Instructions Dinar solution for injection 50 mg/ml ampoule 5 ml in blister No. 10
Composition
active ingredient: ethylmethylhydroxypyridine succinate;
1 ml of solution contains ethylmethylhydroxypyridine succinate (calculated on 100% dry matter) – 50 mg;
Excipients: sodium metabisulfite, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: clear, colorless or slightly yellowish liquid.
Pharmacotherapeutic group
Other agents acting on the nervous system. ATX code N07X X.
Pharmacological properties
Pharmacodynamics
Dinar is an inhibitor of free radical processes, a membrane protector, has antihypoxic, stress-protective, nootropic, anticonvulsant and anxiolytic effects. The drug increases the body's resistance to the action of various damaging factors, to oxygen-dependent pathological conditions (shock, hypoxia and ischemia, cerebral circulation disorders, intoxication with alcohol and antipsychotics (neuroleptics)).
The drug improves cerebral metabolism and blood supply to the brain, improves microcirculation and rheological properties of blood, reduces platelet aggregation. Stabilizes membrane structures of blood cells (erythrocytes and platelets) during hemolysis. Has a hypolipidemic effect, reduces the content of total cholesterol and low-density lipoproteins (LDL). Reduces enzymatic toxemia and endogenous intoxication in acute pancreatitis.
The mechanism of action is due to its antioxidant and membrane-protective properties. It inhibits lipid peroxidation, increases the activity of superoxide oxidase, increases the lipid-protein ratio, reduces membrane viscosity. Modulates the activity of membrane-bound enzymes (calcium-independent phosphodiesterase, adenylate cyclase, acetylcholinesterase), receptor complexes (benzodiazepine, gamma-aminobutyric acid (GABA), acetylcholine), which increases their ability to bind to ligands, contributes to the preservation of the structural and functional organization of biomembranes, the transport of neurotransmitters and the improvement of synaptic transmission. Dinar increases the content of dopamine in the brain. Causes increased compensatory activation of aerobic glycolysis and a decrease in the degree of inhibition of oxidative processes in the Krebs cycle under conditions of hypoxia with an increase in the content of adenosine triphosphate (ATP) and creatine phosphate, activation of energy-synthesizing functions of mitochondria, stabilization of cell membranes.
Dinar normalizes metabolic processes in ischemic myocardium, reduces the area of necrosis, restores and improves electrical activity and myocardial contractility, and also increases coronary blood flow in the ischemic area, reduces the effects of reperfusion syndrome in acute coronary insufficiency. Increases the antianginal activity of nitro drugs. Dinar contributes to the preservation of retinal ganglion cells and optic nerve fibers in progressive neuropathy, the consequences of which are chronic ischemia and hypoxia. Improves the functional activity of the retina and optic nerve, increasing visual acuity.
Pharmacokinetics
When administered intramuscularly, the drug is detected in the blood plasma within 4 hours after administration. The time to reach maximum concentration is 0.45–0.5 hours. The maximum concentration at doses of 400–500 mg is 3.5–4.0 μg/ml. Dinar is rapidly absorbed from the bloodstream into organs and tissues and is rapidly eliminated from the body. The drug is excreted from the body with urine, mainly in the glucuronide conjugated form and in small quantities in unchanged form.
Indication
- Acute cerebrovascular accident;
- traumatic brain injury, consequences of traumatic brain injuries;
- dyscirculatory encephalopathy;
- vegetative dystonia syndrome;
- mild cognitive disorders of atherosclerotic genesis;
- anxiety disorders in neurotic and neurosis-like conditions;
- acute myocardial infarction (from the first day) as part of complex therapy;
- primary open-angle glaucoma of various stages, as part of complex therapy;
- relief of withdrawal syndrome in alcoholism with a predominance of neurosis-like and vegetative-vascular disorders;
- acute intoxication with antipsychotic drugs;
- acute purulent-inflammatory processes of the abdominal cavity (acute necrotic pancreatitis, peritonitis) as part of complex therapy.
Contraindication
Acute hepatic or renal failure, increased individual sensitivity to the drug. Pregnancy or breastfeeding. Children's age.
Interaction with other medicinal products and other types of interactions
The drug Dinar enhances the effect of benzodiazepine anxiolytics, anticonvulsants (carbamazepine), antiparkinsonian drugs (levodopa). Potentiates the effect of nitro-containing drugs, antihypertensive drugs. Reduces the toxic effect of ethyl alcohol.
Application features
After completion of parenteral administration, it is recommended to continue using the drug orally in tablet form to maintain the achieved effect.
Use during pregnancy or breastfeeding
The drug Dinar is contraindicated during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment, caution should be exercised when driving or operating other machinery, given the possibility of side effects that may affect reaction speed and ability to concentrate.
Method of administration and doses
Intramuscularly (IM) or intravenously (IV) (jet or drip). For infusion administration, the drug should be diluted in 0.9% sodium chloride solution.
The drug Dinar should be administered slowly by jet injection over 5–7 minutes, or drip injection at a rate of 40–60 drops per minute. The maximum daily dose should not exceed 1200 mg.
In acute cerebral circulation disorders, the drug Dinar is prescribed in the first 10–14 days - intravenously drip 200–500 mg 2–4 times a day, then - intramuscularly 200–250 mg 2–3 times a day for 2 weeks.
In case of traumatic brain injury and the consequences of traumatic brain injury, the drug Dinar should be used for 10–15 days by intravenous drip injection of 200–500 mg 2–4 times a day.
