Milgamma injection solution 2p x 10 ampoules (2ml) — Made in Germany — Free Delivery

Pharmacological properties

Pharmacodynamics. Neurotropic B vitamins have a positive effect on inflammatory and degenerative diseases of the nerves and musculoskeletal system. they are prescribed to eliminate deficiency conditions, and in high doses they have an analgesic effect, improve blood circulation, normalize the functioning of the nervous system and the process of hematopoiesis.

Vitamin B1 is an essential active ingredient. In the body, it is phosphorylated to form biologically active thiamine diphosphate (cocarboxylase) and thiamine triphosphate (TTP).

Thiamine diphosphate as a coenzyme takes part in important functions of carbohydrate metabolism, which are of decisive importance in the metabolic processes of nervous tissue, affects the conduction of nerve impulses in synapses. With a deficiency of vitamin B1 in the tissues, the accumulation of metabolites occurs, primarily lactic and pyruvic acids, which leads to various pathological conditions and dysfunctions of the nervous system.

Vitamin B6 in phosphorylated form (pyridoxal-5'-phosphate - PALP) is a coenzyme of a number of enzymes that interact in the overall non-oxidative metabolism of amino acids. Through decarboxylation, they participate in the formation of physiologically active amines (for example, adrenaline, histamine, serotonin, dopamine, tyramine), through transamination, in anabolic and catabolic metabolic processes (for example, glutamate oxaloacetate transaminase, glutamate pyruvate transaminase, α-ketogramine), and various GABA processes of cleavage and synthesis of amino acids. Vitamin B6 acts on 4 different steps in tryptophan metabolism. In the process of hemoglobin synthesis, vitamin B6 catalyzes the formation of α-amino-β-ketoadinic acid.

Vitamin B12 is essential for cellular metabolic processes. It affects the function of hematopoiesis (external antianemic factor), takes part in the formation of choline, methionine, creatinine, nucleic acids, and has an analgesic effect.

Pharmacokinetics. When administered orally, vitamin B6 and its derivatives are mostly rapidly absorbed in the upper digestive tract by passive diffusion and excreted within 2–5 hours. After parenteral administration, thiamine is distributed in the body. About 1 mg of thiamine is metabolized daily. Metabolites are excreted in the urine. Dephosphorylation occurs in the kidneys. The biological half-life of thiamine is 0.35 hours. The accumulation of thiamine in the body does not occur due to poor dissolution in fats.

Vitamin B6 is phosphorylated and oxidized to pyridoxal-5'-phosphate. In blood plasma, pyridoxal-5'-phosphate and pyridoxal bind to albumin. It is transported in the form of pyridoxal. For passage through the cell membrane, pyridoxal-5'-phosphate bound to albumin is hydrolyzed by alkaline phosphate to pyridoxal.

Vitamin B12, after parenteral administration, forms transport protein complexes that are rapidly absorbed by the liver, bone marrow and other organs. Vitamin B12 enters bile and takes part in the intestinal-hepatic circulation, crosses the placental barrier.

Indications

Pills. with neurological diseases caused by a proven deficiency of vitamins B1, B6.

Solution for injection. Neurological diseases of various origins: neuritis, neuralgia, polyneuropathy (diabetic, alcoholic), radicular syndrome, retrobulbar neuritis, lesions of the facial nerve.

Application

Milgamma tablets. used orally with a sufficient amount of liquid.

The recommended dose is 1 tablet per day. In individual cases, the dose is increased and 1 tablet is used 3 times a day.

The tablets should be taken whole with a liquid after meals.

The duration of the course of treatment is determined by the doctor individually in each case. After the maximum treatment period (4 weeks), a decision is made to correct and reduce the dose of the preparation.

Milgamma injection solution. For intramuscular injection.

In severe (acute) cases, treatment begins with 2 ml of solution IM 1 time per day until acute symptoms are eliminated. To continue treatment, appoint 2 ml (1 injection) 2-3 times a week. The course of treatment is at least 1 month.

An IM injection should be performed in the upper outer quadrant of the gluteus maximus.

To maintain or continue the course of therapy or to prevent relapse, the preparation Milgamma, film-coated tablets is recommended.

Contraindications

Pills. hypersensitivity to the components of the preparation. taking vitamin B1 is contraindicated in case of allergic reactions. taking vitamin B6 is contraindicated in case of gastric ulcer and duodenal ulcer in the acute stage (since it is possible to increase the acidity of gastric juice).

During pregnancy and breastfeeding

Solution for injection. Hypersensitivity to the components of the preparation; acute violation of cardiac conduction, acute form of decompensated heart failure.

Vitamin B1 is contraindicated in allergic reactions.

