Lamotrigine

Pronunciation

Pronunciation: la-MOE-tri-jeen
Class: Anticonvulsant

Trade Names

Lamictal
- Tablets 25 mg
- Tablets 100 mg
- Tablets 150 mg
- Tablets 200 mg
- Tablets, chewable dispersible 2 mg
- Tablets, chewable dispersible 5 mg
- Tablets, chewable dispersible 25 mg
- Tablets, orally disintegrating 25 mg
- Tablets, orally disintegrating 50 mg
- Tablets, orally disintegrating 100 mg
- Tablets, orally disintegrating 200 mg

Lamictal ODT Titration Kit
- Tablets, orally disintegrating 25 and 50 mg
- Tablets, orally disintegrating 25, 50, and 100 mg
- Tablets, orally disintegrating 50 and 100 mg

Lamictal Starter Kit
- Tablets 25 mg
- Tablets 25 and 50 mg

Lamictal XR
- Tablets, ER 25 mg
- Tablets, ER 50 mg
- Tablets, ER 100 mg
- Tablets, ER 200 mg

Lamictal XR Titration Kit
- Tablets, ER 25 and 50 mg
- Tablets, ER 25, 50, and 100 mg
- Tablets, ER 50, 100, and 200 mg

Lamotrigine
- Tablets 50 mg
- Tablets 250 mg

Apo-Lamotrigine (Canada)
Gen-Lamotrigine (Canada)
PMS-Lamotrigine (Canada)
ratio-Lamotrigine (Canada)

Pharmacology

Chemically unrelated to existing antiepileptic drugs (AEDs); precise mechanism(s) unknown. One proposed mechanism suggests inhibition of voltage-sensitive sodium channels, thereby stabilizing neuronal membranes that modulate presynaptic transmitter release of excitatory amino acids (eg, aspartate, glutamate).

Slideshow: Flashback: FDA Drug Approvals 2013

Pharmacokinetics

Absorption

Rapidly and completely absorbed after oral administration. Absolute bioavailability is 98%; not affected by food. T max is 1.4 to 4.8 h (immediate release) and 4 to 11 h (ER).

Distribution

Mean Vd is 0.9 to 1.3 L/kg, independent of dose. Approximately 55% protein bound at concentrations from 1 to 10 mcg/mL.

Metabolism

Metabolized predominantly by glucuronic acid conjugation. Major metabolite is 2-N-glucuronide conjugate. Following multiple administrations (150 mg twice daily), lamotrigine induced its own metabolism, resulting in a 25% decrease in half-life and a 37% increase in Cl at steady state.

Elimination

Elimination half-life is 25.4 to 32.8 h. Approximately 94% is excreted in urine and 2% in feces.

Special Populations

Renal Function Impairment

Plasma half-life is 42.9 h in patients with CrCl of 6 to 23 mL/min. In patients undergoing hemodialysis, half-life was 13 h during hemodialysis and 57.4 h between dialysis sessions. On average, approximately 20% of lamotrigine in the body is eliminated during a 4-h hemodialysis session.

Hepatic Function Impairment

Mean half-life is 46, 72, 67, or 100 h in patients with Child-Pugh score A, B, C without ascites, or C with ascites, respectively.

Elderly

Mean half-life was 31.2 h and mean Cl was 0.4 mL/min/kg in elderly patients after a single 150 mg dose.

Children

The oral Cl of lamotrigine was higher, on a body-weight basis, in children than in adults. Weight-normalized Cl was higher in subjects weighing less than 30 kg; the dose may need to be increased by as much as 50% in these patients.

Gender

Mean trough concentrations were 24% to 45% higher in women than men.

Race

Oral Cl was 25% lower in nonwhite patients than in white patients.

Indications and Usage

Bipolar disorder (immediate release only)

Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in adults treated for acute mood episodes with standard therapy.

Epilepsy

Adjunctive therapy for partial seizures, the generalized seizures of Lennox-Gastaut syndrome, and primary generalized tonic-clonic seizures in adults and children 2 yr of age and older (immediate release); for partial-onset seizures with or without secondary generalization and primary generalized tonic-clonic seizures in patients at least 13 yr of age (ER); conversion to monotherapy in adults with partial seizures who are receiving treatment with carbamazepine, phenobarbital, phenytoin, primidone, or valproate as a single AED (immediate release).

Unlabeled Uses

Management of children with absence seizures, juvenile myoclonic epilepsy, and temporal lobe seizures; postpoliomyelitis syndrome; prevention of migraines in adults; rectal administration.

