Topiramate ER 25mg Sprinkle Caps
It is used to treat seizures.It is used to prevent migraine headaches.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticonvulsant, Antimigraine
Pharmacologic Class
Sulfamate-substituted monosaccharide
Pregnancy Category
Category D
FDA Approved
Mar 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Topiramate ER is an extended-release medication used to prevent seizures (epilepsy) and to prevent migraine headaches. It works by affecting certain chemicals in the brain. The sprinkle capsules can be swallowed whole or opened and sprinkled on soft food.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue taking it even if you feel well. It's essential to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
You can take your medication by swallowing the capsule whole or by sprinkling the contents onto a spoonful of soft food, such as applesauce. However, do not crush or chew the medication before swallowing. If you mix the medication with food, be sure to swallow the mixture immediately and do not store it for later use. After taking the medication with food, drink some fluid to ensure the medication is swallowed properly.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed and store all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication, as there may be drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you miss two doses, contact your doctor for further instructions.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue taking it even if you feel well. It's essential to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
You can take your medication by swallowing the capsule whole or by sprinkling the contents onto a spoonful of soft food, such as applesauce. However, do not crush or chew the medication before swallowing. If you mix the medication with food, be sure to swallow the mixture immediately and do not store it for later use. After taking the medication with food, drink some fluid to ensure the medication is swallowed properly.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed and store all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication, as there may be drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you miss two doses, contact your doctor for further instructions.
Lifestyle & Tips
- Stay well-hydrated throughout the day to reduce the risk of kidney stones and decreased sweating.
- Avoid or limit alcohol consumption, as it can increase side effects like dizziness and drowsiness.
- Be cautious when driving or operating machinery until you know how the medication affects you, as it can cause dizziness, drowsiness, and vision problems.
- Monitor for changes in mood, behavior, or thoughts of self-harm and report them to your doctor immediately.
- Avoid becoming overheated or dehydrated, especially during exercise or in hot weather, as topiramate can reduce sweating.
Available Forms & Alternatives
Available Strengths:
- Topiramate 200mg Tablets
- Topiramate 25mg Sprinkle Capsules
- Topiramate 100mg Tablets
- Topiramate 15mg Sprinklecapsules
- Topiramate 25mg Tablets
- Topiramate 50mg Tablets
- Topiramate 100mg Tablets
- Topiramate ER 150mg Sprinkle Caps
- Topiramate ER 200mg Sprinkle Caps
- Topiramate ER 25mg Sprinkle Caps
- Topiramate ER 50mg Sprinkle Caps
- Topiramate ER 100mg Sprinkle Caps
- Topiramate 50mg Tablets
- Topiramate 25mg Tablets
- Topiramate 200mg ER Capsules
- Topiramate ER 100mg Capsules
- Topiramate ER 50mg Capsules
- Topiramate ER 25mg Capsules
- Topiramate 15mg Sprinkle Capsules
- Topiramate 50mg Capsules
Dosing & Administration
Adult Dosing
Standard Dose:
Epilepsy (adjunctive): Initial 50 mg once daily for 7 days, then increase by 50 mg/week to target 200-400 mg once daily. Migraine prophylaxis: Initial 25 mg once daily for 7 days, then increase by 25 mg/week to target 100 mg once daily.
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
Epilepsy (adjunctive):
Initial 50 mg once daily for 7 days, then increase by 50 mg/week to target 200-400 mg once daily. Max 600 mg/day.
Migraine prophylaxis:
Initial 25 mg once daily for 7 days, then increase by 25 mg/week to target 100 mg once daily. Max 200 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Epilepsy (adjunctive, ≥6 years): Initial 25 mg once daily for 7 days, then increase by 25-50 mg/week to target 5-9 mg/kg/day in 1-2 divided doses. Migraine prophylaxis (≥12 years): Initial 25 mg once daily for 7 days, then increase by 25 mg/week to target 100 mg once daily.
Adolescent:
Epilepsy (adjunctive, ≥6 years): Initial 25 mg once daily for 7 days, then increase by 25-50 mg/week to target 5-9 mg/kg/day in 1-2 divided doses. Migraine prophylaxis (≥12 years): Initial 25 mg once daily for 7 days, then increase by 25 mg/week to target 100 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 70 mL/min)
Moderate:
Reduce dose by 50% (CrCl 30-69 mL/min)
Severe:
Reduce dose by 50% (CrCl < 30 mL/min)
Dialysis:
Reduce dose by 50%; supplemental dose may be needed after hemodialysis (approx. 50% of dose removed during 6-hour dialysis session).
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Use with caution; consider lower starting dose and slower titration.
Severe:
Use with caution; consider lower starting dose and slower titration.
