Product Overview
[Drug Name]
Generic Name: Idebenone Tablets
Trade Name: Shenwei
English Name: Idebenone Tablets
Chinese Pinyin: Aidibenkun Pian
[Ingredients]
The main ingredient of this product is idebenone, chemically known as 6-(10-hydroxydecyl)-2,3-dimethoxy-5-methyl-1,4-benzoquinone.
Structural Formula: Molecular Formula: C₁₆H₃₀O₅ (C₁₆H₃₀O₅) Molecular Weight: 338.44
[Properties]
This product is a sugar-coated tablet that appears orange-yellow after removing the sugar coating.
[Indications]
Cerebral impairment caused by chronic cerebrovascular disease and brain trauma. It can improve subjective symptoms, language impairment, anxiety, depression, memory loss, intellectual impairment, and other mental and behavioral disorders.
[Dosage and Administration]
Oral: Adults: 30 mg (1 tablet) three times a day, after meals.
[Adverse Reactions]
The incidence of adverse reactions is approximately 3%, primarily including allergic reactions, rash, nausea, loss of appetite, diarrhea, excitement, insomnia, and dizziness. Leukopenia and liver damage have been reported rarely.
[Contraindications]
This study has not been conducted and no reliable references are available.
[Precautions]
With long-term use, liver function tests such as GOT and GPT should be monitored regularly.
[Use in Special Populations]
Precautions for Children:
This study has not been conducted and no reliable references are available.
Precautions for Pregnancy and Lactation:
1. The safety of this drug in pregnant women has not been fully established, and therefore, it is contraindicated in pregnant women.
2. Because this drug can be transferred into breast milk, it should be used with caution in lactating women.
Precautions for the Elderly:
This study has not been conducted and no reliable references are available.
[Drug Interactions]
This study has not been conducted and no reliable references are available.
[Pharmacological Actions]
This drug improves brain metabolism and psychiatric symptoms. It activates mitochondrial respiratory activity, improves brain energy metabolism in ischemic brains, improves glucose utilization in the brain, increases ATP production in the brain, inhibits lipid peroxide production in the brain mitochondria, and inhibits membrane disorders caused by lipid peroxidation in the brain mitochondrial membrane. This drug has low toxicity and side effects, with an LD50 of >10,000 mg/kg in mice and rats. No significant toxicity was observed after oral administration of 20 mg/kg/day for six months in rats and 100 mg/kg/day for one year in dogs. It is non-teratogenic, carcinogenic, or mutagenic.
[Storage]
Store tightly closed in a cool, dry place (no higher than 20°C).
[Specifications]
30 mg x 12 tablets
[Packaging Size]
Box
[Expiry Life]
24 months.
[Approval Number]
National Medicine Standard H10970137
[Manufacturer]
Company Name: Qilu Pharmaceutical Co., Ltd.
