Composition
Active ingredient:
thioctic acid (lipoic acid) – 300 mg.
Core Excipients:
silicon dioxide colloidal (Aerosil) – 7.5 mg,
microcrystalline cellulose – 50 mg,
hypromellose (oksipropilmetiltselljuloza) – 5 mg,
carboximetilkrahmal sodium (primogel) of 17.5 mg
magnesium stearate 5 mg,
calcium stearate monohydrate 5 mg,
sodium fumarate 5 mg,
magnesium hydrosilicate (talc) – 13.5 mg,
lactose monohydrate (milk sugar) – 91,5 mg.
Pharmacological action
The drug is an endogenous antioxidant that binds free radicals. Thioctic (α-lipoic) acid participates in the mitochondrial metabolism of the cell, it performs the function of a coenzyme in the complex of transformation of substances with a pronounced antitoxic effect. They protect the cell from reactive radicals that occur during intermediate metabolism or during the breakdown of exogenous foreign substances, and from heavy metals. Thioctic acid shows synergism with respect to insulin, which is associated with increased glucose utilization. In patients with diabetes mellitus, thioctic acid leads to a change in the concentration of pyruvic acid in the blood.
Indications
Diabetic polyneuropathy and alcoholic polyneuropathy.
Use during pregnancy and lactation
Contraindicated in pregnancy. Breast-feeding should be discontinued for the duration of treatment.
Contraindications
- Pregnancy.
- Breast-feeding period (there is no sufficient experience of using the drug).
- Hypersensitivity to the components of Thiolipone.
- Children under 18 years of age (efficacy and safety of use have not been established).
- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
With caution, the drug should be used with caution in patients suffering from diabetes mellitus (it may be necessary to adjust the dose of hypoglycemic agents), as well as chronic alcoholism.
Side effects
Possible dyspepsia, including nausea, vomiting, heartburn. In some cases, allergic skin reactions (urticaria) may develop. Anaphylactic shock. Hypoglycemia may occur (due to improved glucose uptake).
Interaction
When used simultaneously, thioctic acid enhances the effect of insulin and oral hypoglycemic agents. Alcohol (ethanol) reduces the therapeutic activity of thioctic acid. Thioctic acid reacts with ionic complexes of metals (for example, with cisplatin), so the effect of cisplatin can be reduced with simultaneous use of the drug Thiolipone. After taking Thiolipone in the morning, it is recommended to use iron and magnesium preparations, as well as to consume dairy products (due to the calcium content in them) in the afternoon or in the evening.
How to take, course of use and dosage
Inside 600 mg 1 time a day. Tablets are taken on an empty stomach, approximately 30 minutes before the first meal, without chewing and with a small amount of water.
The minimum course of therapy is 3 months. In some cases, taking the drug involves a longer treatment, the duration of which is determined by the doctor.
Overdose
Symptoms: headache, nausea, vomiting.
Treatment: symptomatic. There is no specific antidote.
Special instructions
In patients with diabetes mellitus, constant monitoring of blood glucose concentration is necessary, especially at the initial stage of therapy. In some cases, it is necessary to reduce the dose of insulin or an oral hypoglycemic drug to avoid the development of hypoglycemia. During hypoglycemia, the concentration ability and reaction rate required to drive a car or operate machinery may be impaired. Patients taking Thiolipone should refrain from drinking alcohol. Influence on the ability to drive vehicles and mechanisms. The drug does not affect the ability to drive vehicles and work with mechanisms that require increased attention.
Form of production
Film-coated tablets
Storage conditions
In a dark place at a temperature not exceeding 25°C.
Shelf
life is 3 years.
Active ingredient
Thioctic acid
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Description
For adults as directed by your doctor
Indications
Type 1 Diabetes, Type 2 Diabetes, Polyneuropathy
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