Translation of the instructions can be
Oxyprogesterone capronate oil solution for injection 12.5%
Instruction
For medical use of the medicinal product
Oxyprogesterone capronate
(Oxyprogesterone capronate)
Composition:
Active ingredient: 1 ml of solution contains hydroxyprogesterone capronate (calculated on dry matter) 125 mg;
excipients: benzyl benzoate, refined olive oil.
Dosage form.
Oily solution for injection.
Main physicochemical properties: transparent oily liquid from light yellow to greenish yellow in color.
Pharmacotherapeutic group.
Hormones of the sex glands and drugs used in pathologies of the genital area. progesterones. ATC code g03d a03.
Pharmacological properties.
Pharmacodynamics.
Oxyprogesterone capronate is a synthetic analogue of the hormone of the corpus luteum (progesterone). In terms of biological properties, it is similar to progesterone: it causes the transformation of the uterine mucosa from the proliferation phase caused by the follicular hormone to the secretory phase, and after fertilization, it promotes its transition to the state necessary for the development of a fertilized egg; reduces the excitability and contractility of the muscles of the uterus and fallopian tubes, stimulates the development of the terminal elements of the mammary gland. Compared to progesterone, it is more stable in the body, acts more slowly and exhibits a prolonged effect. After a single intramuscular injection, it retains its effect for 7 to 14 days.
Pharmacokinetics.
After intramuscular injection, it is slowly absorbed from the injection site. Therapeutic concentrations are maintained for 7-14 days.
Clinical characteristics.
Indication.
Pathological processes caused by corpus luteum insufficiency: threatened miscarriage; primary and secondary amenorrhea; polymenorrhea; dysfunctional uterine bleeding; hyperplastic processes in the endometrium, endometriosis.
Contraindication.
Hypersensitivity to the components of the drug. second half of pregnancy, ectopic pregnancy or frozen pregnancy, in history, vaginal bleeding of unknown origin, condition after abortion, impaired liver function, liver disease (hepatitis, cirrhosis), cholestatic jaundice during pregnancy or in history, benign hyperbilirubinemia, liver failure, renal failure, porphyria, nervous disorders with depressive symptoms, tachycardia, malignant tumors of the mammary glands and genitals, active venous or arterial thromboembolism, severe thrombophlebitis or such conditions in history.
Interaction with other drugs and other types of interactions.
Oxyprogesterone capronate weakens the effect of drugs that stimulate myometrial contractions (oxytocin, pituitrin), anabolic steroids (retabolil, nerobol), pituitary gonadotropic hormones. When interacting with oxytocin, the lactogenic effect decreases. It enhances the effect of diuretics, antihypertensive drugs, immunosuppressants, bromocriptine and systemic coagulants. It reduces the effectiveness of anticoagulants. It changes the effects of hypoglycemic agents. Progestogenic activity is reduced by microsomal oxidation inducers (carbamazepine, griseofulvin, barbiturates, hydantoins, rifampicin). Joint use
β-adrenomimetics and hydroxyprogesterone caproate to prevent premature birth helps reduce the side effects of β-adrenomimetics.
Hydroxyprogesterone capronate inhibits the metabolism of cyclosporine, which leads to an increase in the concentration of cyclosporine in the blood plasma and the risk of toxic effects.
Application features.
The drug should be used with caution in patients with arterial hypertension, cardiovascular diseases, diabetes mellitus, bronchial asthma, epilepsy, migraine, and depression.
Use with caution in patients with other diseases that contribute to fluid retention, in patients with a history of mental disorders, the drug should be discontinued at the first signs of depression.
The drug should not be used in patients with rare hereditary diseases such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption.
In patients with diabetes mellitus, blood glucose levels should be carefully monitored. The drug should not be used in cases of unexplained genital bleeding and in patients with a history of peripheral arterial disease. When using the drug, it is necessary to be attentive to various signs and symptoms of thromboembolism, and in case of their occurrence, drug therapy should be discontinued.
During treatment, regular check-ups are recommended, the frequency and scope of which are determined individually.