Contraindications

Standard considerations.

Dosage and Administration

As Add-On Therapy for Epilepsy
Lamotrigine Immediate Release Plus AED Regimen Containing Valproate Adults and Children older than 12 yr of age PO Weeks 1 and 2

25 mg every other day.

Weeks 3 and 4

25 mg/day.

Maintenance dose

100 to 400 mg/day in 1 to 2 divided doses. 100 to 200 mg/day in patients using valproate alone. To achieve, escalate dose by 25 to 50 mg/day every 1 to 2 wk.

Children 2 to 12 yr of age PO Weeks 1 and 2

0.15 mg/kg/day in 1 to 2 divided doses. Round down to the nearest whole tablet.

Weeks 3 and 4

0.3 mg/kg/day in 1 to 2 divided doses. Round down to the nearest whole tablet.

Maintenance dose

1 to 5 mg/kg/day (max, 200 mg/day in 1 to 2 divided doses). For patients taking valproate alone, 1 to 3 mg/kg/day. To achieve, add 0.3 mg/kg/day, rounded down to the nearest whole tablet, to the previous daily dose every 1 to 2 weeks. In patients weighing less than 30 kg, may need to increase maintenance dose by as much as 50%, based on clinical response.

Lamotrigine Immediate Release Plus AEDs Other Than Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate Adults and Children older than 12 yr of age PO Weeks 1 and 2

25 mg every day.

Weeks 3 and 4

50 mg/day

Maintenance dose

225 to 375 mg/day in 2 divided doses. To achieve, escalate dose by 50 mg/day every 1 to 2 wk.

Children 2 to 12 yr of age PO Weeks 1 and 2

0.3 mg/kg/day in 1 or 2 divided doses. Round down to the nearest whole tablet.

Weeks 3 and 4

0.6 mg/kg/day in 2 divided doses. Round down to the nearest whole tablet.

Maintenance dose

4.5 to 7.5 mg/kg/day (max, 300 mg/day) in 2 divided doses. To achieve, add 0.6 mg/kg/day, rounded down to the nearest whole tablet, to the previous daily dose every 1 to 2 wk. In patients weighing less than 30 kg, may need to increase maintenance dose by as much as 50%, based on clinical response.

Lamotrigine Immediate Release Plus Enzyme-Inducing Antiepileptic Drugs (EIAEDs) Without Valproate Adults and Children older than 12 yr of age PO Weeks 1 and 2

50 mg/day.

Weeks 3 and 4

100 mg/day in 2 divided doses.

Maintenance dose

300 to 500 mg/day in 2 divided doses. To achieve, escalate dose by 100 mg/day every 1 to 2 wk. In patients receiving multidrug regimens employing EIAEDs without valproic acid, maintenance dosages of lamotrigine as high as 700 mg/day have been used.

Children 2 to 12 yr of age PO Weeks 1 and 2

0.6 mg/kg/day in 2 divided doses. Round down to the nearest whole tablet.

Weeks 3 and 4

1.2 mg/kg/day in 2 divided doses. Round down to the nearest whole tablet.

Maintenance dose

5 to 15 mg/kg/day (max, 400 mg/day in 2 divided doses). To achieve, add 1.2 mg/kg/day, rounded down to the nearest whole tablet, to the previous daily dose every 1 to 2 wk. In patients weighing less than 30 kg, may need to increase maintenance dose by as much as 50%, based on clinical response.

Conversion from an EIAED to Monotherapy With Lamotrigine Immediate Release Adults and Children 16 yr of age and older

PO 500 mg/day given as 2 divided doses. Begin conversion by titrating lamotrigine to the target dose (500 mg in 2 divided doses), while maintaining the dose of the EIAED at a fixed level, then withdraw concomitant EIAED by 20% decrements each week over a 4-wk period.

Conversion from Adjunctive Therapy With Valproate to Monotherapy With Lamotrigine Immediate Release Adults and Children 16 yr of age and older

PO Conversion involves 4 steps.

Step 1

While maintaining valproate at stable dose, achieve lamotrigine dosage of 200 mg/day (if not already on 200 mg/day) as follows:

Weeks 1 and 2

25 mg every other day.

Weeks 3 and 4

25 mg every day.

Week 5 onwards to maintenance (200 mg/day)

Increase by 25 to 50 mg/day every 1 to 2 weeks.

