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TROKENDI XR
Migraine and headache
Seizure disorders
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Drug Name:

TROKENDI XR Rx

Generic Name and Formulations:
Topiramate 25mg, 50mg, 100mg, 200mg; ext-rel caps.

Company:
Supernus Pharmaceuticals, Inc.

Therapeutic Use:

Indications for TROKENDI XR:

Prophylaxis of migraine headache.

Adult:

Swallow whole. Do not sprinkle on food, chew, or crush. Initially 25mg once daily, increase at 1-week intervals by increments of 25mg/week to target dose of 100mg once daily. Renal impairment (CrCl <70mL/min): reduce dose by ½. Hemodialysis: may need extra dose. Concomitant phenytoin and/or carbamazepine: see full labeling.

Children:

<12yrs: not established.

Contraindications:

Recent alcohol use (within 6hrs prior to and 6hrs after topiramate ext-rel). Concomitant metformin during metabolic acidosis.

Warnings/Precautions:

Discontinue if acute myopia and secondary angle-closure glaucoma occur. Consider discontinuing if other visual problems occur. Obtain baseline and periodic serum bicarbonate during therapy; consider reducing dose or discontinuing if acidosis occurs. Obtain CrCl prior to dosing in patients at high risk for renal insufficiency (eg, older age, diabetes, hypertension, autoimmune disease). Monitor closely for oligohydrosis and hyperthermia (esp. children). Suicidal tendencies (monitor). Inborn errors of metabolism, reduced hepatic mitochondrial activity: increased risk of hyperammonemia; measure ammonia levels if encephalopathic symptoms occur. Maintain adequate hydration; avoid ketogenic diets. Avoid abrupt cessation. Females of reproductive potential should use effective contraception during therapy. Labor & delivery. Pregnancy: risk of fetal toxicity; consider alternatives. Nursing mothers.

Interactions:

See Contraindications. Increased severity of metabolic acidosis and risk of kidney stone formation with concomitant other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide); monitor. Phenytoin, carbamazepine reduce topiramate levels. May increase phenytoin levels. May antagonize oral contraceptives, valproic acid. CNS depression potentiated with alcohol, other CNS depressants; avoid. Hyperammonemia (w/ and w/o encephalopathy) and/or hypothermia possible with valproic acid. Caution with other drugs that interfere with temperature regulation (eg, anticholinergics, carbonic anhydrase inhibitors). Monitor lithium levels with high-dose topiramate. May be antagonized by valproic acid, lamotrigine.

Pharmacological Class:

Sulfamate.

Adverse Reactions:

Paresthesia, anorexia, weight decrease, speech disorders/related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision, difficulty with memory/concentration/attention, fever, taste perversion, upper RTI, abdominal pain, diarrhea, hypoesthesia, nausea; metabolic acidosis, cognitive/neuropsychiatric reactions, kidney stones.

How Supplied:

XR caps—100

Indications for TROKENDI XR:

Initial monotherapy and adjunct in partial-onset or primary generalized tonic-clonic seizures. Adjunct in Lennox-Gastaut Syndrome.

Adult:

Swallow whole. Do not sprinkle on food, chew, or crush. Monotherapy: initially 50mg once daily, increase at 1-week intervals by increments of 50mg/week for the first 4 weeks, then increase by 100mg/week for Weeks 5–6 to target dose of 400mg once daily. Adjunctive therapy: ≥17yrs: initially 25–50mg once daily, increase at 1-week intervals by 25–50mg/week until target dose of 200–400mg once daily (partial onset seizures or Lennox-Gastaut) or 400mg once daily (primary generalized tonic-clonic seizures); usual max 1.6g/day. Renal impairment (CrCl <70mL/min): reduce dose by ½. Hemodialysis: may need extra dose. Concomitant phenytoin and/or carbamazepine: see full labeling.

Children:

Swallow whole. Do not sprinkle on food, chew, or crush. Monotherapy: <6yrs: not established. 6–<10yrs (dosing based on weight): Titration period: initially 25mg/day in the PM for the first week, if tolerated, can increase to 50mg/day in second week. Dosage can be increased by 25–50mg/day each subsequent week as tolerated. Attempt titration to the minimum maintenance dose over 5–7 weeks and to the maximum maintenance dose by 25–50mg/day weekly increments (see full labeling). Total daily maintenance dose: (up to 11kg): 150–250mg/day; (12–22kg): 200–300mg/day; (23–31kg): 200–350mg/day; (32–38kg): 250–350mg/day; (>38kg): 250–400mg/day. ≥10yrs: initially 50mg once daily, increase at 1-week intervals by increments of 50mg/week for the first 4 weeks, then increase by increments of 100mg/week for Weeks 5–6 to target dose of 400mg once daily. Adjunctive therapy: <6yrs: not established. 6–16yrs: initially 1–3mg/kg (max 25mg) once in the PM for one week, increase at 1- or 2-week intervals by increments of 1–3mg/kg to target range of 5–9mg/kg once daily or until optimal clinical response. Renal impairment (CrCl <70mL/min): reduce dose by ½. Hemodialysis: may need extra dose. Concomitant phenytoin and/or carbamazepine: see full labeling.

Contraindications:

Recent alcohol use (within 6hrs prior to and 6hrs after topiramate ext-rel). Concomitant metformin during metabolic acidosis.

Warnings/Precautions:

Discontinue if acute myopia and secondary angle-closure glaucoma occur. Consider discontinuing if other visual problems occur. Obtain baseline and periodic serum bicarbonate during therapy; consider reducing dose or discontinuing if acidosis occurs. Obtain CrCl prior to dosing in patients at high risk for renal insufficiency (eg, older age, diabetes, hypertension, autoimmune disease). Monitor closely for oligohydrosis and hyperthermia (esp. children). Suicidal tendencies (monitor). Inborn errors of metabolism, reduced hepatic mitochondrial activity: increased risk of hyperammonemia; measure ammonia levels if encephalopathic symptoms occur. Maintain adequate hydration; avoid ketogenic diets. Avoid abrupt cessation. Females of reproductive potential should use effective contraception during therapy. Labor & delivery. Pregnancy: risk of fetal toxicity; consider alternatives. Nursing mothers.

Interactions:

See Contraindications. Increased severity of metabolic acidosis and risk of kidney stone formation with concomitant other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide); monitor. Phenytoin, carbamazepine reduce topiramate levels. May increase phenytoin levels. May antagonize oral contraceptives, valproic acid. CNS depression potentiated with alcohol, other CNS depressants; avoid. Hyperammonemia (w/ and w/o encephalopathy) and/or hypothermia possible with valproic acid. Caution with other drugs that interfere with temperature regulation (eg, anticholinergics, carbonic anhydrase inhibitors). Monitor lithium levels with high-dose topiramate. May be antagonized by valproic acid, lamotrigine.

Pharmacological Class:

Sulfamate.

Adverse Reactions:

Paresthesia, anorexia, weight decrease, speech disorders/related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision, difficulty with memory/concentration/attention, fever, taste perversion, upper RTI, abdominal pain, diarrhea, hypoesthesia, nausea; metabolic acidosis, cognitive/neuropsychiatric reactions, kidney stones.

How Supplied:

XR caps—100

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