Drugs List

Therapeutic Indications

Uses

Leber's optic atrophy

Contraindications

Children under 12 years
Breastfeeding
Galactosaemia

Precautions and Warnings

Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Pregnancy
Renal impairment

Ensure chromaturia is drug related; exclude any other reasons
Treatment to be initiated and supervised by a specialist
Contains lactose
Contains sunset yellow (E110) - may cause allergic reaction
Advise patient to take with or after food
Monitor patient regularly in accordance to local practice
Advise patient urine may be coloured reddish brown

Pregnancy and Lactation

Pregnancy

Use idebenone with caution in pregnancy.

The manufacturer notes that this medication should only be considered if the expected benefit to the mother is greater than any risk to the foetus.

The safety of idebenone in pregnant women has not been established. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Lactation

Idebenone is contraindicated in breastfeeding.

The manufacturer notes a decision should be made whether to cease breastfeeding or stop taking the medication.

Studies in rats have shown that idebenone is excreted into maternal milk.

Side Effects

Agitation
Agranulocytosis
Alanine aminotransferase increased
Anaemia
Anorexia
Aspartate aminotransferase increased
Azotaemia
Back pain
Bronchitis
Chromaturia
Cough
Delirium
Diarrhoea
Dizziness
Dyskinesia
Dyspepsia
Elevated triglyceride levels
Extremity pain
Gamma glutamyl transferase (GGT) increased
Hallucinations
Headache
Hepatitis
Hypercholesterolaemia
Hyperkinesia
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Leucopenia
Malaise
Nasopharyngitis
Nausea
Neutropenia
Poriomania
Pruritus
Rash
Restlessness
Seizures
Serum bilirubin increased
Stupor
Thrombocytopenia
Vomiting

Presentation

Oral formulation of idebenone.

Drugs List

Therapeutic Indications

Uses

Leber's optic atrophy

Dosage

Adults

Children

Contraindications

Children under 12 years
Breastfeeding
Galactosaemia

Precautions and Warnings

Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Pregnancy
Renal impairment

Ensure chromaturia is drug related; exclude any other reasons
Treatment to be initiated and supervised by a specialist
Contains lactose
Contains sunset yellow (E110) - may cause allergic reaction
Advise patient to take with or after food
Monitor patient regularly in accordance to local practice
Advise patient urine may be coloured reddish brown

Pregnancy and Lactation

Pregnancy

Use idebenone with caution in pregnancy.

The manufacturer notes that this medication should only be considered if the expected benefit to the mother is greater than any risk to the foetus.

The safety of idebenone in pregnant women has not been established. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Lactation

Idebenone is contraindicated in breastfeeding.

The manufacturer notes a decision should be made whether to cease breastfeeding or stop taking the medication.

Studies in rats have shown that idebenone is excreted into maternal milk.

Side Effects

Agitation
Agranulocytosis
Alanine aminotransferase increased
Anaemia
Anorexia
Aspartate aminotransferase increased
Azotaemia
Back pain
Bronchitis
Chromaturia
Cough
Delirium
Diarrhoea
Dizziness
Dyskinesia
Dyspepsia
Elevated triglyceride levels
Extremity pain
Gamma glutamyl transferase (GGT) increased
Hallucinations
Headache
Hepatitis
Hypercholesterolaemia
Hyperkinesia
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Leucopenia
Malaise
Nasopharyngitis
Nausea
Neutropenia
Poriomania
Pruritus
Rash
Restlessness
Seizures
Serum bilirubin increased
Stupor
Thrombocytopenia
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: April 2020

Reference Sources

Summary of Product Characteristics: Raxone 150mg film-coated tablets. Santhera Pharmaceuticals (Deutschland) GmbH. Revised October 2019.