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SIZE:
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GENERIC NAME:
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MANUFACTURER:
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UNIT:
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ADMINISTRATION ROUTE:
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FDA PREGNANCY GROUP:
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C
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INDICATIONS:
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Seizures, partial |
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Bipolar affective disorder |
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Lennox- Gastaut syndrome |
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SIDE EFFECTS:
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Except under special circumstances, this medication should not be used when the following medical problem exists |
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Risk-benefit should be considered when the following medical problems exist |
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Ataxia |
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coordination abnormalities |
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skin rash |
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vision abnormalities , including blurred vision |
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diplopia |
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CNS toxicity, specifically anxiety |
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confusion |
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depression |
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irritability |
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other mood or mental changes |
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increased seizures |
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nystagmus |
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chest pain |
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infection |
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Amnesia |
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angioedema |
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blood dyscrasias, including anemia |
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eosinophilia |
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leukopenia |
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thrombocytopenia |
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erythema multiforme , Stevens-Johnson syndrome , or toxic epidermal necrolysis |
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fever |
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hypersensitivity syndrome |
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petechia |
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CNS effects, specifically dizziness |
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drowsiness |
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headache |
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gastrointestinal effects, specifically nausea |
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vomiting |
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Asthenia |
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constipation |
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diarrhea |
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dryness of mouth |
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dysarthria |
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dysmenorrhea |
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dyspepsia |
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insomnia |
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pain |
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rhinitis |
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tremor |
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weight loss, unusual |
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ABSOLUTE
CONTRAINDICATIONS :
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RELATIVE
CONTRAINDICATIONS : |
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ADULT DOSE:
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Anticonvulsant, adjunctive treatment of partial seizures, and adjunctive treatment of Lennox-Gastaut syndrome-
With enzyme-inducing anticonvulsants only: Oral, 50 mg once a day for two weeks , then 100 mg a day, divided into two doses, for two weeks .
To reach the usual maintenance dose of 300 to 500 mg a day (in two divided doses), subsequent daily doses should be increased by 100 mg a day every one to two weeks.
With enzyme-inducing anticonvulsants and valproic acid: Oral, 25 mg once every other day for two weeks, then 25 mg once a day for two weeks. To reach the usual maintenance dose of 100 to 400 mg a day (in one dose or two divided doses), subsequent daily doses should be increased by 25 to 50 mg a day every one to two weeks.
With valproic acid only: Lamotrigine dosing in patients receiving only concurrent valproic acid has not been established. However, lamotrigine dosing identical to that used in patients receiving lamotrigine with valproic acid and enzyme-inducing anticonvulsants has been used in some patients .
Lamotrigine plasma concentrations in patients receiving only concurrent valproic acid may be up to two times those seen in patients who are also receiving enzyme-inducing anticonvulsants .
Maintenance doses of adjunctive lamotrigine as high as 200 mg a day have been used in patients receiving only concurrent valproic acid .
Note: Since the effect of anticonvulsants (other than enzyme-inducing agents and valproic acid) on the metabolism of lamotrigine cannot be predicted, no specific dosing guidelines exist for concurrent use with these medications. Initial doses and dose escalations should be conservative; maintenance dosing would be expected to fall between the maintenance dose of lamotrigine when given with enzyme-inducing anticonvulsants and the maintenance dose of lamotrigine when given with enzyme-inducing anticonvulsants plus valproic acid.
Anticonvulsant, monotherapy of partial seizures following conversion from a single enzyme-inducing anticonvulsant medication -
Lamotrigine should be added to the single enzyme-inducing anticonvulsant medication at a dose of 50 mg a day for the first two weeks, followed by 100 mg a day for the next two weeks .
To reach the usual maintenance dose of 500 mg a day (in two divided doses), subsequent daily doses should be increased by 100 mg a day every one to two weeks .
Once the maintenance dose of lamotrigine has been achieved, the enzyme-inducing anticonvulsant medication may be withdrawn over a four-week period by tapering the dose by 20% each week .
[Anticonvulsant, monotherapy for treatment of epilepsy following withdrawal of concomitant anticonvulsant medications]-
If the patient is transitioning from polytherapy, concomitant anticonvulsants may be decreased gradually by reducing the dose approximately twenty percent each week over a five-week period .
Dosage may be tapered more slowly if clinically indicated . |
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MAXIMUM ADULT DOSE:
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With enzyme-inducing anticonvulsants only-700 mg a day in two divided doses.
With enzyme-inducing anticonvulsants and valproic acid-400 mg a day in two divided doses . |
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PEDIATRIC DOSE:
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Note: Pediatric patients who weigh less than 17 kg (37.4 pounds) should not take lamotrigine because therapy cannot be initiated with the currently available tablet strengths .
Anticonvulsant, Lennox-Gastaut syndrome-
Children 2 to 12 years of age-
With enzyme-inducing anticonvulsants only:
Initial-
Weeks one and two-Oral, 0.6 mg per kg of body weight per day in two divided doses, rounded down to the nearest 5 mg .
Weeks three and four-Oral, 1.2 mg per kg of body weight per day in two divided doses, rounded down to the nearest 5 mg .
Maintenance-
Oral, 5 to 15 mg per kg of body weight per day, with a maximum of 400 mg per day in two divided doses .
To achieve the usual maintenance dose, subsequent daily doses should be increased every one to two weeks by 1.2 mg per kg of body weight, rounded down to the nearest 5 mg .
With enzyme-inducing anticonvulsants and valproic acid:
Initial-
Weeks one and two-Oral, 0.15 mg per kg of body weight per day, rounded down to the nearest 5 mg, and administered in one dose or two divided doses .
If the initial calculated daily dose of lamotrigine is 2.5 to 5 mg, then 5 mg should be taken every other day for the first two weeks .
Weeks three and four-Oral, 0.3 mg per kg of body weight per day, rounded down to the nearest 5 mg, and administered in one dose or two divided doses .
Maintenance-
Oral, 1 to 5 mg per kg of body weight per day, with a maximum of 200 mg per day in one dose or two divided doses .
To achieve the usual maintenance dose, subsequent daily doses should be increased every one to two weeks by 0.3 mg per kg of body weight, rounded down to the nearest 5 mg .
Note: It is likely that children from 2 to 6 years of age will require a maintenance dose at the higher end of the maintenance dose range .
Children older than 12 years of age-
With enzyme-inducing anticonvulsants only:
Initial-
Weeks one and two-Oral, 50 mg once a day .
Weeks three and four-100 mg a day in two divided doses .
Maintenance-
300 to 500 mg a day in two divided doses; maintenance dose may be achieved by increasing the dose by 100 mg a day every one to two weeks .
With enzyme-inducing anticonvulsants and valproic acid-
Initial-
Weeks one and two-Oral, 25 mg once every other day .
Weeks three and four-25 mg once a day .
Maintenance-
100 to 400 mg a day in one dose or two divided doses; maintenance dose may be achieved by increasing the dose every one to two weeks by 25 to 50 mg a day .
Note: The usual maintenance dose in children older than 12 years of age taking lamotrigine as an adjunct to valproic acid alone is 100 to 200 mg a day . |
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MAXIMUM PEDIATRIC
DOSE:
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Children 2 to 12 years of age-
With enzyme-inducing anticonvulsants only: 400 mg a day (in two divided doses) .
With enzyme-inducing anticonvulsants and valproic acid: 200 mg a day (in one dose or two divided doses) .
Children 12 years of age and older-
See Usual adult prescribing limits . |
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ELDERLY DOSE:
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