Pronunciation:

la-MOE-tri-jeen

Brand Names:

• LaMICtal
• LaMICtal CD
• LaMICtal ODT
• LaMICtal XR
• lamoTRIgine
• lamoTRIgine-100
• lamoTRIgine-150
• lamoTRIgine-25
• Mylan-lamoTRIgine
• Teva-lamoTRIgine

Dosage Forms:

• Tablet
• Tablet, Extended Release
• Tablet, Chewable
• Tablet, Disintegrating

Warnings:

Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, or rash-related death have been caused by lamotrigine. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include: (1) coadministration with valproate; (2) exceeding recommended initial dose of lamotrigine; or (3) exceeding recommended dose escalation for lamotrigine. Benign rashes are also caused by lamotrigine; however, it is not possible to predict which rashes will prove to be serious or life threatening. Lamotrigine should be discontinued at the first sign of rash, unless the rash is clearly not drug related .

Classifications:

Therapeutic—

Anticonvulsant

Chemical—

Phenyltriazine

Uses of This Medicine:

Lamotrigine is used alone or together with other medicines to help control certain types of seizures (eg, partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome) in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it. It can also be used in the treatment of bipolar disorder (manic-depressive illness) in adults.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lamotrigine chewable tablets, disintegrating tablets, tablets for suspension, or tablets in children with certain types of seizures 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of lamotrigine extended-release tablets in children with partial seizures younger than 13 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of lamotrigine chewable tablets, disintegrating tablets, tablets for suspension, or tablets in children with bipolar disorder. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of lamotrigine have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of lamotrigine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving lamotrigine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir
• Calcifediol
• Carbamazepine
• Cenobamate
• Desmopressin
• Dofetilide
• Ezogabine
• Fosphenytoin
• Levoketoconazole
• Lopinavir
• Methotrexate
• Orlistat
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• Valproic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Desogestrel
• Dienogest
• Drospirenone
• Escitalopram
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Gestodene
• Ginkgo
• Ginseng
• Levonorgestrel
• Mestranol
• Methsuximide
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Oxcarbazepine
• Risperidone
• Ritonavir
• Rufinamide
• Sertraline

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems or
• Depression or
• Heart disease (eg, heart attack, heart failure) or
• Heart rhythm problems—May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor to help your condition as much as possible and to decrease the chance of unwanted effects. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Lamotrigine may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

If you are taking the chewable dispersible tablets or tablets for suspension, they may be swallowed whole, chewed, and swallowed, or dispersed in a small amount of liquid and swallowed. If the tablets are chewed, they should be followed with a small amount of water or diluted fruit juice to aid in swallowing. To break up these tablets, add them in enough water or diluted fruit juice to cover the tablets (about a teaspoonful). Wait until the tablets are completely dispersed (about 1 minute), then swirl the solution and swallow it immediately.

If you are taking the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet into your tongue and move it around in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water.

Swallow the extended-release tablets whole. Do not break, crush, or chew it.

Use only the brand of this medicine that your doctor prescribed. Different brands and dosage forms may not work the same way.

This medicine can be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (chewable dispersible tablets, disintegrating tablets, tablets for suspension, or tablets):
  • For treatment of bipolar disorder:
    • Adults not taking valproic acid (Depakote®) and not taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—At first, 25 milligrams (mg) of lamotrigine once a day for 2 weeks, then 50 mg once a day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 200 mg a day.
    • Adults taking valproic acid (Depakote®)—At first, 25 mg of lamotrigine once every other day for 2 weeks, then 25 mg once a day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 100 mg a day.
    • Adults not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—At first, 50 mg of lamotrigine once a day for 2 weeks, then a total of 100 mg divided into 2 smaller doses each day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 400 mg a day.
    • Adults who are discontinuing valproic acid (Depakote®) or discontinuing carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—Dose will be determined by your doctor.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of epilepsy:
    • Adults not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—At first, 50 milligrams (mg) of lamotrigine once a day for 2 weeks, then a total of 100 mg divided into 2 smaller doses each day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 500 mg a day.
    • Adults not taking valproic acid (Depakote®), carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—At first, 25 mg of lamotrigine once a day for 2 weeks, then 50 mg once a day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 375 mg a day.
    • Adults taking valproic acid (Depakote®)—At first, 25 mg of lamotrigine once every other day for 2 weeks, then 25 mg once a day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 400 mg a day.
    • Adults who are discontinuing valproic acid (Depakote®) or discontinuing carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—Dose will be determined by your doctor.
    • Children 2 to 12 years of age:
      • Children not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)— At first, 0.6 milligrams per kilogram (mg/kg) of body weight of lamotrigine divided into 2 smaller doses each day for 2 weeks, then 1.2 mg/kg of body weight divided into 2 smaller doses each day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 400 mg a day.
      • Children not taking valproic acid (Depakote®), carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)— At first, 0.3 mg/kg of body weight of lamotrigine given in one dose or two smaller doses each day for 2 weeks, then 0.6 mg/kg of body weight divided into 2 smaller doses each day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 300 mg a day.
      • Children taking valproic acid (Depakote®)— At first, 0.15 mg/kg of body weight of lamotrigine given in one dose or two smaller doses each day for 2 weeks, then 0.3 mg/kg of body weight given in one dose or two smaller doses each day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 200 mg a day.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (extended-release tablets):
  • For seizures:
    • Adults and children older than 13 years of age not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—At first, 50 milligrams (mg) of lamotrigine once a day for 2 weeks, then 100 mg once a day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 600 mg a day.
    • Adults and children older than 13 years of age not taking valproic acid (Depakote®), carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—At first, 25 mg of lamotrigine once a day for 2 weeks, then 50 mg once a day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 400 mg a day.
    • Adults and children older than 13 years of age taking valproic acid (Depakote®)—At first, 25 mg of lamotrigine once every other day for 2 weeks, then 25 mg once a day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 250 mg a day.
    • Children younger than 13 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your or your child's progress at regular visits, especially during the first few months of your treatment with lamotrigine. This will allow your doctor to change your dose, if necessary, and will help reduce any unwanted effects.

