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topiramate (Rx)Brand and Other Names:Topamax, Trokendi XR, more...Qudexy XR

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet (Topamax)

  • 25mg
  • 50mg
  • 100mg
  • 200mg

capsule, sprinkle (Topamax Sprinkle)

  • 15mg
  • 25mg

capsule, extended-release

  • 25mg (Trokendi XR, Qudexy XR)
  • 50mg (Trokendi XR, Qudexy XR)
  • 100mg (Trokendi XR, Qudexy XR)
  • 150mg (Qudexy XR)
  • 200mg (Trokendi XR, Qudexy XR)
more...

Partial-Onset or Primary Generalized Tonic-Clonic Seizures

Monotherapy

  • Topamax, Topamax Sprinkles: 25 mg PO q12hr initially; may increase by 50 mg/day at weekly intervals to 200 mg PO q12hr
  • Trokendi XR, Qudexy XR: 50 mg PO qDay initially; may increase by 50 mg/day at weekly intervals for first 4 weeks, then 100 mg/day for weeks 5 to 6; target dose is 200-400 mg/day for partial onset seizures and 400 mg/day for generalized seizures

Adjunctive therapy

  • Topamax, Topamax Sprinkles: 25-50 mg/day PO initially; increase by 25-50 mg/day at weekly intervals to 100-200 mg q12hr for partial onset seizures and 200 mg q12hr
  • Trokendi XR, Qudexy XR: 25-50 mg PO qDay initially; increase by 25-50 mg/day at weekly intervals to achieve effective dose; not to exceed 200-400 mg/day

Lennox-Gastaut Syndrome

Indicated as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS)

Topamax, Topamax Sprinkles: 25-50 mg/day PO initially; increase by 25-50 mg/day at weekly intervals to 100-200 mg q12hr

Trokendi XR, Qudexy XR: 25-50 mg PO qDay initially; increase by 25-50 mg/day at weekly intervals to achieve effective dose; not to exceed 200-400 mg/day

Migraine Headache (Topamax)

Indicated for prophylaxis of migraine headache

Titrate over 4 wk to achieve a dose of 50 mg PO BID

Week 1: 25 mg PO qHS

Week 2: 25 mg PO BID

Week 3: 25 mg PO in the morning and 50 mg HS

Week 4: 50 mg PO BID

Guide dose/titration rate by clinical outcome; if needed, use longer intervals between dose adjustments

Dosing Modifications

Renal impairment

  • CrCl <70 mL/min: Reduce dose by 50%
  • Hemodialysis: Cleared by hemodialysis at rate 4-6 times greater than normal; prolonged period of dialysis may decrease topiramate serum concentrations

Hepatic impairment

  • Clearance may decrease; monitor

Cluster Headache (Off-label)

Prophylaxis

Initial: 25 mg PO qDay for 7 days

Increase by 25 mg/day every week to no more than 200 mg/day

Alcoholism (Off-label)

Initial: 25 mg PO qDay week 1

May increase to maximum 300 mg/day by weeks 5-14; may divide 300 mg dose q8hr (case reports)

Maintenance: 200 mg/day divided q12hr or 300 mg/day divided q8hr

Injectable topiramate (Orphan)

Orphan designation for Captisol-enabled topiramate injection for the treatment of partial onset or primary generalized tonic-clonic seizures in hospitalized patients with epilepsy or those being treated in an emergency care setting who are unable to take oral topiramate

Orphan sponsor

  • Ligand Pharmaceuticals, Inc.; 11119 North Torrey Pines Road, Suite 200; La Jolla, CA 92037

Dosage Forms & Strengths

tablet (Topamax)

  • 25mg
  • 50mg
  • 100mg
  • 200mg

capsule, sprinkle (Topamax Sprinkle)

  • 15mg
  • 25mg

capsule, extended-release

  • 25mg (Trokendi XR, Qudexy XR)
  • 50mg (Trokendi XR, Qudexy XR)
  • 100mg (Trokendi XR, Qudexy XR)
  • 150mg (Qudexy XR)
  • 200mg (Trokendi XR, Qudexy XR)
more...

