Lamlique

Lamlique (lamotrigine oral suspension) is 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 2 years and older
• alone to treat partial-onset seizures in people aged 16 years and older when changing from 1 other medicine
• 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.

Lamlique is a ready-to-use oral suspension of lamotrigine that is given in 1 to 2 divided doses daily.

The exact way Lamlique (lamotrigine) works is not known. For seizure control, it is thought to act mainly on voltage-sensitive sodium channels (tiny gateways that control the flow of sodium into nerve cells). By blocking these channels, lamotrigine helps stabilize overactive nerve cell membranes and reduces the release of excitatory chemical messengers (such as glutamate and aspartate) that can trigger seizures. The way Lamlique works in bipolar disorder has not been established.

Lamlique (lamotrigine oral suspension) received FDA approval on September 25, 2026. Lamotrigine has been approved since December 1994 and is a well-established treatment for epilepsy and bipolar disorder.

Lamlique carries a Boxed Warning for serious skin rashes.

Skin Rashes

Lamlique 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 Lamlique, 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 Lamlique.

The risk of getting a serious skin rash is higher if you:

• take Lamlique while taking valproate [valproic acid or Depakote (divalproex sodium)].
• take a higher starting dose of Lamlique than your healthcare provider prescribed.
• increase your dose of Lamlique 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 Lamlique, 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 Lamlique.

Other serious side effects

Other serious reactions, including serious blood problems or liver problems. Lamlique 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 or tenderness in the area towards the top of your stomach (enlarged liver or spleen)

Lamlique can cause abnormal heart rhythms, which may be life-threatening. This risk may be increased in people with underlying heart problems. Call your healthcare provider right away if you have:

• a fast, slow, or pounding heartbeat.
• loss of consciousness (fainting)
• dizziness
• shortness of breath.
• chest pain.

Like other antiepileptic drugs, Lamlique 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
• suicide attempt
• 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 Lamlique without first talking to a healthcare provider.

• Stopping Lamlique 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.

Lamlique 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 Lamlique, which your healthcare provider would check for if you developed meningitis while taking Lamlique.

Lamlique can cause other serious side effects. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you. Be sure to read the section below entitled "What are the possible side effects of Lamlique?"

People prescribed Lamlique have sometimes been given the wrong medicine because many medicines have names similar to Lamlique, so always check that you receive Lamlique.

Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for Lamlique:

• Make sure you can read it clearly.
• Talk to your pharmacist to check that you are given the correct medicine.
• Lamlique (lamotrigine) Oral Suspension, 5 mg/mL and 25 mg/mL is a white to off-white suspension, supplied in white HDPE bottles.

Common side effects

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

The effectiveness of Lamlique is based on studies of lamotrigine oral tablets, and the oral suspension was shown to deliver a similar amount of medicine into the body. In epilepsy studies, lamotrigine reduced how often seizures happened when it was added to other antiepileptic drugs:

• In adults with partial-onset seizures, a 500 mg daily dose reduced seizure frequency by a median of 36%, compared with 8% for placebo (an inactive treatment).
• In children aged 2 to 16 years with partial-onset seizures, seizures were reduced by a median of 36%, compared with 7% for placebo.
• In patients with Lennox-Gastaut syndrome, major motor seizures fell by a median of 32%, compared with 9% for placebo, and drop attacks fell by 34%, compared with 9%.
• In patients with primary generalized tonic-clonic seizures, these seizures fell by a median of 66%, compared with 34% for placebo.

When used alone (monotherapy) in adults converting from carbamazepine or phenytoin, fewer people taking lamotrigine met the study's criteria for worsening seizures (42%) than those taking low-dose valproate (69%).

In bipolar I disorder, two studies in adults showed that lamotrigine was better than placebo at delaying the time until a new mood episode (depression, mania, hypomania, or a mixed episode) occurred. The benefit was clearest for delaying depression. Doses above 200 mg per day did not add benefit. Lamlique is used for maintenance treatment to delay mood episodes, not to treat an episode that is already happening.

• Take Lamlique exactly as prescribed.
• Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
• Lamlique may be taken with or without food.
• Shake the suspension well before taking.
• The pharmacy should provide you with an oral dosing syringe that is needed to correctly measure your dose of Lamlique. Do not use a household teaspoon or tablespoon.
• Do not stop taking Lamlique without talking to your healthcare provider. Stopping Lamlique suddenly may cause serious problems. For example, if you have epilepsy and you stop taking Lamlique suddenly, you may have seizures that do not stop. Talk with your healthcare provider about how to stop Lamlique slowly.
• If you miss a dose of Lamlique, 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 2 doses at the same time.
• If you take too much Lamlique, call your healthcare provider or your local Poison Control Center or go to the nearest hospital emergency room right away.
• You may not feel the full effect of Lamlique 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.

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

Do not take Lamlique if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in Lamlique. See the end of this leaflet for a complete list of ingredients in Lamlique.

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

• have had a rash or allergic reaction to another medicine to treat seizures.
• 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 problems, including genetic abnormalities.
• have had aseptic meningitis after taking Lamlique (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 Lamlique may cause side effects (such as dizziness, lack of coordination, or double vision). Starting these medicines may lessen how well Lamlique works.
• are pregnant or plan to become pregnant. It is not known if Lamlique may harm your unborn baby. If you become pregnant while taking Lamlique, 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 or visiting http://www.aedpregnancyregistry.org/. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
• are breastfeeding. Lamlique passes into breast milk and may cause side effects in a breastfed baby. If you breastfeed while taking Lamlique, 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 Lamlique.

It is not known if Lamlique is safe or effective in people younger than 18 years with mood episodes such as bipolar disorder or depression.

It is not known if Lamlique is safe or effective when used alone as the first treatment of seizures.

It is not known if Lamlique is safe or effective for people with mood episodes who have not already been treated with other medicines.

Lamlique should not be used for the acute treatment of manic or mixed mood episodes.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• Store Lamlique at room temperature between 68°F and 77°F (20°C and 25°C).
• Throw away (discard) any unused medicine 60 days after first opening the bottle.

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

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Lamlique for a condition for which it was not prescribed. Do not give Lamlique to other people, even if they have the same symptoms that you have. It may harm them.

If you take a urine drug screening test, Lamlique may make the test result positive for another drug. If you require a urine drug screening test, tell the healthcare professional administering the test that you are taking Lamlique. You can ask your healthcare provider or pharmacist for information about Lamlique that is written for health professionals.

Some medicines change the amount of lamotrigine in the body, which can affect how well Lamlique works or raise the risk of side effects. Your healthcare provider may need to adjust your dose. Key interactions include:

• Valproate (valproic acid or divalproex sodium) raises lamotrigine levels by more than 2-fold and increases the risk of serious skin rash.
• Carbamazepine, phenytoin, phenobarbital, primidone, and rifampin lower lamotrigine levels by about 40%.
• Estrogen-containing oral contraceptives (birth control pills) lower lamotrigine levels by about 50%. Dose adjustments are usually needed when starting or stopping these products.
• The protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir lower lamotrigine exposure by about 50% and 32%, respectively.
• Taking Lamlique with organic cationic transporter 2 (OCT2) substrates that have a narrow therapeutic index (medicines where the safe and unsafe doses are close together) is not recommended.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, since this is not a complete list of interactions.

Active ingredient: lamotrigine.

Inactive ingredients: colloidal silicon dioxide, fumaric acid, hydrochloric acid, purified water, simethicone emulsion, sodium benzoate, sodium hydroxide, sucralose, and xanthan gum.

Lamlique is manufactured for Azurity Pharmaceuticals, Inc., Woburn, MA 01801