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Lamotrigine XR

Class
Anticonvulsants
Subclass
Phenyltriazines
Substance name
lamoTRIgine XR
Brand names
Lamictal XR®
Common formulations
Film-coated tablet
See also
Lamotrigine (Lamictal®)
Dosage and administration
Adults patients
Focal seizures • In patients taking valproate
•
Start at: 25 mg PO q48h for 2 weeks, followed by 25 mg PO daily for another 2 weeks and 50 mg PO daily, 100 mg PO daily, and 150 mg PO daily for weeks 5, 6, and 7, respectively
•
Maintenance: 200-250 mg PO daily
Switch to maintenance dose by week 8.
Focal seizures • In patients not taking carbamazepine, phenytoin, phenobarbital, primidone, or valproate
•
Start at: 25 mg PO daily for 2 weeks, followed by 50 mg PO daily for another 2 weeks and 100 mg PO daily, 150 mg PO daily, and 200 mg PO daily for weeks 5, 6, and 7, respectively
•
Maintenance: 300-400 mg PO daily
Switch to maintenance dose by week 8.
Focal seizures • In patients taking carbamazepine, phenytoin, phenobarbital, or primidone, but not taking valproate
•
Start at: 50 mg PO daily for 2 weeks, followed by 100 mg PO daily for another 2 weeks and 200 mg PO daily, 300 mg PO daily, and 400 mg PO daily for weeks 5, 6, and 7, respectively
•
Maintenance: 400-600 mg PO daily
Switch to maintenance dose by week 8.
Generalized tonic-clonic seizures • Primary, in patients taking valproate
•
Start at: 25 mg PO q48h for 2 weeks, followed by 25 mg PO daily for another 2 weeks and 50 mg PO daily, 100 mg PO daily, and 150 mg PO daily for weeks 5, 6, and 7, respectively
•
Maintenance: 200-250 mg PO daily
Switch to maintenance dose by week 8.
Generalized tonic-clonic seizures • Primary, in patients taking carbamazepine, phenytoin, phenobarbital, or primidone, but not taking valproate
•
Start at: 50 mg PO daily for 2 weeks, followed by 50 mg PO daily for another 2 weeks and 100 mg PO daily, 150 mg PO daily, and 200 mg PO daily for weeks 5, 6, and 7, respectively
•
Maintenance: 400-600 mg PO daily
Switch to maintenance dose by week 8.
Generalized tonic-clonic seizures • Primary, in patients not taking carbamazepine, phenytoin, phenobarbital, primidone, or valproate
•
Start at: 25 mg PO daily for 2 weeks, followed by 50 mg PO daily for another 2 weeks and 100 mg PO daily, 150 mg PO daily, and 200 mg PO daily for weeks 5, 6, and 7, respectively
•
Maintenance: 300-400 mg PO daily
Switch to maintenance dose by week 8.
Indications for use
Labeled indications
Adults
•
Adjunctive treatment for focal seizures (in patients not taking carbamazepine, phenytoin, phenobarbital, primidone, or valproate)
•
Adjunctive treatment for focal seizures (in patients taking carbamazepine, phenytoin, phenobarbital, or primidone, but not taking valproate)
•
Adjunctive treatment for focal seizures (in patients taking valproate)
•
Adjunctive treatment for generalized tonic-clonic seizures (primary, in patients not taking carbamazepine, phenytoin, phenobarbital, primidone, or valproate)
•
Adjunctive treatment for generalized tonic-clonic seizures (primary, in patients taking carbamazepine, phenytoin, phenobarbital, or primidone, but not taking valproate)
•
Adjunctive treatment for generalized tonic-clonic seizures (primary, in patients taking valproate)
Safety risks
Boxed warnings
Stevens-Johnson syndrome, toxic epidermal necrolysis
•
Use extreme caution in all patients.
Contraindications
Hypersensitivity to lamotrigine or its components
Warnings and precautions
Blood dyscrasias, aseptic meningitis, hemophagocytic lymphohistiocytosis
•
Maintain a high level of suspicion, as lamotrigine has been associated with an increased risk for these adverse events.
Cardiac arrhythmias
•
Use caution in patients with clinically important structural or functional heart disease. Recognize that concomitant use of other sodium channel blockers may firther increase the risk of cardiac arrhythmias.
Decreased serum lamotrigine levels
•
Use caution in patients taking estrogen-containing oral contraceptives. Adjust lamotrigine dosage in patients initiating or discontinuing estrogen-containing oral contraceptives.
DRESS syndrome
•
Use caution in all patients. Recognize that early manifestations of hypersensitivity, such as fever and lymphadenopathy, may be present even though a rash is not evident. Instruct patients to report any rash or other signs or symptoms of hypersensitivity.
Seizure
•
Do not discontinue abruptly in patients taking the drug for a prolonged period.
Suicidal ideation
•
Use caution in all patients. Monitor for new or worsening depression, suicidal thoughts/behavior, and/or changes in mood or behavior.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 30 mL/min
•
Use with caution. Reduce maintenance dose.
Renal replacement therapy
Continuous renal replacement
•
Use acceptable. No dose adjustment required. Monitor serum concentrations.
Intermittent hemodialysis
•
Use acceptable. No dose adjustment required. Titrate with caution. Monitor serum concentrations.
Peritoneal dialysis
•
Use acceptable. No dose adjustment required. Titrate with caution.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Reduce maintenance dose. Reduce dose by 25%. Titrate to response.
Child-Pugh C (severe)
•
Reduce maintenance dose. Reduce dose by 25-50%. Titrate to response.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals. Enroll patients in a dedicated pregnancy outcome monitoring registry. Provide pre-pregnancy counseling in patients with epilepsy planning to become pregnant. Do not abruptly discontinue antiepileptic therapy during pregnancy, as this may lead to breakthrough seizures in both the mother and fetus.
•
Physiological changes during pregnancy can alter drug concentrations and therapeutic effects, requiring dose adjustments. Advise patients to inform their healthcare provider if they intend to begin or discontinue the use of oral contraceptives or other female hormonal treatments, as this may significantly impact the concentrations of lamotrigine.
Breastfeeding
Use only if benefits outweigh potential risks.
Low excretion in breastmilk (5-25%).
Low-moderate levels in breastfed infants (25-45%).
Unlikely to cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
Dizziness
Common 1-10%
•
Agitation, amblyopia, atopic dermatitis, bronchospasm, contact dermatitis, hyperreflexia, hyporeflexia, migraine, alcohol intolerance, nystagmus, peptic ulcer disease, peripheral edema, pharyngitis, anxiety, asthenia, blurred vision, confusion, constipation, cough, depression, diarrhea, diplopia, dry mouth, dyspnea, emotional lability, fatigue, flatulence, flu-like symptoms, hot flashes, hypoesthesia, incoordination, ↑ libido, itching, loss of appetite, myalgia, nausea, neck pain, nightmares, paresthesia, skin flushing, skin rash, somnolence, suicidal ideation, sweating, throat pain, urinary frequency, vertigo, visual disturbances, vomiting, weight loss, sinusitis, skin dryness, rectal bleeding, tremor
Uncommon < 1%
•
Acne vulgaris, angioedema, choreoathetosis, conjunctivitis, delirium, dysarthria, dyskinesia, ecchymosis, epididymitis, erythema multiforme, exfoliative dermatitis, gastritis, gingivitis, glossitis, goiter, hirsutism, hyperesthesia, hypertension, hypertonia, hypothyroidism, change in taste, gastrointestinal bleeding, gingival bleeding, hypotonia, ↑ blood glucose, ↑ liver enzymes, ↑ serum TBIL, maculopapular rash, menorrhagia, orthostatic hypotension, petechiae, ptosis, renal failure, akathisia, ↓ libido, dysphagia, dysuria, erectile dysfunction, euphoria, hematemesis, hiccups, hostility, ↑ appetite, malaise, melena, nocturia, palpitations, paranoid ideation, photophobia, syncope, tinnitus, ear pain, urinary incontinence, urinary retention, urinary urgency, visual hallucinations, yawning, skin discoloration, skin erythema, Stevens-Johnson syndrome, stomatitis, tachycardia, toxic epidermal necrolysis, urticaria, uveitis
Unknown frequency
•
Acute liver failure, acute pancreatitis, aseptic meningitis, cardiac arrhythmias, disseminated intravascular coagulation, DRESS syndrome, ↓ serum sodium, hemolytic anemia, hemophagocytic lymphohistiocytosis, lymphadenopathy, lupus-like symptoms, rhabdomyolysis, splenomegaly, hepatomegaly, tubulointerstitial nephritis, vasculitis
Interactions
Drug(s)
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