In the presence of any progestogen-dependent tumor, for example, meningioma in the past and / or its progression during pregnancy or previous hormonal therapy, patients should be under close medical supervision.
With prolonged use of large doses, menstruation may stop.
Use during pregnancy or breastfeeding.
The ability to influence the reaction speed when driving or working with other mechanisms.
The drug may cause visual impairment and increased fatigue. During treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.
Method of administration and doses.
Before use, slightly warm the ampoule with the drug in a water bath (up to 30-40 ºС). In case of crystals, heat the ampoule in a boiling water bath until they are completely dissolved. Administer intramuscularly and subcutaneously.
In case of threatened or initiated miscarriage in the first trimester of pregnancy, administer 125-250 mg (1-2 ml of a 12.5% solution) once a week.
In case of primary or secondary amenorrhea - immediately after stopping the use of estrogen drugs, administer 250 mg once or divided into two doses.
In order to normalize the menstrual cycle (with polymenorrhea, dysfunctional uterine bleeding), the drug is administered at a dose of 65-125 mg (0.5-1 ml of a 2.5% solution) per
20-22nd day of the cycle.
Women with endometrial hyperplasia (in the absence of hormonally active ovarian tumors) up to 45 years of age in the first phase of the menstrual cycle should be prescribed estrogens (ethinyl estradiol 0.05 mg per day from the 5th to the 25th day of the cycle) and Oxyprogesterone capronate 1 ml of 12.5% solution once a week on the 5th, 12th and 19th day of the cycle for 4-5 cycles. Women from 45 years of age should be administered only Oxyprogesterone capronate 2 ml of 12.5% solution once a week for 6-8 menstrual cycles.
Children.
There is no experience with the use of the drug in children, so it cannot be used in pediatric practice.
Overdose.
When using increased doses of the drug, side effects described in the relevant section occur more often. If progestogen-dependent side effects appear, treatment should be discontinued, and after they disappear, treatment should be continued.
in smaller doses. If necessary, carry out symptomatic treatment.
Adverse reactions.
From the cardiovascular system: possible increase in blood pressure, tachycardia, shortness of breath, circulatory disorders, venous thromboembolism.
Metabolic: possible edema, fluid retention, albuminuria, poor glucose tolerance, changes in plasma lipid profile.
On the part of the digestive system: change in appetite, bloating, abdominal pain, constipation, diarrhea, impaired liver function and changes in liver function tests, cholestatic jaundice, rarely (with prolonged use) - nausea, vomiting.
From the side of the central nervous system (CNS): rarely (with prolonged use) - headache, dizziness, depression, insomnia, drowsiness, weakness, increased fatigue, paresthesia.
On the part of the endocrine system: rarely (with prolonged use) - weight gain, pain and tension in the mammary glands, change in vaginal discharge, irregular uterine bleeding, amenorrhea, oligomenorrhea, menstrual cycle disorders, premenstrual syndrome, decreased libido, hirsutism.
Genital: uterine spasms, disorders of the external genitalia such as burning, dryness, genital itching, vaginal discharge, vaginal mycosis.
Immune system disorders: hypersensitivity reactions, anaphylactic reactions, angioedema, urticaria.
Skin and subcutaneous tissue disorders: alopecia, acne, yellow pigment spots on the face (chloasma), possible allergic skin reactions (rash, itching), erythema multiforme.
On the part of the organs of vision: visual impairment, retinal thrombosis, inflammation of the optic nerves.
General disorders and administration site conditions: fever; injection site conditions including pain and swelling.
Effect on the fetus: excessive amounts of progesterone can cause virilization of the female fetus (up to uncertainty of sex).
Expiration date.
5 years.
Storage conditions.
Store in the original packaging to protect from light at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Incompatibility.
The drug should not be mixed with other medicines in the same container.
Packaging.
1 ml in an ampoule; 5 ampoules in a blister; 2 blisters in a cardboard pack.
Vacation category.
According to the recipe.
Producer.
LLC "FZ" Biofarma ", Ukraine.
Location of production and its address of place of business.
Ukraine, 09100, Kyiv region, M. Bila Tserkva, Kyivska st., 37.
