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The following safety information provides crucial details about the potential risks and necessary precautions when using this medication. It is essential to carefully review these warnings and consult your healthcare provider if you have any concerns.

• Seizure Risk: Use of Ampyra (dalfampridine) may lead to seizures, even if you have no prior history. Seizures can occur within days or weeks of starting treatment. Inform your healthcare provider if you have a history of seizures or conditions that increase seizure risk. Immediate medical attention is required if a seizure occurs. If you experience a seizure, discontinuation of Ampyra (dalfampridine) treatment is likely. Increased seizure risk is associated with a history of seizures or taking more than the recommended dose of 10 mg twice daily.

• Kidney Function Concerns: Ampyra (dalfampridine) is eliminated from the body through the kidneys. Impaired kidney function can cause the drug to accumulate, increasing the likelihood of side effects, including seizures. Dose adjustment below 10 mg is not feasible for individuals with kidney issues, hence the medication is not recommended for use in these cases. Avoid use if you have existing kidney problems.

• Severe Allergic Reactions: There is a potential for severe allergic reactions to Ampyra (dalfampridine), including life-threatening symptoms such as swelling of the mouth or face, shock, or anaphylaxis. If you experience hives, rash, redness, swelling of the lips or tongue, or difficulty breathing, discontinue use immediately and seek emergency medical care.

Contraindications

This medication should not be used under the following conditions due to significant health risks. Consult your healthcare provider if any of these apply:

• A history of seizures
• Moderate to severe kidney issues

Ensure you discuss any concerns or pre-existing conditions with your healthcare provider to determine if Ampyra (dalfampridine) is safe for you.

Common side effects:

• Trouble sleeping (insomnia)
• Dizziness
• Headache
• Nausea
• Feelings of weakness or lack of energy
• Urinary tract infections
• Symptoms resembling a common cold (runny nose)

Less common but important to monitor:

• Back pain
• Balance problems
• Constipation
• Upset stomach
• Burning or prickling sensation in the hands and feet

Serious side effects:

• Mental or mood changes (severe confusion or memory problems)
• Seizures
• Severe allergic reaction (hives, swelling of the face, lips, or tongue, difficulty breathing)

Interactions with high risk of serious adverse effects and should be avoided:

• 4-AP, 4-Aminopyridine, fampridine (similar drugs that could increase the risk of seizures)

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Dolutegravir
• Lacosamide
• Trilaciclib