Lamictal Chewable Dispersible Tabs Generic Name & Formulations
Legal Class
Rx
General Description
Lamotrigine 2mg, 5mg, 25mg; blackcurrant flavor.
Pharmacological Class
Phenyltriazine.
See Also
How Supplied
Tabs 25mg, 100mg—100; 150mg, 200mg—60; Chewable Dispersible tabs 2mg—30; 5mg, 25mg—100; Starter kit 25mg x 35 tabs—1; 25mg x 84 tabs + 100mg x 14 tabs—1; 25mg x 42 tabs + 100mg x 7 tabs—1; ODT Maintenance Packs—30; ODT Titration Kit 25mg x 21 tabs + 50mg x 7 tabs—1; 50mg x 42 tabs + 100mg x 14 tabs—1; 25mg x 14 tabs, 50mg x 14 tabs, 100mg x 7 tabs—1
Manufacturer
Lamictal Chewable Dispersible Tabs Indications
Indications
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 with standard therapy.
Limitations of Use
Not recommended for treatment of acute manic or mixed episodes. Not established for acute treatment of mood episodes.
Lamictal Chewable Dispersible Tabs Dosage and Administration
Adult
≥18yrs: Not on enzyme-inducing antiepileptic drugs (EIAEDs, eg, phenytoin, carbamazepine, phenobarbital, primidone), or valproate: 25mg daily for 2 weeks, then 50mg daily for 2 weeks, then 100mg daily for 1 week, then to target dose of 200mg daily. Concomitant valproate: 25mg every other day for 2 weeks, then 25mg daily for 2 weeks, then 50mg daily for 1 week, then to target dose of 100mg daily. Concomitant EIAEDs and not valproate: 50mg daily for 2 weeks, then 100mg daily in divided doses for 2 weeks, then increase weekly by 100mg daily in divided doses to target dose of 400mg daily in divided doses. Discontinuing valproate: double lamotrigine dose over 2 weeks in equal weekly increments. Discontinuing EIAEDs: maintain lamotrigine dose for 1 week after discontinuing EIAEDs, then reduce lamotrigine dose by ½ over 2 weeks in equal weekly decrements then adjust as needed. Reevaluate periodically. Concomitant estrogen-containing oral contraceptives, hormone replacement therapy, lopinavir/ritonavir, or atazanavir/ritonavir: see full labeling. Hepatic impairment: if moderate or severe (w/o ascites) reduce dose by 25%; if severe (w. ascites) reduce dose by 50%.
Children
<18yrs: not established.
Lamictal Chewable Dispersible Tabs Contraindications
Not Applicable
Lamictal Chewable Dispersible Tabs Boxed Warnings
Boxed Warning
Serious skin rashes.
Lamictal Chewable Dispersible Tabs Warnings/Precautions
Warnings/Precautions
Discontinue at first sign of rash (unless clearly not drug related); avoid rechallenge. Avoid rapid dose increases and exceeding recommended dose (may increase risk of serious rash). History of allergy or rash to other AEDs (may increase frequency of nonserious rash). Reevaluate if fever, rash, or other hypersensitivity reaction occurs; discontinue if hypersensitivity occurs. Evaluate for hemophagocytic lymphohistiocytosis if signs of systemic inflammation develops. Structural or functional cardiac disease (eg, heart failure, valvular or congenital heart disease, conduction system disease, ventricular arrhythmias, Brugada syndrome, ischemic heart disease, multiple risk factors for coronary artery disease). Moderate or severe hepatic impairment. Significant renal impairment: consider reduced dose. Suicidal behavior and ideation (monitor). Increased risk of aseptic meningitis; evaluate and treat if signs/symptoms develop. Possible ophthalmologic effects after prolonged use. Avoid abrupt cessation; taper over at least 2 weeks if possible. Elderly. Pregnancy: may need dose adjustments. Nursing mothers: monitor infants.
Lamictal Chewable Dispersible Tabs Pharmacokinetics
See Literature
Lamictal Chewable Dispersible Tabs Interactions
Interactions
Concomitant OCT2 substrates with narrow therapeutic index (eg, dofetilide): not recommended. Lamotrigine levels increased by valproate. Lamotrigine levels decreased by phenytoin, carbamazepine, phenobarbital, primidone, rifampin, lopinavir/ritonavir, or atazanavir/ritonavir. Monitor with other anticonvulsants. Lamotrigine levels may be decreased by estrogen-containing oral contraceptives and increased when they are stopped (if monotherapy: adjust dose), and may affect hormonal replacement therapy or other hormonal contraceptive efficacy. May potentiate other folate inhibitors. Valproate may increase risk of serious rash. Increased incidence of dizziness, diplopia, ataxia, blurred vision with carbamazepine. Increased risk of proarrhythmia with other sodium channel blockers. May cause false (+) results for PCP.
