Lamotrigine is a prescription medication used to treat epilepsy and bipolar disorder. Lamotrigine belongs to a group of drugs called anticonvulsants, which decrease abnormal brain activity.
WARNING: SERIOUS SKIN RASHES
Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (2 to 16 years of age) receiving lamotrigine as adjunctive therapy for epilepsy and 0.3% (3 per 1,000) in adults on adjunctive therapy for epilepsy. In clinical trials of bipolar and other mood disorders, the rate of serious rash was 0.08% (0.8 per 1,000) in adult patients receiving lamotrigine as initial monotherapy and 0.13% (1.3 per 1,000) in adult patients receiving lamotrigine as adjunctive therapy. In a prospectively followed cohort of 1,983 pediatric patients (2 to 16 years of age) with epilepsy taking adjunctive lamotrigine, there was 1 rash-related death. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate.
Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash caused by lamotrigine. There are suggestions, yet to be proven, that the risk of rash may also be increased by (1) coadministration of lamotrigine with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of lamotrigine, or (3) exceeding the recommended dose escalation for lamotrigine. However, cases have occurred in the absence of these factors.
Nearly all cases of life-threatening rashes caused by lamotrigine have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash.
Although benign rashes are also caused by lamotrigine, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring.
Lamotrigine is a prescription medicine used together with other medicines to treat certain types of seizures in people 2 years or older.
Lamotrigine is also used for the treatment of bipolar disorder in people 18 years or older who have been treated for mood episodes with other medicine.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Lamotrigine may cause a serious skin rash that may cause you to be hospitalized or even cause death.
There is no way to tell if a mild rash will become more serious. A serious skin rash can happen at any time during your treatment with lamotrigine, but is more likely to happen within the first 2 to 8 weeks of treatment. Children between 2 to 16 years of age have a higher chance of getting this serious skin rash while taking lamotrigine.
The risk of getting a serious skin rash is higher if you:
- take lamotrigine while taking valproate [Depakene (valproic acid) or Depakote (divalproex sodium)]
- take a higher starting dose of lamotrigine than your doctor prescribed
- increase your dose of lamotrigine faster than prescribed.
Call your doctor right away if you have any of the following:
- a skin rash
- blistering or peeling of your skin
- painful sores in your mouth or around your eyes
These symptoms may be the first signs of a serious skin reaction. A doctor should examine you to decide if you should continue taking lamotrigine.
Other serious reactions, including serious blood problems or liver problems. Lamotrigine can also cause other types of allergic reactions or serious problems that may affect organs and other parts of your body like your liver or blood cells. You may or may not have a rash with these types of reactions. Call your doctor right away if you have any of these symptoms:
- frequent infections
- severe muscle pain
- swelling of your face, eyes, lips, or tongue
- swollen lymph glands
- unusual bruising or bleeding
- weakness, fatigue
- yellowing of your skin or the white part of your eyes
Like other antiepileptic drugs, lamotrigine may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a doctor right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempt to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
Lamotrigine may rarely cause aseptic meningitis, a serious inflammation of the protective membrane that covers the brain and spinal cord.
Call your doctor right away if you have any of the following symptoms:
- stiff neck
- unusual sensitivity to light
- muscle pains
Meningitis has many causes other than lamotrigine, which your doctor would check for if you developed meningitis while taking lamotrigine.
Common side effects of lamotrigine include:
- blurred or double vision
- lack of coordination
- nausea, vomiting
- abdominal pain
- back pain
- dry mouth
Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of lamotrigine. For more information, ask your doctor or pharmacist.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Lamotrigine and other medicines may affect each other. Always check with your doctor before starting or stopping any medicines. Especially tell your doctor if you take:
- valproic acid (Depakene);
- divalproex (Depakote);
- methotrexate (Rheumatrex, Trexall); other medications for seizures such as carbamazepine (Tegretol), oxcarbazepine (Trileptal), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), and primidone (Mysoline);
- pyrimethamine (Daraprim);
- rifampin (Rifadin, Rimactane);
- trimethoprim (Proloprim);
- hormonal contraceptives (birth control pills, patches, rings, injections, implants, or intrauterine devices)
- hormone replacement therapy medicines (estrogens, progestins and combination medicines)
You should not take lamotrigine if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in lamotrigine.
Lamotrigine has cause serious problems including:
- serious skin rash
- serious blood problems
- liver problems
- suicidal thoughts or actions
- aseptic meningitis (a serious inflammation of the protective membrane that covers the brain and spinal cord)
Patients prescribed lamotrigine have sometimes been given the wrong medicine because many medicines have names similar to lamotrigine, so always check that you receive lamotrigine.
