Instructions Lipoflavone lyophilisate for emulsion for injection No. 1
Composition
active ingredients: 1 vial or bottle contains: lecithin standard (calculated as lecithin) – 550 mg, quercetin (calculated as dry matter) – 15 mg;
excipient: lactose monohydrate.
Dosage form
Lyophilisate for emulsion for injection.
Main physicochemical properties: amorphous mass of light yellow or light yellow color with a lemon tint and a characteristic odor, easily suspended in aqueous solutions with the formation of an emulsion.
Pharmacotherapeutic group
Combined cardiac drugs.
ATX code C01E X.
Pharmacological properties
Pharmacodynamics
The drug has antioxidant, antihypoxic and anti-inflammatory effects. It exhibits antiarrhythmic and cardioprotective effects. The therapeutic effect is due to the complex action of the drug components: blockade of the 5-lipoxygenase pathway of arachidonic acid metabolism by quercetin, as well as the antihypoxic and antioxidant effects of lecithin liposomes. The drug restores the functional activity of the vascular endothelium, synthesis and/or release of endothelial relaxation factor (nitric oxide). Inhibits lipid peroxidation processes in the blood and tissues, supports the activity of the body's antioxidant systems, prevents a decrease in the energy metabolism of cells, and exhibits membrane and endothelium-protective effects. The use of the drug in combination with basic therapy: in the treatment of acute myocardial infarction without a Q wave, unstable angina pectoris leads to a faster positive dynamics of the activity of creatine phosphokinase-MB fraction, the level of C-reactive protein, prevents an increase in the level of the pro-inflammatory cytokine IL-8 in the blood serum, promotes electrical stability of the myocardium; in the treatment of stable angina pectoris - to a decrease in the severity of angina attacks, a decrease in platelet aggregation, an improvement in blood rheological parameters (decrease in viscosity and aggregation of erythrocytes) and its microcirculation; in polychemotherapy of breast cancer with anthracyclines - to a positive dynamics of the level of cardiospecific troponins, regression of extrasystolic arrhythmia and stabilization of vagosympathetic balance. The drug has no cumulative properties.
Pharmacokinetics
After intravenous administration as a liposomal emulsion, it circulates in the blood for up to 2 hours. The maximum accumulation of the drug is observed in the liver and spleen (up to 20%). The drug is excreted in the urine and feces.
Indication
In complex treatment:
- acute myocardial infarction without Q wave,
- unstable and stable angina (CHD),
- myocarditis,
- to prevent toxic myocardial damage during cycles of polychemotherapy for breast cancer.
Contraindication
Individual hypersensitivity to any components of the drug, drugs with P-vitamin activity; allergic reactions to vaccines or protein in history.
Interaction with other medicinal products and other types of interactions
It is forbidden to use Lipoflavone together with cardiac glycosides and to mix other drugs with Lipoflavone in one syringe. Lipoflavone should be prescribed in complex treatment with cardiovascular and antitumor drugs. The interval between the administration of Lipoflavone and the administration of other drugs should be at least 30 minutes.
When using quercetin:
- with ascorbic acid preparations, summation of effects is observed;
- with nonsteroidal anti-inflammatory drugs, the anti-inflammatory effect of the latter is enhanced while the ulcerogenic effect is reduced;
- with digoxin, the maximum serum concentration and the total area under the digoxin concentration-time curve increase;
- with cyclosporine, the bioavailability and blood concentration of cyclosporine increases;
- with paclitaxel – effect on the metabolism of the latter;
- with verapamil, the bioavailability of the latter increases;
- with tamoxifen, bioavailability increases, metabolism and excretion of the latter decrease.
Application features
The drug should be administered as soon as possible after the appearance of signs of ischemia, which will ensure a more positive prognosis of the disease. Lipoflavone should be administered slowly, under the control of blood pressure. In case of a sharp (more than 40 mmHg) decrease in systemic blood pressure, the rate of administration should be reduced or the drug should be stopped. The drug should be administered only in 0.9% sodium chloride solution for injection or infusion, preheated to 37-39 °C, after thorough mixing. The drug should not be administered in case of stratification of the resuspended emulsion.
The drug contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not be prescribed this drug.
Use during pregnancy or breastfeeding
Due to the currently limited information, Lipoflavone is not recommended for use during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
You should refrain from driving or operating machinery if you experience a decrease in blood pressure during treatment.
Method of administration and doses
Administer intravenously. Before use, keep the vial (bottle) with the drug at room temperature for 30 minutes. Prepare the Lipoflavone emulsion for jet administration immediately before use by adding 10-20 ml of 0.9% sodium chloride solution for injection or infusion to the vial (bottle), which is preheated to 37-39 °C. Shake the vial (bottle) vigorously for 2 minutes until a liposomal emulsion is formed.
In acute myocardial infarction without a Q wave, the emulsion formed by adding 0.9% sodium chloride solution for injection or infusion to 2 vials (bottles) of the drug should be injected slowly over 5 minutes. The following administrations of the drug should be repeated according to the same scheme after 12 hours during the first 2 days with a decrease in the dose of Lipoflavone from the 3rd day (1 time per day 2 vials (bottles) for another 3-5 days).
In the treatment of myocarditis, unstable and stable angina (CHD), the emulsion formed by adding 0.9% sodium chloride solution for injection or infusion to 2 vials (bottles) should be administered by jet, slowly once a day for 7-10 days.
To prevent toxic myocardial damage during polychemotherapy cycles with anthracyclines, Lipoflavon should be administered at the same dose of 2 vials (bottles) per day before the administration of the cytostatic, and then administered at the same dose for 3 days from the moment of administration of the cytostatic. The further duration of use of the drug is determined by the doctor.
Children
Due to the currently limited information, Lipoflavone is not recommended for use in children.
Overdose
Manifestations of individual intolerance are possible, requiring discontinuation of the drug and symptomatic therapy.
Adverse reactions
On the part of the immune system: allergic reactions.
Nervous system: headache, dizziness, tremor of the limbs, tingling sensation in the limbs.
Cardiac: tachycardia, palpitations.
Vascular: decreased blood pressure.
On the part of the respiratory system, chest organs, mediastinum: feeling of lack of air, difficulty breathing, shortness of breath.
Gastrointestinal: nausea, vomiting, diarrhea.
Skin and subcutaneous tissue disorders: rash, urticaria, itching.
General disorders and administration site conditions: weakness, pain in the lumbar and thoracic spine, hyperthermia; changes, hyperemia at the injection site.
Expiration date
1 year.
Storage conditions
Store in the freezer at a temperature of minus 20 ° C to minus 10 ° C. Keep out of the reach of children.
Incompatibility
It is forbidden to use Lipoflavone together with cardiac glycosides. Do not mix in the same syringe with other medicines.
Packaging
1 vial or bottle per pack.
Vacation category
According to the recipe.
Producer
PJSC "PHARMSTANDART-BIOLIK".
Location of the manufacturer and its business address
PJSC "PHARMSTANDART-BIOLIK"
61070, Ukraine, Kharkiv, Pomirky.
