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lamotrigine |
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lamotrigine /la·mo·tri·gine/ (lah-mo´tri-jen) an anticonvulsant used in the treatment of certain forms of epilepsy. lamotrigine (l n brand name: Lamictal; drug class: antiepileptic; action: may be result of blockage of voltage-dependent sodium channels with inhibition of excitatory amino acids; uses: adjunctive treatment of refractive partial seizures in adults. lamotrigine Lamictal, Lamictal Chewable Dispersible Pharmacologic class: Phenyltriazine Therapeutic class: Anticonvulsant Pregnancy risk category C FDA Boxed Warning• Drug has been linked to serious rashes (including Stevens-Johnson syndrome) requiring hospitalization and drug discontinuation; one rash-related death occurred. Rare postmarketing cases of toxic epidermal necrolysis and rash-related death have occurred worldwide. Nearly all cases of life-threatening rashes have arisen within 2 to 8 weeks of treatment initiation. However, isolated cases have been reported after prolonged treatment (such as 6 months). Withdraw drug at first sign of rash, unless rash clearly isn't drug-related. However, know that withdrawal may not prevent rash from becoming life-threatening or permanently disabling or disfiguring. ActionUnknown. Thought to block sodium channel membranes, which in turn inhibits release of the neurotransmitters glutamate and aspartate in brain. AvailabilityTablets: 25 mg, 100 mg, 150 mg, 200 mg Tablets (chewable): 2 mg, 5 mg, 25 mg ⊘Indications and dosages ➣ Partial seizures, generalized seizures of Lennox-Gastaut syndrome, and primary generalized tonic-clonic seizures in patients receiving valproate Adults and children ages 12 and older: 25 mg P.O. every other day during weeks 1 and 2; then 25 mg daily during weeks 3 and 4. Then week 5 onwards to maintenance, increase dosage by 25 to 50 mg/day every 1 to 2 weeks. Usual maintenance dosage is 100 to 400 mg/day in one or two divided doses. For those taking valproate alone, maximum dosage is 200 mg/day. Children ages 2 to 12: 0.15 mg/kg/day P.O. (rounded down to nearest whole tablet) in one or two divided doses during weeks 1 and 2; then 0.3 mg/kg/day P.O. (rounded down to nearest whole tablet) in one or two divided doses during weeks 3 and 4. Then week 5 onwards to maintenance, increase every 1 to 2 weeks as 0.3 mg/kg/day (rounded down to nearest whole tablet) added to previously administered daily dose. Usual maintenance dosage is 1 to 5 mg/kg/day. Maximum dosage is 200 mg/day in one or two divided doses. For patients taking valproate alone, maintenance dosage is 1 to 3 mg/kg/day. May need to increase maintenance dose by as much as 50% in patients weighing less than 30 kg (66 lb), based on clinical response. ➣ Partial seizures, generalized seizures of Lennox-Gastaut syndrome, and primary generalized tonic-clonic seizures in patients receiving antiepileptic drugs (AEDs) other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate Adults and children ages 12 and older: 25 mg P.O. every day during weeks 1 and 2; then 50 mg daily during weeks 3 and 4. Increase by 50 mg/day every 1 to 2 weeks. Usual maintenance dosage is 225 to 375 mg/day in two divided doses. Children ages 2 to 12: 0.3 mg/kg/day P.O. in one or two divided doses (rounded down to nearest whole tablet) during weeks 1 and 2; then 0.6 mg/kg/day P.O. in two divided doses (rounded down to nearest whole tablet) during weeks 3 and 4. Then week 5 onwards to maintenance, increase every 1 to 2 weeks as 0.6 mg/kg/day (rounded down to nearest whole tablet) added to previously administered daily dose. Usual maintenance dosage is 4.5 to 7.5 mg/kg/day (maximum, 300 mg/day) in two divided doses. May need to increase maintenance dose by as much as 50% in patients weighing less than 30 kg, based on clinical response. ➣ Partial seizures, generalized seizures of Lennox-Gastaut syndrome, and primary generalized tonic-clonic seizures in patients receiving carbamazepine, phenytoin, phenobarbital, or primidone, but not receiving valproate Adults and children ages 12 and older: 50 mg/day P.O. during weeks 1 and 2; then 100 mg/day in two divided doses during weeks 3 and 4. Then week 5 onwards to maintenance, increase by 100 mg/day every 1 to 2 weeks. Usual maintenance dosage is 300 to 500 mg/day in two divided doses. Children ages 2 to 12: 0.6 mg/kg/day P.O. in two divided doses (rounded down to nearest whole tablet) during weeks 1 and 2; then 1.2 mg/kg/day in two divided doses (rounded down to nearest whole tablet) during weeks 3 and 4. Then week 5 onwards to maintenance, increase every 1 to 2 weeks as 1.2 mg/kg/day (rounded down to nearest whole tablet) added to previously administered daily dose. Usual maintenance dosage is 5 to 15 mg/kg/day (maximum, 400 mg/day) in two divided doses. May need to increase maintenance dose by as much as 