Fampridine Extended Release Tablet 10mg
IntroductionFampiron® )Fampridine 10mg) _ manufactured by Faran shimi pharmaceutical company_ is an oral tablet form of the potassium (K +) channel-blocker. Fampiron® is indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. Impaired ability to walk constitutes one of the major disabling neuromuscular deﬁcits associated with MS. It is often the most visible sign of MS. The drug is thought to act by restoring conduction in focally demyelinated axons and by enhancing neurotransmission, thereby leading to improved neurological function.
Fampiron® is supplied in 10mg extended-release tablets for oral administration. 28 tablets are packed in a bottle and 2 bottles are packaged in one box with a leaflet.
IndicationsTreatment to improve walking in patients with multiple sclerosis (MS).
10 mg every 12 hours (maximum daily dose: 20 mg)
Dosing: Renal Impairment:
Moderate-to-severe renal impairment (CrCl ≤50 mL/minute): Use is contraindicated.
Dosing: Hepatic Impairment:
Dosage adjustment not necessary.
AdministrationAdminister with or without food. Do not crush, break, chew, or dissolve the tablets.
Do not administer double or extra doses if a dose is missed.
Moderate Interactions (Risk C)Inhibitors of organic cation transporter 2 (OCT2) such as Cimetidine, Metformin, and Quinidine.
PregnancyPregnancy category C; Risk cannot be ruled out.
Breast-FeedingDue to the potential for serious adverse reactions in the breastfed infant, recommended a decision be made to discontinue breastfeeding.
Contraindications & Cautions
ContraindicationsPatients who are hypersensitive to fampridine (dalfampridine), 4-aminopyridine, or any component of the formulation.
Severe renal impairment (CrCl ≤50mL/minute).
History of seizure.
Warnings/PrecautionsThis product should be used with caution in the patients:
Who are pregnant and breasƞeeding (pregnancy category C).
Who Use Other Forms Of 4-Aminopyridine.
With renal impairment.
With risk of seizure, Fampiridine can cause seizures.
With history of anaphylaxis shock, Fampiridine can cause anaphylaxis and severe allergic reactions.
With Urinary tract infections (UTIs).