Trokendi XR

Initial monotherapy for treatment of partial-onset or primary generalized tonic-clonic seizures in patients ≥6 yr. Adjunctive therapy for treatment of partial-onset seizures, primary generalized tonic-clonic seizures, & seizures associated w/ Lennox-Gastaut syndrome in patients ≥6 yr. Prophylaxis of migraine headache in patients ≥12 yr.

Monotherapy Epilepsy Adult & childn ≥10 yr w/ partial onset or primary generalized tonic-clonic seizures 400 mg orally once daily. Titrate according to schedule: Wk 1: 50 mg once daily. Wk 2: 100 mg once daily. Wk 3: 150 mg once daily. Wk 4: 200 mg once daily. Wk 5: 300 mg once daily. Wk 6: 400 mg once daily. Childn 6-9 yr Initially 25 mg/day nightly for 1st wk, dose may be increased to 50 mg daily in 2nd wk based upon tolerability. Maintenance dosing based on wt: >38 kg Min: 250 mg daily. Max: 400 mg daily, 32-38 kg Min: 250 mg daily. Max: 350 mg daily, 23-31 kg Min: 200 mg daily. Max: 350 mg daily, 12-22 kg Min: 200 mg daily. Max: 300 mg daily, ≤11 kg Min: 150 mg daily. Max: 250 mg daily. Adjunctive Therapy Epilepsy Adult ≥17 yr w/ partial-onset seizures or Lennox-Gastaut syndrome 200-400 mg orally once daily. Patient w/ primary generalized tonic-clonic seizures 400 mg orally once daily. Initiate therapy at 25-50 mg once daily followed by titration to an effective dose in increments of 25-50 mg every wk. Childn 6-16 yr w/ partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated w/ Lennox-Gastaut syndrome Approx 5-9 mg/kg orally once daily. Begin titration at 25 mg once daily (or less, based on a range of 1-3 mg/kg daily) given nightly for the 1st wk. Subsequently, increase dose at 1- or 2-wk intervals by increments of 1-3 mg/kg daily. Migraine Prophylaxis Patient ≥12 yr 100 mg once daily. Titrate according to schedule: Wk 1: 25 mg once daily. Wk 2: 50 mg once daily. Wk 3: 75 mg once daily. Wk 4: 100 mg once daily. Patient w/ renal impairment (CrCl <70 mL/min/1.73 m²) ½ of usual adult dose. Patient undergoing hemodialysis Supplemental dose of Trokendi XR may be required to avoid rapid drops in topiramate plasma conc during hemodialysis.

May be taken with or without food: Swallow cap whole & intact. Do not sprinkle on food, chew/crush.

Patient w/ recent alcohol use (ie, w/in 6 hr prior to & after Trokendi XR use).

Discontinue use if syndrome consisting of acute myopia associated w/ secondary angle closure glaucoma symptoms, visual problems or hypothermia occurs. Reports of visual field defects (independent of elevated IOP). Monitor closely for evidence of decreased sweating (oligohydrosis) & increased body temp (hyperthermia), esp in ped patients. May cause hyperchloremic, non-anion gap, metabolic acidosis (ie, decreased serum bicarbonate below the normal reference range in the absence of chronic resp alkalosis). Measurement of baseline & periodic serum bicarbonate during treatment is recommended. Consider dose reduction or discontinuation (using dose tapering) if metabolic acidosis develops & persists. Consider alkali treatment if decision is made to continue treatment in the face of persistent acidosis. Extreme caution if used in combination w/ alcohol & other CNS depressants. Completely avoid alcohol use w/in 6 hr prior to & after administration. Monitor for emergence or worsening of depression, suicidal thoughts or behaviour, &/or any unusual changes in mood or behaviour. Routine monitoring of patients for adequate control of diabetic disease state in concomitant use w/ pioglitazone. Antiepileptic drugs should be gradually w/drawn in patients w/ or w/o history of seizures or epilepsy to minimize potential for seizures or increased seizure frequency. Hyperammonemia w/ or w/o encephalopathy (reported more frequently when used concomitantly w/ valproic acid). Patients w/ inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia w/ or w/o encephalopathy. Hyperammonemic encephalopathy should be considered & ammonia level should be measured in patients who develop unexplained lethargy, vomiting, or changes in mental status associated w/ any topiramate treatment. Increased risk of kidney stones. Avoid concomitant use w/ any other drug producing metabolic acidosis, or potentially in patients on ketogenic diet. Hydration is recommended to reduce new stone formation. Cognitive/neuropsychiatric adverse reactions. Moderate or severe renal impairment; patients undergoing hemodialysis. Women of childbearing potential should be informed of the potential risk of oral clefts to the fetus. Consider alternative therapeutic options for women who are planning a pregnancy. Women of childbearing potential who are not planning a pregnancy should use effective contraception. May cause fetal harm when administered to pregnant woman. Newborns of mothers treated w/ topiramate should be monitored for metabolic acidosis. Also associated w/ pre-term labor & premature delivery. Effects of topiramate on milk production are unknown. Safety & effectiveness in ped patients <12 yr have not been established for the prophylaxis treatment of migraine headache. Safety & effectiveness for treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndromes in ped patients <6 yr has not been established. Elderly w/ CrCl <70 mL/min/1.73 m².

