Fampiron

Fampridine Extended Release Tablet 10mg


Introduction

Fampiron® )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.

Indications

Treatment to improve walking in patients with multiple sclerosis (MS).

Important Information

Dosing

Adult;
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.

Administration

Administer 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.

Pregnancy

Pregnancy category C; Risk cannot be ruled out.

Breast-Feeding

Due to the potential for serious adverse reactions in the breastfed infant, recommended a decision be made to discontinue breastfeeding.

Contraindications & Cautions

Contraindications

Patients who are hypersensitive to fampridine (dalfampridine), 4-aminopyridine, or any component of the formulation.
Patients with;
Severe renal impairment (CrCl ≤50mL/minute).
History of seizure.


Warnings/Precautions

This 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).

Side Effects

Urinary tract infection.
Iran