Dalfampridine

Dalfampridine is a prescription medicine used to improve walking in patients with multiple sclerosis.

• Dalfampridine is available under the following different brand names: Ampyra

Common side effects of Dalfampridine include:

• headache
• dizziness
• weakness
• drowsiness
• sleep problems (insomnia)
• nausea
• constipation
• upset stomach
• stuffy nose
• sinus pain
• sore throat
• back pain

Serious side effects of Dalfampridine include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• seizure
• pain or burning while urinating
• numbness
• burning pain
• tingly feeling
• problems with balance
• relapse or worsening of MS symptoms

Rare side effects of Dalfampridine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet, extended-release

• 10 mg

Multiple sclerosis

Adult and geriatric dosage

• 10 mg orally two times a day with or without food; take doses 12 h apart
• Extended-release tablet; swallow the tablet whole and do not chew, crush, divide, or dissolve tablets

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Dalfampridine has serious interactions with no other drugs.
• Dalfampridine has serious interactions with the following drug:
  • trilaciclib
• Dalfampridine has moderate interactions with the following drug:
  • dolutegravir
  • metformin
• Dalfampridine has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• Moderate or severe renal impairment (CrCl below 50 mL/min)
• History of seizure

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Dalfampridine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Dalfampridine?"

Cautions

• Seizures reported; permanently discontinue if a seizure occurs; most seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures
• Age-related decreases in renal function and mild renal impairment are common after the age of 50 years; plasma levels may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk for seizures; even when serum creatinine is normal, renal function should be assessed by estimating creatinine clearance
• Do not take with other forms of 4-aminopyridine (fampridine) to avoid adverse reactions due to the same active ingredient
• Estimate CrCl before initiating (see Contraindications and Renal Impairment)
• Do not double the dose or take extra if the dose is missed
• Anaphylaxis and severe allergic reactions; signs and symptoms have included respiratory compromise, urticaria, and angioedema of the throat and or tongue; discontinue immediately and do not restart (see Contraindications)
• UTIs reported more frequently in clinical trials vs placebo

Pregnancy and Lactation

• There are no adequate data on the developmental risk associated with use in pregnant women
• Lactation
  • There are no data on the presence of drugs in human milk, its effects on the breastfed infant, or milk production; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition