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QUDEXY XR
Migraine and headache
Seizure disorders
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Drug Name:

QUDEXY XR Rx

Generic Name and Formulations:
Topiramate 25mg, 50mg, 100mg, 150mg, 200mg; ext-rel caps.

Company:
Upsher-Smith Laboratories, Inc.

Therapeutic Use:

Indications for QUDEXY XR:

Prophylaxis of migraine headache.

Adult:

Swallow whole or may open caps and sprinkle contents on a teaspoonful of soft food. 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:

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 mellitus, 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. 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, glyburide, diltiazem. 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. May be potentiated by HCTZ; may need to adjust dose. Caution with concomitant pioglitazone; monitor for adequate glycemic control.

Pharmacological Class:

Sulfamate.

Adverse Reactions:

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

How Supplied:

XR caps—30, 90, 500

Indications for QUDEXY XR:

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

Adult:

Swallow whole or may open caps and sprinkle contents on a teaspoonful of soft food. 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 increments of 25–50mg/week to target dose of 200–400mg once daily (partial onset seizures or Lennox-Gastaut) or 400mg (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 or may open caps and sprinkle contents on a teaspoonful of soft food. <2yrs: not established. Monotherapy: 2–<10yrs: initially 25mg once daily given nightly for the 1st week, then increase to 50mg once daily in 2nd week; may increase by 25–50mg once daily each subsequent week as tolerated. Minimum maintenance dose: ≤11kg: 150mg/day; 12–31kg: 200mg/day; ≥32kg: 250mg/day; titrate over 5–7 weeks. May further titrate up to the maximum maintenance dose if tolerated and clinically indicated; see full labeling. ≥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: 2–16yrs: initially 25mg once daily (based on range: 1–3mg/kg/day) given nightly for the 1st 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:

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 mellitus, 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. 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, glyburide, diltiazem. 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. May be potentiated by HCTZ; may need to adjust dose. Caution with concomitant pioglitazone; monitor for adequate glycemic control.

Pharmacological Class:

Sulfamate.

Adverse Reactions:

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

How Supplied:

XR caps—30, 90, 500

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