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Amifampridine oral


Oral formulation of amifampridine.

Drugs List

  • amifampridine 10mg tablets
  • FIRDAPSE 10mg tablets
  • Therapeutic Indications


    Myasthenic Eaton-Lambert syndrome



    Starting dose
    15mg daily in divided doses three or four times a day. This can be increased in 5mg increments every 4 to 5 days, up to a maximum of 60mg per day. Maximum single dose 20mg.

    Patients with Renal Impairment

    Moderate to severe renal impairment
    Starting dose: 5mg daily.

    Mild renal impairment
    Starting dose: 5mg twice a day.

    Titrate slowly with doses increased in 5mg increments every 7 days.

    If any adverse reaction occurs, upward dose titration should be discontinued.

    Patients with Hepatic Impairment

    Moderate to severe hepatic impairment
    Starting dose: 5mg daily.

    Mild hepatic impairment
    Starting dose: 5mg twice a day.

    Titrate slowly with doses increased in 5mg increments every 7 days.

    If any adverse reaction occurs, upward dose titration should be discontinued.


    Children under 18 years
    Epileptic disorder
    Long QT syndrome
    Torsade de pointes
    Uncontrolled asthma

    Precautions and Warnings

    Family history of long QT syndrome
    Females of childbearing potential
    Predisposition to epileptic disorder
    Electrolyte imbalance
    Hepatic impairment
    History of asthma
    History of torsade de pointes
    Renal impairment

    Correct electrolyte disorders before treatment
    Reduce dose and/or alter dose interval in patients with hepatic impairment
    Reduce dose and/or alter dose interval in patients with renal impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Treatment to be initiated and supervised by a specialist
    Assess patient for predisposing risk factors which lower seizure threshold
    Discontinue treatment if patient develops seizures
    Monitor patients with hepatic impairment
    Monitor patients with renal impairment
    Monitor serum electrolytes
    Perform ECG when initiating treatment and yearly thereafter
    Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
    Discontinue at first sign of arrhythmia - perform ECG
    Male & female: Ensure adequate contraception during treatment

    The use of amifampridine in patients with the non-paraneoplastic form of LEMS should only be commenced following a thorough assessment of the risk-benefit to the patient.

    Schwannoma should be considered for patients who present with symptoms such as a mass that is painful on palpation or similar symptoms to a compressive neuropathy. Treatment with amifampridine should be reviewed if any patient develops a Schwannoma. Caution is advised in patients at risk of Schwannomas, such as a past medical history of such tumours, neurofibromatosis Type 2 or schwannomatosis.

    Pregnancy and Lactation


    Amifampridine is contraindicated during pregnancy.

    Use of amifampridine during pregnancy is contraindicated by the manufacturer. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.


    Amifampridine is contraindicated during breastfeeding.

    The manufacturer advises that the patient either discontinues amifampridine or discontinues breastfeeding. Animal data reports significant levels of amifampridine in the breast milk, however presence in human breast milk is unknown.

    Side Effects

    Abdominal pain
    Aggravation of existing asthma
    Blurred vision
    Cardiac arrhythmias
    Cold extremities
    Cold sweat
    Increase of liver transaminases
    Increased bronchial secretions
    Prolongation of QT interval
    Raynaud's syndrome
    Sleep disturbances


    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 2020

    Reference Sources

    NICE Evidence Services Available at: Last accessed: 21 August 2019

    Summary of Product Characteristics: Firdapse 10mg tablets. BioMarin Europe Ltd. Revised August 2019.

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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.