active substance:1 tablet contains 300 mg alpha lipoic acid or 600 mg alpha lipoic acid
excipients: lactose monohydrate, cellulose microcrystalline croscarmellose sodium; corn starch sodium lauryl sulfate; silicon dioxide colloidal magnesium stearateshell:mix for film coating Opadry II Yellow (lactose monohydrate, hypromellose (hydroxypropyl methylcellulose), polyethylene glycol (macrogol) indigotin (E 132), sunset yellow FCF (E 110) quinoline yellow (E 104), titanium dioxide (E 171) triacetin).The
basic physico-chemical properties:
300 mgpill round shape with concave surface, film-coated yellow color
600 mglong-lasting chamfer tablets, risk-free on both sides, coated with yellow film.The
products that affect the digestive system and metabolic processes. Code A16A ATX X01.The
Thioctic acid is an endogenous vitamin-like substance, performs the function of coenzyme and participates in oxidative decarboxylation of ?-keto acids. As a result of hyperglycemia, which occurs in diabetes mellitus, glucose is attached to the matrix proteins of blood vessels and the formation of so-called "end products of accelerated glycolizuvannya". This process leads to a decrease in endoneural blood flow and endoneural hypoxia/ischemia, which in turn leads to increased formation of oxygen-containing free radicals that damage the peripheral nerves. There was also a decrease in the level of antioxidants, such as glutathione, in the peripheral nerves.
after oral administration, thioctic acid is rapidly absorbed. As a result of significant presystemic metabolism, the absolute bioavailability of thioctic acid is approximately 20%. Due to the rapid distribution in the tissues, the half-life of thioctic acid in the blood plasma is approximately 25 minutes. Relative bioavailability of thioctic acid in oral administration of solid dosage forms is more than 60% in proportion to the drinking solution. The maximum plasma concentration of 4 µg/ml was measured approximately 30 minutes after ingestion of 600 mg of thioctic acid. In urine, only a small amount of substance in unchanged form is found. Metabolism is carried out by oxidative reduction of the lateral chain (?-oxidation) and/or S-methylation of the corresponding thiols. Thioctic acidin vitroreacts with complexes of metal ions, for example, cisplatin, and forms moderately soluble complexes with sugar molecules.
Paresthesia in diabetic polyneuropathy.
Hypersensitivity to thioctic acid or to any of the components of the drug.The
the Effectiveness of cisplatin is reduced by simultaneous application with the drug alpha-lipon. Thioctic acid is a complexing agent of metals and therefore, according to the basic principles of pharmacotherapy, it should not be used simultaneously with metal compounds (for example, with food additives containing iron or magnesium, with dairy products, since they contain calcium). If the total daily dose of the drug is used 30 minutes before Breakfast, food additives containing iron and magnesium should be used in the middle of the day or in the evening. When using thioctic acid in patients with diabetes mellitus may increase the effect of insulin and oral antidiabetic agents, so, especially at the initial stage of treatment, it is recommended to carefully monitor blood sugar levels. In order to avoid symptoms of hypoglycemia in some cases, you may need a lower dose of insulin or oral antidiabetic agents.
at the beginning of treatment of polyneuropathy through regenerative processes, a short-term increase in paresthesia with the feeling of "creeping goosebumps"is possible. When using thioctic acid in patients with diabetes requires frequent monitoring of blood glucose levels. In some cases, it is necessary to reduce the dose of antidiabetic drugs to prevent the development of hypoglycemia.
Regular consumption of alcoholic beverages is a significant risk factor for the development and progression of polyneuropathy and can hinder success in treatment, so alcohol consumption should be avoided during treatment and between treatments.
the drug alpha-lipon contains lactose, so it should not be used in patients with rare hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose absorption syndrome. The dye E 110, which is included in the composition of the shell of the tablets may cause allergic reactions.
use during pregnancy or lactation.
thioctic acid Is not recommended during pregnancy due to the lack of appropriate clinical data. Data on the penetration of thioctic acid in breast milk is not, therefore, apply it in the period of breast-feeding is not recommended.
