Thiolepta [Alpha-lipoic Acid or Thioctic Acid]

Formulation and Packaging

Tablets with 300 or 600 mg of the active ingredient (alpha-lipoic acid).

Inactive ingredients include calcium stearate, lactose, microcrystalline cellulose, castor oil, potato starch, fumed silica, povidone and croscarmellose sodium.

Application and Dosage

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

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. Minimum interval is 2 hours.

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

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

Overdose

Generally, the drug is well tolerated.

Overdose symptoms may include headache, nausea and vomiting.

Treatment: symptomatic treatment and anticonvulsant therapy, if necessary. 

Storage Conditions and Shelf Life

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 solution.

Manufacturer

CJSC Canonpharma production. Russia

Thiolepta 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 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.

Counterindications

  • 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).


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