Expiration date: 09/2025
The composition and form of issue:
Thioctacid 600 T
Concentrate for solution for infusion 1 vials contains:
thioctic acid (in the form trometamol salt) 600 mg
excipients: trometamol water for injections
in a contour acheikova package 5 vials of dark glass, 24 ml in a cardboard pack 1 or 2 packs.
Thioctacid HR
Tablets, film-coated 1 tablet contains:
thioctic acid (&alpha-lipoic acid) 600 mg
excipients: nizkosoleva hydroxypropyl cellulose (L-HPC LH-22) hydroxypropyl cellulose (Klucel EF) magnesium stearate
shell: hypromellose (hydroxypropylmethyl cellulose) macrogol 6000 talc titanium dioxide (E171) quinoline yellow aluminium salt (E104) Indigo Carmine aluminium salt (E132)
in dark glass bottles for 30 tables. in the box 1 vial.
Description pharmaceutical form:
The solution for the on/in the introduction: clear, yellowish solution.
Tablets: green-yellow biconvex oblong tablet, coated.
Pharmacokinetics:
Thioctacid HR
When ingestion rapidly and completely absorbed from the gastrointestinal tract. Simultaneous food intake may reduce the absorption of the drug. Cmax in blood plasma after taking 1 tab. Of thioctacid HR is 4 mcg/ml and the time to achieve 25 to 30 min. Has the effect of "first passage" through the liver. The relative bioavailability of Thioctacid HR more than 60%. T1/2 of 25 minutes in the Main path of metabolism — oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%).
Description pharmacological action:
Thioctic (&alpha-lipoic acid) is involved in mitochondrial metabolism in the cell, functions as a coenzyme in the complex transformation of substances having pronounced anti-toxic effect. They protect the cells from free radicals produced in intermediate metabolism or the decay of exogenous foreign substances and heavy metals. Known synergistic effect of &alpha-lipoic acid against insulin on enhancing utilization of glucose. Patients with diabetes thioctic acid leads to a change in the concentration of pyruvic acid in the blood.
Indications:
- Treatment of symptoms of peripheral (sensory-motor), diabetic polyneuropathy.
Contraindications:
- hypersensitivity to thioctic (&alpha-lipoic) acid or other components of the drug
- childhood and adolescence (there are no clinical data on the use of drugs in children and adolescents).
Application of pregnancy and breast-feeding:
The available data on the impact on reproductive performance do not allow to draw conclusions about the harmful effects on the fetus.
Use the drug during pregnancy is possible only in the case when the expected benefit to the mother outweighs risk to the fetus and under the strict supervision of a physician.
Unknown, does thioctic (&alpha-lipoic acid) in breast milk, so the time of treatment should stop breastfeeding.
Side effects:
Thioctacid 600 T
With the rapid on/in the introduction sometimes there is increased intracranial pressure and breath holding, which pass on their own.
Possible allergic reactions such as skin rash, hives, itching, and systemic allergic reactions up to anaphylactic shock.
In some cases after I/V administration were observed convulsions, diplopia, point bleeding and tendency to bleeding (due to dysfunction of platelets).
Thioctacid HR
In some cases, the development of such gastrointestinal symptoms as nausea, vomiting, abdominal pain, diarrhea.
Sometimes there may be allergic reactions: skin rash, hives, itching.
For both drugs
In some cases, due to improved glucose utilization can decrease its level in the blood. With the possible development of hypoglycemia, the symptoms of which include dizziness, sweating, headache, disorders of vision.
Drug interactions:
Thioctacid 600 T
Thioctacid HR
While the appointment of a reduction in the effectiveness of cisplatin. These drugs bind metals, so it should not be administered concurrently with drugs, containing metals (e.g. iron preparations, magnesium, calcium-containing dairy products).
With simultaneous use may increase the action of insulin and antidiabetic drugs for oral administration, it is therefore recommended that regular monitoring of glucose levels in the blood, especially in the beginning of treatment with Thioctacid 600 T or Thioctacid® BV. In some cases it is possible to reduce the dose of hypoglycemic medications to avoid the development of symptoms of hypoglycemia (too low blood glucose level).
If Thioctacid HR take 30 minutes before Breakfast, preparations containing iron or magnesium, can be taken day or evening.
Alcohol can reduce the effectiveness of Thioctacid HR. Therefore, patients are advised to refrain from taking alcoholic beverages during treatment with the drug.
Method of application and dose:
Thioctacid 600 T
In/in slowly (not faster than 50 mg thioctic acid, 2 ml of a solution of Thioctacid 600 T / min).
It is possible in/with the introduction of the undiluted solution via a syringe for injection and perfusor, in this case, the time of administration should be not less than 12 min.
Daily dose of early treatment when expressed violations of sensitivity in severe diabetic polyneuropathy is 1 amp. Of thioctacid 600 T (equivalent to 600 mg thioctic acid) for 2-4 weeks. In the future, can be assigned to 300 mg of thioctic acid per day.
Due to the sensitivity of active substance to the light, the vials should be removed from their cartons until immediately before use.
Recommendations for infusion
Thioctacid 600 T can be used in the form of infusion in isotonic sodium chloride solution (diluted to 100-250 ml) for 30 min.
The infusion solution should be protected from light (e.g. aluminium foil).
Solution for injection, protected from light, use within 6 hours In a solvent for intravenous solution of Thioctacid 600 T to use only isotonic solution of sodium chloride.
Thioctacid HR
Inside, erh, 30 minutes before Breakfast without chewing and drinking plenty of water. It is recommended to take 1 table. Of thioctacid HR (equivalent to 600 mg thioctic acid), 1 time per day.
Overdose:
Thioctacid HR
Symptoms: in case of thioctic (&alpha-lipoic) acid in a dose of from 10 to 40 g, especially when combined with alcohol, there are serious signs of intoxication, as generalized convulsive seizures marked disorders of acid-base balance, leading to lactic acid acidosis hypoglycemic coma severe blood clotting disorder, which sometimes results in a fatal outcome.
Treatment: when suspected drug intoxication (e.g. taking more than 10 table. adults or 50 mg/kg child) need immediate hospitalization with conducting General therapeutic measures of detoxification (artificial vomiting, gastric lavage, administration of activated charcoal, etc.) and symptomatic therapy.
Precautions:
If there are any side effects should consult a doctor.
Constant use of alcohol is a risk factor for the development of polyneuropathy and can reduce the effectiveness of Thioctacid 600 T. Therefore, patients are advised to refrain from taking alcoholic beverages during the treatment and in periods out of treatment.
