Description overdue on 07/17/2014
- Latin name: Thiogamma
- ATC code: A16AX01
- Active substance: Thioctic acid (Thioctic acid)
- Manufacturer: Vervag Pharma GmbH & Co. KG. KG (Worwag Pharma GmbH & Co. KG), Boeblingen, Germany
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications
- Contraindications
- Side effects
- Tiogamma, instructions for use (method and dosage)
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Cautions
- Analogs
- Synonyms
- Babies
- During pregnancy (and lactation)
- Reviews
- Price, where to buy
Composition
Concentrate for solution It consists of the following components:
- meglumine tioktat (acting as the main active substance) - 1167, 7 mg (in terms of weight corresponds to 600 mg thioctic acid );
- macrogol 300 - 4000 mg;
- meglumine - 6-18 mg;
- Purified water for injection - up to 20 ml.
Solution for infusion It has such components as:
- meglumine salt of thioctic acid - 1167, 7 mg (corresponding to 600 mg thioctic acid in dry matter);
- macrogol 300 - 4000 mg;
- meglumine ;
- Water for injection - up to 50 ml.
Pills comprise:
- thioctic acid - 600 mg;
- microcrystalline cellulose (MCC) - 49 mg;
- lactose monohydrate - 49 mg;
- talc - 36, 364 mg;
- hypromellose - 25 mg;
- colloidal silica - 25 mg;
- carmellose sodium - 16 mg;
- magnesium stearate - 16 mg;
- - 3, 636 mg (desired ratio dimethicone and colloidal silica - 94: 6).
The shell of each tablet comprises:
- hypromellose - 2, 8 mg;
- talc - 2 mg;
- Macrogol 6000 - 0, 6 mg;
- Sodium lauryl sulfate - 0, 025 mg.
Product form
The pharmacy pharmaceutical preparations available in the following variations:
- in vials of 20 ml each yellow or greenish-yellow. The vials are made of brown glass type I, each marked with white paint as a point. Cardboard tray delimited under section accommodates 5 vials. The pack consists of 1, 2 or 4 plates and a false case, providing light protection, which is made of black PE.
- Transparent Ready solution for infusion administration light yellow or green tint, 50 ml vials of glass type cinnamon II, each of which is closed with a rubber stopper. Recent fixed to the bottle by aluminum cap with a polypropylene gasket on top. The pack is placed on 1 or 10 vials, separated by cardboard partitions, complete with overhead Sun Shield Case on the number of vials.
- Oblong and lenticular 600 mg Tablets packed into blisters of PVC or aluminum foil of 10 pieces each. Tablets are light yellow with splashes of white and yellow color of varying intensity. On both surfaces are typical risks. The cross section shows a tablet core and a light yellow color, covered with a dense shell. The carton is usually accommodates 3, 6 or 10 contour plates.
Pharmacological action
The main active component of the pharmaceutical preparation Tiogamma, regardless of the form of release is thioctic or alpha-lipoic acid (two names for the same active compound). This is a natural part of the metabolism, that is normal, this acid is formed in the body and serves as the mitochondrial coenzyme complexes energy metabolism of pyruvic acid and alpha-keto acids by oxidative decarboxylation of ways. Also thioctic acid - is an endogenous antioxidant As it is able to bind free radicals and safeguard the cells from their destructive action thereby.
Part of the important role of the drug and . It reduces glucose circulating freely in the blood and accumulation of glycogen in the liver cells. Due to this property, thioctic acid reduces cells, that is, the physiological response to this hormone passes more actively.
Participates in regulation of lipid metabolism . Particularly noticeable influence on the metabolism of the active substance cholesterol as hypocholesterolemic agents - acid reduces circulating lipid low and very low density and increase the percentage of high-density lipids in blood serum). That is thioctic acid has a certain and cleans the micro and makrotsirkulyatornoe direction from the excess fat.
Detoxification effect the pharmaceutical preparation can also be seen in cases of poisoning by salts of heavy metals and other forms of intoxication . This action is driven by activation of processes in the liver, thereby improving its function. However, thioctic acid is not conducive to the physiological exhaustion of its reserves, but on the contrary has a strong hepatoprotective properties .
It should be noted that the drugs on the basis of alpha-lipoic acid are widely used in the diabetes As constituent components help reduce the formation of advanced glycation end metabolites and increase the content of glutathione to physiologically normal parameters. Also improves trophic nerves endoneural and blood flow, which leads to a qualitative improvement of the state of generalized peripheral nerve fibers and prevents the development of diabetes polyneuropathy (nosological unit that develops as a result of nerve damage to the pillars elevated glucose and its metabolites).
By its pharmacological properties (hepato- and nervoprotektornomu, of detoxification, antioxidant, hypoglycemic, and many others) like thioctic acid Vitamins Group B .
Cosmetology through the following pharmacological effects on skin
- removes hypersensitivity ;
- pulling the skin folds, reduces wrinkles Making them invisible even in difficult areas such as the corners of the eyes and lips;
- heals marks acne (acne), and As well as penetrating the intercellular substance that stimulates the normal operation of the repair mechanisms;
- sebaceous glands , Thus eliminating the problems of oily or greasy skin;
- It acts as a powerful antioxidant endogenous origin.
Pharmacodynamics and pharmacokinetics
With oral It should be noted that the simultaneous use of the drug with food intake reduces the absorbability Tiogammy. After the first passage through the liver, a significant portion of the active component undergoes irreversible changes (in the pharmaceutical literature, this phenomenon is described as the effect of the first passage ) Because the bioavailability of the drug is from 30 to 60 percent, depending on the individual metabolic capacity of the organism.
Tiogamma for medicine droppers The period of delivery into the systemic circulation is about 10-11 minutes, and the maximum plasma concentration in this case - 20 ug / ml.
Metabolised drug, regardless of the form used, liver by oxidation of a side chain and further conjugation. Plasma clearance - 10-15 ml / min. Thioctic acid and its metabolites output predominantly kidney (about 80-90 percent). The small amount of urine is found not changed integral component of the pharmaceutical preparation. The half-life of the drug Tiogamma 600 (figure 600 indicates the weight content of alpha-lipoic acid on dry) - 25 minutes, and the enhanced form of the drug called Tiogamma Turbo - From 10 to 20 minutes.
Indications
- Diabetic neuropathy ;
- alcohol damage nerve trunks;
- liver disease - and cirrhosis of different origin, fatty degeneration of hepatocytes;
- or peripheral sensory-motor polyneuropathy ;
- intoxication with severe manifestations (eg, salts of heavy metals or fungi).
Contraindications
- acquired or hereditary intolerance integral components of a pharmaceutical preparation;
- Children age ;
- during pregnancy and breastfeeding;
- severe dysfunction of kidney or liver (especially jaundice any origin);
- acute phase flow myocardial infarction ;
- decompensated stage cardiovascular or respiratory insufficiency ;
- stomach ulcer or expressed hyperacid gastritis ;
- dehydration and exsicosis;
- chronic alcoholism ;
- decompensated form Diabetes ;
- sharp cerebrovascular accidents ;
- predisposition to develop lactic acidosis (in particular to the form of preparation for parenteral administration);
- malabsorption
Side effects
- On the side blood coagulation : Petechial hemorrhages in the form purpura (purpura) thrombophlebitis . thrombocytopenia .
- On the side Nervous System : dizziness . headache , Increased sweating, rarely - ballism individual muscles.
- On the side : violation of the visual apparatus due to hypoglycemic conditions (reducing the concentration of free glucose in serum), which mainly manifests as diplopia .
- Alimentary tract (for tablets and Tiogamma Tiogamma Turbo for parenteral administration): dyspepsia Rarely - a violation of the sensitivity of the flavoring apparatus.
- Local reactions: local redness . eczema or hives at the injection site.
- When unduly rapid intravenous drug - increased intracranial pressure and disorder of the respiratory cycle ( dyspnea ).
- Others - allergic conditions until anaphylactic shock .
Tiogamma, instructions for use (method and dosage)
Instructions for use Tiogammy varies considerably depending on the pharmaceutical form of the drug.
600 mg Tablets applied orally, once a day. Do not chew them, as it can damage the lining, it is recommended to wash down with a little water. The duration of the course prescribed individually by the attending physician, because it depends on the extent of the disease.
used for parenteral administration by intravenous drip infusion. The daily dosage of 600 mg once a day 1 - calculated on the contents of one vial or ampoule. The course of this form of therapy of the drug is from 2 to 4 weeks (duration less conservative treatment performance due to higher peak plasma concentrations after parenteral administration).
Concentrate for intravenous infusion is used as follows: the contents of 1 ampoule (in terms of the main active substance - 600 mg thioctic acid) is mixed with 50-250 isotonic (0, 9 per cent) sodium chloride solution. Immediately following the preparation of a mixture of medical vial served light protective sheath (mandatory drug is available in a complete set on the basis of one case for one bottle of the drug). Immediately the solution is administered by intravenous drip infusion over 20-30 minutes. The maximum period of storage of the prepared solution Tiogamma - no more than 6 hours.
