Espa-lipon pills film coated 600mg N30
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Active ingredients
Thioctic acid
Release form
Pills
Composition
1 tablet contains: Thioctic (α-lipoic) acid 600 mg. Additional substances: lactose monohydrate - 289 mg, povidone (collidon 25) - 29.5 mg, microcrystalline cellulose - 33 mg, cellulose powder - 22 mg, silicon dioxide, colloidal - 11 mg, silicon dioxide - 27.5 mg, sodium carboxymethyl starch - 44 mg, magnesium stearate - 44 mg. The composition of the film coating: hypromellose - 4.5 mg, macrogol 6000 - 500 μg, talc - 1.395 mg, titanium dioxide (E171) - 1.125 mg, dye quinoline yellow (E104) - 225 mkg.
Pharmacological effect
The drug is an endogenous antioxidant that binds free radicals. Thioctic (α-lipoic) acid is involved in the mitochondrial metabolism of the cell, it performs the function of coenzyme in the complex of transformation of substances that have a pronounced antitoxic effect. They protect the cell from reactive radicals arising from the intermediate metabolism or the decomposition of exogenous foreign substances, and from heavy metals. Thioctic acid shows synergism with respect to insulin, which is associated with increased glucose utilization. In diabetic patients, thioctic acid leads to a change in the concentration of pyruvic acid in the blood.
Pharmacokinetics
After ingestion, it is quickly and completely absorbed from the gastrointestinal tract (food intake reduces absorption), Cmax is achieved within 25–60 minutes. Bioavailability is 30–60% (due to presystemic biotransformation). In the liver, it is oxidized and conjugated. The volume of distribution is about 450 ml / kg. Excreted by the kidneys as metabolites (80–90%) with a T1 / 2 of 20–50 min. Total plasma Cl - 10–15 ml / min.
Indications
Polyneuropathy of various genesis (diabetic, alcoholic, etc.), chronic hepatitis, cirrhosis of the liver, poisoning with salts of heavy metals, mushrooms, chronic intoxication, as a hypolipidemic agent for the prevention and treatment of atherosclerosis.
Contraindications
Hypersensitivity to the drug.
Precautionary measures
Alcohol consumption is a risk factor for the development of polyneuropathy and may reduce the effectiveness of Thioctacid, so patients should refrain from taking alcoholic beverages both during treatment with the drug and during periods outside of treatment.
Use during pregnancy and lactation
The drug is contraindicated during pregnancy and lactation, because there is insufficient experience with the drug during these periods.
Dosage and administration
When the severity of symptoms of polyneuropathy treatment should begin with parenteral administration of the drug. Espa-lipon is prescribed in a dose of 600 mg / day daily in / in drip with an isotonic solution of sodium chloride; in severe cases, the daily dose is increased to 900-1200 mg. Infusion rate should not exceed 50 mg / min. Initial therapy in these doses is carried out for 10-20 days. In the future, they switch to maintenance therapy with oral dosage forms at a dose of 600 mg 1–3 times a day for 1–3 months. For the prevention of diabetic polyneuropathy, the initial dose is 300 mg / day i.v. for 20 days or by mouth 600 mg 1 time per day for 20-30 days. Maintenance dose - 400-600 mg / day orally for 1-2 months. With the other, listed above, metabolic disorders, liver diseases, chronic intoxication, the dose is set individually, taking into account the severity of the disease, age and body weight of the patient.
Side effects
Allergic reactions (urticaria, eczema), hypoglycemia (due to improved glucose utilization); in some cases, after rapid i / v administration, convulsions, diplopia, with too rapid administration of the drug - a feeling of heaviness in the head and difficulty in breathing, which disappear on their own. In some cases, after i / v administration of the drug, hemorrhages in the skin and mucous membranes were observed. In most cases, side effects disappear on their own.
Overdose
Symptoms: headache, nausea, vomiting. Treatment: symptomatic therapy, maintenance of vital functions. The specific antidote is unknown.
Interaction with other drugs
With simultaneous administration of thioctic acid and cisplatin, cisplatin decreases in effectiveness. With simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may increase, therefore regular monitoring of blood glucose levels is recommended, especially at the start of thioctic acid therapy. In some cases, it is permissible to reduce the dose of hypoglycemic drugs in order to avoid the development of symptoms of hypoglycemia. Ethanol and its metabolites weaken the action of thioctic acid. Pharmaceutical interaction The infusion solution of thioctic acid is incompatible with dextrose solution, Ringer's solution and with solutions,reacting with disulfide and S-groups, ethanol.
special instructions
During the period of treatment, regular monitoring of blood glucose concentrations (especially at the beginning of therapy) in patients with diabetes mellitus is necessary.