Idebenone

Indications
 Oral
Friedreich's ataxia
Adult: For symptomatic treatment: Lower dose therapy: Patients ≤45 kg: 150 mg tid; >45kg: 300 mg tid. After at least 6 mth of low dose therapy, may increase to higher dose if clinical benefit and tolerability are observed. Higher dose therapy: Patients ≤45 kg: 450 mg tid; >45kg: 750 mg tid. Return to lower dose if no additional improvement is observed after 6 mth on high dose therapy.
Topical/Cutaneous
Cosmetic treatment of wrinkles
Adult: As a 1% cream: Apply a pea-sized amount of cream to clean, dry face and neck once daily for the first wk. If tolerated, may increase to twice daily.
Contraindications
 Moderate or severe hepatic impairment; severe renal impairment.
Warnings / Precautions
 Oral preparation: Leucocytopenia and agranulocytosis have been reported (rarely) from post-marketing experience. Monitor CBC before initiation of treatment; after dosage increment, and regularly thereafter. Use with caution in mild hepatic impairment; mild to moderate renal impairment. May cause increases in liver function test (LFT) values, monitor LFT before initiation of therapy; after dosage increment, and regularly thereafter. Safety and efficacy have not been established in pediatric patients <8 yr and in elderly patients >65 yr. Not recommended in pregnancy and lactation. Topical preparation: Allergic reactions including itching, burning, redness, or swelling may occur.
Adverse Reactions
 Oral: Nausea, diarrhoea, abdominal pain, dyspepsia, headache, leucocytopenia, agranulocytosis, abnormal LFT values, and increased BUN. Topical: Allergic reactions, rashes, and contact dermatitis.
Overdose Reactions
 In the event of overdose, provide general supportive treatment. No known specific antidotes for Idebenone.
Drug Interactions
 Concurrent use with CYP2C19, CYP1A2, CYP3A4 inhibitors and inducers may affect metabolism of Idebenone, but clinical relevance is unknown.
See Below for More idebenone Drug Interactions
Food Interactions
 Administration with a high fat meal increases Idebenone bioavailability.
Mechanism of Actions
 Idebenone is a benzoquinone derivative with structural similarity to ubiquinone (coenzyme Q10). Exact mechanism of action is unknown, it is thought to have antioxidant activity and is believed to facilitate electron flow through respiratory chain, thus improving energy production by body cells.
Absorption: Rapidly absorbed following oral admin. Tmax: Within 1 hr.
Distribution: Widely distributed with relatively high levels in the gut, liver and kidney. Enters the brain; with significant amount present in the mitochondria. Protein binding: About 96%.
Metabolism: Undergoes first pass metabolism to conjugated Idebenone, Phase I metabolites (QS10, QS6, and QS4) and their corresponding Phase II metabolites (glucuronide and sulphates). Conjugated Idebenone and QS4 are the main metabolites in plasma.
Excretion: Mainly excreted in urine.
Storage Conditions
 Oral: Store at 15-30°C.
ATC Classification
 N06BX13 - idebenone ; Belongs to the class of other psychostimulants and nootropics.
Storage
 Oral: Store at 15-30°C.
Available As
  • Idebenone 1% w/w
  • Idebenone 100 mg
  • Idebenone 30 mg
  • Idebenone 45 mg

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