Names and pronunciation
(toh-pire′ah-mate) Eprontia, Qudexy XR, Topamax, Topamax Sprinkle, Trokendi XR
Source page 1313
Individual generic drug information
Extracted information for topiramate only.
(toh-pire′ah-mate) Eprontia, Qudexy XR, Topamax, Topamax Sprinkle, Trokendi XR
Source page 1313
Func. class.: Anticonvulsant—miscel- laneous
Source page 1313
Chem. class.: Monosaccharide T derivative
Source page 1313
Do not confuse: Topamax/Toprol XL
Source page 1313
ACTION: May prevent seizure spread as opposed to an elevation of seizure threshold, increases GABA activity
Source page 1313
USES: Partial seizures in adults and children 2-16 yr old; tonic-clonic seizures; seizures with Lennox-Gastaut syndrome; migraine prophylaxis
Source page 1313
Unlabeled uses: Antipsychotic-induced weight gain, cluster headache, binge eat- ing disorder, essential tremor
Source page 1314
Extracted information for topiramate only.
CONTRAINDICATIONS: Hyper- sensitivity, metabolic acidosis, pregnancy Precautions: Breastfeeding, children, renal/hepatic disease, acute myopia, sec- ondary closed-angle glaucoma, behavioral disorders, COPD, dialysis, encephalopa- thy, status asthmaticus, status epilepticus, surgery, paresthesias, maculopathy, neph- rolithiasis
Source page 1314
SIDE EFFECTS CNS: Dizziness, fatigue, cognitive dis- orders, insomnia, anxiety, depression, paresthesia, memory loss, tremors, motor retardation, suicidal ideation, poor balance, ataxia CV: Flushing, chest pain EENT: Diplopia, vision abnormality GI: Diarrhea, anorexia, nausea, dys- pepsia, abdominal pain, constipation, dry mouth, pancreatitis GU: Breast pain, dysmenorrhea, men- strual disorder INTEG: Rash, alopecia MISC: Weight loss, leukopenia, meta- bolic acidosis, increased body tempera- ture; unexplained death (epilepsy) RESP: Upper respiratory tract infection, pharyngitis, sinusitis
Source page 1314
INTERACTIONS Increase: renal stones—carbonic anhy- drase inhibitors Increase: effect of amitriptyline Increase: CNS depression—alcohol, CNS depressants Increase: topiramate levels—metFOR- MIN, hydroCHLOROthiazide, lamoTRIgine Decrease: levels of hormonal contracep- tives, estrogen, digoxin, valproic acid, lithium, risperiDONE Decrease: topiramate levels—phenytoin, carBAMazepine, valproic acid, probenecid
Source page 1315
Extracted information for topiramate only.
DOSAGE AND ROUTES Adjunctive therapy for seizures • Adult/adolescent/child ≥10 yr: PO 25-50 mg/day initially, titrate by 25-50 mg/wk, up to 200-400 mg/day in 2 di- vided doses • Adult/adolescent/child ≥10 yr: PO (Qudexy XR, Trokendi XR) 50 mg daily, increase by 50 mg weekly during wk 2, 3, 4, increase by 100 mg weekly, wk 5, 6, final dose 400 mg daily • Child 2-9 yr: PO week 1: 25 mg in PM, then 25 mg bid if tolerated (week 2), then increase by 25-50 mg/day each week as tolerated over 5- to 7-wk titration period, maintenance given in 2 divided doses; <11 kg, minimum 150 mg/day, max 250 mg/ day; 12-22 kg, minimum 200 mg/day, max 300 mg/day; 23-31 kg, minimum 200 mg/day, max 350 mg/day; 32-38 kg, minimum 250 mg/day, max 350 mg/day; >38 kg, minimum 250 mg/ day, max 400 mg/day; Qudexy XR 25 mg daily at night, may increase to 50 mg week 2, if tolerated, increase by 25-50 mg each week over 5- to 7-wk titration period, max dose based on weight • Child ≤11 kg: PO Qudexy XR mini- mum 150 mg daily, max 250 mg daily • Child 12-22 kg: minimum 200 mg daily, max 300 mg daily • Child 23-31 kg: minimum 200 mg daily, max 350 mg daily • Child 32-38 kg: minimum 250 mg daily, max 350 mg daily • Child >38 kg: minimum 250 mg daily, max 400 mg daily Migraine prophylaxis • Adult: PO 25 mg/day initially, increase by 25 mg/day/wk up to 100 mg/day in 2 divided doses Renal dose • Adult: PO CCr <70 mL/min, give 1/2 dose
Source page 1314
Available forms: Tabs 25, 50, 100, 200 mg; ext rel caps 25, 50, 100, 200 mg; ext rel cap (sprinkles 24 hr) 25, 50, 100, 150, 200 mg; oral solution 25 mg/mL
Source page 1314
Administer: • Swallow tabs whole; do not break, crush, or chew tabs; very bitter • May take without regard to meals • Sprinkle cap can be given whole or opened and sprinkled on soft food; do not chew, drink water after sprinkle • Store at room temperature away from heat, light
Source page 1314
Extracted information for topiramate only.
