Description
Thioctacid 600 T Ampoules, 24 ml, #5 Solution
Composition
Each ampoule contains 600 mg of Thioctic acid (Alpha-lipoic acid) in a 24 ml aqueous solution. Excipients may include sterile water for injection, sodium chloride, and sodium hydroxide for pH adjustment. The product is supplied in cartons of 5 ampoules.
Pharmacological Action
Thioctic acid is a naturally occurring compound that functions as a coenzyme in the mitochondrial energy metabolism. It exhibits strong antioxidant properties, scavenging reactive oxygen species (ROS) and regenerating other antioxidants such as vitamin C, vitamin E, and glutathione. Its neuroprotective and hepatoprotective effects make it beneficial in diabetic polyneuropathy and chronic liver diseases.
Indications
- Diabetic peripheral neuropathy
- Alcoholic neuropathy
- Hepatic disorders, including chronic hepatitis and liver cirrhosis
- Supportive treatment in atherosclerosis and metabolic syndrome
Contraindications
- Hypersensitivity to thioctic acid or any component of the solution
- Pediatric use (safety not established in children)
- Pregnancy and lactation unless clinically justified
Dosage and Administration
The recommended dose is one ampoule (600 mg/24 ml) once daily, diluted in 250 ml of 0.9% sodium chloride and infused slowly intravenously over 2–4 hours. Intravenous treatment is typically prescribed for 2–4 weeks, after which therapy may be continued with oral thioctic acid formulations.
Administration should be done under medical supervision. The infusion solution should be freshly prepared and protected from light (use light-resistant tubing or wrap with aluminum foil).
Side Effects
- Gastrointestinal: Nausea, vomiting, abdominal pain, metallic taste
- Allergic reactions: Rash, itching, urticaria, or in rare cases, anaphylaxis
- Metabolic: Hypoglycemia, especially in diabetic patients receiving concurrent glucose-lowering therapies
- Local: Redness or burning sensation at the injection site
Drug Interactions
- Antidiabetic agents (e.g., insulin, metformin): Potential potentiation of hypoglycemic effects; monitor glucose closely
- Iron, magnesium, and calcium supplements: May reduce bioavailability of thioctic acid; separate administration by at least 2 hours
- Cisplatin: Reduced effectiveness due to chelation
Overdose
Symptoms of overdose include severe gastrointestinal disturbances, hypoglycemia, convulsions, or lactic acidosis. Life-threatening toxicity has been observed in doses exceeding 10 grams, particularly in children. Immediate medical intervention with supportive care and monitoring is crucial. No specific antidote exists.
Precautions
- Monitor blood glucose levels in diabetic patients
- Avoid alcohol during treatment, as it may exacerbate neuropathy and reduce efficacy
- Use with caution in patients with renal or hepatic impairment
Use in Pregnancy and Lactation
Thioctic acid should only be used during pregnancy if the expected benefit justifies the potential risk to the fetus. Use during breastfeeding is not recommended due to lack of data on excretion in human milk.
Storage
- Store at 15–25°C (59–77°F)
- Protect from light
- Do not freeze
- Once opened, use immediately and discard unused portion
Packaging
5 ampoules of 24 ml each per carton. Each ampoule contains 600 mg of thioctic acid in aqueous solution.
Reviews
There are no reviews yet.