Instructions Dialipon Turbo solution for infusions 1.2% bottle 50 ml No. 10
Composition
active ingredient: α-lipoic acid;
1 ml of solution contains 23.354 mg of alpha-lipoic acid meglumine salt, which corresponds to 12 mg of alpha-lipoic acid;
Excipients: meglumine, polyethylene glycol 300 (macrogol 300), water for injections.
Dosage form
Solution for infusion.
Main physicochemical properties: transparent yellow-green liquid.
Pharmacotherapeutic group
Drugs affecting the digestive system and metabolic processes. ATX code A16A X01.
Pharmacological properties
Pharmacodynamics
α-Lipoic acid is a substance that is synthesized in the body and functions as a coenzyme in the oxidative decarboxylation of α-keto acids; plays an important role in the process of energy formation in the cell. It helps to reduce blood sugar levels and increase the amount of glycogen in the liver. Lack or disruption of the metabolism of α-lipoic acid (thioctic acid) due to intoxication or excessive accumulation of certain decay products (for example, ketone bodies) leads to disruption of aerobic glycolysis. α-Lipoic acid can exist in two physiologically active forms (oxidized and reduced), which have antitoxic and antioxidant effects. α-Lipoic acid affects cholesterol metabolism, participates in the regulation of lipid and carbohydrate metabolism, improves liver function (due to hepatoprotective, antioxidant, detoxification effects). α-Lipoic acid is similar in pharmacological properties to B vitamins.
Pharmacokinetics
α-Lipoic acid undergoes significant changes during the first pass through the liver. There is significant intersubject variation in the systemic availability of α-lipoic acid. It is excreted by the kidneys mainly as metabolites. The formation of metabolites occurs as a result of side chain oxidation and conjugation. The half-life of Dialipon® Turbo from blood serum is 10–20 minutes.
Indication
Sensory impairment in diabetic polyneuropathy.
Contraindication
Hypersensitivity to α-lipoic acid or to other components of the drug.
Interaction with other medicinal products and other types of interactions
α-Lipoic acid may enhance the blood sugar-lowering effect of insulin and/or other antidiabetic agents, therefore, especially at the beginning of treatment with thioctic acid (α-lipoic acid), regular monitoring of blood sugar levels is indicated. To prevent the appearance of symptoms of hypoglycemia, in individual cases it may be necessary to reduce the dose of insulin or oral antidiabetic agents.
Ethanol reduces the therapeutic efficacy of α-lipoic acid.
Warning: Regular alcohol consumption is a significant risk factor for the development and progression of the clinical picture of neuropathy and, therefore, may negatively affect the course of treatment with the drug. Therefore, patients with diabetic neuropathy are usually advised to abstain from alcohol. Limiting alcohol consumption also applies to breaks between courses of treatment.
Application features
During intravenous administration of the drug Dialipon® Turbo, light-protective black bags should be used, which are placed on top of the vial.
The main factor in effective treatment of diabetic polyneuropathy is optimal correction of the patient's blood sugar level.
When using Dialipon® Turbo parenterally, there is a risk of allergic reactions, including anaphylactic shock, so patients should be monitored for such reactions. If signs such as itching, nausea, malaise appear, the drug should be immediately discontinued and the necessary therapeutic measures taken.
In isolated patients with decompensated or inadequately controlled diabetes mellitus and worsening general health, severe anaphylactic reactions associated with the use of the drug Dialipon® Turbo may develop.
During the treatment of polyneuropathy, due to regeneration processes, a short-term increase in sensitivity is possible, accompanied by paresthesia with a feeling of "crawling ants".
A certain limitation for intravenous administration of α-lipoic acid preparations is old age (over 75 years).
Cases of autoimmune insulin syndrome have been reported with α-lipoic acid treatment. Patients with certain human leukocyte antigen (HLA) genotypes, such as HLA-DRB1*04:06 and HLA-DRB1*04:03, are more likely to develop autoimmune insulin syndrome (a disorder of the hormones that regulate blood glucose with severe low blood sugar) with α-lipoic acid treatment. The HLA-DRB1*04:03 allele (odds ratio for susceptibility to autoimmune insulin syndrome 1.6) is primarily found in Caucasians and is more common in Southern Europe than in Northern Europe; the HLA-DRB1*04:06 allele (odds ratio for susceptibility to autoimmune insulin syndrome 56.6) is found primarily in patients from Japan and Korea.