It is important to tell your doctor if you become pregnant while using this medicine. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

You should not start or stop using birth control pills or other female hormonal products while you are using this medicine until you have consulted your doctor.

Tell your doctor right away if you have unusual changes in your menstrual cycle such as breakthrough bleeding while taking lamotrigine and birth control pills or other female hormonal products.

This medicine may increase the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Lamotrigine may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, or drowsiness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If these reactions are especially bothersome, check with your doctor.

Skin rash may be a sign of a serious unwanted effect. Check with your doctor immediately if you or your child develop a rash, fever, flu-like symptoms, or swollen glands, or if your seizures becomes worse.

This medicine may cause hemophagocytic lymphohistiocytosis, a rare and life-threatening disorder wherein the body makes too many activated immune cells (macrophages and lymphocytes). Talk to your doctor if you have any concerns.

Lamotrigine may cause serious allergic reactions affecting multiple body organs (eg, liver or kidney). Check with your doctor right away if you or your child have the following symptoms: fever, dark urine, headache, hives, muscle pain or stiffness, stomach pain, unusual tiredness, or yellow eyes or skin.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

Check with your doctor right away if you or your child start to have a stiff neck, confusion, drowsiness, fever, chills, headache, nausea, vomiting, rash, or sensitivity to light. These could be symptoms of a rare and serious condition called aseptic meningitis.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Do not stop taking lamotrigine without first checking with your doctor. Stopping this medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blurred vision

changes in vision

chest pain, discomfort, or tightness

clumsiness or unsteadiness

decreased urine output

dilated neck veins

double vision

irregular breathing

irregular heartbeat

nausea

pain or discomfort in the arms, jaw, back, or neck

poor coordination

seizure that will not stop

skin rash

sweating

swelling of the face, fingers, feet, or lower legs

trouble breathing

unusual tiredness or weakness

vomiting

weight gain

Less common

Anxiety

chest pain

confusion

continuous, uncontrolled back and forth or rolling eye movements

depression

increase in seizures

infection

irritability

Rare

Blistering, peeling, or loosening of the skin

chills

cough

dark urine

diarrhea

fever

general feeling of discomfort or illness

headache

itching

joint pain

loss of appetite

memory loss

muscle cramps, pain, or weakness

red or irritated eyes

runny nose

shivering

small red or purple spots on the skin

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling of the face, mouth, hands, or feet

swollen lymph nodes

trouble sleeping

unusual bleeding or bruising

yellow eyes or skin

Incidence not known

Back, leg, or stomach pains

bleeding gums

bloating

blood in the urine

bloody, black or tarry stools

bluish lips or skin

constipation

cough

coughing or vomiting blood

difficulty with swallowing

fainting

fast heartbeat

general body swelling

heartburn

high fever

hoarseness

lightheadedness

loss of balance control

lower back or side pain

mask-like face

muscle spasms

nosebleeds

not breathing

pain or burning in the throat

painful or difficult urination

pains in the stomach or side, possibly radiating to the back

pale skin

persistent bleeding or oozing from puncture sites, mouth, or nose

rapid, shallow breathing

redness, soreness, or itching skin

shuffling walk

slowed movement

slurred speech

sores, welting, or blisters

stiffness of the arms and legs

swollen or painful glands

tic-like (jerky) movements

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Clumsiness or unsteadiness (severe)

continuous, uncontrolled back and forth or rolling eye movements (severe)

dizziness (severe)

drowsiness (severe)

dryness of the mouth (severe)

headache (severe)

increased heart rate

loss of consciousness

slurred speech (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Dizziness

drowsiness

Less common

Indigestion

loss of strength

menstrual pain

pain

trembling or shaking

trouble with sleeping

unusual weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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