Pharmacology
Mechanism of Action
The exact mechanism of action is not fully understood. It is thought to involve multiple mechanisms: blockade of voltage-dependent sodium channels, potentiation of GABA-A receptor activity, antagonism of AMPA/kainate glutamate receptors, and inhibition of carbonic anhydrase (primarily isoenzymes II and IV). These actions collectively contribute to its anticonvulsant and migraine prophylactic effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 81% (oral)
Tmax:
Extended-release: 6-8 hours (Qudexy XR), 24 hours (Trokendi XR)
FoodEffect:
Minimal effect on bioavailability; can be taken with or without food.
Distribution:
Vd:
0.6-0.8 L/kg
ProteinBinding:
13-17%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 21 hours
Clearance:
Primarily renal clearance
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 70-80%
Pharmacodynamics
OnsetOfAction:
Gradual (requires titration)
PeakEffect:
Steady state achieved in 4-8 days with regular dosing.
DurationOfAction:
24 hours (extended-release formulation)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Acidosis (Too Much Acid in the Blood): Confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, upset stomach, vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal.
High Ammonia Levels: Irregular heartbeat, abnormal breathing, confusion, pale skin, slow heartbeat, seizures, sweating, vomiting, or twitching.
Unexplained Bleeding or Bruising: Any unusual bruising or bleeding.
Neurological Symptoms: Confusion, difficulty focusing, changes in behavior, memory problems, loss of memory, speech difficulties, sleep disturbances, balance problems, severe dizziness, or fainting.
Kidney Stone Symptoms: Back pain, abdominal pain, or blood in the urine.
Other Severe Symptoms: Burning, numbness, or tingling sensations, bone pain, chest pain, muscle pain or weakness, shakiness, difficulty walking, or uncontrolled eye movements.
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, especially in people with a history of suicidal behavior. If you experience any new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek help right away.
Eye Problems: This medication can cause severe eye problems, potentially leading to permanent vision loss if left untreated. Contact your doctor immediately if you experience blurred vision, changes in vision, eye pain, or eye redness.
Liver Problems: Rarely, this medication can cause liver problems, which can be life-threatening. If you experience dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor immediately.
Heat-Related Illness: This medication can cause sweating problems and high body temperatures, which can lead to hospitalization. Be cautious in hot weather and during physical activity. If you experience a fever or decreased sweating, contact your doctor immediately.
Severe Skin Reaction: A rare but potentially life-threatening skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) can occur. If you experience red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes, seek medical help immediately.
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Changes in taste
Weight loss
Feeling nervous or excitable
Dizziness, drowsiness, tiredness, or weakness
Headache
Flushing
Common cold symptoms
* Joint pain
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Acidosis (Too Much Acid in the Blood): Confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, upset stomach, vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal.
High Ammonia Levels: Irregular heartbeat, abnormal breathing, confusion, pale skin, slow heartbeat, seizures, sweating, vomiting, or twitching.
Unexplained Bleeding or Bruising: Any unusual bruising or bleeding.
Neurological Symptoms: Confusion, difficulty focusing, changes in behavior, memory problems, loss of memory, speech difficulties, sleep disturbances, balance problems, severe dizziness, or fainting.
Kidney Stone Symptoms: Back pain, abdominal pain, or blood in the urine.
Other Severe Symptoms: Burning, numbness, or tingling sensations, bone pain, chest pain, muscle pain or weakness, shakiness, difficulty walking, or uncontrolled eye movements.
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, especially in people with a history of suicidal behavior. If you experience any new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek help right away.
Eye Problems: This medication can cause severe eye problems, potentially leading to permanent vision loss if left untreated. Contact your doctor immediately if you experience blurred vision, changes in vision, eye pain, or eye redness.
Liver Problems: Rarely, this medication can cause liver problems, which can be life-threatening. If you experience dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor immediately.
Heat-Related Illness: This medication can cause sweating problems and high body temperatures, which can lead to hospitalization. Be cautious in hot weather and during physical activity. If you experience a fever or decreased sweating, contact your doctor immediately.
Severe Skin Reaction: A rare but potentially life-threatening skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) can occur. If you experience red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes, seek medical help immediately.
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Changes in taste
Weight loss
Feeling nervous or excitable
Dizziness, drowsiness, tiredness, or weakness
Headache
Flushing
Common cold symptoms
* Joint pain
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden vision changes or eye pain (can be signs of acute angle-closure glaucoma)
- Fever, decreased sweating, or hot, dry skin (can be signs of oligohidrosis/hyperthermia)
- Confusion, memory problems, or difficulty concentrating (cognitive side effects)
- Persistent fatigue, rapid breathing, or loss of appetite (signs of metabolic acidosis)
- Severe back or side pain, blood in urine, or painful urination (signs of kidney stones)
- Unexplained bleeding or bruising (rare, but possible blood dyscrasias)
- Any new or worsening depression, anxiety, or thoughts of self-harm
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require alertness.