50% in patients weighing less than 30 kg, based on clinical response. ➣ Conversion to monotherapy for seizures in patients receiving carbamazepine, phenytoin, phenobarbital, primidone, or valproate as a single agent Adults and children ages 16 and older: Usual maintenance dosage is 500 mg/day P.O. in two divided doses. ➣ Conversion from carbamazepine, phenytoin, phenobarbital, or primidone to monotherapy with lamotrigine for seizures Adults and children ages 16 and older: 50 mg/day P.O. during weeks 1 and 2; then 100 mg/day in two divided doses during weeks 3 and 4. Then week 5 onwards to maintenance, increase by 100 mg/day every 1 to 2 weeks. Usual maintenance dosage is 300 to 500 mg/day in two divided doses. After achieving lamotrigine maintenance dosage of 500 mg/day P.O., withdraw concomitant AED by 20% decrements each week over 4-week period. ➣ Conversion from adjunctive therapy with valproate to monotherapy with lamotrigine for seizures Adults and children ages 16 and older: Achieve lamotrigine dosage of 200 mg/day P.O. and maintain previous stable valproate dosage. Maintain lamotrigine dosage of 200 mg/day and decrease valproate dosage to 500 mg/day by decrements no greater than 500 mg/day; maintain regimen for 1 week. Then increase lamotrigine dosage 300 mg/day while simultaneously decreasing valproate to 250 mg/day; maintain regimen for 1 week. Then discontinue valproate completely and increase lamotrigine dosage by 100 mg/day every week to 500 mg/day. ➣ Maintenance treatment of bipolar I disorder to delay time to occurrence of mood episodes in patients treated with standard therapy for acute mood episodes Adults: Target dosage is 200 mg P.O. daily titrated over 7 weeks (or 100 mg daily in patients taking valproate, or 400 mg daily in patients not taking valproate who are receiving carbamazepine, rifampin, phenytoin, phenobarbital, or primidone). If other psychotropic drugs are withdrawn following stabilization, adjust lamotrigine dosage as indicated. Dosage adjustment• Moderate to severe hepatic dysfunction Off-label uses• Drug-resistant seizures Contraindications• Hypersensitivity to drug or its components PrecautionsUse cautiously in: Administration• Give with or without food.
Adverse reactionsCNS: dizziness, vertigo, headache, drowsiness, ataxia, incoordination, insomnia, sleep disorders, tremor, depression, anxiety, irritability, impaired memory, poor concentration, emotional lability, racing thoughts, dysarthria, malaise, asthenia, somnolence, amnesia, hypoesthesia, decreased or increased reflexes, fatigue, migraine, dream abnormality, suicidal ideation, seizures CV: palpitations, hemorrhage EENT: diplopia, nystagmus, blurred vision, possible long-term ophthalmologic effects, ear disorder, rhinitis, epistaxis, sinusitis, pharyngitis GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, dry mouth, anorexia, peptic ulcer, flatulence, rectal hemorrhage GU: dysmenorrhea, amenorrhea, vaginitis, increased libido, urinary tract infection, urinary frequency, penis disorder Musculoskeletal: muscle spasm, neck pain, back pain, arthralgia, myalgia Respiratory: cough, dyspnea, bronchitis, bronchospasm Skin: pruritus, contact dermatitis, dry skin, sweating, photosensitivity, eczema, alopecia, rash, urticaria, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome Other: infection, pain, weight changes, chest pain, accidental injury, lymphadenopathy, flulike syndrome, fever, tooth disorder, edema, peripheral edema, facial edema, hypersensitivity reactions (rare) including anaphylaxis InteractionsDrug-drug. Carbamazepine, phenobarbital, phenytoin, primidone: decreased lamotrigine steady-state level Estrogen-containing oral contraceptives, rifampin: increased lamotrigine clearance Folate inhibitors (such as methotrexate, co-trimoxazole): additive effects of lamotrigine Topiramate: increased topiramate concentrations Valproate: decreased lamotrigine clearance, increased steady-state level Drug-diagnostic tests. Liver function tests: abnormal Drug-behaviors. Sun exposure: photosensitivity Patient monitoring☞ Watch for signs and symptoms of hypersensitivity reaction (Stevens-Johnson syndrome or anaphylaxis). Patient teaching• Tell patient or caregiver that drug may be taken with or without food. |
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| For example, development of sustained release/extended release formulations such as GSKs Lamictal XR can slow generic incursion. Despite the commercial success of Lamictal (lamotrigine) and Depakote (valproate), the late-stage bipolar disorder pipeline only includes one anticonvulsant class molecule, Novartis licarbazepine. These include the development of antidepressants (Cymbalta), antiepileptic agents (Lyrica and Prialt) glutamate antagonists (Namenda, Lamictal and CNS 5161) and the cannabinoid agonist (Sativex). |
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