Finished product reference
Idebenone
Capsule · Oral · 45 mg
- List code
- 52287
- Pharmacologic class
- Synthetic benzoquinone antioxidant (short-chain coenzyme Q10 analogue)
What it is and how it works
Idebenone is a short-chain benzoquinone structurally related to coenzyme Q10. It acts as an antioxidant and as a mitochondrial electron carrier that can transfer electrons directly to complex III, bypassing defective complex I and restoring cellular ATP production.
Indications
In the EU, treatment of visual impairment in adolescents and adults with Leber’s hereditary optic neuropathy (LHON). In some countries it has also been used for cognitive and memory disorders, with limited evidence.
Dosage and administration (summary)
LHON: 900 mg daily orally (300 mg three times daily) taken with food; lower doses are used in other indications according to the local product information.
Contraindications
Hypersensitivity to idebenone or excipients.
Warnings and precautions
Monitor liver function and discontinue if significant abnormalities occur; caution in hepatic or renal impairment. May cause harmless reddish-brown discolouration of urine. Gastrointestinal upset (diarrhoea, nausea) is common.
Pregnancy
Data are limited; avoid in pregnancy unless the benefit outweighs the risk.
Storage and supply
Store below 25–30 °C.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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