Oktolipen tab n / 600mg film about 30 pc

Description

Composition
Active substance:
Thioctic acid (thioctic acid) BAN accepted for use in the UK.
Excipients:
Giproloza low-substituted (low substituted hydroxypropylcellulose L-HPC LH-B1) – 120.9 mg, giproloza (hydroxypropyl cellulose (Klucel EF)) – 32.04 mg Colloidal silicon dioxide (Aerosil) – 24.03 mg magnesium stearate – 24.03 mg. Opadry yellow (OPADRY 03F220017 Yellow) – 28 mg (hypromellose (hydroxypropyl) – 15.8 mg macrogol 6000 (polyethylene glycol 6000) – 4,701 mg, titanium dioxide – 5.27 mg talc – 2.019 mg, quinoline yellow aluminum lake (E104) – 0.162 mg , iron oxide yellow dye (E172) – 0.048 mg). 10 pieces. – packings Valium planimetric (3) – packs cardboard. 10 pieces. – packings Valium planimetric (6) – packs cardboard. 10 pieces. – packings Valium planimetric (10) – packs cardboard.
Product form:
OKTOLIPENV® Valium. Valium. film-coated, 600 mg 30, 60 or 100 pieces. Tablets, film-coated from light yellow to yellow color, oval, biconcave, scored on one side, to break – from light yellow to yellow. 1 tab. thioctic (O ± lipoic acid) 600 mg.
Contraindications
– pregnancy – lactation (breastfeeding), – child and adolescence to 18 years (effectiveness and safety have not been established), – hypersensitivity to the thioctic acid and the components of the preparation.
Dosage
600 mg
Indications
– diabetic polyneuropathy, – alcoholic polyneuropathy.
Interaction with other drugs
It enhances the anti-inflammatory effects of corticosteroids. Reduces the effectiveness of cisplatin. Potentiates the effect of insulin and oral hypoglycemic medication (must be corrected their doses, as well as regular monitoring of blood glucose to prevent hypoglycaemia). Simultaneous administration of the drug OktolipenV® and iron preparations, magnesium and calcium are not recommended (due to complex formation with metals). The interval between doses should be at least 2 hours. The ethanol and its metabolites weaken the therapeutic activity of thioctic acid.
Overdose
Symptoms of headache, nausea, vomiting. In severe cases (when receiving thioctic acid at a dose of 10-40 g or more tab 10. 600 mg for adults, or in a dose of> 50 mg / kg body weight in children) psychomotor agitation or clouding of consciousness, generalized convulsions expressed human acid -schelochnogo equilibrium with lactic acidosis, hypoglycemia (up to the development of coma), rhabdomyolysis, hemolysis, DIC, suppression of bone marrow, multiple organ failure. Treatment for suspected significant overdosing recommended immediate hospitalization and the use of measures in accordance with the general principles adopted Accidental poisoning (call emesis, gastric lavage, activated carbon, etc.). Treatment of generalized seizures, lactic acidosis, and other life-threatening intoxication effects – symptomatic, it must be conducted in accordance with the principles of modern intensive care. No specific antidote. Hemodialysis, hemoperfusion or filtering techniques with positive thioctic acid excretion from the body are not effective.
pharmachologic effect
Pharmacological group:
Drug with antioxidant action, regulates carbohydrate and lipid metabolism.
Pharmacological properties:
Thioctic acid (lipoic acid O ±) – coenzyme mitochondrial multienzyme complexes involved in the oxidative decarboxylation of pyruvic acid, and O ± ketokislot. Is an endogenous antioxidant binds free radicals, restores the level of intracellular glutathione, increase the activity of superoxide dismutase. Improves the trophism of neurons and axonal conduction. By the nature of the biochemical action of thioctic acid is similar to B vitamins plays an important role in energy metabolism. Participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism. Contributes to lower blood glucose, increase the glycogen content in the liver, reducing insulin resistance. Has lipotropic effect, it improves liver function. It has a detoxication effect for poisoning by heavy metal salts and other intoxications.
Pharmacokinetics:
When ingestion rapidly and completely absorbed in the gastrointestinal tract, intake of food at the same time reduces the absorption of the drug. Bioavailability – 30-60% due to the effect of “first pass” through the liver. Time to reach Cmax – 25-60 min. It is metabolized in the liver by the oxidation of side chain conjugation. Vd – 450 ml / kg. Total plasma clearance – 10-15 ml / min. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). T1 / 2 – 25 min.
Pregnancy and breast-feeding
Use of the drug is contraindicated in pregnancy due to the lack of sufficient clinical experience with thioctic acid in pregnant women. Reproductive toxicity studies revealed no risks to fertility, effects on fetal growth and any embryotoxic properties of the drug. Use of the drug OktolipenV® lactation contraindicated due to the absence of data on the penetration of thioctic acid in breast milk. Use in children The use of medication in children and adolescents under the age of 18 years is contraindicated (effectiveness and safety have been established).
Conditions of supply of pharmacies
Drug prescription.
side effects
Possible side effects of the drug when applied OktolipenV® listed in descending frequency of occurrence is very often (1c Ґ1 ‰ / 10), often (in Ґ1 ‰ / 100,
special instructions
During treatment (especially at the initial stage) requires regular monitoring of blood glucose in patients with diabetes. In some cases it may be necessary to reduce the dose of insulin or oral hypoglycemic agents to prevent the development of hypoglycemia. Patients taking the drug OktolipenV® should abstain from alcohol. Simultaneous food intake may inhibit absorption of the drug. Before the drug OktolipenV® consumption of dairy products is not recommended (because of content of calcium). The interval between doses should be at least 2 hours.
Effects on ability to drive vehicles and management mechanisms
Influence not been specifically studied for the ability to drive vehicles and mechanisms. Caution should be exercised when driving and classes of potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
The drug should be stored in reach of children at a temperature not higher than 25 ° C. Shelf life – 2 years.
Dosing and Administration
The drug is taken orally on an empty stomach, 30 minutes before the meal. The tablets should be swallowed whole without chewing, drinking plenty of fluids. The recommended dose – 1 tab. (600 mg), 1 time / day. Perhaps a sequential therapy oral medication is started after 2-4 weeks of parenteral administration of thioctic acid. The maximum rate of reception of tablets – 3 months. In some cases, drug therapy OktolipenV® implies a long-term use. Course duration determined by the attending physician.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist