| Fact Table | |
|---|---|
| Formula | C9H7Cl2N5 |
| License | FDA approved (initial U.S. approval 1994; Lamictal NDA 020241); Health Canada marketed, including Lamictal DINs 02243803, 02240115, 02142082, 02142104 and 02142112 |
| Bioavailability | 98% oral absolute bioavailability; not affected by food |
| Legal status | Prescription only (Rx; Schedule: Prescription in Canada) |
| Chemical Name | 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine; 6-(2,3-dichlorophenyl)-1,2,4-triazine-3,5-diamine |
| Elimination half-life | Approximately 25–33 hours in adults without interacting drugs; shortened to about 13–14 hours with enzyme-inducing antiepileptics and prolonged to about 48–70 hours with valproate |
| Dosage (Strength) | Tablets: 25 mg, 100 mg, 150 mg and 200 mg; chewable/dispersible tablets: 2 mg, 5 mg and 25 mg; ODT: 25 mg, 50 mg, 100 mg and 200 mg. Dose is individualized and titrated slowly; bipolar maintenance target commonly 200 mg/day, adjusted for valproate or enzyme-inducing drugs |
| Pregnancy | Pregnancy Category C in older labeling; use only if potential benefit justifies fetal risk. Pregnancy can lower lamotrigine concentrations, so clinical monitoring and dose adjustment may be needed |
| Brands | Lamictal; Lamictal ODT; Lamictal XR; Lamictal CD/chewable dispersible; generic lamotrigine tablets, chewable/dispersible tablets, ODT and extended-release tablets |
| Protein binding | Approximately 55% |
| PubChem CID | 3878 |
| MedlinePlus | a695007 |
| ChEBI | 6367 |
| ATC code | N03AX09 |
| DrugBank | DB00555 |
| KEGG | D00354 |
| Routes of administration | By mouth (oral tablets, chewable/dispersible tablets, orally disintegrating tablets and extended-release tablets) |
Lamictal (lamotrigine) is a prescription drug taken by mouth. It is used to treat certain seizures and to help manage bipolar I disorder. It works as an antiepileptic or anticonvulsant that helps reduce overactive signals in the brain. As a result, it can help reduce seizures and prevent mood episodes from coming back. Lamictal comes as regular tablets, chewable tablets that can be mixed with water or juice, and tablets that dissolve on the tongue.
Lamictal is taken by mouth once or twice per day, exactly as prescribed and around the same time each day.
The dose depends on the condition being treated, among other factors. Treatment usually starts with a low dose that is increased slowly over several weeks to reduce the risk of a serious rash.
Starter or titration kits may be used to help follow the correct dose schedule.
Swallow regular tablets whole.
Chewable tablets can be chewed, swallowed with a little water, or mixed with a small amount of water or fruit juice.
Dissolving tablets should be placed on the tongue until they melt.
Do not stop Lamictal suddenly due to the risk of possible seizures. If you need to stop, your doctor will usually lower the dose slowly over at least 2 weeks.
The active ingredient in Lamictal is lamotrigine. Inactive ingredients may include lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, and coloring agents such as FD and C dyes or iron oxides.
Before using this medication, you may want to consult a healthcare provider about the following:
Lamictal carries a boxed warning about life-threatening skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. The risk is higher in children, especially if Lamictal is started at a higher than recommended dose, the dose is increased too quickly, or it is combined with valproate.
Tell your healthcare provider right away about any rash, fever, swollen lymph nodes, mouth sores, blistering or peeling skin, unusual bruising, or yellowing of the skin or eyes. These can be signs of a serious hypersensitivity reaction (also known as DRESS), which can affect the liver, blood cells, and other organs.
A rare but serious immune problem called hemophagocytic lymphohistiocytosis (HLH) has been reported. Signs can include persistent fever, severe rash, enlarged lymph nodes, easy bleeding or bruising, and severe fatigue.
Lamictal could cause serious irregular heart rhythms in people with certain underlying heart conditions. Tell your provider about a history of heart disease, abnormal heart rhythm, or other heart problems before starting Lamictal.
Antiepileptic medicines, including Lamictal, can increase the risk of suicidal thoughts or behavior. Watch for new or worsening depression, anxiety, agitation, panic attacks, irritability, or thoughts of self-harm.
Lamictal may cause aseptic meningitis in rare cases. Symptoms include severe headache, stiff neck, fever, nausea, vomiting, sensitivity to light, and confusion.
Blood problems such as low white blood cells, low platelets, or low overall blood counts can occur. Tell your provider about unusual tiredness, signs of infection (fever, chills, sore throat), easy bruising, or unusual bleeding.
Lamictal may have drug interactions. Valproate can increase lamotrigine levels and increase the risk of rashes, while carbamazepine, phenytoin, phenobarbital, primidone, and rifampin lower lamotrigine levels, which could reduce its effectiveness. Consult a healthcare provider for other potential interactions.
Dose adjustments may be needed in people with moderate or severe liver problems, and reduced maintenance doses may be needed in people with severe kidney problems.
Avoid taking or using this medication if you have a known allergy or hypersensitivity to lamotrigine or to any of the inactive ingredients in Lamictal.
Common side effects of Lamictal include:
Stop using Lamictal and get medical help for any new rash, blistering or peeling of the skin, mouth sores, sores in the eyes or genital area, fever, swollen lymph nodes, or yellowing of the skin or eyes.
These can be early signs of life-threatening reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS).
Other serious side effects include hemophagocytic lymphohistiocytosis (a severe immune reaction), serious irregular heart rhythms in people with certain heart conditions, low blood counts, aseptic meningitis (severe headache with stiff neck and fever), and liver problems.
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (e.g., different shape or color), as trademark laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.