The possibility of autoimmune insulin syndrome should be considered in various diagnoses of spontaneous hypoglycemia in patients receiving α-lipoic acid.
Ability to influence reaction speed when driving vehicles or other mechanisms
When using the drug, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
Use during pregnancy or breastfeeding
There is no sufficient experience of using the drug during pregnancy and breastfeeding, so it should not be prescribed during these periods.
Method of administration and doses
The drug should be administered directly from the vial (i.e. without solvent) as an intravenous drip infusion to adults at a dose of 600 mg per day (contents of 1 vial) for at least 30 minutes.
Due to the fact that α-lipoic acid is sensitive to light, the vials should be stored in the cardboard packaging until their immediate use.
At the beginning of therapy, administer the drug Dialipon® Turbo intravenously. The duration of the course is 2–4 weeks.
For further therapy, use oral forms of α-lipoic acid preparations at a dose of 300–600 mg per day.
Children
The efficacy and safety of the drug in children have not been established, so it should not be prescribed to this age group of patients.
Overdose
Symptoms: nausea, vomiting and headache are possible. When using very high doses of 10 to 40 g of α-lipoic acid in combination with alcohol, severe intoxication is observed, which can be fatal. The clinical picture of poisoning is initially manifested by psychomotor agitation or impaired consciousness and then proceeds with attacks of generalized convulsions and the development of lactic acidosis. The consequences of intoxication may be hypoglycemia, shock, rhabdomyolysis, hemolysis, acute skeletal muscle necrosis, disseminated intravascular coagulation, bone marrow suppression and multiorgan failure.
Treatment. If significant intoxication is suspected (intake of 6000 mg for an adult and > 50 mg/kg body weight for a child), immediate hospitalization and implementation of generally accepted measures are indicated. Treatment of generalized convulsive attacks, lactic acidosis and other consequences of intoxications that threaten the patient's life should comply with modern principles of intensive care and be carried out symptomatically. At present, there is no data on the feasibility of using hemodialysis, hemoperfusion or hemofiltration methods as part of the forced removal of α-lipoic acid.
Adverse reactions
Criteria for determining the frequency of adverse reactions: very common (≥ 10%), common (≥ 1% - < 10%), uncommon (≥ 0.1% - < 1%), rare (≥ 0.01% - 0.1%), very rare (< 0.01%), frequency unknown.
Injection site reactions: Very rare: reactions at the injection site.
Immune system disorders: Frequency unknown: insulin autoimmune syndrome.
Hypersensitivity reactions: allergic skin reactions, skin rashes, urticaria, itching, eczema, as well as systemic reactions up to the development of anaphylactic shock.
Central nervous system: Very rare: change or disturbance of taste.
After intravenous administration of α-lipoic acid, seizures and double vision (diplopia) have been observed very rarely.
From the blood system: after intravenous administration of α-lipoic acid, hemorrhagic rashes (purpura) and thrombopathies were very rarely observed.
General adverse reactions: with rapid intravenous administration, increased intracranial pressure and respiratory distress syndrome may very often be observed - these symptoms resolve on their own.
Due to improved glucose absorption, in some cases blood sugar levels may decrease, while very rarely symptoms similar to those of hypoglycemia are observed, such as dizziness, increased sweating, headache, and visual disturbances.
Expiration date
4 years.
Do not use the drug 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 reach of children.
Incompatibility
α-Lipoic acid reacts in vitro with metal ion complexes (e.g. cisplatin). With sugar molecules α-Lipoic acid forms poorly soluble complex compounds (e.g. levulose solution).
The α-lipoic acid solution is incompatible with glucose solution, Ringer's solution, and solutions that may react with SH groups or disulfide bonds.
Do not use with drugs containing metals (e.g. iron, magnesium).
If necessary, only saline solution can be used as a solvent for the administration of Dialipon® Turbo solution.
Packaging
50 ml per bottle. 10 bottles per pack.
Vacation category
According to the recipe.
Producer
JSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