Lamictal Chewable Dispersible Tabs Adverse Reactions
Adverse Reactions
Nausea, diarrhea, insomnia, somnolence, back pain, fatigue, rhinitis, non-serious rash, abdominal pain, dry mouth, headache, dizziness, abnormal dreams; rare: serious rash (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), hypersensitivity, multiorgan failure, blood dyscrasias.
Lamictal Chewable Dispersible Tabs Clinical Trials
See Literature
Lamictal Chewable Dispersible Tabs Note
Notes
Register pregnant patients exposed to lamotrigine by calling (800) 336-2176.
Lamictal Chewable Dispersible Tabs Patient Counseling
See Literature
Lamictal Chewable Dispersible Tabs Generic Name & Formulations
Legal Class
Rx
General Description
Lamotrigine 2mg, 5mg, 25mg; blackcurrant flavor.
Pharmacological Class
Phenyltriazine.
See Also
How Supplied
Tabs 25mg, 100mg—100; 150mg, 200mg—60; Chewable Dispersible tabs 2mg—30; 5mg, 25mg—100; Starter kit 25mg x 35 tabs—1; 25mg x 84 tabs + 100mg x 14 tabs—1; 25mg x 42 tabs + 100mg x 7 tabs—1; ODT Maintenance Packs—30; ODT Titration Kit 25mg x 21 tabs + 50mg x 7 tabs—1; 50mg x 42 tabs + 100mg x 14 tabs—1; 25mg x 14 tabs, 50mg x 14 tabs, 100mg x 7 tabs—1; XR tabs—30; XR Titration Kit 25mg x 21 tabs + 50mg x 7 tabs—1; 50mg x 14 tabs + 100mg x 14 tabs + 200mg x 7 tabs—1; 25mg x 14 tabs + 50mg x 14 tabs + 100mg x 7 tabs—1
Manufacturer
Lamictal Chewable Dispersible Tabs Indications
Indications
Adjunct in partial seizures, Lennox-Gastaut syndrome, or primary generalized tonic-clonic seizures in adults and children (≥2yrs). Conversion to monotherapy in adults (≥16yrs) with partial seizures who are on carbamazepine, phenytoin, phenobarbital, primidone, or valproate as a single antiepileptic drug (AED).
Lamictal Chewable Dispersible Tabs Dosage and Administration
Adult
Chew tabs: give only whole tabs, round dose down to nearest whole tab (may be swallowed whole, chewed, or mixed in water or diluted fruit juice). ODT: dissolve on tongue and swallow with or without water. Adding to antiepileptic drug (AED) regimens that include valproate: initially 25mg every other day for 2 weeks, then 25mg once daily for 2 weeks; may increase by 25–50mg/day at 1–2 week intervals; usual maintenance 100–400mg/day in 1 or 2 divided doses. Adding to valproate only: usual maintenance 100–200mg/day. Adding to AED regimens other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate: initially 25mg once daily for 2 weeks; then 50mg once daily for 2 weeks; may increase by 50mg/day at 1–2 week intervals; usual maintenance 225–375mg/day in 2 divided doses. Adding to AED regimens without valproate: initially 50mg per day for 2 weeks, then 100mg daily in 2 divided doses for 2 weeks; may increase by 100mg/day at 1–2 week intervals; usual maintenance 300–500mg/day in 2 divided doses. Converting from one AED (not valproate) to lamotrigine monotherapy (first titrate lamotrigine, then withdraw AED): initially 50mg per day for 2 weeks, then 100mg daily in 2 divided doses for 2 weeks; may increase by 100mg/day at 1–2 week intervals to 500mg/day in 2 divided doses. Then reduce AED dose by 20% per week for 4 weeks. Converting from valproate to lamotrigine monotherapy: see full labeling. Concomitant estrogen-containing oral contraceptives, hormone replacement therapy, lopinavir/ritonavir, or atazanavir/ritonavir: see full labeling. Hepatic impairment: if moderate or severe (w/o ascites) reduce dose by 25%; if severe (w. ascites) reduce dose by 50%.
