Cocarnit (liof.d/sol. i.m. 187.125 amp. 2ml No. 3+sol.)
A country
Egypt
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Compound
1 ampoule contains: triphosadenine disodium trihydrate 10 mg, cocarboxylase 50 mg, cyanocobalamin 0.5 mg, nicotinamide 20 mg.
Excipients: glycine - 105.875 mg, methyl parahydroxybenzoate - 0.6 mg, propyl parahydroxybenzoate - 0.15 mg. Solvent: lidocaine hydrochloride - 10 mg, water for injection - up to 2 ml. Lyophilisate for preparing a solution for intramuscular administration in the form of a pink lyophilized mass. The reconstituted solution is transparent and pink in color.
pharmachologic effect
The drug is a rationally selected complex of metabolic substances and vitamins. Trifosadenine is an adenosine derivative that stimulates metabolic processes. Has a vasodilating effect, incl. to the coronary and cerebral arteries. Improves metabolism and energy supply to tissues. Has hypotensive and antiarrhythmic effects. Under the influence of ATP, blood pressure decreases, smooth muscles relax, and the conduction of nerve impulses improves. Cocarboxylase is a coenzyme formed in the body from thiamine (vitamin B1) supplied from outside. It is part of the carboxylase enzyme, which catalyzes the carboxylation and decarboxylation of β-keto acids. Indirectly promotes the synthesis of nucleic acids, proteins and lipids. Reduces the concentration of lactic and pyruvic acids in the body and promotes the absorption of glucose. Improves trophism of nervous tissue. Cyanocobalamin (vitamin B12) is converted into methylcobalamin and 5-deoxyadenosylcobalamin in the body. Methylcobalamin is involved in the conversion of homocysteine to methionine and S-adenosylmethionine - key reactions in the metabolism of pyrimidine and purine bases (hence DNA and RNA). If there is insufficiency of the vitamin in this reaction, it can be replaced by methyltetrahydrofolic acid, and folate-requiring metabolic reactions are disrupted. 5-deoxyadenosylcobalamin serves as a cofactor in the isomerization of L-methylmalonyl-CoA to succinyl-CoA, an important reaction in carbohydrate and lipid metabolism. Vitamin B12 deficiency leads to impaired proliferation of rapidly dividing cells of hematopoietic tissue and epithelium, as well as impaired formation of the myelin sheath of neurons. Nicotinamide is one of the forms of vitamin PP, participates in redox processes in the cell, improves carbohydrate and nitrogen metabolism, and regulates tissue respiration.
Indications for use
Symptomatic treatment of diabetic polyneuropathy.
Mode of application
The drug is injected deep IM (into the gluteal muscle). In cases of severe pain, it is advisable to start treatment with intramuscular administration of 2 ml (1 amp.)/day until acute symptoms subside. Duration of use: 9 days. After improvement of symptoms or in cases of moderately severe symptoms of polyneuropathy, 2 ml (1 amp.) is prescribed 2-3 times a week for 2-3 weeks. The recommended course of treatment is 3-9 injections depending on the severity of the disease. The duration of treatment and repeated courses are determined by the doctor depending on the nature and severity of the disease.
Interaction
In patients using hypoglycemic agents of the biguanide group (metformin), due to impaired absorption of cyanocobalamin from the gastrointestinal tract, a decrease in the concentration of cyanocobalamin in the blood may be observed. Drug interactions with other hypoglycemic agents have not been described. Cyanocobalamin is not compatible with ascorbic acid, heavy metal salts, thiamine, thiamine bromide, pyridoxine, riboflavin, folic acid. Cyanocobalamin should not be used simultaneously with drugs that increase blood clotting. In addition, concomitant use of cyanocobalamin with chloramphenicol should be avoided. Aminoglycosides, salicylates, antiepileptic drugs, colchicine, potassium preparations reduce the absorption of cyanocobalamin. When combined with drugs containing triphosadenine and dipyridamole, the effect of dipyridamole is enhanced, in particular its vasodilating effect. Dimiridamol enhances the effect of triphosadenine. Some antagonism appears when the drug is used together with purine derivatives (caffeine, theophylline). It should not be administered simultaneously with cardiac glycosides in large doses, as the risk of adverse reactions from the cardiovascular system increases. When used simultaneously with xanthinol nicotinate, the effect of the drug is reduced. Nicotinamide potentiates the effect of sedatives, tranquilizers, and antihypertensive drugs.
Side effect
The frequency of adverse reactions is given in accordance with the WHO classification: very often (more than 1/10); often (less than 1/10, but more than 1/100); uncommon (less than 1/100, but more than 1/1000); rare (less than 1/1000, but more than 1/10,000); very rare (less than 1/10,000), including isolated cases; frequency unknown. From the immune system: rarely - allergic reactions (skin rash, difficulty breathing, anaphylactic shock, Quincke's edema). From the nervous system: very rarely - dizziness, headache, agitation, confusion. From the cardiovascular system: - very rarely - tachycardia; - in some cases, bradycardia, arrhythmia; — frequency unknown — pain in the heart area, redness of the skin of the face and upper half of the body with a tingling and burning sensation, “hot flashes.” From the gastrointestinal tract: very rarely - vomiting, diarrhea. From the skin and subcutaneous tissues: very rarely - increased sweating, acne, itching, urticaria. From the side of musculoskeletal and connective tissue: very rarely - convulsions. General disorders and disorders at the injection site: very rarely - irritation, pain and burning at the injection site, weakness may occur. If any of these adverse reactions worsen or any other adverse reactions not listed in the instructions appear, the patient should inform the doctor. If severe adverse reactions develop, the drug is discontinued.