Ability to influence the reaction rate when driving motor transport or operating other mechanisms.
During treatment, care must be taken, driving vehicles, machinery or doing other potentially hazardous activities, require increased attention and psychomotor speed reactions, through the possibility of adverse reactions such as hypoglycemia (dizziness and blurred vision).
the Daily dose is 600 mg of thioctic acid (2 tablets of 300 mg or 1 tablet of 600 mg), which should be used as a single dose 30 minutes before the first meal. Simultaneous food intake makes it difficult to absorb, so patients, which are characterized by prolonged gastric emptying, it is especially important to use drugs before eating. Pills do not chew and wash down with sufficient amount of liquid, for example, 1 Cup of water.
with intensive paresthesia, treatment can begin with parenteral administration of thioctic acid by applying appropriate dosage forms.
alpha-lipon should not be prescribed to children, as there is not enough clinical experience for this age group.
symptoms. Overdose can cause nausea, vomiting and headache. After occasional use or in a suicide attempt with oral use of thioctic acid in doses from 10 g to 40 g in combination with alcohol showed a significant intoxication, in some cases with fatal outcome.
at the initial stage, the clinical picture of intoxication may manifest itself in psychomotor excitation or in an Eclipse of consciousness. In the future, there are generalized seizures and lactic acidosis. In addition, during intoxication with high doses of thioctic acid has been described hypoglycemia, shock, acute necrosis of skeletal muscles, hemolysis, disseminated intravascular coagulation, depression of bone marrow function and multiple organ failure.
Treatment. Even if you suspect severe intoxication drug alpha lipon (for example, using more than 20 tablets of 300 mg for adults, or a dose of 50 mg/kg of body weight in children) is recommended immediate hospitalization and the adoption of measures in case of accidental poisoning (e.g. vomiting, gastric lavage, administration of activated charcoal). The treatment of generalized seizures, lactic acidosis and other effects of intoxication, life-threatening, should be symptomatic and should be undertaken in accordance with the principles of modern intensive care. So far, the benefits of hemodialysis, hemoperfusion or filtration methods with forced thioctic acid withdrawal have not been confirmed.
on the part of the nervous system:change or disruption of taste.
from the gastrointestinal tract:nausea, vomiting, abdominal pain and gastrointestinal pain, diarrhea.
on the part of metabolism:reduction of blood sugar levels. There have been reports of complaints that indicate hypoglycemic conditions, namely dizziness, excessive sweating, headache and blurred vision.
the immune systemallergic reactions, including skin rashes, hives (urticarial rash), itching, shortness of breath.
Others:eczema (frequency estimation cannot be done according to available data).The
Store in its original packaging at a temperature not exceeding 25 ° C.
keep out of reach of children.The
for a dose of 300 mg. There are 10 tablets in blister, 3 blisters in a pack.
for a dose of 600 mg.6 tablets in a blister, 5 blisters in a pack.
there are 10 tablets in blister, 3 or 6 blisters in a pack.The
According to the recipe.The
PJSC "Kyiv vitamin factory".
04073, Ukraine, G.. Kyiv, Kopylivska, 38.
the Solution for injection "aktrapid NM" is used for the treatment of diabetes. The drug lowers blood sugar by uptake of tissue glucose after a bunch of insulin on fat cells and muscle receptors. Also, the solution inhibits the release of glucose from the liver. "Actrapid" based on the short-acting insulin, after injection the result observed for half an hour, and the maximum effect occurs within 2-3.5 hours. The product is valid for 8 hours.
the duration of excretion from the blood insulin a couple of minutes, and the duration of action of the drug depends on the dose of injected insulin, thickness of the subcutaneous tissue, stage of diabetes and site of injection.
among the contraindications of the drug revealed:
Daily insulin requirement for a person 0.3-1 IU/kg, however, depending on the age and severity of the disease, the dosage of the drug administration can be regulated by the attending physician. Also, the dosage varies with diseases of the endocrine system and kidneys.
Is the injection of the drug "Actrapid" for half an hour before meals, which in its composition contains carbohydrates.