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TIOLEPTA ® (Alpha-Lipoic Acid | Thioctic Acid)

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Tiolepta is an endogenous antioxidant that binds free radicals and stabilizes lipid and carbohydrate metabolism. Thioctic acid (alpha-lipoic acid), its main component, is an organosulfur compound derived from caprylic acid. It is an antioxidant that is widely used as a dietary supplement and as a pharmaceutical drug. Alpha-lipoic acid is most commonly used to treat diabetes and nerve-related symptoms of diabetes including burning, pain, and numbness in the legs and arms. Alpha-lipoic acid is used in the body to break down carbohydrates and to make energy for other organs. It helps prevent certain kinds of cell damage and also restores vitamin E and vitamin C levels.

Alpha-lipoic acid has hepatoprotective, lipid-lowering, hypocholesterolemic, and hypoglycemic properties. It lowers blood glucose by binding to the insulin receptor in the body which increases glucose utilization. Also, due to its antioxidant activity, alpha-lipoic acid is used to treat nerve damage due to uncontrolled blood sugar level that causes pain, tingling, or numbness over hands and feet (diabetic neuropathy).

 

Indications

  • Diabetic neuropathy and alcoholic polyneuropathy.

 

Contraindications

  • Hypersensitivity to the components of the drug;
  • Pregnancy and lactation;
  • Children under 18 years of age;
  • Lactose intolerance, lactase deficiency, or glucose-galactose malabsorption (for tablets).

 

Produced by Canonfarma, Russia.

 

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Contents

In 1 tablet:

Active ingredient: alpha-lipoic acid 300 or 600 mg;
Inactive ingredients: calcium stearate, lactose, microcrystalline cellulose, castor oil, potato starch, fumed silica, povidone, and croscarmellose sodium.

Dosage and administration

To be administered orally on an empty stomach 30 mins before the first meal. You should wash down the pills. The dosage is 600 mg once a day. The duration of the treatment course should be prescribed by a doctor.

Overdose

Generally, the drug is well tolerated. Overdose symptoms may include headache, nausea, and vomiting.

Treatment: symptomatic treatment and anticonvulsant therapy, if necessary.

Drug interaction

Alpha-lipoic acid lowers the effect of cisplatin.

It is not recommended to co-administer alpha-lipoic acid with metal-containing drugs (iron, magnesium, and calcium medications) and milk because of its metal binding effect. The minimum interval is 2 hours.

Tiolepta enhances the effect of insulin, oral anti-diabetic drugs, and glucocorticoids.

The effect of alpha-lipoic acid is lowered by ethanol and its metabolites.

Storage conditions

Store at a temperature not higher than 25°C (77°F) in the original package. Keep out of the reach of children.
Shelf life is 2 years for tablets, and 3 years for a solution.

Manufacturer

Canonfarma Production, Russia.

OFFICIAL INSTRUCTION

  1. C McIlduff, S Rutkove (2011) Critical appraisal of the use of alpha lipoic acid (thioctic acid) in the treatment of symptomatic diabetic polyneuropathy https://www.ncbi.nlm.nih.gov/pubmed/21941444
  2. J Leysen, O Aerts (2016) Further evidence of thioctic acid (α-lipoic acid) being a strong cosmetic sensitizer https://www.ncbi.nlm.nih.gov/pubmed/26899808
  3. Wang et al (2018) Alpha lipoic acid combined with epalrestat: a therapeutic option for patients with diabetic peripheral neuropathy https://www.ncbi.nlm.nih.gov/pubmed/30233145
  4. N Nguyen, J Takemoto (2018) A Case for Alpha-Lipoic Acid as an Alternative Treatment for Diabetic Polyneuropathy https://www.ncbi.nlm.nih.gov/pubmed/30139425
  5. Salehi et al (2019) Insights on the Use of α-Lipoic Acid for Therapeutic Purposes https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6723188/

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