Assess: • Seizures: location, type, duration, aura; seizure precautions: padded side rails; move objects that may harm patient • Bipolar disorder: mood, behavior, activity • Renal studies: urinalysis, BUN, urine creatinine, electrolytes q3mo; symptoms of renal colic • Hepatic studies: ALT, AST, bilirubin if patient receiving long-term treatment • CBC during long-term therapy (ane- mia); serum bicarbonate (metabolic aci- dosis) • Migraines: pain location, duration; al- leviating factors • Mental status: mood, sensorium, affect, behavioral changes, suicidal thoughts/behaviors; if mental status changes, notify prescriber • Body weight, perception of body im- age; eating disorders may occur or be exacerbated, especially in adolescents; evidence of cognitive disorder • Assistance with ambulation during early part of treatment; dizziness oc- curs • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk, birth de- fects have occurred; pregnant patients should register with the Antiepileptic Drug Pregnancy Registry, 1-888-233- 2334; may decrease effectiveness of hormonal contraceptives; cautious use in breastfeeding, excretion unknown • Beers: avoid in older adults unless safer alternative is unavailable; may cause ataxia, impaired psychomotor function
Source page 1315
Evaluate: • Therapeutic response: decreased sei- zure activity
Source page 1315
CLINICAL CONSIDERATIONS
Source page 1315
Patient and caregiver information: • To carry emergency ID stating pa- tient’s name, products taken, condi- tion, prescriber’s name, and phone number • To avoid driving, other activities that require alertness, until response is known • Not to discontinue medication quickly after long-term use; do not restart with- out close supervision if several doses are missed; to follow prescriber’s directions closely • To notify prescriber immediately of blurred vision, periorbital pain; that vision loss may occur • To maintain adequate fluid intake • About administration procedure and expected results • To use nonhormonal contraceptive; that effect of oral contraceptives is de creased • To drink plenty of fluids to prevent kidney stones • May need to increase amount of food consumed; weight loss may occur • To swallow ext rel product whole • That minor hair loss may occur; to report to prescriber if severe T HIGH ALERT
Source page 1315
Extracted information for topiramate only.
PHARMACOKINETICS Well absorbed, peak 2 hr, terminal half- life 19-25 hr, excreted in urine (55%- 97% unchanged), crosses placenta, excreted in breast milk, protein binding (9%-17%), steady state 4 days
Source page 1314
Filter the extracted dose blocks for this individual drug.
Adjunctive therapy for seizures
• Adult/adolescent/child ≥10 yr: PO 25-50 mg/day initially, titrate by 25-50 mg/wk, up to 200-400 mg/day in 2 di- vided doses
Candidate age grouping · source page 1314
Adjunctive therapy for seizures
• Adult/adolescent/child ≥10 yr: PO (Qudexy XR, Trokendi XR) 50 mg daily, increase by 50 mg weekly during wk 2, 3, 4, increase by 100 mg weekly, wk 5, 6, final dose 400 mg daily
Candidate age grouping · source page 1314
Adjunctive therapy for seizures
• Child 2-9 yr: PO week 1: 25 mg in PM, then 25 mg bid if tolerated (week 2), then increase by 25-50 mg/day each week as tolerated over 5- to 7-wk titration period, maintenance given in 2 divided doses; <11 kg, minimum 150 mg/day, max 250 mg/ day; 12-22 kg, minimum 200 mg/day, max 300 mg/day; 23-31 kg, minimum 200 mg/day, max 350 mg/day; 32-38 kg, minimum 250 mg/day, max 350 mg/day; >38 kg, minimum 250 mg/ day, max 400 mg/day; Qudexy XR 25 mg daily at night, may increase to 50 mg week 2, if tolerated, increase by 25-50 mg each week over 5- to 7-wk titration period, max dose based on weight
Candidate age grouping · source page 1314
Adjunctive therapy for seizures
• Child ≤11 kg: PO Qudexy XR mini- mum 150 mg daily, max 250 mg daily
Candidate age grouping · source page 1314
Adjunctive therapy for seizures
• Child 12-22 kg: minimum 200 mg daily, max 300 mg daily
Candidate age grouping · source page 1314
Adjunctive therapy for seizures
• Child 23-31 kg: minimum 200 mg daily, max 350 mg daily
Candidate age grouping · source page 1314
Adjunctive therapy for seizures
• Child 32-38 kg: minimum 250 mg daily, max 350 mg daily
Candidate age grouping · source page 1314
Adjunctive therapy for seizures
• Child >38 kg: minimum 250 mg daily, max 400 mg daily Migraine prophylaxis
Candidate age grouping · source page 1314
Adjunctive therapy for seizures
• Adult: PO 25 mg/day initially, increase by 25 mg/day/wk up to 100 mg/day in 2 divided doses Renal dose
Candidate age grouping · source page 1314
Adjunctive therapy for seizures
• Adult: PO CCr <70 mL/min, give 1/2 dose
Candidate age grouping · source page 1314