Vitamin B6 is contraindicated for use in case of stomach and duodenal ulcers in the acute stage (since the acidity of gastric juice may increase).

Vitamin B12 is contraindicated for erythremia, erythrocytosis, thromboembolism.

Lidocaine. Hypersensitivity to lidocaine or other amide local anesthetics, a history of epileptiform seizures when taking lidocaine, severe bradycardia, severe arterial hypotension, cardiogenic shock, severe forms of chronic heart failure (II-III degree), sick sinus syndrome, WPW c-m , Adams-Stokes syndrome, AV block II and III degree, hypovolemia, severe liver / kidney dysfunction, porphyria, myasthenia gravis.

During pregnancy and breastfeeding.

Side effects

Pills

From the digestive tract: nausea, vomiting, diarrhea, abdominal pain, increased acidity of gastric juice.

On the part of the cardiovascular system: tachycardia.

From the immune system: hypersensitivity reactions, including anaphylactic shock; anaphylaxis; hives.

On the part of the skin: skin rashes, itching.

In extremely rare cases - a state of shock.

From the nervous system: long-term use (more than 6-12 months) in doses of more than 50 mg of vitamin B6 daily can lead to peripheral sensory neuropathy, nervous excitement, dizziness, headache.

From the endocrine system: the release of prolactin is inhibited.

Solution for injection. Long-term use (more than 6-12 months) of vitamin B6 at a dose of 50 mg daily can lead to peripheral sensory neuropathy, nervous excitement, malaise, dizziness, headache.

From the digestive tract: gastrointestinal disorders, including nausea, vomiting, diarrhea, abdominal pain, increased acidity of gastric juice.

From the immune system: hypersensitivity reactions (skin rash, respiratory failure, anaphylactic shock, Quincke's edema), increased sweating.

On the part of the skin: itching, urticaria, acne; extremely rare - generalized exfoliative dermatitis, angioedema.

From the side of the cardiovascular system: tachycardia, arrhythmia, bradycardia, deceleration of cardiac conduction, transverse heart block, cardiac arrest, peripheral vasodilation, collapse; very rarely - tachycardia, increase / decrease in blood pressure, heart pain.

From the nervous system: excitation of the central nervous system (when used in high doses), anxiety, headache, dizziness, sleep disturbance, confusion, drowsiness, loss of consciousness, coma; in patients with hypersensitivity - euphoria, tremor, trismus, motor restlessness, paresthesia, convulsions.

From the side of the organ of vision: nystagmus, reversible blindness, diplopia, flashing of flies before the eyes, photophobia, conjunctivitis.

On the part of the organ of hearing: hearing impairments, tinnitus, hyperacusis.

From the respiratory system: shortness of breath, rhinitis, depression or respiratory arrest.

Others: feeling of heat, cold or numbness of the extremities, edema, weakness, malignant hyperthermia, sensory disturbances, motor block.

General disorders: reactions at the injection site.

In the case of very rapid parenteral administration, systemic reactions in the form of seizures may develop.

Special instructions

Pills. the question of the use of the preparation milgam for the treatment of patients with severe and acute forms of decompensated heart failure is decided by the doctor individually, taking into account the patient's condition.

When vitamin B12 is used, the clinical picture, as well as laboratory tests for funicular myelosis or pernicious anemia, may lose their specificity.

Since the preparation contains vitamin B6, it is necessary to prescribe it with caution to patients with gastric and duodenal ulcers, a history of severe hepatic and renal failure.

Patients with neoplasms should not use Milgam's preparation, with the exception of cases associated with megaloblastic anemia and vitamin B12 deficiency. The preparation is used in severe or acute form of decompensated cardiac activity and angina pectoris.

If signs of peripheral sensory neuropathy (paresthesia) appear, the dose should be revised and the use of Milgam should be suspended, if necessary. With long-term intake (more than 6-12 months) daily doses exceeding 50 mg of vitamin B6, as well as with short-term intake (more than 2 months) of more than 1 g of vitamin B6 per day, neuropathies were observed, in this regard, constant monitoring is recommended with prolonged use.

The preparation contains sucrose. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not use this preparation.

Solution for injection. The preparation should not be administered intravenously. IM injections of vitamin B12 can cause anaphylactoid reactions in hypersensitive patients.

Parenteral administration of vitamin B12 may temporarily affect the diagnosis of funicular myelosis or pernicious anemia.

Long-term use of vitamin B6 (more than 6-12 months) in doses above 50 mg daily or above 1000 mg / day (more than 2 months) can lead to reversible peripheral sensory neuropathy. If symptoms of peripheral sensory neuropathy (paresthesia) occur, dose adjustment or discontinuation of the preparation is necessary.

The preparation contains sodium compounds. This must be taken into account in patients on a salt-free diet. Each ampoule may contain potassium residues.

