Test Catalog

Test Id : TOPI

Topiramate, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring serum concentrations of topiramate

 

Assessing compliance

 

Assessing potential toxicity

Method Name
A short description of the method used to perform the test

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Topiramate, S

Aliases
Lists additional common names for a test, as an aid in searching

Topiramate (Topamax)

Topamax (Topiramate)

Specimen Type
Describes the specimen type validated for testing

Serum Red

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Collection Container/Tube: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Serum must be separated from cells within 2 hours of drawing.

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Neurology Specialty Testing Client Test Request (T732)

-Therapeutics Test Request (T831)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Red Refrigerated (preferred) 28 days
Ambient 28 days
Frozen 28 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring serum concentrations of topiramate

 

Assessing compliance

 

Assessing potential toxicity

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Topiramate is a broad spectrum, antiepileptic drug used for various types of seizures, Lennox-Gastaut syndrome (a type of childhood onset epilepsy), and migraine prophylaxis. Topiramate blocks voltage-dependent sodium channels, potentiates gamma-aminobutyric acid (GABA) activity at some of the GABA receptors, and inhibits potentiation of the glutamate receptor and carbonic anhydrase enzyme, which all contribute to its antiepileptic and antimigraine efficacy.

 

In general, topiramate shows favorable pharmacokinetics with good absorption (1-4 hours for the immediate-release formulation), low protein binding, and minimal hepatic metabolism. Elimination is predominantly renal and it is excreted unchanged in the urine with an elimination half-life of approximately 21 hours. As with other anticonvulsant drugs eliminated by the renal system, patients with impaired renal function exhibit decreased topiramate clearance and a prolonged elimination half-life.

 

Serum concentrations of other anticonvulsant drugs are not significantly affected by the concurrent administration of topiramate with the exception of patients on phenytoin, whose serum concentrations can increase after the addition of topiramate. Other drug-drug interactions include the coadministration of phenobarbital, phenytoin, or carbamazepine, which can result in decreased topiramate concentrations. In addition, concurrent use of posaconazole and topiramate may result in the elevation of topiramate serum concentrations. Therefore, changes in cotherapy with these medications (phenytoin, carbamazepine, posaconazole, or phenobarbital) may require dose adjustment of topiramate and therapeutic drug monitoring could assist with this. The most common adverse drug effects associated with topiramate include: weight loss, loss of appetite, somnolence, dizziness, coordination problems, memory impairment, and paresthesia.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Depends on clinical use:

Anticonvulsant: 5.0-20.0 mcg/mL

Psychiatric: 2.0-8.0 mcg/mL

Interpretation
Provides information to assist in interpretation of the test results

Most individuals display optimal response to topiramate with serum levels 5.0 to 20.0 mcg/mL when used to control seizures. Some individuals may respond well outside of this range, or may display toxicity within the therapeutic range, thus interpretation should include clinical evaluation.

 

Therapeutic ranges are based on specimens drawn at trough (ie, immediately before the next dose).

 

Toxic levels have not been well established.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test cannot be performed on whole blood.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Hiemke C, Baumann P, Bergemann N, et al: AGNP consensus guidelines for therapeutic drug monitoring in psychiatry: Update 2011. Pharmacopsychiatry 2011;44:195-235

2. Patslos PN, Berry DJ, Bourgeois BF, et al: Antiepileptic drugs-best practice guidelines for therapeutic drug monitoring: a position paper by the subcommission on therapeutic drug monitoring, ILAE Commission on Therapeutic Strategies. Epilepsia 2008 Jul;49(7):1239-1276

3. Johannessen SI, Tomsom T: Pharmacokinetic variability of newer antiepileptic drugs: when is monitoring needed? Clin Pharmacokinet 2006;45(11):1061-1075

4. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. Edited by CA Burtis, ER Ashwood, DE Bruns. Saunders, 2012

Method Description
Describes how the test is performed and provides a method-specific reference

Samples are diluted and extracted online extraction by liquid chromatography, with detection by tandem mass spectrometry.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 2 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80201

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports