Formulary
Idebenone: Indications, Dosing, Side Effects and Interactions
Idebenone is a nootropic and antioxidant that is thought to act by restoring cellular ATP generation, thereby reactivating retinal ganglion cells.
MedNext Academy | 3 min read
Idebenone: Indications, Dosing, Side Effects and Interactions
Idebenone is a nootropic and antioxidant that is thought to act by restoring cellular ATP generation, thereby reactivating retinal ganglion cells.
Drug action
Idebenone is a nootropic and antioxidant that is thought to act by restoring cellular ATP generation, thereby reactivating retinal ganglion cells.
Indications and dose
**Leber's hereditary optic neuropathy (initiated by a specialist)**
- **Adult** (By Mouth): 300 mg 3 times a day.
**Leber's hereditary optic neuropathy (initiated by a specialist) for idebenone**
- **Child 12-17 years** (By mouth): 300 mg 3 times a day.
Side effects
Common or very common Cough; diarrhoea; increased risk of infection; pain Frequency not known Agranulocytosis; anaemia; anxiety; appetite decreased; azotaemia; delirium; dizziness; dyspepsia; hallucination; headache; hepatitis; leucopenia; malaise; movement disorders; nausea; neutropenia; poriomania; seizure; skin reactions; stupor; thrombocytopenia; urine discolouration; vomiting Side-effects, further information The metabolites of idebenone may cause red-brown discolouration of the urine. This effect is harmless, but the manufacturer advises caution as this may mask colour changes due to other causes (e.g. renal or blood disorders).
Interactions
**Other interactions (8):**
- Data from in vitro studies have demonstrated that idebenone and its metabolite QS10 do not exert systemic inhibition of cytochrome P450 isoforms CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4 at...
- In vivo idebenone is a mild inhibitor of CYP3A4.
- Data from a drug-drug interaction study in 32 healthy volunteers indicate that on the first day of oral administration of 300 mg idebenone t.i.d., the metabolism of midazolam, a CYP3A4 substrate,...
- After repeated administration C max and AUC of midazolam were increased by 28% and 34%, respectively, when midazolam was administered in combination with 300 mg idebenone t.i.d.
- Therefore, CYP3A4 substrates known to have a narrow therapeutic index such as alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, or...
- Idebenone may inhibit P-glycoprotein (P-gp) with possible exposure increases of, e.g., dabigatran etexilate, digoxin or aliskiren.
Pregnancy
Manufacturer advises avoid unless potential benefit outweighs risk-no information available.
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Hepatic impairment
Manufacturer advises caution (no information available).
Renal impairment
Manufacturer advises use with caution-no information available.
Medicinal forms
Tablet
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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