Topiramate warnings and precautions

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Topiramate
TOPIRAMATE® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Topiramate
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]

For patient information, click here.

Warnings and Precautions

  • Acute myopia and secondary angle closure glaucoma: Untreated elevated intraocular pressure can lead to permanent visual loss. The primary treatment to reverse symptoms is discontinuation of topiramate as rapidly as possible.
  • Oligohidrosis and hyperthermia: Monitor decreased sweating and increased body temperature, especially in pediatric patients .
  • Metabolic acidosis: Baseline and periodic measurement of serum bicarbonate is recommended. Consider dose reduction or discontinuation of topiramate if clinically appropriate.
  • Suicidal behavior and ideation: Antiepileptic drugs increase the risk of suicidal behavior or ideation.
  • Cognitive/neuropsychiatric: Topiramate may cause cognitive dysfunction. Patients should use caution when operating machinery including automobiles. Depression and mood problems may occur in epilepsy and other populations.
  • Fetal Toxicity: Topiramate use during pregnancy can cause cleft lip and/or palate .
  • Withdrawal of AEDs: Withdrawal of topiramate should be done gradually .
  • Hyperammonemia and encephalopathy associated with or without concomitant valproic acid use: Patients with inborn errors of metabolism or reduced mitochondrial activity may have an increased risk of hyper­ammonemia. Measure ammonia if encephalopathic symptoms occur.
  • Kidney stones: Use with other carbonic anhydrase inhibitors, other drugs causing metabolic acidosis, or in patients on a ketogenic diet should be avoided (5.10).
  • Hypothermia has been reported with and without hyperammonemia during topiramate treatment with concomitant valproic acid use.[1]

References

  1. "TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]". Retrieved 6 February 2014.

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