Description
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.
This product is available in the following dosage forms:
- Tablet
- Suspension
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 rufinamide in children younger than 1 year of age. 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 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.
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.
- Calcifediol
- Cariprazine
- Desogestrel
- Dienogest
- Diltiazem
- Drospirenone
- Estradiol Cypionate
- Estradiol Valerate
- Ethinyl Estradiol
- Ethynodiol Diacetate
- Etonogestrel
- Fentanyl
- Hydroxychloroquine
- Levonorgestrel
- Macimorelin
- Medroxyprogesterone Acetate
- Meperidine
- Mestranol
- Nifedipine
- Norelgestromin
- Norethindrone
- Norgestimate
- Norgestrel
- Orlistat
- Paclitaxel
- Paclitaxel Protein-Bound
- Piperaquine
- Ulipristal
- Valproic Acid
- Warfarin
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
- Fosphenytoin
- Lamotrigine
- Phenobarbital
- Phenytoin
- Primidone
- Triazolam
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:
- Depression, history of or
- Heart rhythm problems (eg, shortened QT interval) or
- Leukopenia (low white blood cells) or
- Mental illness, history of—Use with caution. May make these conditions worse.
- Familial Short QT syndrome (heart rhythm problem)—Should not be used in patients with this condition.
- Liver disease, mild to moderate or
- Patients undergoing dialysis—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Liver disease, severe—Use is not recommended in patients with this condition.
Proper Use
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 forms (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 1 year 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 1 year of age—Use and dose must be determined by your doctor.
- For seizures:
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
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. Blood tests may be needed to check for unwanted effects.
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 (eg, liver, kidneys, or heart). Check with your doctor right away if you or your child have more than one of the following symptoms: a fever, dark-colored urine, headache, rash, itching, extra fluid around the face, stomach pain, swollen, painful, or tender lymph glands in neck, armpit, or groin, unusual tiredness, or yellow eyes or skin.
Do not suddenly stop taking this medicine without checking first with your doctor. Your seizures may return or occur more often if you stop this medicine suddenly. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.
Check with your doctor if you notice any signs of fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cell counts.
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.
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
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
- black, tarry stools
- chest pain
- chills
- cough
- cough producing mucus
- diarrhea
- difficult or painful urination
- 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
- sensation of spinning
- shakiness and unsteady walk
- shivering
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stuffy or runny nose
- sweating
- swollen glands
- tightness in the chest
- trouble sitting still
- trouble sleeping
- trouble walking
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Rare
- Bleeding gums
- blood in the urine or stools
- burning while urinating
- 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
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- troubled breathing with exertion
- 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.
DRG-20072403