Step 2

Maintain lamotrigine at 200 mg/day and decrease valproate to 500 mg/day by decrements no greater than 500 mg/day per week, then maintain valproate dosage at 500 mg/day for 1 wk.

Step 3

Increase lamotrigine to 300 mg/day for 1 wk while simultaneously decreasing valproate to 250 mg/day for 1 wk.

Step 4

Increase lamotrigine by 100 mg/day every week to achieve maintenance dosage of 500 mg/day and discontinue valproate.

Lamotrigine ER Plus AED Regimen Containing Valproate
Adults and Children 13 yr of age and older PO Weeks 1 and 2

25 mg every other day.

Weeks 3 and 4

25 mg/day.

Week 5

50 mg/day.

Week 6

100 mg/day.

Week 7

150 mg/day.

Maintenance dose

200 to 250 mg/day.

Lamotrigine ER Plus AEDs Other than Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate
Adults and Children 13 yr of age and older PO Weeks 1 and 2

25 mg/day.

Weeks 3 and 4

50 mg/day.

Week 5

100 mg/day.

Week 6

150 mg/day.

Week 7

200 mg/day.

Maintenance dose

300 to 400 mg/day.

Lamotrigine ER Plus EIAEDs Without Valproate
Adults and Children 13 yr of age and older PO Weeks 1 and 2

50 mg/day.

Weeks 3 and 4

100 mg/day.

Week 5

200 mg/day.

Week 6

300 mg/day.

Week 7

400 mg/day.

Maintenance dose

400 to 600 mg/day.

Lamotrigine Immediate Release Escalation Regimen for Patients with Bipolar Disorder
Patients Not Taking an EIAED or Valproate Adults 18 yr of age and older PO Weeks 1 and 2

25 mg/day.

Weeks 3 and 4

50 mg/day.

Week 5

100 mg/day.

Weeks 6 and 7

200 mg/day.

Patients Taking Valproate Adults 18 yr of age and older PO Weeks 1 and 2

25 mg every other day.

Weeks 3 and 4

25 mg/day.

Week 5

50 mg/day.

Weeks 6 and 7

100 mg/day.

Patients Taking an EIAED and Not Taking Valproate Adults 18 yr of age and older PO Weeks 1 and 2

50 mg/day.

Weeks 3 and 4

100 mg/day in divided doses.

Week 5

200 mg/day in divided doses.

Week 6

300 mg/day in divided doses.

Week 7

Up to 400 mg/day in divided doses.

Lamotrigine Dosing Adjustments for Patients With Bipolar Disorder Following Discontinuation of Psychotropics
After Discontinuation of Valproate (Current Lamotrigine Dosage 100 mg/day) Adults 18 yr of age and older PO Week 1

150 mg/day.

Week 2

200 mg/day.

Week 3 and onward

200 mg/day.

After Discontinuation of EIAEDs (Current Lamotrigine Dosage 400 mg/day) Adults 18 yr of age and older PO Week 1

400 mg/day.

Week 2

300 mg/day.

Week 3 and onward

200 mg/day.

Adjustments to Maintenance Dose of Lamotrigine in Patients Taking Oral Contraceptives
Taking or Starting Oral Contraceptives in Patients Not Taking an EIAED Adults

PO Maintenance dose of lamotrigine may need to be increased 2-fold over recommended target maintenance dose, according to clinical response. If a patient is starting oral contraceptives, the dose increase should start at the same time the oral contraceptive is introduced and continue, based on clinical response, no more rapidly than 50 to 100 mg/day every week.

Stopping Oral Contraceptives in Patients Not Taking an EIAED Adults

PO Maintenance dose of lamotrigine may need to be decreased 50%, according to clinical response. Decrease in lamotrigine dose should not exceed 25% of total daily dose per week over a 2-wk period.

Conversion to ER Formulation Adults and Children 13 yr of age and older

Should match the total daily dose of the immediate release, given once daily. Monitor patients closely for seizure control and adjust based on clinical response.

Discontinuation of Lamotrigine

PO Lamotrigine should not be abruptly discontinued. A step-wise dose reduction over at least 2 wk (approximately 50% per week) is recommended, unless safety concerns require a more rapid withdrawal.

Hepatic Function Impairment

PO Initial, escalation, and maintenance doses should generally be reduced by approximately 25% in patients with moderate and severe liver impairment without ascites and by 50% in patients with severe liver impairment with ascites. Adjust escalation and maintenance doses according to clinical response.

