TROKENDI XR Rx

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.

Children:

<12yrs: not established.

Contraindications:

Recent alcohol use (within 6hrs prior to and 6hrs after topiramate ext-rel).

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. 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. Renal impairment; obtain CrCl prior to initiation. Avoid abrupt cessation. Females of reproductive potential should use effective contraception during therapy. Labor & delivery. Pregnancy: risk of fetal toxicity; consider alternatives. Nursing mothers.

Pharmacological Class:

Sulfamate.

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 need to adjust dose. May increase amitriptyline, phenytoin levels. May antagonize oral contraceptives, valproic acid. May be potentiated by HCTZ. CNS depression potentiated with alcohol, other CNS depressants; avoid. Hyperammonemia (w/ and w/o encephalopathy) and/or hypothermia possible with valproic acid. Monitor glucose with pioglitazone. 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.

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—30, 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). Renal impairment (CrCl <70mL/min): reduce dose by ½. Hemodialysis: may need extra dose.

Children:

Swallow whole. Do not sprinkle on food, chew, or crush. Monotherapy: <6yrs: not established. 6–9yrs (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 daily 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; max 400mg/day. Renal impairment (CrCl <70mL/min): reduce dose by ½. Hemodialysis: may need extra dose.

Contraindications:

Recent alcohol use (within 6hrs prior to and 6hrs after topiramate ext-rel).

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. 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. Renal impairment; obtain CrCl prior to initiation. Avoid abrupt cessation. Females of reproductive potential should use effective contraception during therapy. Labor & delivery. Pregnancy: risk of fetal toxicity; consider alternatives. Nursing mothers.

Pharmacological Class:

Sulfamate.

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 need to adjust dose. May increase amitriptyline, phenytoin levels. May antagonize oral contraceptives, valproic acid. May be potentiated by HCTZ. CNS depression potentiated with alcohol, other CNS depressants; avoid. Hyperammonemia (w/ and w/o encephalopathy) and/or hypothermia possible with valproic acid. Monitor glucose with pioglitazone. 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.

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—30, 100