Dalfampridine sustained-release tablets are a potassium channel blocker designed specifically to improve walking ability in adult patients with multiple sclerosis (MS).

1、 Drug name

1. Product Name: AMPYRA ®

2. Common name: dalfampridine sustained-release tablets

2、 Indications

This product is suitable for improving the walking ability of adult patients with multiple sclerosis, and clinical studies have shown that it can increase walking speed.

3、 Specifications and characteristics

10mg、 tablet

4、 Main components

Active ingredient: dalfampridine 10mg

5、 Usage and dosage

1. Regular dosage: 10mg each time, twice a day, once in the morning and once in the evening, with an interval of about 12 hours.

2. Usage: Swallow the whole tablet, do not break, crush, chew or dissolve. Can be taken with food or on an empty stomach.

3. Daily maximum dose: no more than 2 tablets (20mg), higher doses have no additional benefits and increase the risk of adverse reactions such as epilepsy.

6、 Dose adjustment

Patients with renal insufficiency:

1. Mild renal insufficiency (CrCl51-80mL/min): The benefits and risk of epilepsy should be carefully evaluated.

2. Moderate to severe renal insufficiency (CrCl ≤ 50mL/min): This product is contraindicated.

3. The estimated creatinine clearance rate (CrCl) should be monitored at least once a year before and during treatment.

7、 Medication precautions

1. Usage: Swallow the whole tablet, do not chew or dissolve.

2. Omission treatment: If one dose is missed, the next dose should be taken according to the original plan and not double the dosage.

3. Vomiting treatment: If vomiting occurs shortly after taking medication, it is recommended not to take it again to avoid excessive dosage.

4. Taken with food: Slight impact on absorption, no need to adjust dosage.

5. Avoid co administration with other drugs containing 4-aminopyridine.

8、 Medication for special populations

1. Elderly people: Due to common renal dysfunction, CrCl must be evaluated before medication.

2. Children (<18 years old): Safety and efficacy have not been established yet.

3. Pregnant women: There is currently insufficient data, and animal experiments have shown that high doses may affect fetal development.

4. Breastfeeding women: It is not yet clear whether it is secreted through breast milk, and should be used after weighing the pros and cons.

9、 Adverse reactions

1. Common adverse reactions (incidence ≥ 2% and higher than placebo) include:

Urinary tract infections, insomnia, dizziness, headache, nausea, fatigue, back pain, balance disorders, recurrent multiple sclerosis, sensory abnormalities, nasopharyngitis, constipation, indigestion, sore throat.

2. Serious adverse reactions include epilepsy and allergic reactions (such as anaphylactic shock and angioedema).

10、 Contraindications

1. Individuals with a history of epilepsy.

2. Moderate to severe renal insufficiency (CrCl ≤ 50mL/min).

3. Individuals allergic to aminopyridine or 4-aminopyridine.

11、 Drug interactions

1. OCT2 inhibitors (such as cimetidine): may increase the blood concentration of aminopyridine and increase the risk of epilepsy.

2. Baclofen: No clinically significant interaction.

3. Avoid co administration with other drugs containing 4-aminopyridine.

12、 Storage method

1. Storage temperature: 25 ° C (77 ° F), allowing short-term fluctuations between 15 ° C-30 ° C (59 ° F-86 ° F).

2. Keep out of reach of children and handle properly when expired or no longer in use.

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