Renal Function Impairment

PO Reduced maintenance doses may be effective for patients with significant renal impairment.

General Advice

  • Patients taking rifampin or other drugs that induce lamotrigine glucuronidation and increase Cl should follow the same dosing titration/maintenance regimen as that used with EIAEDs that have this effect.
  • Tablets, chewable dispersible tablets, and orally disintegrating tablets are interchangeable on mg-for-mg basis.
  • Administer prescribed dose without regard to meals. Administer with food if GI upset occurs.
  • Administer immediate-release tablets whole. Chewing tablet may leave a bitter taste.
  • ER tablets must be swallowed whole and should not be chewed, crushed, or divided.
  • Chewable dispersible tablets may be chewed, swallowed whole, or dispersed in water or diluted fruit juice. If chewed, provide a small amount of water or diluted fruit juice to aid in swallowing. Whole tablets and not fractions of tablets must be administered.
  • To disperse chewable dispersible tablets, add prescribed number of tablets to a small amount (1 tsp or enough to cover tablets) of water or diluted fruit juice. Wait about 1 min for tablet to disperse, then swirl the solution and administer immediately. Do not attempt to administer partial quantities of the dispersed tablets.
  • Orally disintegrating tablets should be placed onto the tongue and moved around in the mouth. The tablet will disintegrate rapidly and can be swallowed with or without water.

Storage/Stability

Store at controlled room temperature (59° to 86°F). Protect from light and moisture.

Drug Interactions

Acetaminophen, carbamazepine, hydantoins (eg, phenytoin), oral contraceptives, orlistat, oxcarbazepine, phenobarbital, primidone, protease inhibitors (eg, ritonavir), rifamycins (eg, rifampin), succinimides (eg, ethosuximide)

Lamotrigine plasma levels may be reduced by these agents, decreasing the therapeutic effect. Observe the clinical response of the patient and adjust the lamotrigine dose as needed when starting, stopping, or changing the dose of one of these agents.

Carbamazepine

The risk of carbamazepine toxicity may be increased. When adding lamotrigine to regimens containing carbamazepine, monitor for carbamazepine toxicity and reduce the carbamazepine dose as needed.

Clozapine

Clozapine plasma concentrations may be elevated, increasing the pharmacologic effects and risk of adverse reactions. Monitor the clinical response of the patient when starting or stopping lamotrigine. Adjust the clozapine dose as needed.

Folate inhibitors

Lamotrigine is an inhibitor of dihydrofolate reductase. Use caution with other agents that inhibit folate metabolism.

Levonorgestrel

Levonorgestrel plasma levels may be decreased.

Sertraline

Sertraline may elevate lamotrigine plasma concentrations increasing the pharmacologic effects and risk of adverse reactions. Monitor the clinical response of the patient. If an interaction is suspected, adjust the lamotrigine dose as needed when starting or stopping sertraline.

Topiramate

Topiramate plasma levels may be increased. The magnitude of the change is not likely to be clinically important; however, monitor the clinical response of the patient. If an interaction is suspected, adjust the topiramate dose as needed.

Valproic acid

Plasma levels may be reduced by lamotrigine, decreasing the therapeutic effect. Valproate increases lamotrigine levels. Because valproate reduces lamotrigine Cl, the dosage of lamotrigine in the presence of valproate is less than 50% of that required without valproate. Monitor the clinical response of the patient and adjust the dose of one or both drugs as needed.

Adverse Reactions

Cardiovascular

Hot flush (2%); vasculitis (postmarketing).

CNS

Dizziness (54%); headache (29%); ataxia (28%); somnolence (17%); insomnia, tremor (10%); asthenia, fatigue (8%); abnormal coordination (7%); anxiety, mania (including hypomania and mixed mood episodes) (5%); amnesia, hypesthesia, increased libido, increased or decreased reflexes, nystagmus, suicidal ideation (2% to 5%); abnormal dreams, abnormal thoughts, agitation, depression, dyspraxia, migraine (1% to 5%); gait abnormality (4%); cerebellar condition/balance disorder, convulsions, irritability, speech disorder, vertigo (3%); concentration disturbance, nervousness, seizure exacerbation (2%); confusion, paresthesias (at least 1%); aseptic meningitis, exacerbation of Parkinsonian symptoms in patients with preexisting Parkinson disease, tics (postmarketing).

Dermatologic

Rash (14%); contact dermatitis, dry skin, sweating (2% to 5%); pruritus (3%); eczema, photosensitivity (2%); Stevens-Johnson syndrome, TEN.

