Lamictal

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.

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

This product is available in the following dosage forms:

• Tablet


• Tablet, Chewable


• Tablet, Extended Release

Before Using

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.

Pediatric

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

Geriatric

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.

Pregnancy

Breastfeeding

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.

Drug Interactions

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

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.

• Carbamazepine


• Desogestrel


• Escitalopram


• Estradiol Cypionate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Ginkgo


• Levonorgestrel


• Lopinavir


• Mestranol


• Methsuximide


• Norethindrone


• Norgestimate


• Norgestrel


• Oxcarbazepine


• Phenobarbital


• Primidone


• Rifampin


• 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


• Depressiona€”May make these conditions worse.

• Heart diseasea€”It is not clear if patients who have problems with heart rhythms will have increased problems while taking lamotrigine.

• Kidney disease or


• Liver diseasea€”Higher blood levels of lamotrigine may occur, which may increase the chance of unwanted effects; your doctor may need to change your dose .

• Thalassemiaa€”Lamotrigine may cause your body to stop making or to make fewer red blood cells.

Proper Use

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 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, 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 the 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.

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 moved 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, or tablets):
  
  
  
  • For treatment of bipolar disorder:
    
    
    
    • Adults not taking valproic acid (e.g., DepakoteA®) and not taking carbamazepine (e.g., TegretolA®), phenobarbital (e.g., LuminalA®), phenytoin (e.g., DilantinA®), and/or primidone (e.g., MysolineA®)a€”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 gradually increase your dose if needed. However, the dose is usually not more than 200 mg a day.
    
    
    • Adults taking valproic acid (e.g., DepakoteA®)a€”At first, 25 mg of lamotrigine once every other day for two weeks, then 25 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 100 mg a day.
    
    
    • Adults not taking valproic acid (e.g., DepakoteA®) but taking carbamazepine (e.g., TegretolA®), phenobarbital (e.g., LuminalA®), phenytoin (e.g., DilantinA®), and/or primidone (e.g., MysolineA®)a€”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 gradually increase your dose if needed. However, the dose is usually not more than 400 mg a day.
    
    
    • Adults who are discontinuing valproic acid (e.g., DepakoteA®) or discontinuing carbamazepine (e.g., TegretolA®), phenobarbital (e.g., LuminalA®), phenytoin (e.g., DilantinA®), and/or primidone (e.g., MysolineA®)a€”Dose will be determined by your doctor .
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  
  
  
  • For treatment of epilepsy:
    
    
    
    • Adults and teenagers not taking valproic acid (e.g., DepakoteA®) but taking carbamazepine (e.g., TegretolA®), phenobarbital (e.g., LuminalA®), phenytoin (e.g., DilantinA®), and/or primidone (e.g., MysolineA®)a€”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 gradually increase your dose if needed. However, the dose is usually not more than 500 mg a day.
    
    
    • Adults and teenagers not taking valproic acid (e.g., DepakoteA®), carbamazepine (e.g., TegretolA®), phenobarbital (e.g., LuminalA®), phenytoin (e.g., DilantinA®), and/or primidone (e.g., MysolineA®)a€”At first, 25 mg of lamotrigine once a day for two weeks, then 50 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 375 mg a day.
    
    
    • Adults and teenagers taking valproic acid (e.g., DepakoteA®) and also taking carbamazepine (e.g., TegretolA®), phenobarbital (e.g., LuminalA®), phenytoin (e.g., DilantinA®), and/or primidone (e.g., MysolineA®)a€”At first, 25 mg of lamotrigine once every other day for two weeks, then 25 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 400 mg a day.
    
    
    • Adults who are discontinuing valproic acid (e.g., DepakoteA®) or discontinuing carbamazepine (e.g., TegretolA®), phenobarbital (e.g., LuminalA®), phenytoin (e.g., DilantinA®), and/or primidone (e.g., MysolineA®)a€”Dose will be determined by your doctor .
    