Stopping the Medication
Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually discontinue it.
Monitoring and Lab Tests
Follow your doctor's instructions for regular blood work and other lab tests to ensure your safety while taking this medication.
Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, cannabis, or prescription or over-the-counter medications that may cause drowsiness.
Risk of Metabolic Acidosis
This medication may cause a condition called metabolic acidosis, which can be more likely in children, people with kidney problems, breathing difficulties, or diarrhea. The risk may also increase if you take certain other medications, undergo surgery, or follow a ketogenic diet. If left untreated, metabolic acidosis can lead to kidney stones, bone problems, or growth issues in children.
Bleeding Risk
This medication may increase your risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.
Interaction with Valproic Acid
Taking this medication with valproic acid can cause low body temperature, leading to tiredness, confusion, or coma. Consult your doctor if you are taking valproic acid.
Special Considerations for Children
If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. This medication may affect growth in children and teens, and regular growth checks may be necessary. Discuss this with your doctor.
Birth Control and Pregnancy
Birth control pills and other hormone-based birth control methods may not be effective while taking this medication. Use an additional form of birth control, such as a condom, to prevent pregnancy. If you experience any changes in your bleeding pattern while taking hormone-based birth control, consult your doctor.
Pregnancy and Breastfeeding
This medication may harm the unborn baby if taken during pregnancy. If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately. If you are able to become pregnant and do not wish to, use a reliable form of birth control while taking this medication. If you are breastfeeding, inform your doctor to discuss any potential risks to your baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require alertness.
Stopping the Medication
Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually discontinue it.
Monitoring and Lab Tests
Follow your doctor's instructions for regular blood work and other lab tests to ensure your safety while taking this medication.
Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, cannabis, or prescription or over-the-counter medications that may cause drowsiness.
Risk of Metabolic Acidosis
This medication may cause a condition called metabolic acidosis, which can be more likely in children, people with kidney problems, breathing difficulties, or diarrhea. The risk may also increase if you take certain other medications, undergo surgery, or follow a ketogenic diet. If left untreated, metabolic acidosis can lead to kidney stones, bone problems, or growth issues in children.
Bleeding Risk
This medication may increase your risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.
Interaction with Valproic Acid
Taking this medication with valproic acid can cause low body temperature, leading to tiredness, confusion, or coma. Consult your doctor if you are taking valproic acid.
Special Considerations for Children
If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. This medication may affect growth in children and teens, and regular growth checks may be necessary. Discuss this with your doctor.
Birth Control and Pregnancy
Birth control pills and other hormone-based birth control methods may not be effective while taking this medication. Use an additional form of birth control, such as a condom, to prevent pregnancy. If you experience any changes in your bleeding pattern while taking hormone-based birth control, consult your doctor.
Pregnancy and Breastfeeding
This medication may harm the unborn baby if taken during pregnancy. If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately. If you are able to become pregnant and do not wish to, use a reliable form of birth control while taking this medication. If you are breastfeeding, inform your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Convulsions
- Drowsiness
- Speech disturbance
- Blurred vision
- Diplopia (double vision)
- Impaired mentation
- Lethargy
- Ataxia (loss of coordination)
- Abdominal pain
- Hypotension (low blood pressure)
- Palpitations
- Nystagmus (involuntary eye movements)
- Metabolic acidosis
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and may include gastric lavage, activated charcoal, and hemodialysis (topiramate is dialyzable).
Drug Interactions
Major Interactions
- Valproic acid (increased risk of hyperammonemia with or without encephalopathy)
- Oral contraceptives (decreased efficacy of estrogen-containing contraceptives)
- Carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide, dichlorphenamide - increased risk of metabolic acidosis and kidney stones)
Moderate Interactions
- CNS depressants (e.g., alcohol, benzodiazepines, opioids - increased risk of CNS depression)
- Phenytoin (altered phenytoin levels, altered topiramate levels)
- Carbamazepine (decreased topiramate levels)
- Digoxin (decreased digoxin levels)
- Lithium (altered lithium levels)
- Metformin (altered metformin levels)
- Pioglitazone (decreased pioglitazone levels)
- Hydrochlorothiazide (increased topiramate levels)
Minor Interactions
- Amitriptyline (altered amitriptyline levels)
- Propranolol (altered propranolol levels)
Monitoring
Baseline Monitoring
Serum bicarbonate levels
Rationale: To establish baseline and monitor for metabolic acidosis.