Since Milgamma contains vitamin B6, the preparation should be used with caution in patients with a history of peptic ulcers of the stomach and duodenum, with severe renal and liver dysfunction.

In patients with neoplasms, except for cases accompanied by megaloblastic anemia and vitamin B12 deficiency, the preparation should not be used.

The preparation is not used in severe cardiac decompensation and angina pectoris.

Since Milgamma contains lidocaine, it should be noted that when treating the injection site with disinfectant solutions containing heavy metals, the risk of developing a local reaction in the form of pain and swelling increases.

Since lidocaine has a pronounced antiarrhythmic effect and can itself act as an arrhythmogenic factor that can lead to the development of arrhythmias, the preparation should be used with caution in persons with a history of arrhythmia complaints.

Use with caution in patients with moderate heart failure, moderate arterial hypotension, incomplete AV blockade, impaired intraventricular conduction, moderate liver and kidney dysfunction (creatinine clearance 10 ml / min), impaired respiratory function, epilepsy, after surgery heart, with a genetic predisposition to hyperthermia, in debilitated patients and elderly patients.

When using lidocaine, ECG monitoring is mandatory. In case of violations of the sinus node, lengthening of the P – Q interval, widening of the QRS or with the development of new arrhythmias, the dose should be reduced or the preparation should be discontinued.

Before using lidocaine for heart disease (hypokalemia reduces the effectiveness of lidocaine), it is necessary to normalize the level of potassium in the blood.

With intramuscular administration, it is possible to increase the concentration of creatinine, which can lead to an error in establishing the diagnosis of acute myocardial infarction.

Application during pregnancy or lactation. During pregnancy and lactation, the recommended daily intake of vitamin B1 is 1.4–1.6 mg, for vitamin B6, 2.4–2.6 mg. During pregnancy, these doses may be exceeded if the patient is deficient in vitamins B1 and B6.

Vitamins B1 and B6 pass into breast milk. High doses of vitamin B6 can reduce milk supply.

The preparation in the form of a solution contains 100 mg of vitamin B6 in ampoules, so it should not be used during pregnancy and lactation.

Children. The efficacy and safety of the preparation in children have not been established, therefore it is not used in patients of this age category.

The ability to influence the reaction rate when driving vehicles or other mechanisms. The preparation does not affect the ability to drive vehicles and work with complex mechanisms.

If dizziness is noted during treatment, you should refrain from driving or working with other mechanisms.

Interactions

The action of thiamine is inactivated by fluorouracil, since the latter competitively inhibits the phosphorylation of thiamine into thiamine pyrophosphate. loop diuretics, such as furosemide, which inhibit tubular reabsorption, with prolonged therapy can cause an increase in the excretion of thiamine, thereby reducing its level.

Simultaneous use with levodopa is contraindicated, since vitamin B6 can reduce the severity of the antiparkinsonian action of levodopa. Concomitant use with pyridoxine antagonists (for example, isoniazid, hydralazine, penicillamine or cycloserine), oral contraceptives may increase the need for vitamin B6.

Drinking beverages containing sulfites (such as wine) increases the degradation of thiamine.

Lidocaine enhances the depressing effect on the respiratory center of anesthetics (hexobarbital, sodium thiopental IV), hypnotics and sedatives; weakens the cardiotonic effect of digitoxin. With simultaneous use with hypnotics and sedatives, it is possible to increase the inhibitory effect on the central nervous system.

Ethanol enhances the inhibitory effect of lidocaine on respiration.

Blockers of adrenergic receptors (including propranolol, nadolol) slow down the metabolism of lidocaine in the liver, enhance the effects of lidocaine (including toxic ones) and increase the risk of developing bradycardia and hypotension.

Curariform preparations - it is possible to deepen muscle relaxation (before paralysis of the respiratory muscles).

Norepinephrine, mexiletine - the toxicity of lidocaine increases (the clearance of lidocaine decreases).

Izadrin and glucagon - the clearance of lidocaine increases.

Cimetidine, midazolam - the concentration of lidocaine in the blood plasma increases. Cimetidine displaces from the connection with proteins and slows down the inactivation of lidocaine in the liver, which leads to an increased risk of increased side effects of lidocaine. Midazolam moderately increases the concentration of lidocaine in the blood.

Anticonvulsants, barbiturates (including phenobarbital) - it is possible to accelerate the metabolism of lidocaine in the liver, decrease the concentration in the blood.

Antiarrhythmic preparations (amiodarone, verapamil, quinidine, aymalin, disopyramide), anticonvulsants (hydantoin derivatives) - the cardiodepressant effect is enhanced; simultaneous use with amiodarone can lead to the development of seizures.

