NEVRALON (Tablets)
(thiamine hydrochloride, pyridoxine hydrochloride, cyanocobalamin)
COMPOSITION
1 membranous film-coated tablet contains
Vitamin B1 (thiamine hydrochloride) 250 mg,
Vitamin B6 (pyridoxine hydrochloride) 250 mg,
Vitamin B12 (cyanocobalamin) 1 mg.
PHARMACOLOGICAL PROPERTIES
Nevralon is a vitamin B complex.
Neurotropic group B vitamins have positive effect in inflammatory and degenerative diseases of nerves and musculoskeletal system. In high doses they have analgesic properties; they enhance blood circulation and normalize the function of nervous system and haematopoiesis.
Thiamine hydrochloride (vitamin B1) is an important active element. In human organism, as a result of phosphorylation, it transforms into cocarboxylase, which is a coenzyme of many fermentative reactions. It plays important role in carbohydrate, protein and lipid metabolism, and also in transmission of nerve impulses in synapses. It protects cell membranes against toxic effect of peroxidation products.
Pyridoxine hydrochloride (vitamin B6) in phosphorylated form is a component of enzymes, which take part in decarboxylation and transamination of amino acids, as well as lipid metabolism. It is essential for normal function of peripheral and central nervous system (CNS).
Physiological function of both vitamins appears to be potentiation of one another’s function, which may be observed in their positive effect on neuromuscular and cardiovascular systems. Widely spread conditions associated with vitamin B6 deficiency, are quickly contained when the vitamin is absorbed.
Cyanocobalamin (vitamin B12) is essential for cellular metabolism. It affects haematopoiesis (external antianemic factor); takes part in the formation of choline, methionine, creatinine and nucleic acids; it has analgesic properties.
PHARMACOKINETICS
After parenteral administration thiamine hydrochloride (vitamin B1) is quickly absorbed from duodenum and small intestine. To a significant degree it metabolizes in liver and its main metabolites are thiamine carboxylic acid and pyridine (2.5-dimethyl-4-aminopyridine). Metabolites, together with small amount of unchanged thiamine are excreted via gastrointestinal tract and kidneys. Pyridoxine hydrochloride (vitamin B6) is quickly absorbed from gastrointestinal tract. It is metabolized in liver with the formation of pharmacologically active metabolites: pyridoxal phosphate and pyridoxamine phosphate. Vitamin B6 functions as a coenzyme after phosphorylation of СН2ОН group at the 5-position, i.e. after the formation of pyridoxal-5-phosphate (PALP). Approximately 80% of (PALP) binds with blood plasma proteins. Pyridoxine predominantly concentrates in muscles, liver and CNS. The final product of pyridoxine metabolism is 4-pyridoxic acid, which is excreted from the organism via kidneys.
Most of Cyanocobalamin (vitamin B12) is absorbed after binding with “Castle’s intrinsic factors”.
Vitamin B12 is concentrated mainly in liver. Blood serum elimination half-life is approximately 5 days, liver – approximately 1 year. It is excreted from organism with bile and urine.
THERAPEUTIC INDICATIONS
As part of complex therapy in symptomatic treatment of such nervous system disorders as:
- neuritis, neuralgia (including trigeminal nerve neuralgia), polyneuritis, polyneuropathy (including diabetic and alcoholic), herpes zoster, myalgia, radicular syndromes (associated with degenerative changes in the spine), optic neuritis and facial nerve paresis;
- systemic neurological disorders associated with manifested vitamin B1, B6 and B12 deficiency.
The medication may be administered in following disorders as well:
- cardiomyopathy (associated with vitamin B1 deficiency);
- vomiting after surgery;
- acute radiation syndrome;
- chronic intoxication associated with alcoholism.
CONTRADICTIONS
- hypersensitivity to any components of the medication.
SIDE EFFECTS
In isolated cases – sweating, acne, skin reactions (urticaria). Seldom –hypersensitivity (skin rash, respiratory disorders, anaphylactic shock, angioedema).
DOSAGE AND ADMINISTRATION
Nevralon tablets should be taken enterally, whole, and washed down with sufficient amount of water. The dose for prevention is 1 tablet daily.
The dose for treatment is 2-4 tablets daily. When the symptoms improve the dose may be adjusted to 1 tablet per day.
The duration of treatment should be no shorter than 1 month.
PACKAGING
Membranous film-coated tablets.
10 tablets are in a blister.
2 or 5 blisters together with a leaflet are in a carton box.