Ctrl

K

Topiramate XR

Class
Anticonvulsants
Subclass
Monosaccharide derivatives
Generic name
Topiramate XR
Brand names
Qudexy XR®
Common formulations
Capsule
See also
Topiramate (Topamax®)
Dosage and administration
Adults patients
Treatment
Alcohol use disorder • Maintenance of abstinence • Off-label
•
Start at: 25 mg PO daily
•
Maintenance: 300 mg PO daily
Titrate by 25 to 50 mg/day at weekly intervals based on response and tolerability.
Bulimia nervosa • Off-label
•
Start at: 25 mg PO daily
•
Maintenance: 100-400 mg PO daily
Titrate by 25 to 50 mg/day at weekly intervals based on response and tolerability.
Essential tremor • Off-label
•
Start at: 25-50 mg PO daily
•
Maintenance: 200 mg PO daily
•
Maximum: 400 mg per day
Titrate by 25 to 50 mg/day at weekly intervals based on response and tolerability.
Adjunctive treatment
Focal seizures
•
Start at: 25-50 mg PO daily
•
Maintenance: 200-400 mg PO daily
Titrate by 25 to 50 mg/day in weekly increments.
Generalized tonic-clonic seizures • Primary
•
Start at: 25-50 mg PO daily
•
Maintenance: 200-400 mg PO daily
Titrate by 25 to 50 mg/day in weekly increments.
Prevention
Prevention of migraine attacks
•
Start at: 25 mg PO daily for 1 week
•
Maintenance: 100 mg PO daily
Titrate in minimum increments of 25 mg weekly, based on response and tolerability.
Other off-label uses
•
Treatment of antipsychotic-induced weight gain
•
Treatment of binge eating disorder
•
Treatment of cocaine use disorder
•
Treatment of obesity
•
Adjunctive treatment for OCD
•
Adjunctive treatment for seizures in patients with alcohol withdrawal syndrome
•
Prevention of cluster headache
•
Prevention of vomiting episodes in patients with cyclic vomiting syndrome
Indications for use
Labeled indications
Adults
•
Treatment of epilepsy (focal seizures)
•
Treatment of generalized tonic-clonic seizures (primary)
•
Adjunctive treatment for Lennox-Gastaut syndrome
•
Adjunctive treatment for focal seizures
•
Adjunctive treatment for generalized tonic-clonic seizures (primary)
•
Prevention of migraine attacks
Off-label indications
Adults
•
Treatment of alcohol use disorder (maintenance of abstinence)
•
Treatment of antipsychotic-induced weight gain
•
Treatment of binge eating disorder
•
Treatment of bulimia nervosa
•
Treatment of cocaine use disorder
•
Treatment of essential tremor
•
Treatment of obesity
•
Adjunctive treatment for OCD
•
Adjunctive treatment for seizures in patients with alcohol withdrawal syndrome
•
Prevention of cluster headache
•
Prevention of vomiting episodes in patients with cyclic vomiting syndrome
Safety risks
Warnings and precautions
Acute myopia, secondary angle-closure glaucoma
•
Maintain a high level of suspicion, as topiramate can cause acute myopia and secondary angle-closure glaucoma, potentially leading to vision loss. Monitor for changes in vision or eye pain during the first month of therapy. Discontinue topiramate promptly and manage intraocular pressure as needed.
Hyperammonemia, encephalopathy
•
Use caution in patients with inborn errors of metabolism, reduced hepatic mitochondrial activity, or those taking concomitant valproic acid, as they may be at increased risk for hyperammonemia with or without encephalopathy. Monitor ammonia levels regularly, especially in high-risk patients or those experiencing symptoms such as lethargy, vomiting, or changes in mental status.
Hypothermia
•
Use caution in patients taking valproic acid concomitantly, as this combination increases the risk of hypothermia (body core temperature <35°C or 95°F), which may occur with or without hyperammonemia.
Increased body temperature, hypohidrosis
•
Maintain a high level of suspicion, as topiramate may cause oligohidrosis and hyperthermia, especially in pediatric patients, during high temperatures, or when combined with drugs that predispose to heat-related disorders, such as carbonic anhydrase inhibitors and anticholinergic drugs.
Metabolic acidosis
•
Use extreme caution in patients with conditions or therapies that predispose them to acidosis, such as kidney disease, severe pulmonary disease, status epilepticus, diarrhea, a ketogenic diet, or certain drugs, as these may have additive effects with topiramate's bicarbonate-lowering action. Monitor serum bicarbonate levels regularly, and consider dose reduction or discontinuation if acidosis persists.
Nephrolithiasis
•
Maintain a high level of suspicion, as topiramate increases the risk of kidney stone formation, particularly in males, pediatric patients, and those on a ketogenic diet or taking concomitant drugs that cause metabolic acidosis.
Seizures
•
Do not discontinue abruptly topiramate, as this may increase the risk or frequency of seizures, even in patients without a history of seizures or epilepsy.
Somnolence, cognitive impairment, neuropsychiatric disorder, paresthesia