Do not drive a car or operate complex, hazardous machinery until you know how lamotrigine affects you.
Do not stop taking lamotrigine without talking to your doctor. Stopping lamotrigine suddenly may cause serious problems including seizures that do not stop. Your doctor will help you to gradually decrease your dose.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of lamotrigine there are no specific foods that you must exclude from your diet when receiving lamotrigine.
Before taking lamotrigine, tell your doctor about all of your medical conditions, including if you:
- have had a rash or allergic reaction to another antiseizure medicine.
- have or have had depression, mood problems or suicidal thoughts or behavior.
- have had aseptic meningitis after taking lamotrigine or lamotrigine XR.
- are taking oral contraceptives (birth control pills) or other female hormonal medicines. Do not start or stop taking birth control pills or other female hormonal medicine until you have talked with your doctor. Tell your doctor if you have any changes in your menstrual pattern such as breakthrough bleeding. Stopping these medicines may cause side effects (such as dizziness, lack of coordination, or double vision). Starting these medicines may lessen how well lamotrigine works.
- are pregnant or plan to become pregnant. It is not known if lamotrigine will harm your unborn baby. If you become pregnant while taking lamotrigine, talk to your doctor about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
- are breastfeeding. Lamotrigine passes into breast milk and may cause side effects in a breastfed baby. If you breastfeed while taking lamotrigine, watch your baby closely for trouble breathing, episodes of temporarily stopping breathing, sleepiness, or poor sucking. Call your baby’s doctor right away if you see any of these problems. Talk to your doctor about the best way to feed your baby if you take lamotrigine.
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if lamotrigine will harm your unborn baby.
Tell your doctor if you are breastfeeding or planning to breastfeed. Lamotrigine passes into breast milk and may cause side effects in a breastfed baby. If you breastfeed while taking lamotrigine, watch your baby closely for trouble breathing, episodes of temporarily stopping breathing, sleepiness, or poor sucking. Call your baby’s healthcare provider right away if you see any of these problems. Talk to your healthcare provider about the best way to feed your baby if you take lamotrigine.
- Take lamotrigine exactly as prescribed.
- Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
- Do not stop taking lamotrigine without talking to your healthcare provider. Stopping lamotrigine suddenly may cause serious problems. For example, if you have epilepsy and you stop taking lamotrigine suddenly, you may get seizures that do not stop. Talk with your healthcare provider about how to stop lamotrigine slowly.
- If you miss a dose of lamotrigine, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take two doses at the same time.
- You may not feel the full effect of lamotrigine for several weeks.
- If you have epilepsy, tell your healthcare provider if your seizures get worse or if you have any new types of seizures.
- Swallow lamotrigine tablets whole.
- If you have trouble swallowing lamotrigine tablets, tell your healthcare provider because there may be another form of lamotrigine you can take.
- Lamotrigine ODT should be placed on the tongue and moved around the mouth. The tablet will rapidly disintegrate, can be swallowed with or without water, and can be taken with or without food.
- Lamotrigine Chewable Dispersible tablets may be swallowed whole, chewed, or mixed in water or diluted fruit juice. If the tablets are chewed, drink a small amount of water or diluted fruit juice to help in swallowing. To break up lamotrigine Chewable Dispersible tablets, add the tablets to a small amount of liquid (1 teaspoon, or enough to cover the medicine) in a glass or spoon. Wait at least 1 minute or until the tablets are completely broken up, mix the solution together and take the whole amount right away.
- If you receive lamotrigine in a blisterpack, examine the blisterpack before use. Do not use if blisters are torn, broken, or missing.
Take lamotrigine exactly as prescribed by your doctor. Follow the directions on your presciption label carefully. Your doctor will determine the best dose for you. Often patients begin taking a low dose for the first 2 weeks and that is followed by a dose increase for weeks 3 and 4. Then from week 5 on, a dose increase every 1 to 2 weeks is added until the best dose is achieved.
If you take too much lamotrigine call your local Poison Control Center or seek emergency medical attention right away.
- Store lamotrigine at room temperature between 68 F to 77 F (20 C to 25 C).
- Keep lamotrigine and all medicines out of the reach of children.
Lamotrigine may cause a serious skin rash that may cause you to be hospitalized or even cause death.
- There is no way to tell if a mild rash will become more serious.
- A serious skin rash can happen at any time during your treatment with lamotrigine, but is more likely to happen within the first 2 to 8 weeks of treatment.
- Children between 2 to 16 years of age have a higher chance of getting this serious skin rash while taking lamotrigine.
Do not start or stop taking birth control pills or other female hormonal medicine until you have talked with your doctor. Starting these medicines may lessen how well lamotrigine works.
You may not feel the full effect of lamotrigine for several weeks.