Instructions for Ingesta injection solution in ethyl oleate 2.5% ampoule 1 ml No. 5
Composition
active ingredient: progesterone;
1 ml of solution contains progesterone in terms of 100% substance 10 mg or 25 mg;
excipients: 2.5% solution – benzyl benzoate, ethyl oleate; 1% solution – ethyl oleate.
Dosage form
Solution for injection.
Main physicochemical properties: oily liquid of light green or light yellow color with a specific odor.
Pharmacotherapeutic group
Progestogens. ATX code G03D A04.
Pharmacological properties
Pharmacodynamics
Pharmacodynamics.
Progesterone is a hormone of the corpus luteum. The drug causes the transformation of the proliferation phase of the uterine mucosa into the secretory phase, which is necessary for normal implantation of a fertilized egg, and after fertilization promotes its development. Progesterone 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 the mammary glands. In small doses, it stimulates, and in large doses, it suppresses the secretion of gonadotropic hormones. Inhibits the action of aldosterone, which leads to increased secretion of sodium and chlorine with urine. Has a catabolic and immunosuppressive effect.
Pharmacokinetics
After intramuscular or subcutaneous injection, it is quickly and well absorbed from the injection site. Progesterone metabolism occurs in the liver, a small part of it accumulates in subcutaneous fat. The main product of progesterone conversion is biologically active pregnanediol. Pregnanediol, after conjugation with glucuronic acid, enters the blood from the liver and then into the urine. A smaller part of progesterone is converted to pregnenolol and pregnanedione. All progesterone metabolites excreted in the urine are inactive.
Indication
Amenorrhea, dysfunctional (anovulatory) uterine bleeding; endocrine infertility, including those caused by corpus luteum insufficiency; miscarriage, oligomenorrhea, algodysmenorrhea (against hypogonadism).
Contraindication
Liver disease, liver dysfunction, hepatitis, hepatic and renal failure, cholestatic jaundice during pregnancy (history), benign hyperbilirubinemia; neoplasms of the breast and genitals; tachycardia, tendency to thrombosis, active venous or arterial thromboembolism, severe thrombophlebitis or these conditions in history; nervous disorders with depressive symptoms; porphyria; pregnancy after the 36th week; ectopic pregnancy or a history of a frozen pregnancy; vaginal bleeding of unknown origin, condition after an abortion; hypersensitivity to the components of the drug.
Interaction with other medicinal products and other types of interactions
Ingesta® 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. The effect of Ingesta® is reduced with simultaneous use of barbiturates. It changes the effects of hypoglycemic agents. When used simultaneously with inducers of liver enzymes, an increase or decrease in the concentration of Ingesta® in the blood plasma is possible.
Application features
It should be used with caution in diseases of the cardiovascular system, arterial hypertension, chronic renal failure, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression, hyperlipoproteinemia.
Ingesta® should also be used with caution in patients with a history of mental disorders, and the drug should be discontinued at the first signs of depression.
Patients with diabetes need to carefully monitor blood glucose levels.
When using Ingesta®, it is necessary to be attentive to early signs and symptoms of thromboembolism, and if they occur, therapy with the drug should be discontinued.
Since steroid hormone metabolism occurs in the liver, Ingest® should not be used in patients with impaired liver function.
With prolonged use of high doses of Ingesta®, menstruation may stop.
The drug should not be used in cases of unexplained genital bleeding and in patients with a history of peripheral arterial disease. Regular check-ups are recommended during treatment, the frequency and extent of which are determined individually.
Patients with a history of any progesterone-dependent tumor, such as meningioma, and/or progression during pregnancy or previous hormonal therapy should be closely monitored.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug may cause dizziness and drowsiness. During treatment, it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require increased attention and speed of psychomotor reactions.
Use during pregnancy or breastfeeding
During pregnancy, the drug should only be used for the prevention and treatment of threatened miscarriage. After the 36th week of pregnancy, the drug is contraindicated. Do not use the drug in women planning a pregnancy in the near future. The risk of congenital anomalies, including sexual anomalies in children of both sexes, associated with the action of exogenous progesterone during pregnancy has not been fully established. Ingesta® penetrates into breast milk, so the drug should not be used during breastfeeding.
Method of administration and doses
The drug is administered intramuscularly or subcutaneously. In case of dysfunctional uterine bleeding, the drug is administered at a dose of 5–15 mg daily for 6–8 days. If curettage of the uterine mucosa was previously performed, injections should be started after 18–20 days. If curettage is not possible, Ingesta® should be administered even during bleeding. When using Ingesta® during bleeding, its temporary increase (for 3–5 days) may be observed, which is why patients with moderate and severe anemia are recommended to undergo a blood transfusion (200–250 ml) beforehand. If bleeding has stopped, treatment should not be interrupted earlier than after 6 days. If bleeding has not stopped after 6–8 days of treatment, further administration of Ingesta® is inappropriate.
In hypogonadism and amenorrhea, treatment should be initiated with estrogenic drugs to achieve sufficient endometrial proliferation. Immediately after the end of estrogenic drugs, administer Ingesta® 5 mg daily or 10 mg every other day for 6–8 days.
For dysmenorrhea, treatment with Ingesta® should begin 6–8 days before menstruation. The drug should be administered daily at 5–10 mg for 6–8 days. The course of treatment can be repeated several times.
To prevent and eliminate the threat of miscarriage, administer 10–25 mg of Ingesta® daily or every other day until the symptoms of the threat of miscarriage disappear completely. In case of habitual miscarriage, administer the drug until the 4th month of pregnancy.
The highest single and daily dose for adults when administered intramuscularly is 25 mg (2.5 ml of a 1% solution or 1 ml of a 2.5% solution).
Children
The drug should not be used in pediatric practice.
Overdose
When using higher doses of the drug, side effects described in the relevant section occur more often. If side effects appear, treatment with the drug should be discontinued, and after their disappearance, continue in lower doses. If necessary, carry out symptomatic treatment.
Adverse reactions
Progesterone is usually well tolerated, but in rare cases the following side effects may occur:
from the cardiovascular system: tachycardia, circulatory disorders, increased blood pressure, venous thromboembolism;
from the nervous system: headache, dizziness, drowsiness, insomnia, depression;
on the part of the reproductive system and mammary glands: swelling, increased sensitivity and pain of the mammary glands, disorders of the external genital organs, such as burning, dryness, genital itching, change in vaginal discharge, bleeding, vaginal mycosis, premenstrual syndrome, menstrual cycle disorders, acyclic spotting, amenorrhea, oligomenorrhea, hirsutism, decreased libido, uterine spasms;
from the digestive tract: bloating, abdominal pain, nausea, vomiting, constipation, diarrhea, flatulence;
endocrine disorders: poor glucose tolerance;
Respiratory system: shortness of breath;
Hepatobiliary system: liver dysfunction and changes in liver function tests, cholestatic jaundice;
metabolic and nutritional disorders: changes in appetite, weight gain or loss, edema, albuminuria;
Skin and soft tissue: allergic skin reactions, erythema multiforme, itching, urticaria, skin rash, acne, chloasma, alopecia, hirsutism;
General disorders and administration site conditions: fatigue, weakness, fever, hypersensitivity reactions, including anaphylactic reactions; fluid retention, paresthesia; injection site conditions, including pain and swelling;
laboratory indicators: changes in plasma lipid profile;
effect on the fetus: excessive amounts of progesterone can cause virilization of the female fetus (up to uncertainty of gender).
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
1 ml in an ampoule. 5 ampoules in a pack. 5 ampoules in a blister. 1 blister in a cardboard pack.
Vacation category
According to the recipe.
Producer
JSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
