Can cause serious and potentially life-threatening rash, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death. (See Dermatologic Reactions under Cautions.)
Risk of serious rash is greater in pediatric patients than in adults (see Pediatric Use under Cautions) and may be increased by concomitant use of valproic acid (valproate, divalproex sodium) or by exceeding the recommended initial dosage or dosage escalation schedule for lamotrigine.
Cases of life-threatening rash associated with immediate-release lamotrigine almost always have occurred within 2–8 weeks of treatment initiation; however, isolated cases have been reported following prolonged treatment (e.g., 6 months).
Can also cause benign rashes; however, it is not possible to predict which rashes will become serious or life-threatening. Discontinue therapy at the first sign of rash (unless the rash is clearly not drug related).
Discontinuance of therapy may not prevent rash from becoming life-threatening or permanently disabling or disfiguring.
REMS:
FDA approved a REMS for lamotrigine 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 However, FDA later rescinded REMS requirements.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. These tablets may be swallowed whole, chewed, mixed in water, or diluted in fruit juice to aid swallowing. Follow the directions on the prescription label. To mix the tablets in water or juice, add the tablets to a small amount of liquid (1 teaspoon or enough to cover the medicine) in a glass or spoon. The tablets will dissolve in about 1 minute. Once dissolved, mix or swirl the liquid and take the entire solution immediately. It is important that you swallow all of the liquid used to prepare the dose, so that the full prescribed dose is given. Take your doses at regular intervals. Do not take your medicine more often than directed.
A special MedGuide will be given to you by the pharmacist with each new prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years 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.
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. If you take this medicine for seizures, wear a Medic Alert bracelet or necklace. Carry an identification card with information about your condition, medicines, and doctor or health care professional.
It is important to take this medicine exactly as directed. When first starting treatment, your dose will need to be adjusted slowly. It may take weeks or months before your dose is stable. You should contact your doctor or health care professional if your seizures get worse or if you have any new types of seizures. Do not stop taking this medicine unless instructed by your doctor or health care professional. Stopping your medicine suddenly can increase your seizures or their severity.
Contact your doctor or health care professional right away if you develop a rash while taking this medicine. Rashes may be very severe and sometimes require treatment in the hospital. Deaths from rashes have occurred. Serious rashes occur more often in children than adults taking this medicine. It is more common for these serious rashes to occur during the first 2 months of treatment, but a rash can occur at any time.
You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks.
If you are taking this medicine for bipolar disorder, it is important to report any changes in your mood to your doctor or health care professional. If your condition gets worse, you get mentally depressed, feel very hyperactive or manic, have difficulty sleeping, or have thoughts of hurting yourself or committing suicide, you need to get help from your health care professional right away. If you are a caregiver for someone taking this medicine for bipolar disorder, you should also report these behavioral changes right away. 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.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.
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 you should report to your doctor or health care professional as soon as possible:
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 reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 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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