•
Maintain a high level of suspicion, as topiramate may cause cognitive dysfunction (e.g., confusion, memory issues), psychiatric disturbances (e.g., depression, mood changes), and somnolence or fatigue, particularly with higher doses or rapid titration. Utilize slower titration schedules and the lowest effective dose, and monitor for cognitive, psychiatric, or fatigue-related symptoms during treatment.
Stevens-Johnson syndrome, toxic epidermal necrolysis
•
Maintain a high level of suspicion, as topiramate has been associated with an increased risk of serious skin reactions.
Suicidal ideation
•
Maintain a high level of suspicion, as antiepileptic drugs, including topiramate, are associated with an increased risk of suicidal thoughts or behaviour. Monitor patients closely for signs of depression, suicidal thoughts, or mood changes, especially during the first week of treatment and throughout therapy.
Visual field defect
•
Maintain a high level of suspicion, as topiramate is associated with visual field defects, independent of elevated intraocular pressure. Discontinue topiramate if visual problems occur, as most cases resolve after the drug is stopped.
Specific populations
Renal impairment
CrCl ≥ 70 mL/min
•
Reduce dose by 50%. Titrate slowly. Monitor for renal calculi.
CrCl < 70 mL/min
•
Reduce dose. Reduce dose by 50%. Titrate slowly. Monitor for renal calculi.
Renal replacement therapy
Continuous renal replacement
•
Reduce dose. Reduce dose by 50%. Titrate slowly. Monitor for nephrolithiasis.
Intermittent hemodialysis
•
Reduce dose. Reduce dose by 50%. Titrate slowly. Monitor for nephrolithiasis. Supplemental dose may be required.
Peritoneal dialysis
•
Reduce dose. Reduce dose by 50%. Titrate slowly. Monitor for nephrolithiasis.
Hepatic impairment
Any severity
•
No guidance available. Use with caution.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Avoid use. Evidence of fetal harm in humans. Use during pregnancy can cause major congenital malformations (particularly oral clefts) and small for gestational-age infants. Women of childbearing potential who are not planning a pregnancy should use effective contraception to mitigate these risks.
Breastfeeding
Acceptable for use during breastfeeding.
Low-moderate excretion in breastmilk (25-45%).
Low levels in breastfed infants (5-25%).
Unlikely to cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
Dysgeusia, ↑ blood ammonia, abdominal pain, dizziness, fatigue, fever, loss of appetite, memory impairment, nausea, paresthesia, somnolence, weight loss
Common 1-10%
•
AV block, acne vulgaris, acute cystitis, agitation, alopecia, anemia, aphasia, ataxia, bradycardia, bronchospasm, candidiasis, cerebellar syndrome, conjunctivitis, ↓ WBC count, ↓ WBC count, ↓ blood glucose, ↓ platelet count, ↓ serum calcium, ↓ serum phosphate, dehydration, delirium, diabetes mellitus, dyskinesia, dysphonia, dystonia, EEG abnormalities, esophagitis, fecal incontinence, gastroesophageal reflux disease, gastritis, gingival swelling, gingivitis, glossitis, hemorrhoids, hyperhidrosis, hyperkinesia, hyperlacrimation, hypertension, hyperthyroidism, hypertonia, hypertrichosis, hyporeflexia, hypotension, ↑ blood eosinophil count, ↑ blood glucose, ↑ platelet count, ↑ serum sodium, involuntary movements, laryngitis, leukorrhea, lymphadenopathy, menorrhagia, migraine, nephrolithiasis, nystagmus, orthostatic hypotension, pulmonary embolism, pallor, pancytopenia, peripheral neuropathy, peripheral vasodilation, pharyngitis, psychomotor retardation, psychosis, ptosis, purpura, amenorrhea, angina pectoris, anxiety, asthenia, blurred vision, body odor, chest pain, confusion, constipation, cough, ↓ libido, depression, diarrhea, diplopia, dry mouth, dyspepsia, dysphagia, dyspnea, emotional lability, erectile dysfunction, euphoria, eye pain, flatulence, hallucinations, headache, hearing loss, hematuria, hot flashes, hypersalivation, ↑ appetite, insomnia, irritability, itching, low urine output, melena, menstrual irregularity, nocturia, nosebleed, paranoid ideation, parosmia, photophobia, polydipsia, polyuria, seizure, skin flushing, skin rash, syncope, tinnitus, urinary frequency, urinary incontinence, urinary retention, vaginal bleeding, vertigo, visual disturbances, vomiting, weight gain, rhinitis, sinusitis, skin discoloration, stomatitis, thrombosis, tremor, xerophthalmia
Uncommon < 1%
•
↓ serum sodium, mydriasis, polycythemia, ↑ libido, mania
Unknown frequency
•
Acute pancreatitis, ecchymosis, encephalopathy, erythema multiforme, ↑ intraocular pressure, myopia, pemphigus vulgaris, skin rash, suicidal ideation, Stevens-Johnson syndrome, toxic epidermal necrolysis
Interactions
Drug(s)
Check Interactions
Reset

What did you think about this content?

Create free account

Sign up for free to access the full drug resource