TIOGAMMA
Active material: Thioctic acid
When ATH: A16AX01
CCF: Preparation, regulates lipid and carbohydrate metabolism
ICD-10 codes (testimony): G63.2
When CSF: 02.11.01
Manufacturer: WÖRWAG PHARMA GmbH & Co. KG (Germany)
Pharmaceutical form, composition and packaging
Pills, coated pale yellow color with white patches, kapsulovidnoy form, scored on both sides.
| 1 tab. | |
| thioctic acid | 600 mg |
Excipients: microcrystalline cellulose, lactose, talc, colloidal silicon dioxide, gipromelloza, lactose monohydrate, sodium carboxymethylcellulose, simethicone, magnesium stearate, macrogol 6000, sodium lauryl.
10 PC. – blisters (3) – packs cardboard.
10 PC. – blisters (6) – packs cardboard.
10 PC. – blisters (10) – packs cardboard.
Concentrate for solution for infusion a clear solution was yellowish green color.
| 1 ml | 1 amp. | |
| thioctic acid meglumine salt | 58.385 mg | 1167.7 mg, |
| that respectively. thioctic acid content | 30 mg | 600 mg |
Excipients: meglumine, macrogol 300, water d / and.
20 ml – vials of dark glass (5) – Cardboard trays (1) – packs cardboard.
20 ml – vials of dark glass (5) – Cardboard trays (2) – packs cardboard.
20 ml – vials of dark glass (5) – Cardboard trays (4) – packs cardboard.
Solution for infusion light yellow or yellowish-green color, clear.
| 1 ml | 1 fl. | |
| thioctic acid meglumine salt | 23.354 mg | 1167.7 mg, |
| that respectively. thioctic acid content | 12 mg | 600 mg |
Excipients: meglumine, macrogol 300, water d / and.
50 ml – vials of dark glass (1) – packs cardboard.
50 ml – vials of dark glass (10) – packs cardboard.
Pharmacological action
Metabolic drug. Thioctic (a-липоевая) acid – эndogennыy antioxidant (It binds free radicals), synthesized in the body from the oxidative decarboxylation of alpha-keto acids. As coenzyme mitochondrial multienzyme complexes involved in the oxidative decarboxylation of pyruvic acid and alpha-keto acid. Thereby reducing the concentration of glucose in the blood and increased glycogen content in the liver, and overcome insulin resistance.
By the nature of the biochemical steps thioctic acid is close to the B vitamins. It participates in the regulation of lipid and carbohydrate metabolism, stimulates metabolism of cholesterol, improves liver function. It has hepatoprotective, gipolipidemicescoe, hypocholesterolemic and hypoglycemic effect. Improves trophic neurons.
The use of solutions for on / in the meglumine salt of thioctic acid (having a neutral reaction) It can reduce the severity of side effects.
Pharmacokinetics
Absorption
After oral thioctic acid is rapidly and almost completely absorbed from the gastrointestinal tract. At simultaneous reception with food absorption is reduced. Tmax is 40-60 m. Bioavailability – 30%.
The on / in a Tmax is 10-11 m, Cmax – 25-38 ug / ml, AUC – 5 g × h / ml.
Distribution
Vd – about 450 ml / kg.
Metabolism
Treated effect “first pass” through the liver. The formation of metabolites occurs as a result of oxidation of the side chain conjugation.
Deduction
Thioctic acid and its metabolites 80-90% the kidneys. T1/2 is 20-50 m. The total plasma clearance – 10-15 ml / min.
Testimony
- Diabetic polyneuropathy.
Dosage regimen
Inside appoint 300-600 mg 1 time / day.
The tablets are not liquid, drinking a small amount of liquid.
The drug is also administered in / dose 600 mg / day (1 amp. concentrate for solution for infusion 30 mg / ml or 1 vial of solution for infusion 12 mg / ml).
At the beginning of treatment is recommended to introduce the drug in / for 2-4 weeks. Then you can continue taking the drug orally at a dose 300-600 mg / day. During the I / infusion should be administered slowly, at no more than 50 mg / min (equivalent 1.7 ml concentrate for solution for infusion 30 mg / ml).
Terms of preparation and administration of infusion solution
To prepare the infusion solution The contents 1 ampoule 20 ml (equivalent to that of thioctic acid 600 mg) mixed with 50-250 ml 0.9% solution of sodium chloride and administered as an infusion for 20-30 m. Infusions made from bottles, which are placed in the attached pendant dimming Cases, made of polyethylene black.
In the application of the solution for infusion in vials 50 ml (equivalent to that of thioctic acid 600 mg) infusion produced directly from these vials, which are placed in the attached pendant dimming Cases, made of polyethylene black.
Side effect
From the digestive system: while taking the drug inside – dyspepsia (incl. nausea, vomiting, heartburn).
CNS: rarely (After the on / in administration) – convulsions, diplopia; the rapid introduction – intracranial hypertension (the emergence of a feeling of heaviness in the head).
From the blood coagulation system: rarely (After the on / in administration) – petechial hemorrhages in mucous membranes, skin, thrombocytopenia, Hemorrhagic rash (purpura), tromboflebit.
The respiratory system: with the rapid on / in a possible difficulty in breathing.
These side effects are independently.
Allergic reactions: hives, systemic reactions (until the development of anaphylactic shock).
Other: may develop hypoglycemia (in connection with the improvement of glucose uptake).
Contraindications
- Pregnancy;
- Lactation (breast-feeding);
- Children's age (efficacy and safety have not been established);
- Hypersensitivity to the drug.
Pregnancy and lactation
The drug Tiogamma® contraindicated during pregnancy and lactation (breast-feeding).
Cautions
Patients, receiving the drug Tiogamma®, should refrain from drinking alcohol.
Patients with diabetes mellitus during treatment with Tiogamma®, especially early in treatment, you need to control the level of glucose in the blood. In some cases it may be necessary to adjust the dose of insulin or oral hypoglycemic agents in order to avoid hypoglycaemia.
Overdose
Symptoms: nausea, vomiting, headache.
Treatment: symptomatic therapy. No specific antidote.
Drug Interactions
In a joint application Tiogamma® as a solution for infusion may reduce the effectiveness of cisplatin.
In an application Tiogamma® It enhances the action of insulin and oral hypoglycemic agents.
At simultaneous reception with ethanol reduced therapeutic efficacy thioctic acid.
Pharmaceutical interaction
In vitro thioctic acid reacts with the metal ion complex (eg, cisplatin), and forms poorly soluble complexes with sugar molecules. Hence, infusion solution is incompatible with dextrose, Ringer's solution and solutions, which can react with substances, Have SH-groups or disulfide bonds.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug is in the form of tablets should be stored in a dry place at temperatures no higher than 25 ° C. Shelf life – 3 year.
The drug is in the form of a concentrate for solution for infusion in vials and solution for infusion vials must be stored in a dark place at a temperature no higher than 25 ° C. Shelf life – 5 years.
Vials and ampoules should be stored in the primary packaging to the direct application.
The drug should be stored in places, inaccessible to children.
