Dalfarosis 10 mg 20 tablets

Dalfarosis 10 mg 20 tablets

Description:

Dalfarosis (Dalfampridine) is a potassium channel blocker, formulated as an extended-release tablet for twice-daily oral administration.


Ingredients:

Each tablet contains 10 mg of dalfampridine.

Indications for Use:

Dalfarosis is indicated to improve walking in adult patients with multiple sclerosis (MS), demonstrated by an increase in walking speed.

Dosage and Administration:

Dosage Information: The maximum recommended dosage of Dalfarosis is one 10 mg tablet twice daily, not exceeding this dose. Take doses approximately 12 hours apart.

Dalfarosis can be taken with or without food. Administer tablets whole; do not divide, crush, chew, or dissolve tablets. If a dose is missed, do not take a double dose.

Renal Monitoring: Estimated creatinine clearance (CrCl) should be known before initiating treatment and monitored at least annually during treatment.

Renal Impairment: Contraindicated in patients with moderate or severe renal impairment (CrCl ≤50 mL/min). In patients with mild renal impairment (CrCl 51-80 mL/min), the risk of seizures is higher.

Contraindications:

History of seizure

Moderate or severe renal impairment (CrCl ≤50 mL/min)

History of hypersensitivity to Dalfarosis or 4-aminopyridine.

Warnings and Precautions:

-Seizures: Dalfarosis may cause seizures, especially at higher doses. Permanently discontinue in patients who experience a seizure.

-Renal Impairment: Contraindicated in patients with moderate or severe renal impairment

-Concurrent Use with Other 4-Aminopyridine Products: Avoid concomitant use with other 4-aminopyridine products.

-Anaphylaxis: May cause anaphylaxis. Discontinue use immediately if signs of anaphylaxis occur.

Side Effects:

Common adverse reactions include:

Seizures

Anaphylaxis

Dizziness

Headache

Balance disorder

Urinary tract infections

Nausea.

Pregnancy and Lactation:

Pregnancy: Limited data on the use of Dalfarosis during pregnancy. The risks for birth defects and miscarriage are unknown.

Lactation: No data on the presence of Dalfarosis in human milk. Caution is recommended.

Storage Conditions:

Store at a temperature not exceeding 30°C in a dry place.

Packaging:

Carton box containing 2 strips each with 10 extended-release tablets.