Dalfampridine (oral route)


    Brand Name

    US Brand Name

    Ampyra


    Description

    Dalfampridine is used to help improve walking in patients with multiple sclerosis. This medicine is a potassium channel blocker.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Tablet, Extended Release

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of dalfampridine in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dalfampridine in the elderly. However, elderly patients are more likely to have seizures and age-related kidney problems, which may require caution in patients receiving dalfampridine.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Bictegravir
    • Bupropion
    • Dolutegravir
    • Fedratinib
    • Fexinidazole
    • Trilaciclib

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
    • Kidney disease, moderate to severe or
    • Seizures, history of—Should not be used in patients with these conditions.

    Proper Use

    Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not change your dose without checking first with your doctor.

    This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

    Swallow the extended release tablet whole. Do not crush, break, chew, or dissolve it. Tell your doctor if you have trouble swallowing the tablet whole.

    You may take this medicine with or without food.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (extended release tablets):
      • For walking impairment:
        • Adults—10 milligrams (mg) 2 times a day (taken at least 12 hours apart). Do not take more than 2 tablets in a 24-hour period.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

    Check with your doctor right away if you have seizures while taking this medicine.

    Do not take dalfampridine together with other aminopyridine medicines (eg, compounded 4-AP, fampridine). Taking these medicines together will increase the chance for more serious side effects.

    This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

    This medicine may make you dizzy, lightheaded, or feel a constant movement of self or surroundings. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    • Bladder pain
    • bloody or cloudy urine
    • difficult, burning, or painful urination
    • frequent urge to urinate
    • lower back or side pain

    Less common

    • Blurred vision
    • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
    • difficulty controlling your bladder or bowels
    • feeling sad or depressed
    • forgetful
    • muscle cramps
    • problems with swallowing
    • slurred speech
    • unusual tiredness or weakness

    Incidence not known

    • Chest tightness
    • cough
    • dizziness or lightheadedness
    • fast heartbeat
    • feeling of constant movement of self or surroundings
    • hives, itching, skin rash
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • sensation of spinning
    • vomiting

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Confusion
    • increased sweating
    • memory loss
    • reduced awareness
    • seizures
    • weakness

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Headache
    • lack or loss of strength
    • nausea
    • problems with balance
    • trouble sleeping

    Less common

    • Back pain
    • constipation
    • fever
    • muscle aches
    • sore throat
    • stomach discomfort, upset, or pain
    • stuffy or runny nose

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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