Lamotrigine — uses, dosing, side effects & the brands that sell it · pharmaranks
Lamotrigine: uses, dosing, side effects & brands
Lamotrigine is an anti-epileptic agent sold in the U.S. under 6 brand and generic names, for bipolar disorder, partial epilepsies and seizures. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
From the FDA label for Lamictal (application NDA020241). Other lamotrigine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Dosing is based on concomitant medications, indication, and patient age. ( 2.1 , 2.2 , 2.3 , 2.4 ) • To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations should not be exceeded. LAMICTAL Starter Kits and LAMICTAL ODT Patient Titration Kits are available for the first 5 weeks of treatment. ( 2.1 , 16 ) • Do not restart LAMICTAL in patients who discontinued due to rash unless the potential benefits clearly outweigh the risks. ( 2.1 , 5.1 ) • Adjustments to maintenance doses will be necessary in most patients starting or stopping estrogen-containing products, including oral contraceptives. ( 2.1 , 5.9 ) • Discontinuation: Taper over a period of at least 2 weeks (approximately 50% dose reduction per week). ( 2.1 , 5.10 ) Epilepsy: • Adjunctive therapy—See Table 1 for patients older than 12 years and Tables 2 and 3 for patients aged 2 to 12 years. ( 2.2 ) • Conversion to monotherapy—See Table 4 . ( 2.3 ) Bipolar disorder: See Tables 5 and 6 . ( 2.4 ) 2.1 General Dosing Considerations Rash There are suggestions that the risk of severe, potentially life-threatening rash may be increased by (1) coadministration of LAMICTAL with valproate, (2) exceeding the recommended initial dose of LAMICTAL, or (3) exceeding the recommended dose escalation for LAMICTAL. However, cases have occurred in the absence of these…
Lamotrigine side effects
The following serious adverse reactions are described in more detail in the Warnings and Precautions section of the labeling: • Serious Skin Rashes [see Warnings and Precautions ( 5.1 )] • Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions ( 5.2 )] • Multiorgan Hypersensitivity Reactions and Organ Failure [see Warnings and Precautions ( 5.3 )] • Cardiac Rhythm and Conduction Abnormalities [see Warnings and Precautions ( 5.4 )] • Blood Dyscrasias [see Warnings and Precautions ( 5.5 )] • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.6 )] • Aseptic Meningitis [see Warnings and Precautions ( 5.7 )] • Withdrawal Seizures [see Warnings and Precautions ( 5.10 )] • Status Epilepticus [see Warnings and Precautions ( 5.11 )] Epilepsy: Most common adverse reactions (incidence ≥10%) in adults were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, pharyngitis, and rash. Additional adverse reactions (incidence ≥10%) reported in children included vomiting, infection, fever, accidental injury, diarrhea, abdominal pain, and tremor. ( 6.1 ) Bipolar disorder: Most common adverse reactions (incidence >5%) in adults were nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, and xerostomia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088…
Every lamotrigine product we track (6)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Lamotrigine pill imprints
Imprint
Strength
Colour
Shape
Maker
U;U;111
25 mg
white
oval
—
U;U;112
100 mg
white
triangle
—
U;U;113
150 mg
white
triangle
—
U;U;114
200 mg
blue
triangle
—
ZC;80
100 mg
white
round
—
U;U;113
150 mg
Frequently asked questions
What is lamotrigine?
LAMICTAL (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as -triazine, its molecular formula is C 9 H 7 N 5 Cl 2 , and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pK a 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 tablets are supplied for oral administration as 25-mg (white), 100-mg (peach), 150-mg (cream), and 200-mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose; magnesium stearate; microcrystalline cellulose; povidone; sodium starch glycolate; FD&C Yellow No. 6 Lake (100-mg tablet only); ferric oxide, yellow (150-mg tablet only); and FD&C Blue No. 2 Lake (200-mg tablet only). LAMICTAL tablets for oral suspension are supplied for oral administration. The tablets contain 2 mg (white), 5 mg (white), or 25 mg (white) of lamotrigine and the following inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate. The tablets for oral suspension meet Organic Impurities…
What kind of drug is lamotrigine?
The FDA classifies lamotrigine as an anti-epileptic agent. Anti-epileptic (anticonvulsant) drugs calm the abnormal, excessive electrical activity that triggers seizures. They do this by stabilizing overactive sodium or calcium channels in nerve cells, boosting the brain's natural calming chemical GABA, or dampening excitatory signals, which makes nerves less likely to fire uncontrollably. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take lamotrigine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run lamotrigine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take lamotrigine
LAMICTAL is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning , Warnings and Precautions ( 5.1 , 5.3 )] . Hypersensitivity to the drug or its ingredients. ( Boxed Warning , 4 )
Lamotrigine drug interactions
Significant drug interactions with LAMICTAL are summarized in this section. Uridine 5´-diphospho-glucuronyl transferases (UGT) have been identified as the enzymes responsible for metabolism of lamotrigine. Drugs that induce or inhibit glucuronidation may, therefore, affect the apparent clearance of lamotrigine. Strong or moderate inducers of the cytochrome P450 3A4 (CYP3A4) enzyme, which are also known to induce UGT, may also enhance the metabolism of lamotrigine. Those drugs that have been demonstrated to have a clinically significant impact on lamotrigine metabolism are outlined in Table 13 . Specific dosing guidance for these drugs is provided in the Dosage and Administration section, and, for women taking estrogen‑containing products, including oral contraceptives, in the Warnings and Precautions section [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.9 )] . Additional details of these drug interaction studies are provided in the Clinical Pharmacology section [see Clinical Pharmacology ( 12.3 )] . Table 13. Established and Other Potentially Significant Drug Interactions ↓ = Decreased (induces lamotrigine glucuronidation). ↑ = Increased (inhibits lamotrigine glucuronidation). ? = Conflicting data. Concomitant Drug Effect on Concentration of Lamotrigine or Concomitant Drug Clinical Comment Estrogen-containing oral contraceptive preparations containing 30…
We track 6 lamotrigine-containing products in the U.S.: Lamictal, Lamictal Cd, Lamictal ODT, Lamictal XR, Lamotrigine and Subvenite. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does lamotrigine come in?
Across the brands we track, lamotrigine is currently marketed as tablet, kit, tablet, orally disintegrating, tablet, extended release, tablet, chewable and suspension, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic lamotrigine?
Yes. Our catalog lists 1 generic lamotrigine product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.