OKTOLIPEN
Active material: Thioctic acid
When ATH: A16AX01
CCF: The drug with antioxidant action, regulates carbohydrate and lipid metabolism. Gepatoprotektor
ICD-10 codes (testimony): G62.1, G63.2
At KFU: 02.11.01
Manufacturer: OAO Pharmstandard-Leksredstva (Russia)
Pharmaceutical form, composition and packaging
Capsules hard gelatin, size №0, opaque, yellow color; contents of capsules – powder of light yellow or yellow; allowed blotches of white.
| 1 caps. | |
| thioctic (a-липоевая) acid | 300 mg |
Excipients: calcium phosphate dibasic (calcium hydrogen phosphate), pre-gelatinized starch, aэrosyl (colloidal silicon dioxide), magnesium stearate.
The composition of the body and cap of the capsule: Medicinal gelatine, Titanium dioxide (E171), quinoline yellow (E104), colorant sunset yellow (E110).
10 PC. – contour cell package (3) – packs cardboard.
Pharmacological action
Metabolic means, It is an endogenous antioxidant, binding free radicals.
Thioctic acid is formed 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 blood glucose and increased glycogen content in the liver, and overcome insulin resistance. By the nature of the biochemical actions of 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.
Oktolipen® okazыvaet hepatoprotektornoe, gipolipidemicescoe, hypocholesteremic, hypoglycemic action. Improves trophic neuronal and axonal conduction, reduces symptoms of diabetic and alcoholic polyneuropathy.
Pharmacokinetics
Absorption
Once inside quickly and completely absorbed from the gastrointestinal tract. Simultaneous eating reduces the absorption of the drug. Tmax is 25-60 m. Bioavailability – 30-60%.
Metabolism
Thioctic acid is subjected to the 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 are excreted in urine c (80-90%). T1/2 – 20-50 m. The total plasma clearance of 10-15 ml / min.
Testimony
- Diabetic polyneuropathy;
- Alcoholic polyneuropathy.
Dosage regimen
Oktolipen® in the form of capsules appointed interior 600 mg (2 caps.) 1 time / day. The capsules are taken in the morning, fasting, for 30 min before the first meal, without chewing, drinking plenty of water. Course duration determined by a physician.
Side effect
From the digestive system: dyspeptic symptoms (incl. nausea, vomiting, heartburn).
Metabolism: Symptoms of hypoglycemia (in connection with the improvement of glucose uptake).
Allergic reactions: hives, systemic allergic reactions (incl. anaphylactic shock).
Contraindications
- Pregnancy;
- Breastfeeding;
- Childhood and adolescence up 18 years (efficacy and safety have not been established);
- Hypersensitivity to the drug.
Pregnancy and lactation
Use of the drug during pregnancy and lactation is contraindicated.
Cautions
In patients with diabetes mellitus, especially at the beginning of treatment, requires frequent monitoring of blood glucose concentrations. In some cases, a reduction in the dose of hypoglycemic agents.
During treatment should strictly abstain from alcohol, tk. Ethanol reduces the therapeutic efficacy of thioctic acid.
Overdose
Symptoms: headache, nausea, vomiting.
Treatment: symptomatic. No specific antidote.
Drug Interactions
While the use of insulin and oral hypoglycemic agents has been increasing hypoglycemic effect.
After a morning reception thioctic acid iron preparations, Magnesium, and dairy products (because they contain calcium) recommended for the afternoon or evening.
Ethanol reduces the therapeutic efficacy of thioctic acid.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug is in the form of capsules should be stored out of reach of children, dry, dark place at a temperature of 15 ° to 25 ° C. Shelf life – 2 year.
