Do not exceed 1–3 mg/kg per minute in pediatric patients.
REMS:
FDA approved a REMS for phenytoin to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
Take this medicine by mouth with a glass of water. Chew it or swallow whole. Follow the directions on the prescription label. Take this medicine with food if it upsets your stomach. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly. This increases the risk of seizures. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. This medicine needs careful monitoring. Your doctor or health care professional may schedule regular blood tests.
Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.
Do not change brands or dosage forms of this medicine without discussing the change with your doctor or health care professional.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.
Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.
This medicine can cause unusual growth of gum tissues. Visit your dentist regularly. Problems can arise if you need dental work, and in the day to day care of your teeth. Try to avoid damage to your teeth and gums when you brush or floss your teeth.
Do not take antacids at the same time as this medicine. If you get an upset stomach and want to take an antacid or medicine for diarrhea, make sure there is an interval of 2 to 3 hours before or after you took your phenytoin.
The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.
Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
poor control of body movements or difficulty walking
redness, blistering, peeling or loosening of the skin, including inside the mouth
unusual bleeding or bruising, pinpoint red spots on skin
vomiting
worsening of mood, thoughts or actions of suicide or dying
yellowing of the eyes or skin
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
constipation
difficulty sleeping
excessive hair growth on the face or body
nausea
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature below 30 degrees C (86 degrees F). Protect from light and moisture. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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