Tiogamma can be used for skin care. For this applies pharmaceutical form for medicine droppers in bottles (ampoules with a concentrate for the preparation of infusions are unsuitable as a cosmetic, as may cause allergic reactions because of the large amount of active ingredient). The contents of one vial is applied to a clean surface of all skin twice a day - in the morning and evening. Before such manipulation is recommended to wash with warm, soapy water in order to clean the entrance gate has deep penetration of thioctic acid.
Overdose
- increased side effects;
- Intensive headache ;
- vomiting and not passing nausea ;
- psychomotor agitation ;
- disturbances of consciousness ;
- seizures or generalized seizures;
- lactic acidosis ;
- hypoglycemic coma ;
- acute circulatory failure - shock ;
- disseminated intravascular clotting ;
- Bone marrow depression;
- multiple organ failure .
Specific antagonists for drug does not exist, therefore the state of overdose symptomatic docked. If the drug is used in the form of tablets, it is recommended wash out the stomach chelators (eg, Activated carbon including the mass of the patient) and medication to induce vomiting as soon as possible after admission.
If you use the parenteral administration of a pharmaceutical preparation, it shows actions such as the introduction of analgesics In order to stop the headache and other drugs as possible to facilitate the patient's condition. Treatment of generalized epileptic seizures, lactic acidosis modern intensive care protocols .
Cooperation
Cisplatin
Preparations containing metal ion (e.g., iron-based) do not exert their therapeutic effect, as the active component binds Tiogammy metals and safely removes them from the body.
Enhanced anti-inflammatory effect glucocorticoid steroids when combined with the use of thioctic acid in Scheme conservative therapy.
Combined use oral hypoglycemic agents and Insulin during treatment Tiogammoy enhances therapeutic effects antidiabetic drugs Because when taking alpha-lipoic acid in patients with diabetes should be adjusted accordingly rehabilitation course of diabetes.
Ethanol and the products of its metabolism weaken the pharmacological action alpha-lipoic acid Contribute to the development or progression of neuropathic disease further, because the use of alcoholic alcoholic beverages during treatment with this drug is not recommended.
To concentrate Tiogammy and other pharmaceutical forms of the drug there is an additional list of interactions:
- Incompatible use thioctic acid with solutions Dextrose , Crystalloid solution Ringer or means binding disulfide or sulfhydryl groups .
- Sugar molecule (e.g., from solutions Levulёzy or Fructose ) Form a poorly soluble complexes with the main component Tiogammy.
Terms of sale
Tiogamma sold strictly on assurances receptor Form.
Storage conditions
-Saving medication in a dry, dark place at temperature no higher than 25 degrees Celsius. Tiogamma also be available for children.
Shelf life
5 years.
Cautions
The pharmaceutical preparation may be used as a cosmetic skin-care facial skin. The active ingredients have powerful antioxidant properties and at least a strong tonic effect because Tiogamma face became very popular in the conservative cosmetology as tightening tonic. How to use Tiogammu peeling of the skin can be found in the instructions to the drug.
Treatment According to the pharmaceutical product does not affect the ability to concentrate for long periods or assiduous attention because DMV or work with other complex mechanisms, potentially dangerous for the life, is not forbidden during the course of conservative therapy.
Analogs Tiogammy
- Mummies
- Omez JEM
- Oktolipen
- Thioctacid
- Figurin
- Actovegin
- Berlition
Analogs Tiogammy make up quite a large group of pharmaceuticals, as provided by the therapeutic effects are now in high demand. Where it is easier to use drugs to prevent severe neuropathies, than to treat them afterwards in a conservative manner, passing a long and exhausting course of drug therapy. So on a par with Tiogammoy used: Valium 300 . Neyrolipon and Oktolipen .
Synonyms
Thioctic acid . lipoic acid . Lipotiokson . Thioctacid .
Babies
The pharmaceutical preparation is strictly contraindicated for use in pediatric patients, as they may develop severe consequences in terms of side effects, which in children is especially difficult cropped.
During pregnancy and lactation
During pregnancy and lactation, the use of the drug is contraindicated due to the possible impact on the child.
Reviews Tiogamme
The pharmaceutical preparation is very popular among patients with diabetes or predisposition to neuropathies . Since Tiogamma provides prophylactic treatment of diseases of the peripheral nervous system and does not allow to lose the ability to work for many years. Due to the relatively short rate can protect yourself from the very serious consequences endocrine pathology .
including occasional seizures).
Experienced physicians and qualified pharmacists are also pleased Tiogammoy because it abundantly used in the hospital.
- pills
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