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Lamictal XR
lamotrigine
Black Box Warnings .
Serious Rash
serious rashes requiring hospitalization and D/C tx incl. Stevens-Johnson syndrome, rare cases of toxic epidermal necrolysis, and rash-related deaths; incidence w/ adjunctive epilepsy tx 0.8% in 2-16 yo and 0.3% in adults; not approved for pts <13 yo; age is only factor identified as predictive for risk of rash occurrence or severity; other risk factors may incl. concurrent valproate use or exceeding initial lamotrigine dose or dose escalation recommendations; most life-threatening rashes occur in 1st 2-8wk of tx w/ isolated cases after prolonged tx; though benign rashes may also occur, D/C tx at 1st sign of rash unless clearly not drug related; D/C tx may not prevent rash from becoming life-threatening or permanently disabling or disfiguring
Adult Dosing .
Dosage forms: ER TAB: 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, 300 mg; blue convenience pack; green convenience pack; orange convenience pack
Special Note
- [blue convenience pack components]
- Info: blue 5-wk starter pack contains 25 mg ER tab x21 and 50 mg ER tab x7
- [green convenience pack components]
- Info: green 5-wk starter pack contains 50 mg ER tab x14 and 100 mg ER tab x14 and 200 mg ER tab x7
- [orange convenience pack components]
- Info: orange 5-wk starter pack contains 25 mg ER tab x14 and 50 mg ER tab x14 and 100 mg ER tab x7
partial seizures
- [valproate adjunct]
- Dose: 200-250 mg PO qd; Start: blue starter pack (25 mg PO qod x2wk, then 25 mg PO qd x2wk, then 50 mg PO qd x1wk), then incr. by 50 mg/day qwk x2wk, then incr. by up to 100 mg/day qwk; Info: retitrate if tx interrupted for >5 half-lives; dose adjustment may be needed during pregnancy and/or postpartum; may convert from IR to ER at same total daily dose; do not cut/crush/chew tab; taper dose over >2wk to D/C
- [enzyme-inducing AED adjunct]
- Dose: 400-600 mg PO qd; Start: green starter pack (50 mg PO qd x2wk, then 100 mg PO qd x2wk, then 200 mg PO qd x1wk), then incr. by 100 mg/day qwk x2wk, then may incr. by up to 100 mg/day qwk; Info: enzyme-inducing AEDs incl. carbamazepine, phenytoin, phenobarbital, primidone; retitrate if tx interrupted for >5 half-lives; dose adjustment may be needed during pregnancy and/or postpartum; may convert from IR to ER at same total daily dose; do not cut/crush/chew tab; taper dose over >2wk to D/C
- [non-valproate, non-enzyme inducing AED adjunct]
- Dose: 300-400 mg PO qd; Start: orange starter pack (25 mg PO qd x2wk, then 50 mg PO qd x2wk, then 100 mg PO qd x1wk), then incr. by 50 mg/day qwk x2wk, then incr. by up to 100 mg/day qwk; Info: retitrate if tx interrupted for >5 half-lives; dose adjustment may be needed during pregnancy and/or postpartum; may convert from IR to ER at same total daily dose; do not cut/crush/chew tab; taper dose over >2wk to D/C
- [conversion from AED monotherapy]
- Dose: 250-300 mg PO qd; Start: see pkg insert for titration schedule; Info: for conversion to lamotrigine monotherapy; not for initial monotherapy; retitrate if tx interrupted for >5 half-lives; dose adjustment may be needed during pregnancy and/or postpartum; do not cut/crush/chew tab; taper dose over >2wk to D/C
seizures, primary generalized tonic clonic
- [valproate adjunct]
- Dose: 200-250 mg PO qd; Start: blue starter pack (25 mg PO qod x2wk, then 25 mg PO qd x2wk, then 50 mg PO qd x1wk), then incr. by 50 mg/day qwk x2wk, then incr. by up to 100 mg/day qwk; Info: retitrate if tx interrupted for >5 half-lives; dose adjustment may be needed during pregnancy and/or postpartum; may convert from IR to ER at same total daily dose; do not cut/crush/chew tab; taper dose over >2wk to D/C
- [enzyme-inducing AED adjunct]
- Dose: 400-600 mg PO qd; Start: green starter pack (50 mg PO qd x2wk, then 100 mg PO qd x2wk, then 200 mg PO qd x1wk), then incr. by 100 mg/day qwk x2wk, then may incr. by up to 100 mg/day qwk; Info: enzyme-inducing AEDs incl. carbamazepine, phenytoin, phenobarbital, primidone; retitrate if tx interrupted for >5 half-lives; dose adjustment may be needed during pregnancy and/or postpartum; may convert from IR to ER at same total daily dose; do not cut/crush/chew tab; taper dose over >2wk to D/C
- [non-valproate, non-enzyme inducing AED adjunct]
- Dose: 300-400 mg PO qd; Start: orange starter pack (25 mg PO qd x2wk, then 50 mg PO qd x2wk, then 100 mg PO qd x1wk), then incr. by 50 mg/day qwk x2wk, then incr. by up to 100 mg/day qwk; Info: retitrate if tx interrupted for >5 half-lives; dose adjustment may be needed during pregnancy and/or postpartum; may convert from IR to ER at same total daily dose; do not cut/crush/chew tab; taper dose over >2wk to D/C
short-lasting unilateral neuralgiform headache attacks prophylaxis (off-label)
- [300-400 mg PO qd]
- Start: 25 mg PO qd x1wk, may incr. by 25-50 mg/day qwk; Info: retitrate if tx interrupted for >5 half-lives; dose adjustment may be needed during pregnancy and/or postpartum; may convert from IR to ER at same total daily dose; do not cut/crush/chew tab; taper dose over >2wk to D/C
neuropathic pain, diabetic (off-label)
- [200-400 mg PO qd]
- Start: 25 mg PO qd x2wk, then 50 mg PO qd x2wk, then may incr. by up to 100 mg/day qwk; Info: retitrate if tx interrupted for >5 half-lives; dose adjustment may be needed during pregnancy and/or postpartum; may convert from IR to ER at same total daily dose; do not cut/crush/chew tab; taper dose over >2wk to D/C
renal dosing
- [see below]
- significant impairment: consider decr. usual maint. dose
- HD/PD: not defined
hepatic dosing
- [adjust dose amount]
- moderate-severe impairment w/o ascites: decr. usual dose by 25%; severe impairment w/ ascites: decr. usual dose by 50%
Peds Dosing .
