LAMOTRIGINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Lamictal

In Canada?

• Lamictal

Another commonly used name is LTG.

Category

• Anticonvulsant
• Antimanic

Description

Lamotrigine (la-MOE-tri-jeen)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 seizuresfor as long as you continue to take it. It can also be used in the treatmentof bipolar disorder (manic-depressive illness) in adults older than 18 yearsof age.

Lamotrigine is available only with your doctor's prescription, in the followingdosage form:

Oral
• Chewable/Dispersible Tablets (U.S.)
• Tablets (U.S. and Canada)

Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to lamotrigine. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Lamotrigine has not been studied in pregnant women.However, if you might become pregnant while taking lamotrigine, your doctormay want you to take folic acid supplements. Studies in animals have shownthat lamotrigine, even when given to the mother in doses smaller than thelargest human dose, may cause some offspring to die. Before taking this medicine,make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding?Lamotrigine passes into breast milk. However, itis not known whether this medicine causes problems in nursing babies. Motherswho are taking lamotrigine and who wish to breast-feed should discuss thiswith their doctor.

Children?Skin rashes may be more likely to occur in childrenyounger than 16 years of age than in adults. Some of these rashes may be seriousand life-threatening. It is especially important that you discuss with thechild's doctor the good that this medicine may do as well as the risks ofusing it. Lamotrigine is not indicated for bipolar disorder in children under18 years of age.

Older adults?Lamotrigine is removed from the body more slowlyin elderly people than in younger people. Higher blood levels of the medicinemay occur, which may increase the chance of unwanted effects. Your doctormay give you a different lamotrigine dose than a younger person would receive.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takinglamotrigine, it is especially important that your health care professionalknow if you are taking any of the following:

• Carbamazepine (e.g., Tegretol) or
• Phenobarbital (e.g., Luminal) or
• Phenytoin (e.g., Dilantin) or
• Primidone (e.g., Mysoline) or
• Valproic acid (e.g., Depakote)?These medicines may increaseor decrease the blood levels of lamotrigine, which may increase the chanceof unwanted effects; your doctor may need to change the dose of either thesemedicines or lamotrigine

• Oral contraceptives (e.g., birth control pills) or
• Other female hormone therapy?Your doctor may need to adjustyour dose of lamotrigine. Also, using birth control pills with lamotriginemay make the birth control pills not work as well.

Other medical problems?The presence of other medicalproblems may affect the use of lamotrigine. Make sure you tell your doctorif you have any other medical problems, especially:

• Heart disease?It is not clear if patients who have problemswith 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 tochange your dose

• Thalassemia?Lamotrigine may cause your body to stop makingor to make fewer red blood cells

Proper Use of This Medicine

Take lamotrigine only as directed by your doctor to help your conditionas much as possible and to decrease the chance of unwanted effects. Do nottake more or less of this medicine, and do not take it more or less oftenthan 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, takeit exactly as directed.

If you are taking the chewable/dispersible tablets: These tablets may be swallowed whole, chewed and swallowed, or dispersedin a small amount of liquid and swallowed. If the tablets are chewed, theyshould be followed with a small amount of water or diluted fruit juice toaid in swallowing. If tablets are to be dispersed: Place tablets in enoughwater or diluted fruit juice to cover the tablets (about a teaspoonful), waituntil the tablets are completely dispersed (about 1 minute), then swirl thesolution and swallow it immediately.

Dosing?The dose of lamotrigine will be different fordifferent patients, and depends on what other medicines you are taking. Follow your doctor's orders or the directions on the label.The following information includes only the average doses of lamotrigine. If your dose is different, do not change it unlessyour doctor tells you to do so.

The number of tablets that you take depends on the strength of 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 aday for two weeks, then a total of 50 each day for two weeks. After this,your doctor may increase the dose gradually if needed. However, the dose isusually not more than 200 mg a day.
    • Adults taking valproic acid (e.g., Depakote)?At first, 25 mgof lamotrigine once every other day for two weeks, then 25 mg once every dayfor two weeks. After this, your doctor may increase the dose gradually ifneeded. 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)?Atfirst, 50 milligrams (mg) of lamotrigine once a day for two weeks, then atotal of 100 mg divided into two smaller doses each day for two weeks. Afterthis, your doctor may increase the dose gradually if needed. However, thedose is usually not more than 400 mg a day.
    • Adults who are discontinuing valproic acid (e.g., Depakote) or discontinuingcarbamazepine (e.g., Tegretol), phenobarbital (e.g., Luminal), phenytoin (e.g.,Dilantin), and/or primidone (e.g., Mysoline)?Dose will be determinedby your doctor.
    • Children under 18 years of age?Use and dose must be determinedby 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)?Atfirst, 50 milligrams (mg) of lamotrigine once a day for two weeks, then atotal of 100 mg divided into two smaller doses each day for two weeks. Afterthis, your doctor may increase the dose gradually if needed. However, thedose 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 onceevery other day for two weeks, then 25 mg once every day for two weeks. Afterthis, your doctor may increase the dose gradually if needed. However, thedose 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): Atfirst, 0.6 milligrams (mg) per kilogram (kg) (0.27 mg per pound) of body weightof 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. Afterthis, your doctor may increase the dose gradually if needed. However, thedose 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 eachday for two weeks, then 0.3 mg/kg (0.136 mg per pound) of body weight givenin one dose or two smaller doses each day for two weeks. After this, yourdoctor may increase the dose gradually if needed. However, the dose is usuallynot 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 assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regularvisits, especially during the first few months of your treatment withlamotrigine. 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 femalehormonal products while you are taking this medicine until you have consultedyour doctor.

Tell your doctor right away if you experience unusual changes in your menstrualcycle such as break-through bleeding while taking lamotrigine and birth controlpills or other female hormonal products.

This medicine may increase the effects of alcohol and other central nervoussystem (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 whileyou are using this medicine.

Lamotrigine may cause blurred vision, double vision, clumsiness, unsteadiness,dizziness, or drowsiness. Make sure you know how youreact to this medicine before you drive, use machines, or do anything elsethat could be dangerous if you are not alert, well-coordinated, or able tosee well. If these reactions are especially bothersome, check withyour doctor.

Skin rash may be a sign of a serious unwanted effect. Check with your doctor immediately if you develop a rash, fever, flu-likesymptoms, or swollen glands, or if your seizures increase.

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

Do not stop taking lamotrigine without first checkingwith your doctor. Stopping this medicine suddenly may cause your seizuresto return or to occur more often. Your doctor may want you to gradually reducethe 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 mayneed medical attention.

Check with your doctorimmediately 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 orpurple spots on skin; sores, ulcers, or white spotson 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/orrolling 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 ormental 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; bleedinggums; bloating; blood inurine; 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 feelingof discomfort or illness or weakness; general feelingof 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; painsin stomach, side, or abdomen, possibly radiating to the back; pale skin; persistent bleeding or oozingfrom puncture sites, mouth, or nose; rapid, shallowbreathing; redness, soreness or itching skin; shortness of breath; shuffling walk; slowed movement; slurredspeech; sores, welting, or blisters; stiffness of arms and legs; swollenor painful glands; tic-like [jerky] movements ofhead, face, mouth, and neck; tightness in chest; unexplained bleeding or bruising; wheezing

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:

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 weightloss

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.