Lamotrigine

Lamotrigine is a prescription oral anticonvulsant medicine used:

• together with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome) in people aged 2 years and older
• alone when changing from one other medicine used to treat partial-onset seizures in people aged 16 years and older
• for the long-term treatment of bipolar I disorder to lengthen the time between mood episodes in people who have been treated for mood episodes with other medicines.

Limitations

• It is not known if lamotrigine is safe or effective in people younger than 18 years with mood episodes such as bipolar disorder or depression.
• It is not known if lamotrigine is safe or effective when used alone as the first treatment of seizures.
• It is not known if lamotrigine is safe or effective for people with mood episodes who have not already been treated with other medicines.
• Lamotrigine should not be used for the acute treatment of manic or mixed mood episodes.

Extended-release tablets are approved for fewer uses than the other forms. Lamotrigine extended-release tablets are used:

• together with other medicines to treat primary generalized tonic-clonic seizures and partial-onset seizures in people aged 13 years and older.
• alone when changing from 1 other medicine used to treat partial-onset seizures in people aged 13 years and older.

Lamotrigine extended-release tablets are not approved for children younger than 13 years, for generalized seizures of Lennox-Gastaut syndrome, or for bipolar disorder. Other forms of lamotrigine are available for these uses and for younger children.

This guide covers all oral forms of lamotrigine: tablets, chewable dispersible tablets, orally disintegrating tablets (ODT), extended-release tablets, and oral suspension. Most of the information below is the same for every form; where a form differs, it is described as such.

Lamlique is a brand of lamotrigine oral suspension, available in 5 mg/mL and 25 mg/mL strengths. It is a liquid form that may be helpful for people who have trouble swallowing tablets or who need a dose that is easier to adjust. Lamlique is made by Azurity Pharmaceuticals. Like other immediate-release forms of lamotrigine, it is approved for the epilepsy and bipolar I disorder uses listed above. It is not an extended-release product.

Different forms and strengths of lamotrigine are not interchangeable. Each time you fill your prescription, check that you received the correct lamotrigine formulation and strength. For Lamlique oral suspension, also check that you received the correct concentration (5 mg/mL or 25 mg/mL).

Lamotrigine carries a Boxed Warning for serious skin rashes.

Serious skin rashes

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 and teenagers aged between 2 and 17 years 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 [valproic acid or divalproex sodium (Depakote)]
• take a higher starting dose of lamotrigine than your healthcare provider prescribed
• increase your dose of lamotrigine faster than prescribed.

The risk of serious skin reactions may be associated with a variant in genes called HLA-B*1502 in people of Asian origin (mainly of Han Chinese and Thai origin). See "Before taking lamotrigine, tell your healthcare provider about all of your health conditions".

Call your healthcare provider right away if you have any of the following:

• a skin rash
• blistering or peeling of your skin
• hives
• painful sores in your mouth or around your eyes

These symptoms may be the first signs of a serious skin reaction. A healthcare provider 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 healthcare provider right away if you have any of these symptoms:

• fever
• frequent infections
• severe muscle pain
• swelling of your face, eyes, lips, or tongue
• swollen lymph glands
• unusual bruising or bleeding, looking pale
• weakness, fatigue
• yellowing of your skin or the white part of your eyes
• trouble walking or seeing
• seizures for the first time or happening more often
• pain and/or tenderness in the area towards the top of your stomach (enlarged liver and/or spleen).

Irregular or slowed heart rhythm

In patients with known heart problems, the use of lamotrigine may lead to an irregular or slowed heart rhythm.

Call your healthcare provider right away if you:

• have a fast, slow, or pounding heartbeat
• feel your heart skip a beat
• have shortness of breath
• have chest pain
• feel lightheaded or pass out (faint). If you pass out, lie down with raised legs and contact your healthcare provider.

Risk of suicidal thoughts or actions

Like other antiepileptic drugs, lamotrigine may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider 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.

Do not stop lamotrigine without first talking to a healthcare provider.

• Stopping lamotrigine suddenly can cause serious problems.
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions in myself or a family member?

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Aseptic meningitis

Lamotrigine may cause aseptic meningitis, a serious inflammation of the protective membrane that covers the brain and spinal cord.

Call your healthcare provider right away if you have any of the following symptoms:

• headache
• fever
• nausea
• vomiting
• stiff neck
• rash
• unusual sensitivity to light
• muscle pains
• chills
• confusion
• drowsiness

Meningitis has many causes other than lamotrigine, which your doctor would check for if you developed meningitis while taking lamotrigine.

Lamotrigine can cause other serious side effects. For more information, ask your healthcare provider or pharmacist. Be sure to read the section below entitled "What are the possible side effects of lamotrigine?"

• Take lamotrigine exactly as prescribed.
• Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
• Check your medicine to make sure you have received lamotrigine. Talk to your pharmacist to check that you are given the correct medicine.
• Lamotrigine may be taken with or without food.
• 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 have 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, skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.
• If you take too much lamotrigine, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
• 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.

Dosage form-specific instructions

How you take each dose depends on the form of lamotrigine you were prescribed:

• Tablets: Swallow lamotrigine tablets whole.
• 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 the tablets in liquid, add them to a small amount of liquid (about 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, and take the whole amount right away.
• Orally disintegrating tablets (ODT): Place on the tongue and move around the mouth. The tablet will rapidly disintegrate, can be swallowed with or without water, and can be taken with or without food. If you receive them in a blister pack, examine the pack before use and do not use if blisters are torn, broken, or missing.
• Extended-release tablets: Swallow the tablets whole. Do not chew, crush, or divide extended-release tablets. Can be taken with or without food.
• Oral suspension: Shake well before each use. The pharmacy should provide you with an oral dosing syringe or dosing cup that is needed to correctly measure your dose. Do not use a household teaspoon or tablespoon. Oral suspension can be taken with or without food. Throw away (discard) any unused Lamlique oral suspension 60 days after first opening the bottle. Other lamotrigine oral suspensions may have a different discard time, such as 90 days, so check your product's instructions.

Do not drive, operate machinery, or do other dangerous activities until you know how lamotrigine affects you.

Do not take lamotrigine:

• if you have had an allergic reaction to lamotrigine or to any of the ingredients in lamotrigine. See the end of this leaflet for a complete list of ingredients in lamotrigine.

Before taking lamotrigine, tell your healthcare provider about all of your health conditions, including if you:

• have had a rash or allergic reaction to another antiseizure medicine
• are of Asian origin, have had HLA testing before, and know you are carrying the genetic variant, HLA-B*1502
• have or have had depression, mood problems, or suicidal thoughts or behavior
• have a history of heart problems or irregular heartbeats, or any of your family members have any heart problem, including genetic abnormalities
• have had aseptic meningitis after taking lamotrigine
• are taking estrogen-containing products, including oral contraceptives (birth control pills) or other female hormonal medicines (such as hormone replacement therapy). Do not start or stop taking birth control pills or other female hormonal medicine until you have talked with your healthcare provider. Tell your healthcare provider if you have any changes in your menstrual pattern such as breakthrough bleeding. Stopping these medicines while you are taking lamotrigine 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 may harm your unborn baby. If you become pregnant while taking lamotrigine, talk to your healthcare provider 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 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.
• have phenylketonuria (PKU). Some forms of lamotrigine, such as orally disintegrating tablets and chewable tablets, contain phenylalanine. Lamlique oral suspension does not contain phenylalanine.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Lamotrigine and certain other medicines may interact with each other. This may cause serious side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Lamotrigine can cause serious side effects. See "What is the most important information I should know about lamotrigine?"

Common side effects

Common side effects of lamotrigine include:

• dizziness
• tremor
• headache
• rash
• blurred or double vision
• fever
• lack of coordination
• abdominal pain
• infections, including seasonal flu
• sleepiness
• back pain
• nausea, vomiting
• diarrhea
• tiredness
• insomnia
• dry mouth
• stuffy nose
• sore throat

These are not all the possible side effects of lamotrigine.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Some medicines can raise or lower the amount of lamotrigine in your body, which may increase side effects or make it work less well. Tell your doctor and pharmacist about all the medicines you take, and don't start, stop, or change a dose without talking to them first. Examples include:

• Valproate (valproic acid, divalproex sodium): can more than double your lamotrigine level, which may raise the risk of a serious rash. Your lamotrigine dose is usually lower when taken together.
• Carbamazepine, phenytoin, phenobarbital, primidone, and the antibiotic rifampin: can lower your lamotrigine level by about 40%.
• Estrogen-containing birth control pills (and some other hormonal medicines): can lower your lamotrigine level by about half. Starting or stopping them may mean your dose needs to change.
• Certain HIV medicines (such as lopinavir/ritonavir and atazanavir/ritonavir): can lower your lamotrigine level.

Keep a list of your medicines to show your doctor and pharmacist.

If you take a urine drug screening test, lamotrigine may make the test result positive for another drug (for example, phencyclidine, also called PCP). If you require a urine drug screening test, tell the healthcare professional administering the test that you are taking lamotrigine.

• Store lamotrigine at room temperature between 68 and 77 degrees Fahrenheit (20 and 25 degrees Celsius).

Oral suspension: Store Lamlique oral suspension at 68 to 77 degrees Fahrenheit (20 to 25 degrees Celsius). Brief periods at 59 to 86 degrees Fahrenheit (15 to 30 degrees Celsius) are allowed. Shake well before each use and throw away (discard) any unused Lamlique suspension 60 days after first opening the bottle. Other lamotrigine oral suspensions may have a different discard time, such as 90 days, so check your product's instructions.

Keep lamotrigine and all medicines out of the reach of children.

Active ingredient: lamotrigine, USP.

Inactive ingredients differ by dosage form and manufacturer.

Lamlique oral suspension contains 5 mg/mL or 25 mg/mL of lamotrigine. Its inactive ingredients are colloidal silicon dioxide, fumaric acid, hydrochloric acid, purified water, simethicone emulsion, sodium benzoate, sodium hydroxide, sucralose, and xanthan gum. Lamlique is sweetened with sucralose and does not contain phenylalanine. Lamlique is manufactured for Azurity Pharmaceuticals, Inc., Woburn, MA 01801.