EENT

Diplopia (49%); blurred vision (25%); pharyngitis, rhinitis (14%); dry mouth (6%); abnormal vision, epistaxis (2% to 5%); pharyngolaryngeal pain (3%); amblyopia (at least 1%).

GI

Nausea (25%); vomiting (20%); diarrhea (11%); abdominal pain (10%); dyspepsia (7%); constipation (5%); anorexia, peptic ulcer, rectal hemorrhage (2% to 5%); flatulence (1% to 5%); esophagitis, pancreatitis (postmarketing).

Genitourinary

Dysmenorrhea (7%); urinary frequency (1% to 5%); vaginitis (4%); UTI (3%); amenorrhea (2%).

Hematologic-Lymphatic

Lymphadenopathy (2%); agranulocytosis, hemolytic anemia (postmarketing).

Metabolic-Nutritional

Weight loss (5%); peripheral edema (2% to 5%); edema, weight gain (1% to 5%).

Musculoskeletal

Back pain (8%); arthralgia, myalgia, neck pain (1% to 5%); rhabdomyolysis in patients experiencing hypersensitivity (postmarketing).

Respiratory

Increased cough (8%); bronchitis (7%); dyspnea (2% to 5%); sinusitis (1% to 5%); bronchospasm (2%); apnea (postmarketing).

Miscellaneous

Infection (20%); fever (15%); flu syndrome (7%); chest pain, pain (5%); facial edema, hemorrhage (2%); lupus-like reaction, progressive immunosuppression (postmarketing).

Precautions

Warnings

Serious rashes (including Stevens-Johnson syndrome) requiring hospitalization and discontinuation of treatment have been reported in 0.8% of children receiving lamotrigine as adjunctive therapy for epilepsy, 0.3% of adults receiving lamotrigine as adjunctive therapy for epilepsy, 0.08% of adults receiving lamotrigine as initial monotherapy for bipolar and other mood disorders, and 0.13% of adults receiving lamotrigine as adjunctive therapy for bipolar and other mood disorders. Other than age (children are at greatest risk), there are no other identified risk factors. There are suggestions that the risk of rash may be increased by coadministration of lamotrigine with valproate, exceeding the recommended initial dose of lamotrigine, or exceeding the recommended dose escalation for lamotrigine. Almost all life-threatening cases have occurred within the first 2 to 8 wk of therapy, but isolated cases have been reported after prolonged (eg, 6 mo) use. Discontinue lamotrigine at the first sign of rash, unless the rash is clearly not drug related.


Monitor

Because of possible pharmacokinetic interactions between lamotrigine and other AEDs, monitoring of plasma levels may be indicated, particularly during dosage adjustments. Closely monitor patients for clinical worsening (including development of new symptoms) and suicidality, especially at the beginning of treatment or at the time of dose changes.


Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

For the treatment of partial seizures, generalized seizures of Lennox-Gastaut syndrome, and primary generalized tonic-clonic seizures, safety and efficacy not established for children younger than 2 yr of age. Safety and efficacy not established in patients younger than 18 yr of age with bipolar disorder. For ER formulation, safety and efficacy is not established in patients younger than 13 yr of age as adjunctive therapy for partial-onset seizures and primary generalized tonic-clonic seizures.

Elderly

Cautiously select dosage, usually starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic and renal function, and of comorbidity.

Hypersensitivity

Fatal or life-threatening hypersensitivity reactions may occur. Early manifestations of hypersensitivity (eg, fever, lymphadenopathy) may be present even though a rash is not evident. Immediately evaluate patient if such signs or symptoms are present and discontinue lamotrigine if an alternative etiology for the signs and symptoms cannot be established.

Renal Function

Use with caution; reduce maintenance doses for patients with significant impairment.

Hepatic Function

Reduce initial, escalation, and maintenance doses approximately 25% in patients with moderate (Child-Pugh class B) and severe (Child-Pugh class B) impairment without ascites and 50% in patients with severe impairment (Child-Pugh class C) with ascites.

Hazardous Tasks

May cause drowsiness or dizziness.

Acute multiorgan failure

Multiorgan failure, which has been fatal or irreversible in some cases, has been observed.

Hematologic effects

Blood dyscrasias have been reported that may or may not be associated with the hypersensitivity syndrome. These include anemia, neutropenia, leukopenia, pancytopenia, thrombocytopenia, and, rarely, aplastic anemia and pure red cell aplasia.

