Lamictal XR

DRUG DESCRIPTION

LAMICTAL XR (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:

LAMICTAL XR (lamotrigine) Structural Formula Illustration

LAMICTAL XR Extended-Release Tablets are supplied for oral administration as 25-mg (yellow with white center), 50-mg (green with white center), 100-mg (orange with white center), 200-mg (blue with white center), 250-mg (purple with white center), and 300-mg (gray with white center) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: glycerol monostearate, hypromellose, lactose monohydrate; magnesium stearate; methacrylic acid copolymer dispersion, polyethylene glycol 400, polysorbate 80, silicon dioxide (25- and 50-mg tablets only), titanium dioxide, triethyl citrate, carmine (250-mg tablet only), iron oxide black (50-, 250-, and 300-mg tablets only), iron oxide yellow (25-, 50-, 100-mg tablets only), iron oxide red (100-mg tablet only), FD&C Blue No. 2 Aluminum Lake (200- and 250-mg tablets only). Tablets are printed with edible black ink.

LAMICTAL XR Extended-Release Tablets contain a modified-release eroding formulation as the core. The tablets are coated with a clear enteric coat and have an aperture drilled through the coats on both faces of the tablet (DiffCORE™) to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.

What are the possible side effects of lamotrigine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause severe or life-threatening skin rash, especially in children and in people who are allergic to other seizure medications. Serious skin rash may also be more likely to occur if you are taking lamotrigine together with valproic acid (Depakene) or divalproex (Depakote). Seek emergency medical attention if...

Read All Potential Side Effects and See Pictures of Lamictal XR »

What are the precautions when taking lamotrigine extended-release tablets (Lamictal XR)?

Before taking lamotrigine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

This drug may make you dizzy, drowsy, or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a...

Read All Potential Precautions of Lamictal XR »


Lamictal XR Consumer (continued)

SIDE EFFECTS: See also Warning section.

Dizziness, drowsiness, headache, blurred/double vision, lack of coordination, shaking (tremor), nausea, vomiting, diarrhea, or hot flushes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, yellowing eyes/skin, dark urine, signs of infection (such as fever, stiff neck, persistent sore throat), muscle pain/tenderness, change in the amount of urine, unusual tiredness, fast heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking lamotrigine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

This drug may make you dizzy, drowsy, or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.


Lamictal XR Patient Information Including Side Effects

Brand Names: Lamictal, Lamictal ODT, Lamictal ODT Patient Titration Kit (Blue), Lamictal ODT Patient Titration Kit (Green), Lamictal ODT Patient Titration Kit (Orange), Lamictal Starter Kit (Blue), Lamictal Starter Kit (Green), Lamictal Starter Kit (Orange), Lamictal XR, Lamictal XR Patient Titration Kit (Blue), Lamictal XR Patient Titration Kit (Green), Lamictal XR Patient Titration Kit (Orange)

Generic Name: lamotrigine (Pronunciation: la MOE tri jeen)

  • What is lamotrigine (Lamictal XR)?
  • What are the possible side effects of lamotrigine?
  • What is the most important information I should know about lamotrigine?
  • What should I discuss with my healthcare provider before taking lamotrigine?
  • How should I take lamotrigine?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking lamotrigine?
  • What other drugs will affect lamotrigine?
  • Where can I get more information?

What is lamotrigine (Lamictal XR)?

Lamotrigine is an anti-epileptic medication, also called an anticonvulsant.

Lamotrigine is used alone or in combination with other medications to treat seizures in adults and children who are at least 2 years old. Lamotrigine is also used to delay mood episodes in adults with bipolar disorder.

Lamotrigine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of lamotrigine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause severe or life-threatening skin rash, especially in children and in people who are allergic to other seizure medications. Serious skin rash may also be more likely to occur if you are taking lamotrigine together with valproic acid (Depakene) or divalproex (Depakote). Seek emergency medical attention if you have a fever, sore throat, swollen glands, and headache with a severe blistering, peeling, and red skin rash.

If you have to stop taking lamotrigine because of a serious skin rash, you may not be able to take it again in the future.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • the first sign of any skin rash;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • chest pain;
  • pale skin, easy bruising or bleeding;
  • fever, chills, body aches, flu symptoms;
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • dizziness or drowsiness;
  • blurred vision;
  • mild nausea, vomiting, diarrhea, upset stomach;
  • headache;
  • lack of coordination;
  • weight loss;
  • sleep problems (insomnia), unusual dreams; or
  • runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about lamotrigine?

This medication may cause severe or life-threatening skin rash, especially in children and in people who are allergic to other seizure medications. Serious skin rash may also be more likely to occur if you are taking lamotrigine together with valproic acid (Depakene) or divalproex (Depakote). Seek emergency medical attention if you have a fever, sore throat, swollen glands, and headache with a severe blistering, peeling, and red skin rash.

If you have to stop taking lamotrigine because of a serious skin rash, you may not be able to take it again in the future.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Do not stop taking lamotrigine without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking lamotrigine suddenly. You will need to use less and less before you stop the medication completely.

Contact your doctor if your seizures get worse or you have them more often while taking lamotrigine.

Taking this medication during early pregnancy can increase the risk of the baby being born with cleft lip or cleft palate. Tell your doctor if you are pregnant or if you become pregnant during treatment.

Related Drug Centers
  • Lamictal
  • Lamictal XR


Related Drugs Index: