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Dalfampridine (Oral route)

Pronunciation:

dal-FAM-pri-deen

Brand Names:

  • Ampyra

Dosage Forms:

  • Tablet, Extended Release

Classifications:

Therapeutic

Central Nervous System Agent

Pharmacologic

Potassium Channel Blocker

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children

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.

Older adults

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.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding

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.

Other medicines

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 of This Medicine:

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 patient information leaflet. 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.

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) two times a day (taken at least 12 hours apart). Do not take more than two 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 While Using This Medicine:

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

Dalfampridine may cause seizures. Stop using this medicine and check with your doctor right away if you have convulsions or seizures while taking this medicine.

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

This medicine may cause serious type of allergic reactions, including anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face, large, hive-like swelling on face, eyelids, lips, tongue and/or throat, If these side effects occur, get emergency help at once.

Urinary tract infections may occur while using this medicine. Check with your doctor right away if you have the following symptoms while using this medicine: bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, frequent urge to urinate, or lower back or side pain.

Side Effects of This Medicine:

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
difficulty walking
feeling sad or depressed
forgetful
muscle cramps
numbness or tingling in your arms, legs, or face
slurred speech or problems with swallowing
unusual tiredness or weakness
Incidence not known
Cough
dizziness
fast heartbeat
hives
itching
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
shortness of breath
skin rash
tightness in the chest

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

Symptoms of overdose
Confusion
epileptic seizure that will not stop
increased sweating
memory loss
problems with memory
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
trouble sleeping
Less common
Back pain
constipation
fever
headache
muscle aches
sore throat
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.


Last Updated: 9/15/2016
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