Monotherapy Epilepsy (Adult ≥16 yr): Paresthesia, wt loss, anorexia, difficulty w/ memory, fatigue, asthenia, insomnia, somnolence. Monotherapy Epilepsy (Childn 6-15 yr): Fever, wt loss, difficulty w/ concentration/attention, flushing, confusion. Adjunctive Therapy Epilepsy (Adult ≥16 yr): Dizziness, speech disorders/related speech problems, somnolence, nervousness, psychomotor slowing, & abnormal vision. Adjunctive Therapy Epilepsy (Childn 2-15 yr): Fatigue & somnolence. Migraine (Adults): Paresthesia, anorexia, wt loss, taste perversion, diarrhea, difficulty w/ memory, hypoesthesia, & nausea. Migraine (Childn 12-17 yr): Paresthesia, URTI, anorexia, & abdominal pain. Other adverse reactions observed during clinical trials: Abnormal coordination, eosinophilia, gingival bleeding, hematuria, hypotension, myalgia, myopia, postural hypotension, scotoma, suicide attempt, syncope, & visual field defect. Acute myopia & secondary angle closure glaucoma, visual field defects, oligohydrosis & hyperthermia, metabolic acidosis, suicidal behavior & ideation, cognitive/neuropsychiatric adverse reactions, w/drawal symptoms of antiepileptic drugs, hyperammonemia & encephalopathy, kidney stones, hypothermia.

Decreased plasma conc w/ phenytoin or carbamazepine. Associated w/ hypothermia & hyperammonemia w/ & w/o encephalopathy in concomitant administration w/ valproic acid. Increased severity of metabolic acidosis & risk of kidney stone formation w/ any other carbonic anhydrase inhibitor (eg, zonisamide or acetazolamide). Possibility of decreased contraceptive efficacy & increased breakthrough bleeding may occur in patients taking combination OC products. Increased in systemic exposure of lithium. May experience a large increase in amitriptyline conc. Decrease INR or prothrombin time when given concomitantly w/ vit K antagonist anticoagulant medications (eg, warfarin). Increased incidence of markedly decreased serum P, markedly increased serum alkaline phosphatase, & decreased serum K in controlled trials of adjunctive topiramate treatment of adults for partial-onset seizures. Increased incidence for an increased result (relative to normal analyte reference range) for the following clinical lab analytes: creatinine, BUN, alkaline phosphatase, & total protein; increased incidence for a decreased result for bicarbonate (ie, metabolic acidosis) & K in ped patients (1-24 mth) receiving adjunctive topiramate for partial-onset seizures. Increased incidence for an increased result (relative to normal analyte reference range) for the following clinical lab analytes: creatinine, BUN, uric acid, Cl, ammonia, alkaline phosphatase, total protein, platelets, & eosinophils in ped patients (ranging from 6-17 yr) for migraine prophylaxis.

Anticonvulsants / Antimigraine Preparations

N03AX11 - topiramate ; Belongs to the class of other antiepileptics.

Rx