Finished product reference

Fampridine

Tablet, Extended Release · Oral · 10 mg

List code
19263
Pharmacologic class
Potassium channel blocker (4-aminopyridine)

What it is and how it works

Fampridine blocks voltage-gated potassium channels exposed on demyelinated axons, reducing leakage of potassium current and prolonging repolarisation. This improves action potential conduction in demyelinated fibres and can enhance motor function.

Indications

Improvement of walking in adults with multiple sclerosis with walking disability (EDSS 4–7); treatment should be continued only if an improvement is seen after an initial assessment period of about 2 weeks.

Dosage and administration (summary)

Oral, 10 mg prolonged-release tablet twice daily, 12 hours apart, taken without food; doses must not be doubled or taken closer together.

Contraindications

History of seizures or current seizure disorder, renal impairment (creatinine clearance below 80 mL/min), concomitant treatment with OCT2 inhibitors such as cimetidine, concomitant other 4-aminopyridine products, and hypersensitivity.

Warnings and precautions

Fampridine lowers the seizure threshold, and seizure risk is dose-related; treatment must be stopped permanently if a seizure occurs. Caution is needed in patients with cardiac rhythm or conduction disorders, and urinary tract infections, insomnia, dizziness and balance disorders are common; anaphylaxis has been reported.

Pregnancy

Avoid use in pregnancy as a precaution.

Storage and supply

Store below 25 °C in the original package to protect from light and moisture.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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