Novocaine, novocainamide - when combined with lidocaine, it is possible to excite the central nervous system and the occurrence of hallucinations.

MAO inhibitors, chlorpromazine, buvicaine, amitriptyline, nortriptyline, imipramine - when combined with lidocaine, the risk of arterial hypotension increases and the local anesthetic effect of lidocaine is prolonged.

Narcotic analgesics (morphine, etc.) - when combined with lidocaine, the analgesic effect of narcotic analgesics increases, and respiratory depression also increases.

Prenylamine - the risk of developing ventricular arrhythmias such as pirouette increases.

Propafenone - an increase in the duration and severity of side effects from the central nervous system is possible.

Rifampicin - a decrease in the concentration of lidocaine in the blood is possible.

Polymyxin B - respiratory function should be monitored.

Procainamide - hallucinations are possible.

Cardiac glycosides - when combined with lidocaine, the cardiotonic effect of cardiac glycosides is weakened.

Digitalis glycosides - against the background of intoxication, lidocaine can increase the severity of AV blockade.

Vasoconstrictors (epinephrine, methoxamine, phenylephrine) - when combined with lidocaine, they slow down the absorption of lidocaine and prolong the effect of the latter.

Guanadrel, guanethidine, mecamylamine, trimetaphan - combined use for spinal and epidural anesthesia increases the risk of severe hypotension and bradycardia.

Blockers of β-adrenergic receptors - with combined use, they slow down the metabolism of lidocaine in the liver, the effects of lidocaine (including toxic ones) are enhanced, the risk of developing bradycardia and arterial hypotension increases. With the simultaneous use of β-adrenergic receptor blockers and lidocaine, it is necessary to reduce the dose of the latter.

Acetazolamide, thiazide and loop diuretics - when combined with lidocaine, the effect of the latter decreases as a result of the development of hypokalemia.

Anticoagulants (including ardeparin, dalteparin, danaparoid, enoxaparin, heparin, warfarin, etc.) - when combined with lidocaine, the risk of bleeding increases.

Anticonvulsants, barbiturates (phenytoin) - when combined with lidocaine, it is possible to accelerate the metabolism of lidocaine in the liver, decrease the concentration in the blood, and increase the cardiodepressant effect.

Preparations that block neuromuscular transmission - when combined with lidocaine, the effect of preparations that block neuromuscular transmission is enhanced, since the latter reduce the conduction of nerve impulses.

Incompatibility. Pyridoxine is incompatible with preparations containing levodopa, since with simultaneous use, the peripheral decarboxylation of the latter increases and, thus, the severity of its antiparkinsonian action decreases.

Thiamine is incompatible with oxidizing and reducing compounds: mercury chloride, iodide, carbonate, acetate, tannic acid, ammonium iron citrate, as well as sodium phenobarbital, riboflavin, benzylpenicillin, glucose and metabisulfite, since it is inactivated in their presence. Copper accelerates the breakdown of thiamine; in addition, thiamine loses its activity with increasing pH 3. Vitamin B12 is incompatible with heavy metal salts.

Overdose

Vitamin B1 has a wide therapeutic range. very high doses (more than 10 g) exhibit a curariform effect, suppressing the conduction of nerve impulses.

Vitamin B6 has a very low toxicity.

Excessive use of vitamin B6 in doses of more than 1 g / day for several months can lead to neurotoxic effects.

Neuropathies with ataxia and sensory disorders, cerebral convulsions with changes in the EEG, as well as, in some cases, hypochromic anemia and seborrheic dermatitis have been described after administration at a dose higher than 2 g / day.

Vitamin B12: after parenteral administration (in rare cases, after oral administration) in doses higher than recommended, allergic reactions, eczematous skin disorders and a benign form of acne were noted.

With prolonged use in high doses, a violation of the activity of liver enzymes, pain in the region of the heart, hypercoagulation are possible.

Treatment: symptomatic therapy.

Lidocaine. Symptoms: psychomotor agitation, dizziness, general weakness, decreased blood pressure, tremor, visual impairment, tonic-clonic seizures, coma, collapse, possible AV blockade, CNS depression, respiratory arrest. The first symptoms of overdose in healthy people occur when the concentration of lidocaine in the blood is 0.006 mg / kg of body weight, convulsions - at 0.01 mg / kg.

Treatment: discontinuation of preparation administration, oxygen therapy, anticonvulsants, vasoconstrictors (norepinephrine, mezaton), with bradycardia - anticholinergics (0.5-1 mg atropine). It is possible to carry out intubation, mechanical ventilation, resuscitation measures. Dialysis is ineffective.

Storage conditions

Tablets: at a temperature not exceeding 25 ° C.

Solution for injection: at a temperature not exceeding 2–8 ° С in original packaging to protect from light.