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Fampridine oral prolonged release

Presentation

Oral modified release formulation of fampridine.

Drugs List

  • fampridine 10mg modified release tablet
  • FAMPYRA 10mg prolonged release tablet
  • Therapeutic Indications

    Uses

    Improvement of walking in patients with multiple sclerosis

    Dosage

    Adults

    10mg twice daily (one tablet in the morning and one tablet in the evening).

    Additional Dosage Information

    Initial treatment should be limited to 2 weeks as clinical benefits should generally be seen after 2 weeks of therapy.

    Contraindications

    Children under 18 years
    Breastfeeding
    History of seizures
    Pregnancy
    Renal impairment - creatinine clearance below 50ml/minute
    Seizures

    Precautions and Warnings

    History of allergies including anaphylaxis
    Cardiac conduction defects
    Reduced seizure threshold

    Advise ability to drive/operate machinery may be affected by side effects
    Treatment to be initiated and supervised by a specialist
    Evaluate renal function before and during treatment
    Assess patient for predisposing risk factors which lower seizure threshold
    Discontinue treatment if patient develops seizures
    Evaluate improvement after 2 weeks using a timed walking test
    Discontinue if there is no evidence of clinical benefit within 2 weeks
    Discontinue permanently if severe hypersensitivity reactions occur
    Advise patient of increased risk of falls
    Advise patient to continue to use walking aids for first 4 to 8 weeks

    A timed walking test, e.g. the Timed 25 Foot Walk (T25FW), is recommended to evaluate improvement after two weeks. If no improvement is observed, fampridine should be discontinued.

    Pregnancy and Lactation

    Pregnancy

    Fampridine is contraindicated in pregnancy.

    The manufacturer states there are limited data on the use of fampridine in pregnancy. Animal studies have shown reproductive toxicity.

    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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Fampridine is contraindicated in breastfeeding.

    It is unknown whether fampridine is excreted in human or animal 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 https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Counselling

    The usual dosing regime should always be followed. A double dose should not be taken if a dose is missed.

    Side Effects

    Anaphylaxis
    Angioedema
    Anxiety
    Asthenia
    Back pain
    Chest discomfort
    Constipation
    Dizziness
    Dyspepsia
    Dyspnoea
    Exacerbation of trigeminal neuralgia
    Headache
    Hypersensitivity reactions
    Hypotension
    Insomnia
    Loss of balance
    Nausea
    Palpitations
    Paraesthesia
    Pharyngolaryngeal pain
    Rash
    Seizures
    Tachycardia
    Tremor
    Urinary tract infections
    Urticaria
    Vertigo
    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: November 2017

    Reference Sources

    Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press Accessed on 19 June 2015.

    Summary of Product Characteristics: Fampyra 10mg prolonged-release tablets. Biogen Idec Ltd. Revised July 2020.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: November 2017.

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