In case of dyscirculatory encephalopathy in the decompensation phase, the drug Dinar should be administered intravenously by jet or drip at a dose of 200–500 mg 1–2 times a day for 14 days. Then intramuscularly at 100–250 mg per day for the next 2 weeks.
For course prevention of dyscirculatory encephalopathy, the drug is administered intramuscularly at a dose of 200–250 mg 2 times a day for 10–14 days.
For mild cognitive impairment in elderly patients and anxiety disorders, the drug should be administered intramuscularly in a daily dose of 100–300 mg per day for 14–30 days.
In acute myocardial infarction as part of complex therapy, the drug Dinar should be administered intravenously or intramuscularly for 14 days against the background of traditional myocardial infarction therapy, which includes nitrates, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, thrombolytics, anticoagulants and antiplatelet agents, as well as symptomatic agents according to indications. In the first 5 days, intravenous administration of the drug Dinar is desirable to achieve maximum effect, in the next 9 days, intramuscular administration of the drug is possible. Intravenous administration should be carried out by drip infusion, slowly (to avoid side effects), in 0.9% sodium chloride solution or 5% dextrose (glucose) solution in a volume of 100–150 ml for 30–90 minutes. If necessary, slow jet injection of the drug Dinar is possible for at least 5 minutes.
The drug Dinar should be administered (intravenously or intramuscularly) 3 times a day every 8 hours. The daily therapeutic dose is 6–9 mg/kg of body weight, a single dose is 2–3 mg/kg of body weight. The maximum daily dose should not exceed 800 mg, a single dose is 250 mg.
In open-angle glaucoma of various stages, as part of complex therapy, the drug Dinar is administered intramuscularly at 100–300 mg 1–3 times a day for 14 days.
For alcohol withdrawal syndrome, the drug Dinar should be administered at a dose of 200–500 mg intravenously dripped or intramuscularly 2–3 times a day for 5–7 days.
In acute intoxication with antipsychotic drugs, the drug should be administered intravenously at a dose of 200–500 mg per day for 7–14 days.
In acute purulent-inflammatory processes of the abdominal cavity (acute necrotic pancreatitis, peritonitis), the drug is prescribed on the first day both in the preoperative and postoperative periods. The doses depend on the form and severity of the disease, the prevalence of the process, and the clinical course. The drug should be discontinued gradually, only after a stable positive clinical and laboratory effect.
In acute edematous (interstitial) pancreatitis, the drug Dinar is prescribed at a dose of 200–500 mg 3 times a day intravenously drip (in 0.9% sodium chloride solution) and intramuscularly.
Mild necrotizing pancreatitis: 100–200 mg 3 times a day intravenously drip (in 0.9% sodium chloride solution) and intramuscularly.
Moderate degree: 200 mg 3 times a day intravenously drip (in 0.9% sodium chloride solution).
Severe course: in pulse dosing 800 mg on the first day with a double injection, then 200–500 mg 2 times a day with a gradual decrease in the daily dose.
Very severe course: initial dose – 800 mg per day until stable relief of pancreatogenic shock, after stabilization of the condition – 300–400 mg 2 times a day intravenously drip (in 0.9% sodium chloride solution) with a gradual decrease in the daily dose.
Children
Strictly controlled clinical studies of the safety of the drug in children have not been conducted, therefore the drug Dinar is contraindicated for use in this category of patients.
Overdose
Symptoms: drowsiness, insomnia.
Treatment: due to low toxicity, overdose is unlikely. Treatment is usually not required, symptoms disappear on their own within 24 hours. In case of severe manifestations, supportive and symptomatic treatment should be carried out.
Adverse reactions
The frequency of side effects was determined according to the World Health Organization (WHO) classification: very common (≥ 10%), common (≥ 1% but < 10%), uncommon (≥ 0.1% but < 1%), rare (≥ 0.01% but < 0.1%), very rare (< 0.01%), frequency unknown (cannot be determined from available data).
On the part of the immune system: very rarely - anaphylactic shock, angioedema, urticaria.
On the part of the psyche: very rarely - drowsiness.
From the nervous system: very rarely - headache, dizziness (may be associated with an excessively high rate of administration and is short-term in nature).
Vascular disorders: very rarely - increased blood pressure, decreased blood pressure (may be associated with an excessively high rate of administration and is short-term in nature).
From the respiratory system, chest and mediastinal organs: very rarely - dry cough, sore throat, chest discomfort, difficulty breathing (may be associated with an excessively high rate of administration and is short-lived).
Gastrointestinal: very rarely - dry mouth, nausea, bad breath, metallic taste in the mouth.
Skin and subcutaneous tissue disorders: very rarely – itching, rash, hyperemia.
General disorders and administration site conditions: very rare – feeling of warmth.
Expiration date
2 years.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Incompatibility.
Do not mix the drug with other medicines.
Use only solvents specified in the instructions.
Packaging
2 ml or 5 ml in an ampoule. 10 ampoules in a pack. 5 ampoules in a blister.
2 blisters per pack.
Vacation category
According to the recipe.
Manufacturers
1) JSC "PHARMAK" (responsible for production and batch control/testing, not including batch release).
2) LLC NVF "MICROCHEM" (responsible for batch release, not including batch control/testing).
Location of manufacturers and address of their place of business.
1) Ukraine, 04080, Kyiv city, Kyrylivska street, building 74.
2) Ukraine, 01013, Kyiv, Budindustrii St., Building 5.
Applicant
LLC NVF "MICROCHEM".
Applicant's location
Ukraine, 01013 Kyiv, Budindustrii St., Building 5.