Children
Chew tabs: give only whole tabs, round dose down to nearest whole tab (may be swallowed whole, chewed, or mixed in water or diluted fruit juice). ODT: dissolve on tongue and swallow with or without water. <2yrs: not recommended. 2–12yrs: Adding to AED regimens that include valproate: initially 0.15mg/kg per day in 1 or 2 divided doses for 2 weeks, then 0.3mg/kg per day in 1 or 2 divided doses for 2 weeks; may increase by 0.3mg/kg per day at 1–2 week intervals in 1 or 2 divided doses; usual maintenance 1–5mg/kg per day; max 200mg/day in 1 or 2 divided doses. Adding to valproate only: usual maintenance 1–3mg/kg per day. Adding to AED regimens other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate: initially 0.3mg/kg per day in 1 or 2 divided doses for 2 weeks, then 0.6mg/kg per day in 2 divided doses for 2 weeks; may increase by 0.6mg/kg per day at 1–2 week intervals; usual maintenance 4.5–7.5mg/kg per day; max 300mg/day in 2 divided doses. Adding to AED regimens without valproate: initially 0.6mg/kg per day in 2 divided doses for 2 weeks, then 1.2mg/kg per day in 2 divided doses for 2 weeks; may increase by 1.2mg/kg per day at 1–2 week intervals; usual maintenance 5–15mg/kg per day; max 400mg/day in 2 divided doses. Patients <30kg: may need higher (≤50%) maintenance dose.
Lamictal Chewable Dispersible Tabs Contraindications
Not Applicable
Lamictal Chewable Dispersible Tabs Boxed Warnings
Boxed Warning
Serious skin rashes.
Lamictal Chewable Dispersible Tabs Warnings/Precautions
Warnings/Precautions
Discontinue at first sign of rash (unless clearly not drug related); avoid rechallenge. Avoid rapid dose increases and exceeding recommended dose (may increase risk of serious rash). History of allergy or rash to other AEDs (may increase frequency of nonserious rash). Reevaluate if fever, rash, or other hypersensitivity reaction occurs; discontinue if hypersensitivity occurs. Evaluate for hemophagocytic lymphohistiocytosis if signs of systemic inflammation develops. Structural or functional cardiac disease (eg, heart failure, valvular or congenital heart disease, conduction system disease, ventricular arrhythmias, Brugada syndrome, ischemic heart disease, multiple risk factors for coronary artery disease). Moderate or severe hepatic impairment. Significant renal impairment: consider reduced dose. Suicidal behavior and ideation (monitor). Increased risk of aseptic meningitis; evaluate and treat if signs/symptoms develop. Possible ophthalmologic effects after prolonged use. Avoid abrupt cessation; taper over at least 2 weeks if possible. Elderly. Pregnancy: may need dose adjustments. Nursing mothers: monitor infants.
Lamictal Chewable Dispersible Tabs Pharmacokinetics
See Literature
Lamictal Chewable Dispersible Tabs Interactions
Interactions
Concomitant OCT2 substrates with narrow therapeutic index (eg, dofetilide): not recommended. Lamotrigine levels increased by valproate. Lamotrigine levels decreased by phenytoin, carbamazepine, phenobarbital, primidone, rifampin, lopinavir/ritonavir, or atazanavir/ritonavir. Monitor with other anticonvulsants. Lamotrigine levels may be decreased by estrogen-containing oral contraceptives and increased when they are stopped (if monotherapy: adjust dose), and may affect hormonal replacement therapy or other hormonal contraceptive efficacy. May potentiate other folate inhibitors. Valproate may increase risk of serious rash. Increased incidence of dizziness, diplopia, ataxia, blurred vision with carbamazepine. Increased risk of proarrhythmia with other sodium channel blockers. May cause false (+) results for PCP.
Lamictal Chewable Dispersible Tabs Adverse Reactions
Adverse Reactions
Adults (adjunctive): dizziness, ataxia, somnolence, headache, diplopia, blurred vision, nausea, vomiting. Adults (monotherapy): vomiting, coordination abnormalities, dyspepsia, nausea, dizziness, rhinitis, anxiety, insomnia, infection, pain, weight loss, chest pain, dysmenorrhea, nystagmus, lymphadenopathy. Children (adjunctive): infection, vomiting, fever, somnolence, accidental injury, dizziness, diarrhea, abdominal pain, nausea, ataxia, tremor, asthenia, bronchitis, flu syndrome, diplopia. Rare: rash (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or benign), hypersensitivity, multiorgan failure, blood dyscrasias. XR: also, cerebellar coordination/balance disorder, asthenic conditions, vertigo.
Lamictal Chewable Dispersible Tabs Clinical Trials
See Literature
Lamictal Chewable Dispersible Tabs Note
Notes
Register pregnant patients exposed to lamotrigine by calling (800) 336-2176.
Lamictal Chewable Dispersible Tabs Patient Counseling
See Literature