Fampyra Comprimidos (Fampridine) – Multiple Sclerosis | HongKong DengYue Medicine

  • Generic Name/Brand Name: Fampridine / Fampyra
  • Indications: Improvement of walking in adult patients with multiple sclerosis with walking disability
  • Dosage Form: Extended-release tablet
  • Specification: 10 mg x 14 tablets

Fampridine Application Scope

Fampridine is indicated for the symptomatic improvement of walking in adult patients with multiple sclerosis (MS) who have a walking disability. Treatment should be initiated and supervised by physicians experienced in the management of MS.

fampridine

Fampridine Characteristics

  • Ingredients: Each extended-release tablet contains 10 mg of fampridine (4-aminopyridine) as the active ingredient.

  • Specification: Extended-release tablets, 10 mg.

  • Packaging Specification: Available in bottles of 60 tablets (60-count, 60 cc HDPE round bottles) and physician samples packaged in 14-count (30 cc HDPE round bottles).

  • Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F).

  • Expiry Date: 36 months from the date of manufacture.

  • Executive Standard: Manufactured in compliance with FDA-approved standards.

  • Approval Number: NDA 22-250.

  • Date of Revision: December 23, 2009.

  • Manufacturer: Acorda Therapeutics, Inc.

Guidelines for the Use of Fampridine

  • Dosage and Administration: The recommended dose is one 10 mg tablet taken twice daily, approximately 12 hours apart. Tablets should be swallowed whole; do not divide, crush, chew, or dissolve. Fampridine can be taken with or without food. If a dose is missed, do not take double or extra doses.

  • Adverse Reactions: Common adverse reactions include urinary tract infections, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain. There is a dose-related increased risk of seizures.

  • Contraindications: Is contraindicated in patients with a history of seizures, moderate or severe renal impairment (creatinine clearance ≤50 mL/min), or hypersensitivity to fampridine or any of its components.

  • Precautions: Assess renal function before initiating treatment and monitor periodically. Use with caution in patients with factors that may lower the seizure threshold. Discontinue use if a seizure occurs during treatment.

 Interactions

  • Drug Interactions: Fampridine is primarily excreted unchanged by the kidneys. Concomitant use with drugs that are inhibitors of the organic cation transporter 2 (OCT2), such as cimetidine and quinidine, is contraindicated due to the potential for increased fampridine plasma concentrations. Use with caution when co-administered with other drugs that can affect renal function.

 

Note:

  • If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
  • It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.
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