Pronunciation:

la-MOE-tri-jeen

Brand Names:

• Lamictal
• Lamictal CD

Dosage Forms:

• Tablet
• Tablet, Chewable

Warnings:

Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of lamotrigine. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (age less than 16 years) 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 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 associated with lamotrigine. There are suggestions, yet to be proven, that the risk of rash may also be increased by coadministration of lamotrigine with valproate (includes valproic acid and divalproex sodium), exceeding the recommended initial dose of lamotrigine, or exceeding the recommended dose escalation for lamotrigine. However, cases have been reported in the absence of these factors.

Nearly all cases of life-threatening rashes associated with lamotrigine have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have been reported after prolonged treatment (eg, 6 months). Accordingly, duration of therapy cannot be relied upon as a means to predict the potential risk heralded by the first appearance of a rash.

Although benign rashes also occur with 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 .

Serious, life-threatening rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of lamotrigine. The risk of rash may also be increased by coadministration of lamotrigine with valproate (includes valproic acid and divalproex sodium), exceeding the recommended initial dose of lamotrigine, or exceeding the recommended dose escalation for lamotrigine. Nearly all cases of life-threatening rashes associated with lamotrigine have occurred within 2 to 8 weeks of treatment initiation. Lamotrigine should ordinarily 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 to help control some types of seizures 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 older than 18 years of age.

Lamotrigine 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—

Skin rashes may be more likely to occur in children younger than 16 years of age than in adults. Some of these rashes may be serious and life-threatening. It is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it. Lamotrigine is not indicated for bipolar disorder in children under 18 years of age.

Older adults—

Lamotrigine is removed from the body more slowly in elderly people than in younger people. Higher blood levels of the medicine may occur, which may increase the chance of unwanted effects. Your doctor may give you a different lamotrigine dose than a younger person would receive.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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—

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.

• Valproic Acid

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:

• Heart disease—It is not clear if patients who have problems with heart rhythms will have increased problems while taking lamotrigine

• Kidney disease or
• Liver disease—Higher blood levels of lamotrigine may occur, which may increase the chance of unwanted effects; your doctor may need to change your dose

• Thalassemia—Lamotrigine may cause your body to stop making or to make fewer red blood cells

Proper Use of This Medicine:

Take lamotrigine 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 or less of this medicine, and do not take it more or less often than your doctor ordered.

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 : These tablets 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. If tablets are to be dispersed: Place tablets 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.

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 (tablets):
  • For treatment of bipolar disorder:
    • Adults not taking valproic acid (e.g., Depakote) and not taking carbamazepine (e.g., Tegretol), phenobarbital (e.g., Luminal), phenytoin (e.g., Dilantin), and/or primidone (e.g., Mysoline)—At first, 25 milligrams (mg) of lamotrigine once a day for two weeks, then a total of 50 mg divided into two smaller doses each day for two weeks. After this, your doctor may increase the dose gradually if needed. However, the dose is usually not more than 200 mg a day.
    • Adults taking valproic acid (e.g., Depakote)—At first, 25 mg of lamotrigine once every other day for two weeks, then 25 mg once every day for two weeks. After this, your doctor may increase the dose gradually if needed. However, the dose is usually not more than 100 mg a day.
    • Adults not taking valproic acid (e.g., Depakote) but taking carbamazepine (e.g., Tegretol), phenobarbital (e.g., Luminal), phenytoin (e.g., Dilantin), and/or primidone (e.g., Mysoline)—At first, 50 mg of lamotrigine once a day for two weeks, then a total of 100 mg divided into two smaller doses each day for two weeks. After this, your doctor may increase the dose gradually if needed. However, the dose is usually not more than 400 mg a day.
    • Adults who are discontinuing valproic acid (e.g., Depakote) or discontinuing carbamazepine (e.g., Tegretol), phenobarbital (e.g., Luminal), phenytoin (e.g., Dilantin), and/or primidone (e.g., Mysoline)—Dose will be determined by your doctor.
    • Children under 18 years of age—Use and dose must be determined by your doctor.
  • For treatment of epilepsy:
    • Adults not taking valproic acid (e.g., Depakote) but taking carbamazepine (e.g., Tegretol), phenobarbital (e.g., Luminal), phenytoin (e.g., Dilantin), and/or primidone (e.g., Mysoline)—At first, 50 milligrams (mg) of lamotrigine once a day for two weeks, then a total of 100 mg divided into two smaller doses each day for two weeks. After this, your doctor may increase the dose gradually if needed. However, the dose is usually not more than 500 mg a day.
    • Adults taking valproic acid (e.g., Depakote) and also taking carbamazepine (e.g., Tegretol), phenobarbital (e.g., Luminal), phenytoin (e.g., Dilantin), and/or primidone (e.g., Mysoline)—At first, 25 mg of lamotrigine once every other day for two weeks, then 25 mg once every day for two weeks. After this, your doctor may increase the dose gradually if needed. However, the dose is usually not more than 400 mg a day.
    • Children 2 to 12 years of age:
      • Children not taking valproic acid (e.g., Depakote) but taking carbamazepine (e.g., Tegretol), phenobarbital (e.g., Luminal), phenytoin (e.g., Dilantin), and/or primidone (e.g., Mysoline): At first, 0.6 milligrams (mg) per kilogram (kg) (0.27 mg per pound) of body weight of lamotrigine once a day for two weeks, then 1.2 mg/kg (0.54 mg per pound) of body weight divided into two smaller doses each day for two weeks. After this, your doctor may increase the dose gradually if needed. However, the dose is usually not more than 400 mg a day.
      • Children taking valproic acid (e.g., Depakote) and also taking carbamazepine (e.g., Tegretol), phenobarbital (e.g., Luminal), phenytoin (e.g., Dilantin), and/or primidone (e.g., Mysoline): At first, 0.15 mg per kg (0.07 mg per pound) of body weight of lamotrigine given in one dose or two smaller doses each day for two weeks, then 0.3 mg/kg (0.136 mg per pound) of body weight given in one dose or two smaller doses each day for two weeks. After this, your doctor may increase the dose gradually if needed. However, the dose is usually not more than 200 mg a day.
    • Children older than 12 years of age usually receive the adult dose.

