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Rufinamide (Oral route)

Pronunciation:

roo-FIN-a-mide

Brand Names:

  • Banzel

Dosage Forms:

  • Suspension
  • Tablet

Classifications:

Therapeutic—

Anticonvulsant

Uses of This Medicine:

Rufinamide is used to control seizures (convulsions) that occur with Lennox-Gastaut syndrome (LGS). It works in the brain to prevent seizures. This medicine will not cure LGS and will only control seizures for as long as you continue to take it.

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 rufinamide in children younger than 4 years of age. 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 rufinamide in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution and an adjustment in the dose for patients receiving rufinamide.

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. 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.

  • Clozapine
  • Cobicistat
  • Elvitegravir
  • Ketorolac
  • Nifedipine
  • Orlistat
  • Piperaquine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Carbamazepine
  • Desogestrel
  • Dienogest
  • Drospirenone
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Fosphenytoin
  • Lamotrigine
  • Levonorgestrel
  • Medroxyprogesterone Acetate
  • Mestranol
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Phenobarbital
  • Phenytoin
  • Primidone
  • Triazolam
  • Valproic Acid

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:

  • Familial Short QT syndrome (heart rhythm problem)—Should not be used in patients with this condition.
  • Heart rhythm problems (e.g., shortened QT interval)—Use with caution. May make this condition worse.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only 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.

This medicine should come with a Medication Guide. The oral liquid should also come with instructions for use. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take this medicine with food. The tablets may be taken whole, broken in half, or crushed if needed.

Measure the oral liquid with the oral dosing syringe that comes with the package. Shake the bottle well just before taking each dose.

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 (suspension or tablets):
    • For seizures:
      • Adults—At first, 400 to 800 milligrams (mg) per day, taken in two divided doses. Your doctor may gradually increase your dose if needed. However, the dose is usually not more than 3200 mg per day.
      • Children 4 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is 10 milligrams (mg) per kilogram (kg) of body weight per day, taken in two divided doses. Your doctor may gradually increase your dose if needed. However, the dose is usually not more than 45 mg/kg/day or 3200 mg per day.
      • Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

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.

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

Store the oral liquid in an upright position. Use the liquid within 90 days after opening the bottle for the first time. Throw away any unused liquid.

Precautions While Using This Medicine:

It is very important that your doctor check you or your child's progress at regular visits to make sure this medicine is working properly.

If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause some people to become dizzy, drowsy, lightheaded, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

This medicine may cause serious allergic reactions that may affect several parts of the body (e.g., liver or kidneys). Check with your doctor right away if you or your child have more than one of the following symptoms: fever, dark-colored urine, headache, rash, itching, extra fluid around the face, stomach pain, unusual tiredness, or yellow eyes or skin.

Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Birth control pills may not work as well while you are using this medicine. To keep from getting pregnant, use another form of birth control together with your birth control pills. Other forms include condoms, diaphragms, or contraceptive foams or jellies.

Tell your doctor if you become pregnant while taking this medicine. Your doctor may want you to join the North American Antiepileptic Drug Pregnancy Registry. The registry is used by pregnant patients who are taking this medicine.

Avoid drinking alcohol while taking this medicine.

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 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
Dizziness
shakiness in the legs, arms, hands, or feet
sleepiness or unusual drowsiness
trembling or shaking of the hands or feet
uncontrolled eye movements
Less common
Attack, assault, or force
chills
cough producing mucus
diarrhea
difficulty with breathing
dizziness or lightheadedness
fear or nervousness
feeling of constant movement of self or surroundings
fever
general feeling of discomfort or illness
headache
joint pain
loss of appetite
muscle aches and pains
nausea
pain or tenderness around the eyes and cheekbones
rash
restlessness
runny nose
sensation of spinning
shakiness and unsteady walk
shivering
shortness of breath or troubled breathing
sore throat
stuffy or runny nose
sweating
tightness in the chest
trouble in walking
trouble sitting still
trouble sleeping
unsteadiness, trembling, or other problems with muscle control or coordination
unusual tiredness or weakness
vomiting
wheezing
Rare
Black, tarry stools
bleeding gums
blood in the urine or stools
burning while urinating
chest pain
difficult or painful urination
fainting
frequent urination
inability to hold urine
increased urge to urinate during the night
increased volume of pale, dilute urine
lower back or side pain
pale skin
pinpoint red spots on the skin
pounding, slow heartbeat
sore tongue
sores, ulcers, or white spots on the lips or in the mouth
swollen glands
swollen, painful, or tender lymph glands in the neck, armpit, or groin
troubled breathing with exertion
unusual bleeding or bruising
waking to urinate at night

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
Blurred vision
double vision
seeing double
Less common
Acid or sour stomach
back pain
belching
change in hearing
decreased appetite
difficulty having a bowel movement (stool)
ear drainage
earache or pain in the ear
heartburn
indigestion
itching skin
stomach discomfort, upset, or pain
upper abdominal or stomach pain
Rare
Increased appetite

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: 11/4/2014

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