Buy Lamictal Online

Lamictal (lamotrigine)

BOXED WARNING

Serious life-threatening rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death reported. Serious rash occurs more often in pediatric patients than in adults. D/C at 1st sign of rash, unless rash is clearly not drug related. Potential increased risk w/ concomitant valproate (including valproic acid and divalproex sodium) or exceeding the recommended initial dose/dose escalation.

View FDA-Approved Full Prescribing Information for Lamictal

OTHER BRAND NAMES

Lamictal ODT

THERAPEUTIC CLASS

Phenyltriazine

DEA CLASS

RX

INDICATIONS

Adjunctive therapy in patients ≥2 yrs of age w/ partial-onset seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome. For conversion to monotherapy in adults (≥16 yrs of age) w/ partial-onset seizures receiving a single antiepileptic drug (AED) (carbamazepine, phenytoin, phenobarbital, primidone, or valproate). Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes w/ standard therapy.

ADULT DOSAGE

Epilepsy

Adjunctive Therapy for Partial-Onset, Primary Generalized Tonic-Clonic Seizures, or Generalized Seizures of Lennox-Gastaut Syndrome:

Taking Valproate:
Weeks 1 and 2:
25mg qod
Weeks 3 and 4:
25mg qd
Week 5 Onward:
Increase every 1-2 weeks by 25-50mg/day
Maint:
100-200mg/day w/ valproate alone or 100-400mg/day w/ valproate and other drugs inducing glucuronidation in 1 or 2 divided doses

Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate:
Weeks 1 and 2:
25mg qd
Weeks 3 and 4:
50mg/day
Week 5 Onward:
Increase every 1-2 weeks by 50mg/day
Maint:
225-375mg/day in 2 divided doses

Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone, w/o Valproate:
Weeks 1 and 2:
50mg/day
Weeks 3 and 4:
100mg/day in 2 divided doses
Week 5 Onward:
Increase every 1-2 weeks by 100mg/day
Maint:
300-500mg/day in 2 divided doses

Bipolar I Disorder

Maint Treatment to Delay the Time to Occurrence of Mood Episodes in Patients Treated for Acute Mood Episodes w/ Standard Therapy:

Taking Valproate:

Weeks 1 and 2: 25mg qod
Weeks 3 and 4: 25mg/day
Week 5: 50mg/day
Weeks 6 and 7: 100mg/day

Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate:
Weeks 1 and 2: 25mg/day
Weeks 3 and 4: 50mg/day
Week 5: 100mg/day
Weeks 6 and 7: 200mg/day

Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone, w/o Valproate:
Weeks 1 and 2: 50mg/day
Weeks 3 and 4: 100mg/day
Week 5: 200mg/day
Week 6: 300mg/day
Week 7: Up to 400mg/day
Weeks 3-7: Take in divided doses

Conversions

Conversion from Adjunctive Therapy to Monotherapy:
≥16 Years:
Monotherapy Maint: 500mg/day in 2 divided doses

From Adjunctive Therapy w/ Carbamazepine, Phenytoin, Phenobarbital, or Primidone:
After achieving a dose of 500mg/day of lamotrigine, withdraw concomitant antiepileptic drug by 20% decrements each week over a 4-week period

From Adjunctive Therapy w/ Valproate:
1. Maintain lamotrigine at 200mg/day and decrease valproate by decrements no >500mg/day/week to 500mg/day and then maintain for 1 week
2. Increase lamotrigine to 300mg/day and maintain for 1 week; simultaneously decrease valproate to 250mg/day and maintain for 1 week
3. Increase lamotrigine by 100mg/day every week to achieve maint dose of 500mg/day; d/c valproate

PEDIATRIC DOSAGE

Epilepsy

Adjunctive Therapy for Partial-Onset, Primary Generalized Tonic-Clonic Seizures, or Generalized Seizures of Lennox-Gastaut Syndrome:

2-12 Years:
Round dose down to the nearest whole tab; give in 1-2 divided doses

Taking Valproate:
Initial Weight-Based Dosing Guide (Weeks 1-4):
Refer to PI
Weeks 1 and 2:
0.15mg/kg/day
Weeks 3 and 4:
0.3mg/kg/day
Week 5 Onward:
Increase every 1-2 weeks by 0.3mg/kg/day
Maint:
1-5mg/kg/day (max 200mg/day) or 1-3mg/kg/day w/ valproate alone 

Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate:
Weeks 1 and 2:
0.3mg/kg/day
Weeks 3 and 4:
0.6mg/kg/day
Week 5 Onward:
Increase every 1-2 weeks by 0.6mg/kg/day
Maint:
4.5-7.5mg/kg/day
Max:
300mg/day in 2 divided doses

Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone, w/o Valproate:
Weeks 1 and 2:
0.6mg/kg/day
Weeks 3 and 4:
1.2mg/kg/day
Week 5 Onward:
Increase every 1-2 weeks by 1.2mg/kg/day
Maint:
5-15mg/kg/day
Max:
400mg/day in 2 divided doses

>12 Years:
Taking Valproate:

Weeks 1 and 2: 25mg qod
Weeks 3 and 4: 25mg qd
Week 5 Onward: Increase every 1-2 weeks by 25-50mg/day
Maint: 100-200mg/day w/ valproate alone or 100-400mg/day w/ valproate and other drugs inducing glucuronidation in 1 or 2 divided doses

Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate:
Weeks 1 and 2: 25mg qd
Weeks 3 and 4: 50mg/day
Week 5 Onward: Increase every 1-2 weeks by 50mg/day
Maint: 225-375mg/day in 2 divided doses

Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone, w/o Valproate:
Weeks 1 and 2: 50mg/day
Weeks 3 and 4: 100mg/day in 2 divided doses
Week 5 Onward: Increase every 1-2 weeks by 100mg/day
Maint: 300-500mg/day in 2 divided doses

DOSING CONSIDERATIONS

Concomitant Medications
Taking Estrogen-Containing Oral Contraceptives w/o Other Drugs Known to Induce Glucuronidation:
May need to increase maint dose of lamotrigine by as much as 2-fold
Starting Estrogen-Containing Oral Contraceptives w/o Other Drugs Known to Induce Glucuronidation:
May need to increase maint dose of lamotrigine by as much as 2-fold
Increase lamotrigine dose at the same time the oral contraceptive is introduced; no more than 50-100mg/day every week
If adverse reactions occur during the pill-free week due to lamotrigine, may need to adjust overall maint dose; dose adjustments limited to pill-free week not recommended
Stopping Estrogen-Containing Oral Contraceptives w/o Other Drugs Known to Induce Glucuronidation:
May need to decrease maint dose of lamotrigine by as much as 50%; decreases should not exceed 25% of total daily dose/week over a 2-week period, unless clinical response or lamotrigine plasma levels indicate otherwise

Taking Atazanavir/Ritonavir But Not Taking Other Glucuronidation Inducers:
Lamotrigine may need to be increased if atazanavir/ritonavir is added or decreased if atazanavir/ritonavir is discontinued

Bipolar Disorder:
Discontinuation of Psychotropic Drugs Excluding Valproate, Carbamazepine, Phenytoin, Phenobarbital, or Primidone:
Maintain current dose of lamotrigine
After Discontinuation of Valproate w/ Current dose of 100mg/day Lamotrigine:
Week 1:
150mg/day
Week 2 Onward:
200mg/day
After Discontinuation of Carbamazepine, Phenytoin, Phenobarbital, or Primidone w/ Current Dose of 400mg/day Lamotrigine:
Week 1:
400mg/day
Week 2:
300mg/day
Week 3 Onward:
200mg/day

Renal Impairment
Significant:
Reduce maint doses

Hepatic Impairment
Moderate/Severe w/o Ascites:
Reduce initial, escalation, and maint doses by approx 25%
Severe w/ Ascites:
Reduce initial, escalation, and maint doses by 50%
Adjust maint and escalation doses based on clinical response

Elderly
Start at lower end of dosing range

Discontinuation

A step-wise reduction over at least 2 weeks (approx 50% per week) is recommended unless safety concerns require a more rapid withdrawal

Other Important Considerations
<30kg: Maint dose may need to be increased by as much as 50%, based on clinical response

ADMINISTRATION

Oral route

Tab, Chewable
May swallow whole, chewed, or dispersed in water or diluted fruit juice
If tabs are chewed, consume a small amount of water or diluted fruit juice to aid in swallowing
To disperse chewable tabs, add tabs to a small amount of liquid (1 tsp, or enough to cover the medication); approx 1 min later when tabs are completely dispersed, swirl sol and consume entire quantity immediately

Tab, Orally Disintegrating
Place onto the tongue and move around in the mouth
Can be swallowed w/ or w/o water and taken w/ or w/ food

HOW SUPPLIED

Tab: 25mg*, 100mg*, 150mg*, 200mg*; Tab, Chewable: 2mg, 5mg, 25mg; Tab, Disintegrating: (ODT) 25mg, 50mg, 100mg, 200mg *scored