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.

Precautions While Using This Medicine:

It is important that your doctor check your 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.

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

Tell your doctor right away if you experience 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 hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; 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. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to see well. 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 develop a rash, fever, flu-like symptoms, or swollen glands, or if your seizures increase.

If suicidal thoughts or behavior occur, especially if you are taking this medicine to treat bipolar disorder, contact your doctor right away.

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.

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

Skin rash

Less common

Increase in seizures

Rare

Blistering, peeling, or loosening of skin

dark-colored urine

fever, chills, and/or sore throat

flu-like symptoms

itching

muscle cramps, pain, or weakness

red or irritated eyes

small red or purple spots on skin

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

swelling of face, mouth, hands, or feet

swollen lymph nodes

trouble in breathing

unusual bleeding or bruising

unusual tiredness or weakness

yellow eyes or skin

Symptoms of overdose

Clumsiness or unsteadiness (severe)

coma

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

dizziness (severe)

drowsiness (severe)

dryness of mouth (severe)

headache (severe)

increased heart rate

slurred speech (severe)

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Blurred or double vision or other changes in vision

clumsiness or unsteadiness

poor coordination

Less common

Anxiety, confusion, depression, irritability, or other mood or mental changes

chest pain

continuous, uncontrolled back and forth and/or rolling eye movements

infection

Rare

Memory loss

Incidence not known

Back, leg, or stomach pains

bleeding gums

bloating

blood in urine

bloody, black or tarry stools

bluish lips or skin

bruising

chills

confusion

constipation

cough or hoarseness

coughing or vomiting blood

dark urine

difficulty breathing

difficulty swallowing

fainting

fast heartbeat

fatigue

fever

general body swelling

general feeling of discomfort or illness or weakness

general feeling of tiredness or weakness

heartburn

high fever

lightheadedness

loss of appetite

loss of balance control

lower back or side pain

mask-like face

muscle spasms

muscle stiffness

nosebleeds

not breathing

pain or burning in throat

painful or difficult urination

pains in stomach, side, or abdomen, 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

shortness of breath

shuffling walk

slowed movement

slurred speech

sores, welting or blisters

stiffness of arms and legs

swollen or painful glands

tic-like [jerky] movements

tightness in chest

unexplained bleeding or bruising

wheezing

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 (more common in women)

drowsiness

headache

nausea

vomiting

Less common

Constipation

diarrhea

dryness of mouth

indigestion

loss of strength

menstrual pain

pain

runny nose

slurred speech

trembling or shaking

trouble in 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.