    
    • Children 2 to 12 years of age:
      
      
      
      • Children not taking valproic acid (e.g., DepakoteA®) but taking carbamazepine (e.g., TegretolA®), phenobarbital (e.g., LuminalA®), phenytoin (e.g., DilantinA®), and/or primidone (e.g., MysolineA®)a€” 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 gradually increase your dose if needed. However, the dose is usually not more than 400 mg a day.
      
      
      • Children not taking valproic acid (e.g., DepakoteA®), carbamazepine (e.g., TegretolA®), phenobarbital (e.g., LuminalA®), phenytoin (e.g., DilantinA®), and/or primidone (e.g., MysolineA®)a€” At first, 0.3 milligrams (mg) per kilogram (kg) (0.14 mg per pound) of body weight of lamotrigine once a day for two weeks, then 0.6 mg/kg (0.27 mg per pound) of body weight divided into two smaller doses each day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 300 mg a day.
      
      
      • Children taking valproic acid (e.g., DepakoteA®) and also taking carbamazepine (e.g., TegretolA®), phenobarbital (e.g., LuminalA®), phenytoin (e.g., DilantinA®), and/or primidone (e.g., MysolineA®)a€” 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 gradually increase your dose if needed. However, the dose is usually not more than 200 mg a day.
      
      
      
      
    
    
    • Children younger than 2 years of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

• For oral dosage form (extended-release tablet):
  
  
  
  • For seizures:
    
    
    
    • Adults and teenagers older than 13 years of age not taking valproic acid (e.g., DepakoteA®) but taking carbamazepine (e.g., TegretolA®), phenobarbital (e.g., LuminalA®), phenytoin (e.g., DilantinA®), and/or primidone (e.g., MysolineA®)a€”At first, 50 milligrams (mg) of lamotrigine once a day for two weeks, then 100 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 600 mg a day.
    
    
    • Adults and teenagers older than 13 years of age not taking valproic acid (e.g., DepakoteA®), carbamazepine (e.g., TegretolA®), phenobarbital (e.g., LuminalA®), phenytoin (e.g., DilantinA®), and/or primidone (e.g., MysolineA®)a€”At first, 25 mg of lamotrigine once a day for two weeks, then 50 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 400 mg a day.
    
    
    • Adults and teenagers older than 13 years of age taking valproic acid (e.g., DepakoteA®)a€”At first, 25 mg of lamotrigine once every other day for two weeks, then 25 mg once a day for two weeks. After this, your doctor may gradually increase your dose if needed. However, the dose is usually not more than 250 mg a day.
    
    
    • Children up to 13 years of agea€”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

It is important that your doctor check the progress of you or your child 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 taking 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. 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 becomes worse.

Lamotrigine may cause serious allergic reactions affecting multiple body organs (e.g., liver or kidney). Check with your doctor right away if you 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.

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

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


• Clumsiness or unsteadiness


• Double vision


• Poor coordination


• Skin rash

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


• Dark-colored urine


• Fever


• Flu-like symptoms


• Itching


• Memory loss


• Muscle cramps, pain, or weakness


• Red or irritated eyes


• 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 with breathing


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• 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


• Bruising


• Constipation


• Cough or hoarseness


• Coughing or vomiting blood


• Difficulty with breathing


• Difficulty with swallowing


• Fainting


• Fast heartbeat


• General body swelling


• General feeling of discomfort or illness


• 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


• Nosebleeds


• Not breathing


• Pain or burning in the throat


• Painful or difficult urination


• Pains in the 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 the arms and legs


• Swollen or painful glands


• Tic-like (jerky) movements


• Tightness in the chest


• Unexplained bleeding or bruising


• Wheezing

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

Symptoms of overdose

• Clumsiness or unsteadiness (severe)


• Coma


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


• Dizziness (severe)


• Drowsiness (severe)


• Dryness of the mouth (severe)


• Headache (severe)


• Increased heart rate


• 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


• Headache


• Nausea


• Vomiting

Less common

• Diarrhea


• Indigestion


• Loss of strength


• Menstrual pain


• Pain


• Runny nose


• 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.