- Dosage forms: ER TAB: 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, 300 mg; blue convenience pack; green convenience pack; orange convenience pack
Special Note
- [blue convenience pack components]
- Info: blue 5-wk starter pack contains 25 mg ER tab x21 and 50 mg ER tab x7
- [green convenience pack components]
- Info: green 5-wk starter pack contains 50 mg ER tab x14 and 100 mg ER tab x14 and 200 mg ER tab x7
- [orange convenience pack components]
- Info: orange 5-wk starter pack contains 25 mg ER tab x14 and 50 mg ER tab x14 and 100 mg ER tab x7
partial seizures
- [valproate adjunct, 13 yo and older]
- Dose: 200-250 mg PO qd; Start: blue starter pack (25 mg PO qod x2wk, then 25 mg PO qd x2wk, then 50 mg PO qd x1wk), then incr. by 50 mg/day qwk x2wk, then incr. by up to 100 mg/day qwk; Info: retitrate if tx interrupted for >5 half-lives; may convert from IR to ER at same total daily dose; do not cut/crush/chew tab; taper dose over >2wk to D/C
- [enzyme-inducing AED adjunct, 13 yo and older]
- Dose: 400-600 mg PO qd; Start: green starter pack (50 mg PO qd x2wk, then 100 mg PO qd x2wk, then 200 mg PO qd x1wk), then incr. by 100 mg/day qwk x2wk, then may incr. by up to 100 mg/day qwk; Info: enzyme-inducing AEDs incl. carbamazepine, phenytoin, phenobarbital, primidone; retitrate if tx interrupted for >5 half-lives; may convert from IR to ER at same total daily dose; do not cut/crush/chew tab; taper dose over >2wk to D/C
- [non-valproate, non-enzyme inducing AED adjunct, 13 yo and older]
- Dose: 300-400 mg PO qd; Start: orange starter pack (25 mg PO qd x2wk, then 50 mg PO qd x2wk, then 100 mg PO qd x1wk), then incr. by 50 mg/day qwk x2wk, then incr. by up to 100 mg/day qwk; Info: retitrate if tx interrupted for >5 half-lives; may convert from IR to ER at same total daily dose; do not cut/crush/chew tab; taper dose over >2wk to D/C
- [conversion from AED monotherapy, 13 yo and older]
- Dose: 250-300 mg PO qd; Start: see pkg insert for titration schedule; Info: for conversion to lamotrigine monotherapy; not for initial monotherapy; retitrate if tx interrupted for >5 half-lives; do not cut/crush/chew tab; taper dose over >2wk to D/C
seizures, primary generalized tonic clonic
- [valproate adjunct, 13 yo and older]
- Dose: 200-250 mg PO qd; Start: blue starter pack (25 mg PO qod x2wk, then 25 mg PO qd x2wk, then 50 mg PO qd x1wk), then incr. by 50 mg/day qwk x2wk, then incr. by up to 100 mg/day qwk; Info: retitrate if tx interrupted for >5 half-lives; may convert from IR to ER at same total daily dose; do not cut/crush/chew tab; taper dose over >2wk to D/C
- [enzyme-inducing AED adjunct, 13 yo and older]
- Dose: 400-600 mg PO qd; Start: green starter pack (50 mg PO qd x2wk, then 100 mg PO qd x2wk, then 200 mg PO qd x1wk), then incr. by 100 mg/day qwk x2wk, then may incr. by up to 100 mg/day qwk; Info: enzyme-inducing AEDs incl. carbamazepine, phenytoin, phenobarbital, primidone; retitrate if tx interrupted for >5 half-lives; may convert from IR to ER at same total daily dose; do not cut/crush/chew tab; taper dose over >2wk to D/C
- [non-valproate, non-enzyme inducing AED adjunct, 13 yo and older]
- Dose: 300-400 mg PO qd; Start: orange starter pack (25 mg PO qd x2wk, then 50 mg PO qd x2wk, then 100 mg PO qd x1wk), then incr. by 50 mg/day qwk x2wk, then incr. by up to 100 mg/day qwk; Info: retitrate if tx interrupted for >5 half-lives; may convert from IR to ER at same total daily dose; do not cut/crush/chew tab; taper dose over >2wk to D/C
renal dosing
- [see below]
- significant impairment: consider decr. usual maint. dose
- HD/PD: not defined
hepatic dosing
- [adjust dose amount]
- moderate-severe impairment w/o ascites: decr. usual dose by 25%; severe impairment w/ ascites: decr. usual dose by 50%