Timing: Before starting therapy
Renal function (BUN, creatinine, eGFR)
Rationale: Topiramate is primarily renally eliminated; assess baseline function.
Timing: Before starting therapy
Eye examination (intraocular pressure)
Rationale: To establish baseline and monitor for acute angle-closure glaucoma.
Timing: Before starting therapy
Routine Monitoring
Serum bicarbonate levels
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Normal range (22-29 mEq/L)
Action Threshold: Persistent decrease below normal range, especially if symptomatic or severe (<17 mEq/L)
Renal function (BUN, creatinine, eGFR)
Frequency: Annually or as clinically indicated, especially in patients with risk factors for kidney stones or renal impairment.
Target: Normal range
Action Threshold: Significant decline in eGFR or signs of renal dysfunction
Weight
Frequency: Periodically
Target: Maintain healthy weight
Action Threshold: Significant or rapid weight loss
Electrolytes (potassium, chloride)
Frequency: Periodically, especially if bicarbonate levels are low.
Target: Normal range
Action Threshold: Abnormal levels
Symptom Monitoring
- Vision changes (e.g., blurred vision, eye pain, sudden decrease in vision)
- Cognitive changes (e.g., difficulty concentrating, memory problems, word-finding difficulties)
- Mood or behavioral changes (e.g., depression, anxiety, suicidal ideation)
- Symptoms of metabolic acidosis (e.g., fatigue, anorexia, rapid breathing, cardiac arrhythmias)
- Symptoms of kidney stones (e.g., flank pain, hematuria, dysuria)
- Decreased sweating or fever (especially in hot weather or during strenuous activity)
- Paresthesias (tingling sensations)
- Nausea, vomiting, abdominal pain (especially with hyperammonemia)
Special Patient Groups
Pregnancy
Topiramate is associated with an increased risk of major congenital malformations, particularly oral clefts (cleft lip/palate) and hypospadias, when used during pregnancy. It is also associated with reduced fetal growth (low birth weight and small for gestational age). Use during pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus. Women of childbearing potential should be counseled on the risks and use effective contraception.
Trimester-Specific Risks:
First Trimester:
Highest risk for major congenital malformations, especially oral clefts and hypospadias.
Second Trimester:
Risk of reduced fetal growth and lower birth weight.
Third Trimester:
Risk of reduced fetal growth and lower birth weight; potential for withdrawal symptoms in neonate if discontinued abruptly.
Lactation
Topiramate is excreted into human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for topiramate, and any potential adverse effects on the breastfed infant from topiramate or from the underlying maternal condition. Monitor breastfed infants for diarrhea, drowsiness, irritability, and poor weight gain.
Infant Risk:
Moderate risk (L3). Potential for infant drowsiness, diarrhea, and poor feeding/weight gain. Long-term effects are unknown.
Pediatric Use
Approved for adjunctive treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (IR formulation, ER for ≥6 years). Approved for migraine prophylaxis in adolescents 12 years of age and older. Pediatric patients are at increased risk for oligohidrosis and hyperthermia, especially in hot weather or during strenuous activity. Monitor for weight loss and metabolic acidosis.
Geriatric Use
Use with caution due to potential for age-related decreases in renal function. Start at the lower end of the dosing range and titrate slowly. Monitor renal function and for adverse effects such as cognitive impairment, dizziness, and falls. Increased risk of kidney stones and metabolic acidosis.
Clinical Information
Clinical Pearls
- Topiramate ER sprinkle capsules can be swallowed whole or opened and sprinkled on a spoonful of soft food (e.g., applesauce) and swallowed immediately without chewing.
- Ensure adequate hydration to minimize the risk of kidney stone formation and oligohidrosis/hyperthermia.
- Counsel patients on the potential for cognitive side effects ('topa-max' or 'dopamax' effect) and weight loss.
- Women of childbearing potential should be advised about the teratogenic risks and the need for effective contraception.
- Titrate dose slowly to minimize adverse effects and improve tolerability.
- Monitor serum bicarbonate levels, especially in pediatric patients and those with renal impairment, due to the risk of metabolic acidosis.
Alternative Therapies
- Other antiepileptic drugs (e.g., levetiracetam, lamotrigine, valproic acid, carbamazepine, oxcarbazepine, zonisamide, gabapentin, pregabalin)
- Other migraine prophylactic agents (e.g., beta-blockers, tricyclic antidepressants, CGRP inhibitors, onabotulinumtoxinA)
Cost & Coverage
Average Cost:
Varies widely, typically $300-$1000+ per 30 capsules (ER)
Generic Available:
Yes
Insurance Coverage:
Tier 2-3 (generic ER may be Tier 1-2, brand ER typically Tier 3)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.