Partial-Onset or Primary Generalized Tonic-Clonic Seizures

Monotherapy (Topamax, Topamax Sprinkles)

  • <2 years: Safety and efficacy not established
  • 2 to <10 years: 25 mg PO qHS for 1 week; titrate dose over 5-7 weeks to target daily maintenance dose (weight based) and divide into q12hr dosing schedule
  • Weight-based dosing
    • Up to 11 kg: 150 mg/day minimum; 250 mg/day maximum
    • 12-22 kg: 200 mg/day minimum; 300 mg/day maximum
    • 23-31 kg: 200 mg/day minimum; 350 mg/day maximum
    • 32-38 kg: 250 mg/day minimum; 350 mg/day maximum
    • >38 kg: 250 mg/day minimum; 400 mg/day maximum
  • ≥10 years
    • 25 mg PO q12hr initially
    • Titrate by increments of 50 mg/week up to 200 mg q12hr

Monotherapy (Trokendi XR)

  • <10 years: Safety and efficacy not established
  • ≥10 years: 50 mg PO qDay initially; may increase by 50 mg/week for first 4 weeks, then 100 mg/week for weeks 5 to 6; target dose is 400 mg PO qDay

Monotherapy (Qudexy XR)

  • <2 years: Safety and efficacy not established
  • 2 to <10 years
    • 25 mg PO qHS initially during the first week; based upon tolerability, the dosage can be increased to 50 mg/day in the second week, and then increased by 25-50 mg/day each subsequent week, as tolerated
    • Titration to the minimum maintenance dose should be attempted over 5-7 weeks
    • Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted in weekly increments by 25-50 mg/day, up to the maximum recommended maintenance dose for each range of body weight
    • Up to 11 kg: 150 mg/day (minimum); 250 mg/day (maximum)
    • 12-22 kg: 200 mg/day (minimum); 300 mg/day (maximum)
    • 23-31 kg: 200 mg/day (minimum); 350 mg/day (maximum)
    • 32-38 kg: 250 mg/day (minimum); 350 mg/day (maximum)
    • >38 kg: 250 mg/day (minimum); 400 mg/day (maximum)
  • ≥10 years
    • 50 mg PO qDay initially
    • Titrate to target dose by increasing 50 mg/week for first 4 weeks, and then 100 mg/week for weeks 5 to 6
    • Ttarget dose is 400 mg PO qDay

Adjunctive therapy (Topamax, Topamax Sprinkles)

  • <2 years: Safety and efficacy not established
  • 2-16 years: 25 mg PO qHS initially for first week (based on 1-3 mg/kg/day); increase dose by 1-3 mg/kg/day PO divided q12hr at 1-2 week intervals to 5-9 mg/kg/day divided q12hr 
  • ≥17 years: 25-50 mg/day PO initially; increase by 25-50 mg/day at weekly intervals to 100-200 mg q12hr for partial onset seizures and 200 mg q12hr for generalized tonic/clonic seizures

Adjunctive therapy (Trokendi XR)

  • <6 years: Safety and efficacy not established
  • ≥6 years: 25 mg PO qHS initially for first week (based on 1-3 mg/kg/day); increase dose by 1-3 mg/kg once daily at 1-2 week intervals to 5-9 mg/kg once daily

Adjunctive therapy (Qudexy XR)

  • <2 years: Safety and efficacy not established
  • ≥2 years: 25 mg PO qHS initially for first week (based on 1-3 mg/kg/day); increase dose by 1-3 mg/kg once daily at 1-2 week intervals to 5-9 mg/kg once daily

Lennox-Gastaut Syndrome

Adjunctive therapy (Topamax, Topamax Sprinkles)

  • <2 years: Safety and efficacy not established
  • 2-16 years: 25 mg PO qHS initially for first week (based on 1-3 mg/kg/day); increase dose by 1-3 mg/kg/day PO divided q12hr at 1-2 week intervals to 5-9 mg/kg/day divided q12hr
  • ≥17 years: 25-50 mg/day PO initially; increase by 25-50 mg/day at weekly intervals to 100-200 mg q12hr for partial onset seizures and 200 mg q12hr for generalized tonic/clonic seizures

Adjunctive therapy (Trokendi XR)

  • <6 years: Safety and efficacy not established
  • ≥6 years: 25 mg PO qHS initially for first week (based on 1-3 mg/kg/day); increase dose by 1-3 mg/kg once daily at 1-2 week intervals to 5-9 mg/kg once daily

Adjunctive therapy (Qudexy XR)

  • <2 years: Safety and efficacy not established
  • ≥2 years: 25 mg PO qHS initially for first week (based on 1-3 mg/kg/day); increase dose by 1-3 mg/kg once daily at 1-2 week intervals to 5-9 mg/kg once daily

Migraine Headache (Topamax)

Indicated for prophylaxis of migraine headache

<12 years: Safety and efficacy not established

Guide dose/titration rate by clinical outcome; if needed, use longer intervals between dose adjustments

≥12 years

  • Titrate over 4 wk to achieve a dose of 50 mg PO BID
  • Week 1: 25 mg PO qHS
  • Week 2: 25 mg PO BID
  • Week 3: 25 mg PO in the morning and 50 mg HS
  • Week 4: 50 mg PO BID

Dosing Modifications

Renal impairment

  • CrCl <70 mL/min: Reduce dose by 50%
  • Hemodialysis: Cleared by hemodialysis at rate 4-6 times greater than normal; prolonged period of dialysis may decrease topiramate serum concentrations
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Interactions

