Shenwei Idebenone Tablets

1. Indications and Usage
Idebenone tablets are indicated for the treatment of brain function impairments caused by chronic cerebrovascular diseases and brain injuries. It can improve subjective symptoms, as well as mental and behavioral disorders such as language difficulties, anxiety, depression, memory loss, and cognitive decline .
Note: In some regions, it is also utilized off-label or in specific guidelines for the symptomatic treatment of Friedreich’s ataxia.
2. Dosage and Administration
Recommended Dose: Adults should take 30 mg (1 tablet) per dose, three times daily.
Administration: The tablets should be taken orally after meals.
Pediatric/Specific Indications: For the treatment of Friedreich’s ataxia in patients aged 8 years and older, the dose is weight-based and taken with food. Initial dose is 150 mg three times daily for patients ≤45 kg, and 300 mg three times daily for patients >45 kg. The dose may be titrated up to 450 mg or 750 mg three times daily, respectively, over 6 months based on tolerance.
3. Mechanism of Action
Idebenone is a synthetic derivative of ubiquinone. It acts as a brain metabolic and mental symptom-improving agent. It activates mitochondrial respiratory activity, improves cerebral energy metabolism in the setting of cerebral ischemia, and enhances glucose utilization in the brain, leading to increased ATP production. Additionally, it inhibits the generation of peroxides by brain mitochondria and membrane damage caused by lipid peroxidation .
4. Safety and Warnings
Hypersensitivity: Patients with known hypersensitivity to idebenone or any excipients should not use this medication.
Hepatic Monitoring: During long-term therapy, liver function tests (e.g., AST/ALT or GOT/GPT) should be monitored regularly .
Pregnancy and Lactation: Safety in pregnancy has not been fully established; it is contraindicated in pregnant women. Since the drug can be transmitted to breast milk, it should be used with caution in nursing mothers .
Special Populations: There is no reliable reference data for the use of idebenone in children and the elderly .
5. Adverse Reactions and Clinical Research
Adverse Reactions: The incidence of adverse reactions is approximately 3%. Common reactions include allergic reactions, rash, nausea, anorexia, diarrhea, excitement, insomnia, and dizziness. Occasional cases of leukopenia and hepatic dysfunction have been reported .
Clinical Research: Clinical experience indicates that idebenone can effectively improve cognitive function and mental states in patients with chronic cerebrovascular diseases and brain injuries.
6. Drug Interactions
Drug Interactions: No formal clinical drug interaction studies have been conducted, and the specific interactions remain unknown .
7. Pharmaceutical Information
Active Ingredient: Idebenone.
Chemical Name: 6-(10-hydroxydecyl)-2,3-dimethoxy-5-methyl-1,4-benzoquinone.
Chemical Formula: C19H30O5.
Molecular Weight: 338.44.
Strengths: 30 mg tablets (Sugar-coated tablets; orange-yellow after removing the coating).
Storage: Keep tightly closed in a dry place at a temperature not exceeding 20°C .