis, cirrhosis), benign hyperbilirubinemia, cholestatic jaundice during pregnancy or a history of; renal failure; malignant tumors of the mammary gland and genitals; an ectopic pregnancy or a history of a missed pregnancy, vaginal bleeding of an unknown genesis, condition after abortion; nervous disorders with symptoms of depression, tachycardia; venous or arterial thromboembolism, severe thrombophlebitis, or a history of these conditions; porphyria.

Side effects

From the endocrine system: weight gain, pain and engorgement of the mammary glands, menstrual irregularities, irregular uterine bleeding, amenorrhea, oligomenorrhea, symptoms of premenstrual syndrome, hirsutism, decreased libido;

from the genital organs: uterine cramps, disorders of the external genitalia, such as burning, dryness, genital itching, vaginal discharge, vaginal mycosis;

from the nervous system: dizziness, headache, depression, fatigue, insomnia, drowsiness, paresthesia;

on the part of the cardiovascular system: increased blood pressure, tachycardia, shortness of breath, circulatory disorders, venous thromboembolism;

from the digestive system: changes in appetite, nausea, vomiting, bloating, abdominal pain, constipation, diarrhea, impaired liver function and changes in liver function tests, cholestatic jaundice;

from the side of metabolism: edema, albuminuria, impaired glucose tolerance, fluid retention, changes in the lipid profile of blood plasma;

from the immune system: anaphylactic reactions, hypersensitivity reactions;

on the part of the skin and subcutaneous tissue: alopecia, acne, yellow age spots on the face (chloasma), allergic reactions to the skin are possible - rashes, itching, urticaria, erythema multiforme, angioedema;

on the part of the organ of vision: visual impairment, retinal thrombosis, inflammation of the optic nerves;

at the injection site: changes at the injection site, including pain and swelling;

general disorders: fever.

Excessive progesterone can cause virilization of the female fetus (to gender uncertainty).

special instructions

With caution, the drug should be used in patients with ag, cardiovascular diseases, diabetes, BA, epilepsy, migraine.

Use with caution in patients with other diseases that contribute to fluid retention, in patients with a history of mental disorders, the drug must be discontinued when the first signs of depression appear.

In patients with diabetes, it is necessary to carefully monitor blood glucose. The drug should not be used for bleeding from the genital tract, the cause of which has not been established, and for patients who have a history of peripheral artery disease. When using the drug, it is necessary to be attentive to the early signs and symptoms of thromboembolism, and if they occur, drug therapy must be discontinued.

During treatment, regular examinations are recommended, the frequency and volume of which are determined individually.

In the presence of any progestogen-dependent tumor, for example, a history of meningioma and / or its progression during pregnancy or previous hormone therapy, the patient should be carefully monitored by a doctor.

With prolonged use of the drug in high doses, a cessation of menstruation is possible.

Use during pregnancy and lactation. Ingesta Oxy is used only in the first trimester of pregnancy with the threat of miscarriage. The risk of congenital anomalies, including sexual abnormalities in children of both sexes, associated with the action of exogenous progesterone during pregnancy, has not been fully established.

During breastfeeding, the use of the drug is not recommended.

Children. There is no experience in the use of the drug in children, so it can not be used in pediatric practice.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Ingesta Oxy can cause visual impairment and fatigue, so you should refrain from driving vehicles and working with other mechanisms.

Interactions

Ingesta hydroxy reduces the effect of drugs that stimulate the reduction of the myometrium (oxytocin and other drugs that stimulate the tone and contractile activity of the myometrium), anabolic steroids (nandrolone, methandienone), gonadotropic hormones of the pituitary gland. when interacting with oxytocin, the severity of the lactogenic effect decreases. enhances the action of diuretics, antihypertensive drugs, immunosuppressants, bromocriptine and systemic coagulants. reduces the effectiveness of anticoagulants. changes the effects of hypoglycemic agents. progestational activity is reduced by microsomal oxidation inducers (carbamazepine, griseofulvin, barbiturates, hydantoin, rifampicin).the combined use of β-adrenergic agonists and hydroxyprogesterone caproate to prevent premature birth helps to reduce the severity of side effects of β-adrenergic agonists.

Hydroxyprogesterone caproate inhibits cyclosporin metabolism, leading to an increase in the concentration of cyclosporin in the blood plasma and the risk of toxic effects.

Overdose

When using the drug in doses higher than recommended, side effects are more likely to occur, described in the corresponding section. when gestagen-dependent side effects appear, treatment should be discontinued, and after their disappearance, continue at low doses. if necessary, carry out symptomatic treatment.

Storage conditions

In the original packaging at a temperature not exceeding 25 ° C.