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Oral formulations containing riluzole

Drugs List

  • RILUTEK 50mg tablets
  • riluzole 50mg tablets
  • riluzole 5mg/ml oral suspension sugar-free
  • TEGLUTIK 5mg/ml oral suspension
  • Therapeutic Indications


    To extend life/time to mechan'l ventil'n in amyotrophic lateral sclerosis

    To extend life or the time to mechanical ventilation in amyotrophic lateral sclerosis form of motor neurone disease.



    50 mg every 12 hours


    50 mg every 12 hours


    Children under 18 years
    Acute porphyria
    Hepatic disorder
    Renal impairment
    Serum transaminases above 3 times upper limit of normal

    Precautions and Warnings

    Abnormal liver function test
    Hereditary fructose intolerance
    History of hepatic impairment

    Advise patient that dizziness/vertigo may affect ability to drive
    Treatment to be initiated by specialist
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Monitor serum transaminases (including ALT) before and during therapy
    Monitor serum ALT every 3 months from month 3 to 12 of therapy
    Monitor serum ALT monthly during first 3 months of therapy
    Advise patient to report any new or worsening respiratory symptoms
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Discontinue if ALT level exceeds 5 times the upper limit of normal
    Discontinue if clinical/laboratory evidence of neutropenia
    Discontinue if evidence of interstitial lung disease

    Patients should report any febrile illness to their physicians. The report of a febrile illness should prompt physicians to check white blood cell counts and to discontinue riluzole in case of neutropenia.

    If any respiratory symptoms develop such as dry cough and/or dyspnoea, chest radiography should be performed. If interstitial lung disease is diagnosed, riluzole should be discontinued immediately.

    Pregnancy and Lactation


    Riluzole is contraindicated in pregnancy.

    Clinical experience in pregnant women is lacking.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Riluzole is contraindicated in breastfeeding.

    It is not known whether riluzole is excreted in human milk.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Altered liver function tests
    Anaphylactoid reaction
    Interstitial lung disease
    Oral paraesthesia


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: November 2015

    Reference Sources

    British National Formulary. 70th ed. London: BMJ Group and Pharmaceutical Press; 2015.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Rilutek. Sanofi Aventis. Revised December 2013

    Summary of Product Characteristics: Riluzole. Martindale Pharmaceuticals. Revised July 2015

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.