Interaction Checker

topiramate and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Decrease in serum bicarbonate (7-67%)

            Dizziness (4-29%)

            Fatigue (9-16%)

            Ataxia (6-16%)

            Nervousness (9-18%)

            Paresthesia (1-11%)

            Psychomotor slowing (3-13%)

            Abnormal vision (2-13%)

            Anorexia (4-24%)

            Confusion (4-11%)

            Decreased memory (2-12%)

            Nausea (6-10%)

            Speech disorder (2-13%)

            Injury (14%)

            1-10%

            Abdominal pain (6-10%)

            Weight loss (4-9%)

            Diplopia (1-10%)

            Mood problems (<6%)

            Pharyngitis (6%)

            Tremor (3-9%)

            Abnormal gait (3-8%)

            Apathy (1%)

            Asthenia (1-5%)

            Dry mouth (2%)

            Menorrhagia (1-2%)

            Skin disorder (2-3%)

            Taste change (2%)

            Edema (2%)

            Hypertension (1-2%)

            Syncope (1%)

            Bradycardia (1%)

            Pallor (1%)

            <1%

            Angina

            Erythema

            Hepatic failure

            Hyperthermia

            Hypokalemia

            Neuropathy

            Toxic epidermal necrolysis

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            Warnings

            Contraindications

            Hypersensitivity

            Extended release: Within 6 hr of alcohol intake; patients with metabolic acidosis that are taking metformin concomitantly

            Cautions

            Maintain adequate fluid intake due to kidney stone risk

            Alcohol use

            Monitor closely for decreased sweating and increased body temperature; oligohydrosis reported with use; monitor during strenuous exercise

            Concomitant use of drugs that predispose patients to heat-related disorders (such as carbonic anhydrase inhibitors and anticholinergics)

            Coadministration with valproic acid increases risk of hyperammonemia (with or without encephalopathy)

            Risk of hyperchloremic, non-anion gap, metabolic acidosis; especially if concomitant renal disease, severe respiratory disorder, status epilepticus, diarrhea, surgery, ketogenic diet, or drugs predisposing to acidosis

            Risks of acute myopia and secondary angle-closure glaucoma (discontinue immediately if vision problems)

            Visual field defects reported independent of elevated IOP; reversible upon discontinuation

            Risk of neuropsychiatric disorder; rapid titration rate and higher initial dose were associated with higher incidence

            Monitor serum bicarbonate at baseline and then periodically; may also monitor serum chloride, ammonia, and phosphorus

            When discontinuing drug, gradually withdraw to decrease risk of seizure or increased seizure frequency

            Increased risk in suicidal thoughts/behavior reported; monitor patients for notable changes in behavior and notify healthcare provider if symptoms occur

            Use caution when operating heavy machinery

            Hypothermia reported with and without hyperammonemia during topiramate treatment with concomitant valproic acid use

            Hyperammonemia with or without encephalopathy with monotherapy or in combination with valproic acid reported in patients that have tolerated each drug alone; risk may increase in patients with inborn errors of metabolism or decreased hepatic mitochondrial activity; monitor for vomiting, lethargy, or unusual changes in mental status

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            Pregnancy & Lactation

            Pregnancy category: D

            Cleft lip and cleft palate observed in newborns whose mothers had taken topiramate during first trimester of pregnancy; prevalence of oral clefts was 1.4%, compared with 0.38-0.55% with other antiepileptic drugs (AEDs) and 0.07% with no AED exposure

            Lactation: Excreted in milk; use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Mechanism unknown; may inhibit neuronal voltage-dependent sodium channels and may enhance the neurotransmitter inhibitory activity of gamma-aminobutyric acid (GABA)

            Weak carbonic anhydrase inhibitor

            Absorption

            Bioavailability: 80%

            Peak serum time: 1-4 hr (IR); 24 hr (ER))

            Distribution

            Protein bound: 13-17% (IR); 15-41% (ER)

            Metabolism

            Hepatic (30%); 70% unchanged

            Enzyme induced: CYP3A4 (weak)

            Enzyme inhibited: CYP2C19 (weak)

            Elimination

            Half-life: 21 hr (IR); 31 hr (ER)

            Dialyzable: Yes

            Total body clearance: 20-30 mL/min; 50% higher in pediatric patients

            Excretion: Urine (70-80%)

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            Administration

            Instructions

            Can be taken without regard to meals

            Trokendi XR

            • Swallow capsule whole and intact
            • Do not sprinkle on food, chew, or crush

            Qudexy XR, Topamax Sprinkle Capsules

            • Capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food
            • This drug/food mixture should be swallowed immediately and not chewed or crushed
            • Do not store drug/food mixture for further use
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            Images

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            Formulary

            FormularyPatient Discounts

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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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