WARNINGS/PRECAUTIONS

Not recommended for treatment of acute manic/mixed episodes. Drug reaction w/ eosinophilia and systemic symptoms (DRESS), also known as multiorgan hypersensitivity reactions, reported. Fatalities from acute multiorgan failure and various degrees of hepatic failure reported. Isolated liver failure w/o rash or involvement of other organs reported. D/C if alternative etiology for signs/symptoms of early manifestations of hypersensitivity cannot be established. Blood dyscrasias (eg, neutropenia, leukopenia) reported. Increased risk of suicidal thoughts or behavior. Increases risk of developing aseptic meningitis; evaluate for other causes of aseptic meningitis and treat appropriately. Avoid abrupt withdrawal due to risk of withdrawal seizures. Treatment-emergent status epilepticus and sudden unexplained death in epilepsy reported. May cause toxicity in the eyes and other melanin-rich tissues due to melanin binding. Medication errors reported. Do not restart therapy in patients who discontinued due to rash associated w/ prior treatment, unless potential benefits outweigh the risks. If restarting after discontinuation, assess the need to restart w/ initial dosing recommendations. May interfere w/ assay used in some rapid urine screens, which can result in false-positive readings, particularly for phencyclidine; use a more specific analytical method to confirm a positive result.

ADVERSE REACTIONS

Rash, dizziness, diplopia, infection, headache, ataxia, blurred vision, N/V, somnolence, fever, pharyngitis, rhinitis, diarrhea, abdominal pain, tremor.

DRUG INTERACTIONS

See Boxed Warning and Dose Modification. Estrogen-containing oral contraceptives, carbamazepine, lopinavir/ritonavir, phenobarbital/primidone, and phenytoin decreased levels. Atazanavir/ritonavir and rifampin decreased exposure. May decrease levels of levonorgestrel. Valproate may increase levels. May increase carbamazepine epoxide levels. Drugs known to induce or inhibit glucuronidation may affect clearance. May increase plasma levels of drugs substantially excreted via organic cationic transporter 2 (OCT2) proteins; avoid w/ OCT2 substrates w/ a narrow therapeutic index (eg, dofetilide).

PREGNANCY AND LACTATION

Category C, caution in nursing.

MECHANISM OF ACTION

Phenyltriazine; has not been established. Suspected to inhibit voltage-sensitive Na+ channels, thereby stabilizing neuronal membranes and consequently modulating presynaptic transmitter release of excitatory amino acids (eg, glutamate, aspartate).

PHARMACOKINETICS

Absorption: Rapid and complete. Absolute bioavailability (98%); Tmax=1.4-4.8 hrs. Distribution: Vd=0.9-1.3L/kg; plasma protein binding (55%); found in breast milk. Metabolism: Liver via glucuronic acid conjugation; 2-N-glucuronide conjugate (major metabolite, inactive). Elimination: Urine (94%; 10% unchanged, 76% 2-N-glucuronide), feces (2%). Refer to PI for variable parameters w/ concomitant AEDs.

ASSESSMENT

Assess for history of allergy/rash to other AEDs, renal/hepatic impairment, depression, systemic lupus erythematosus or other autoimmune diseases, hypersensitivity to drug, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for signs/symptoms of rash, DRESS, multiorgan failure, status epilepticus, blood dyscrasias, emergence/worsening of depression, suicidal thoughts or behavior, unusual mood/behavior changes, aseptic meningitis, ophthalmologic effects, and other adverse reactions. Periodically reassess patients w/ bipolar disorder taking lamotrigine for >16 weeks to determine need for maintenance treatment.

PATIENT COUNSELING

Inform that a rash or other signs/symptoms of hypersensitivity may herald a serious medical event; instruct to report such symptoms to healthcare providers immediately. Instruct to notify healthcare providers immediately if blood dyscrasias, DRESS, acute multiorgan failure, or aseptic meningitis occur. Inform about increased risk of suicidal thoughts and behavior; instruct to be alert for emergence/worsening of symptoms of depression, any unusual changes in mood/behavior, suicidal thoughts/behavior, or thoughts about self-harm. Instruct to immediately report behaviors of concern to healthcare providers. Instruct to notify healthcare providers if worsening of seizure control occurs. Inform that CNS depression may occur; instruct to avoid operating machinery/driving until effects of the drug are known. Instruct to notify healthcare providers if pregnant, intending to become pregnant, or if breastfeeding. Encourage patients to enroll in the North American Antiepileptic Drug Pregnancy Registry. Instruct women to notify healthcare providers if they plan to start/stop use of oral contraceptives or other hormonal preparations. Instruct to promptly notify healthcare providers of changes in menstrual pattern and adverse reactions. Instruct to notify healthcare providers if medication is discontinued and not to resume therapy w/o consulting healthcare providers. Strongly advise to visually inspect tab to verify if correct drug/formulation was dispensed each time prescription is filled.

STORAGE

(Tab/Tab, Chewable) 25°C (77°F); excursions permitted to 15-30°C (59-86°F) in a dry place. (Tab) Protect from light. (Tab, Disintegrating) 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).

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