Contraindications
- hypersensitivity to any component of the drug or solvent; - cardiovascular diseases (acute heart failure, acute myocardial infarction, uncontrolled arterial hypertension, arterial hypotension, severe forms of bradyarrhythmias, AV block II-III degree, chronic heart failure (III-IV functional class according to NYHA), cardiogenic shock and others types of shock, QT prolongation syndrome, thromboembolism, hemorrhagic stroke); - inflammatory lung diseases, COPD, bronchial asthma; - pregnancy; - period of breastfeeding; — age up to 18 years; - hypercoagulation (including in acute thrombosis), erythremia, erythrocytosis; - peptic ulcer of the stomach or duodenum in the acute phase; - gout; - hepatitis, cirrhosis of the liver. The drug should be used with caution for angina pectoris.
Overdose
The components of the drug Cocarnit have a wide therapeutic range. Symptoms Trifosadenine. Exceeding the maximum daily dose (about 600 mg for an adult) can lead to the development of the following symptoms: dizziness, decreased blood pressure, short-term loss of consciousness, arrhythmia, AV block of the second and third degrees, asystole, bronchospasm, ventricular disorders, sinus bradycardia and tachycardia. Cocarboxylase. The following symptoms have been reported after administration of more than 100 times the recommended dose: headache, muscle spasm, muscle weakness, paralysis, arrhythmia. Cyanocobalamin. After parenteral administration of a high dose, eczematous skin disorders and benign acne were observed. When used in high doses, hypercoagulation and disruption of purine metabolism may develop. Nicotinamide. When used in large doses, hyperpigmentation, jaundice, amblyopia, weakness, and exacerbation of gastric and duodenal ulcers were observed. With long-term use, the development of steatohepatosis, an increase in the concentration of uric acid in the blood, and impaired glucose tolerance were noted. Treatment Administration of the drug is stopped immediately, symptomatic therapy is prescribed, incl. desensitizing.
special instructions
If the symptoms of the disease worsen or there is no effect after 9 days, it is necessary to correct the course of treatment. When using the drug Cocarnit, proper selection of the dose of the hypoglycemic drug and adequate control of the course of diabetes mellitus are necessary. The color of the prepared solution should be pink. Do not use the drug if the color of the solution has changed. The solution must be used immediately after its preparation. Use in pediatrics There are no data on the effectiveness and safety of the drug Cocarnit in children. Impact on the ability to drive vehicles and operate machinery If side effects from the central nervous system (dizziness, confusion) occur, it is recommended to refrain from driving vehicles and other mechanisms.
Dispensing conditions in pharmacies
On prescription
Cocarnit
The frequency of adverse reactions is given in accordance with the WHO classification: very often (more than 1/10); often (less than 1/10, but more than 1/100); uncommon (less than 1/100, but more than 1/1000); rare (less than 1/1000, but more than 1/10,000); very rare (less than 1/10,000), including isolated cases; frequency unknown.
From the immune system: rarely - allergic reactions (skin rash, difficulty breathing, anaphylactic shock, Quincke's edema).
From the nervous system: very rarely - dizziness, headache, agitation, confusion.
From the heart: very rarely - tachycardia; in some cases, bradycardia, arrhythmia; frequency unknown - pain in the heart area.
From the side of blood vessels: frequency unknown - redness of the skin of the face and upper half of the body with a feeling of tingling and burning, “hot flashes”.
From the gastrointestinal tract: very rarely - vomiting, diarrhea.
From the skin and subcutaneous tissues: very rarely - increased sweating, acne, itching, urticaria.
From the side of musculoskeletal and connective tissue: very rarely - convulsions.
General disorders and disorders at the injection site: very rarely - irritation, pain and burning at the injection site, weakness may occur.
If any of these adverse reactions worsen or any other adverse reactions not listed in the instructions appear, you must inform your doctor. If severe adverse reactions develop, drug therapy is discontinued.
Overdose symptoms
Trifosadenine: exceeding the maximum daily dose (about 600 mg for an adult) can lead to the development of the following symptoms: dizziness, decreased blood pressure, short-term loss of consciousness, arrhythmia, AV block II and III degrees, asystole, bronchospasm, ventricular disorders, sinus bradycardia and tachycardia.
Cocarboxylase: The following symptoms have been reported after administration of a dose greater than 100 times the recommended dose: headache, muscle spasm, muscle weakness, paralysis, arrhythmia.
Cyanocobalamin: Eczematous skin disorders and benign acne have been observed following high dose parenteral administration. When used in high doses, hypercoagulation and disruption of purine metabolism may develop.
Nicotinamide: when using large doses, hyperpigmentation, jaundice, amblyopia, weakness, and exacerbation of gastric and duodenal ulcers were observed. With long-term use, the development of steatohepatosis, an increase in the concentration of uric acid in the blood, and impaired glucose tolerance were noted.
Administration of the drug is stopped immediately, symptomatic therapy, including desensitizing therapy, is prescribed.