Clinical worsening and suicide risk

Closely monitor patients for clinical worsening (including development of new symptoms) and suicidality, especially at the beginning of treatment and at the time of dose changes (either increase or decrease). Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients who experience clinical worsening and/or emergence of suicidal ideation/behavior, especially if symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Prescribe the smallest quantity of medication consistent with good patient management.

Melanin-containing tissues

Lamotrigine binds to melanin and may cause toxicity with possibility of long-term ophthalmologic effects.

Restarting lamotrigine

Do not restart lamotrigine in patients who discontinued because of rash with prior treatment unless potential benefits clearly outweigh risk. If a decision is made to restart lamotrigine, assess the initial dosing recommendations. The greater the interval since the previous dose, the greater consideration should be given to restarting with the initial dosing recommendations. If a patient has discontinued lamotrigine for a period greater than 5 half-lives, follow initial dosing recommendations and guidelines.

Sudden unexplained death in epilepsy

During premarketing development of lamotrigine, 20 sudden and unexplained deaths were recorded among a cohort of 4,700 patients with epilepsy (5,747 patient-years of exposure).

Withdrawal seizures

Do not abruptly discontinue AEDs because of possibility of increasing seizure frequency. Taper dose over a 2-wk period.

Overdosage

Symptoms

Ataxia, coma, decreased levels of consciousness, increased seizures, intraventricular conduction delay, nystagmus.

Patient Information

  • Advise patient, family, or caregiver to read the Medication Guide before starting therapy and with each refill.
  • Instruct patient, family, or caregiver to continue other medications for seizures or bipolar disorder, unless advised otherwise by health care provider.
  • Advise patient, family, or caregiver that medication will be started at a low dose and then gradually increased as tolerated until maximum benefit has been obtained.
  • Instruct patient, family, or caregiver to take exactly as prescribed and not to change the dose or discontinue therapy unless advised by health care provider. Caution patient, family, or caregiver that if medication is stopped for any reason, to notify health care provider and not to restart the medication without instruction from their health care provider because a dosage adjustment may be necessary if the medication is restarted.
  • Advise patient to swallow immediate-release tablet whole. Chewing the tablets may leave a bitter taste.
  • Advise patient to swallow ER tablet whole; it should not be chewed, crushed, or divided.
  • Instruct patient, family, or caregiver in proper use of chewable dispersible tablets and orally disintegrating tablets.
  • Advise patient, family, or caregiver that each dose may be taken without regard to meals but to take with food if stomach upset occurs.
  • Instruct patient, family, or caregiver to contact health care provider immediately if any of the following occur: fever, hives, painful sores in the mouth or around the eyes, skin rash, swelling of the lips or tongue, or swollen lymph glands.
  • Instruct patient, and family or caregiver of patient, to be alert for abnormal changes in mood or thinking and to immediately report any of the following to health care provider: agitation, akathisia (psychomotor restlessness), anxiety, change in mood, change in personality, hostility or aggressiveness, impulsivity, insomnia, irritability, panic attacks, or suicidal thoughts or behavior. Advise families and caregivers of patients to observe for emergence on a day-to-day basis because changes may be abrupt.
  • Advise patient, family, or caregiver that if medication needs to be discontinued, it will be slowly withdrawn over a period of 2 wk or more unless safety concerns (eg, rash) require a more rapid withdrawal.
  • Advise patient to avoid unnecessary exposure to direct and indirect sunlight or tanning lamps, and to use sunscreen and wear protective clothing to avoid photosensitivity reactions during therapy. Advise patient to discontinue therapy and notify health care provider if any of the following occur following exposure to sunlight or artificial ultraviolet light (eg, sunlamp): blistering, rash or itching, redness, sensation of skin burning, swelling.
  • Caution patient that drug may cause dizziness or drowsiness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Advise women to notify health care provider if they plan to start or stop use of oral contraceptives or other female hormonal preparations. Advise women to notify health care provider if they experience changes in menstrual pattern (eg, breakthrough bleeding) while taking lamotrigine in combination with these medications.
  • Encourage pregnant patients taking lamotrigine to enroll in the North American Antiepileptic Drug Pregnancy Registry.
  • Instruct patient, family, or caregiver to contact health care provider if seizures get worse, if new types of seizures occur, or if bipolar symptoms worsen or do not improve.
  • Advise patient, family, or caregiver to contact health care provider if bothersome adverse reactions occur.

Copyright © 2009 Wolters Kluwer Health.

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