Fampridine oral prolonged release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral modified release formulation of fampridine.
Drugs List
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.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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