Name:
Alpha-lipon. Forms of release Tablets. MHNT thioctic acid. FTH Metabolic agent.
Description:
Pills are round, biconvex, film-coated, yellow. Composition 1 tablet contains alpha-lipoic (thioctic) acid 300 mg; excipients: lactose monohydrate, magnesium stearate, sodium croscarmellose, microcrystalline cellulose, corn starch, sodium lauryl sulfate, anhydrous colloidal silicon dioxide; Shell: Opadry II Yellow Film Coating Blend (Lactose Monohydrate, Hypromellose (Hydroxypropyl Methylcellulose), Polyethylene Glycol (Macrogol), Indigotine (E 132), Sunset Yellow FCF (E 110), Quinoline Yellow (E 104), Titanium Dioxide (E 171) , triacetin). Pharmacotherapeutic group Other drugs used in diseases of the digestive system and metabolic disorders. ATH A16A X01. Pharmacological properties Pharmacodynamics. Thioctic acid (α-lipoic) acid acts as a coenzyme in the oxidative decarboxylation of α-keto acids. α-lipoic acid helps to reduce the end products of glycosylation, improve endoneural blood flow, increase the level of glutathione in patients with diabetes mellitus. In preclinical studies of α-lipoic acid, an improvement in trophic processes in neurons has been shown. In clinical studies in patients with diabetic polyneuropathy, the administration of α-lipoic acid led to a decrease in sensory disorders that accompany diabetic polyneuropathy (pain, paresthesia, dysesthesia, numbness). Pharmacokinetics. After oral administration, α-lipoic acid is rapidly absorbed from the gastrointestinal tract. Absolute oral bioavailability is about 20%. The relative bioavailability of thioctic acid in oral administration of solid dosage forms is over 60% in proportion to the drinking solution. The maximum plasma concentration is approximately 4 mg / ml and is reached approximately 0.5 hours after ingestion of 600 mg of α-lipoic acid. It is excreted by the kidneys (80-90%), mainly in the form of metabolites. The formation of metabolites occurs due to side chain oxidation (beta-oxidation) and/or by S-methylation. The half-life of α-lipoic acid from serum is about 25 minutes. Indications Treatment of symptoms of peripheral (sensory-motor) diabetic polyneuropathy. Contraindications Hypersensitivity to alpha-lipoic acid or other components of the drug. This drug is not prescribed for children and adolescents under 18 years of age, since there are no clinical data on the use of the drug in this category of patients. Interaction with other drugs The drug may reduce the effectiveness of cisplatin when used simultaneously. Alpha lipoic acid can bind metals. Therefore, it should not be given concomitantly with drugs containing metals (eg, iron, magnesium, dairy products because they contain calcium). If Alpha-lipon is taken 30 minutes before breakfast, then preparations that contain iron or magnesium can be taken at lunch or in the evening. It is possible to increase the hypoglycemic effect when using insulin or oral hypoglycemic agents. Therefore, constant monitoring of blood sugar levels is necessary, especially at the initial stage of prescribing alpha-lipoic acid. In some cases, it is necessary to reduce the dose of insulin or oral hypoglycemic drugs. If you are taking any other medicines, consult your doctor about the possibility of using the drug. Precautions Before starting treatment, consult your doctor! In the treatment of patients with diabetes, it is necessary to control the level of sugar in the blood. In some cases, it is necessary to adjust the dose of hypoglycemic agents to prevent hypoglycemia. Regular alcohol consumption is a significant risk factor for the development and progression of polyneuropathy and may interfere with treatment success. Patients with diabetic polyneuropathy are advised to refrain from drinking alcohol. The restriction of alcohol consumption also applies to breaks between courses of treatment. After the use of thioctic acid, a change in the smell of urine is possible, which has no clinical significance. The drug contains lactose, so it should not be used in patients with rare hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome. Dye E 110, which is part of the tablet shell, can cause allergic reactions. Application in children. The drug is not prescribed for children and adolescents under 18 years of age due to the lack of clinical data. Use during pregnancy or lactation The use of thioctic acid during pregnancy is not recommended due to the lack of relevant clinical data. There are no data on the transition of thioctic acid into breast milk, so it is not recommended to use it during breastfeeding. The ability to influence the reaction rate when driving vehicles or other mechanisms In case of signs of adverse reactions from the nervous system, it is necessary to refrain from driving vehicles and working with moving mechanisms. Dosing and Administration The drug is taken in a daily dose of 600 mg 1 time per day. The drug is taken without chewing, drinking plenty of liquid. The simultaneous use of food can affect the absorption of the drug, so it is important to take the tablets 30 minutes before breakfast. It is recommended to take the drug in the morning. Since diabetic polyneuropathy is a chronic disease, long-term therapy may be needed. The attending physician selects the treatment in each individual case. The basis of the treatment of diabetic polyneuropathy is the optimal treatment of diabetes mellitus. Overdose In some cases, especially when combined with alcohol, when taking more than 10 g of alpha-lipoic acid, serious, even life-threatening signs of intoxication were observed (such as generalized convulsive seizures, severe acid-base balance disorders leading to lactic acidosis, severe blood clotting disorders) . After taking large doses of alpha-lipoic acid, shock, acute skeletal muscle necrosis, hemolysis, disseminated intravascular coagulation (DIC), bone marrow depression and multiple organ failure can develop. At the slightest concern about possible intoxication with the drug (for example, when taking more than 20 tablets of 300 mg or more than 50 mg per kilogram of the child’s weight), immediate hospitalization is indicated with general therapeutic detoxification measures (for example, artificial induction of vomiting, gastric lavage, activated charcoal and etc.), in the treatment of possible consequences and signs, it is necessary to be guided by the principles of modern intensive care and a symptomatic approach. Side effects Adverse reactions are classified according to their frequency of occurrence: very often (> 1/10), often (from 1/10 to 1/100), infrequently (from 1/1000 to 1/100), rarely (from 1/10,000 to 1/1000), very rare (<1/10,000). From the nervous system: often - dizziness; very rarely - a change in taste sensations. From the gastrointestinal tract: often - nausea; very rarely - gastrointestinal disorders such as vomiting, pain in the stomach and intestines, diarrhea. Metabolic disorders: very rarely - a decrease in blood sugar levels. There have been reports of symptoms of hypoglycemic conditions - dizziness, increased sweating, headache and visual disturbances. Immune system disorders: very rarely - allergic reactions (skin rash, urticaria, itching). Others: frequency unknown - shortness of breath, eczema. In case of any adverse reactions, you should consult your doctor! Shelf life 3 years. The drug should not be used after the expiration date indicated on the package. Storage conditions Store in the original packaging at a temperature not exceeding 25 °C. Keep out of the reach of children. Leave conditions By prescription. Packing: 10 tablets in a blister made of PVC film and printed lacquered aluminum foil. 3 or 6 blisters, together with a leaflet, are put into a pack of cardboard for consumer packaging. Buy Alpha-lipon tablets p/o 300mg №10x3 Price for Alpha-lipon tablets p/o 300mg №10x3
INN | THIOCTIC ACID |
---|---|
The code | 133 428 |
Barcode | 4 820 011 186 939 |
Active substance | Thioctic acid |
Manufacturer | Kyiv Vitamin Plant PJSC, Ukraine |
Importer | UE "MedPharmInvest", Minsk, Republic of Belarus, Minsk region, Minsk district, Papernyansky village, 50/1-1 district, Dubovlyany village |
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