Alpha Lipon Thioctic Acid Injection

1. Indications and Usage
Diabetic Peripheral Neuropathy: Thioctic Acid Injection is indicated for the treatment of symptomatic diabetic peripheral neuropathy.
2. Dosage and Administration
Dosage: For severe symptomatic diabetic peripheral neuropathy, 300-600 mg is administered intravenously once daily for 2-4 weeks.
Administration: Must be diluted only in 0.9% sodium chloride injection. It should be infused slowly (max 50 mg/min) over approximately 30 minutes.
Light Protection: The drug is photosensitive. The solution must be prepared immediately before use and protected from light (e.g., with aluminum foil).
3. Mechanism of Action
Antioxidant: Thioctic acid (alpha-lipoic acid) and its reduced form, dihydrolipoic acid, act as potent antioxidants.
Metabolic Effects: It reduces lipid peroxidation in neural tissue, inhibits protein glycosylation, regenerates other antioxidants (such as vitamins C and E, glutathione), and may inhibit aldose reductase.
4. Safety and Warnings
Hypoglycemia: It may potentiate the hypoglycemic effects of insulin and oral antidiabetic agents. Blood glucose must be monitored closely, especially at the initiation of treatment.
Administration Precautions: Incompatible with glucose, fructose, and Ringer’s solution.
Hypersensitivity: Severe allergic reactions, including anaphylactic shock, have been reported.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Rapid infusion may cause rare head fullness and dyspnea. Other reported reactions include headache, nausea, allergic skin reactions (urticaria, pruritus), seizures, diplopia, and thrombocytopenia.
Clinical Research: Clinical trials demonstrate significant improvement in neuropathic symptoms and nerve conduction velocity.
6. Drug Interactions
Antidiabetics: Potentiates insulin and oral hypoglycemics, potentially requiring dose reduction to avoid hypoglycemia.
Cisplatin: May reduce the efficacy of this anticancer agent.
7. Pharmaceutical Information
Active Ingredient: Thioctic Acid.
Excipients: Tris(hydroxymethyl)aminomethane and water for injections.
Appearance: Yellow-green, clear liquid.
Storage: Protect from light and store at or below 25°C.