Topiramate ER 150mg 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; Migraine Prophylaxis
Pharmacologic Class
Sulfamate-substituted monosaccharide; Voltage-gated sodium channel blocker; GABA-A receptor potentiator; AMPA/kainate receptor antagonist; Carbonic anhydrase inhibitor
Pregnancy Category
Not available
FDA Approved
Mar 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Topiramate ER is an extended-release capsule used to prevent seizures (epilepsy) and to prevent migraine headaches. It works by affecting several chemicals and electrical signals in the brain. The 'sprinkle caps' 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 swallow the medication whole or mix it with 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, consume the mixture immediately and do not store it for later use. After eating the food and medication mixture, 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. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missing 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 guidance.
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 swallow the medication whole or mix it with 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, consume the mixture immediately and do not store it for later use. After eating the food and medication mixture, 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. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missing 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 guidance.
Lifestyle & Tips
- Stay well-hydrated by drinking plenty of fluids throughout the day to reduce the risk of kidney stones and decreased sweating.
- Avoid alcohol and other CNS depressants, as they can increase drowsiness and dizziness.
- Do not stop taking this medication suddenly, as it can lead to increased seizure frequency. Always consult your doctor before making any changes.
- Be aware of potential cognitive side effects like difficulty concentrating or memory problems, especially during initial therapy or dose changes.
- Monitor for changes in vision or eye pain and report them immediately to your doctor.
- If you are a woman of childbearing potential, discuss effective birth control methods with your doctor, as topiramate can reduce the effectiveness of oral contraceptives and carries risks during pregnancy.
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:
Initial: 25 mg once daily for 7 days; Titrate weekly by 25-50 mg/day. Maintenance: 100-400 mg once daily (epilepsy); 50-200 mg once daily (migraine prophylaxis).
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
Epilepsy (Adjunctive):
Initial: 25 mg once daily for 7 days, then increase by 25-50 mg/day weekly. Target: 100-400 mg/day once daily.
Migraine Prophylaxis:
Initial: 25 mg once daily for 7 days, then increase by 25 mg/day weekly. Target: 50-200 mg/day once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Epilepsy (âĨ6 years): Initial 25 mg once daily for 7 days, then increase by 25-50 mg/day weekly. Target: 100-400 mg/day once daily based on weight (e.g., 5-9 mg/kg/day). Migraine Prophylaxis (âĨ12 years): Initial 25 mg once daily for 7 days, then increase by 25 mg/day weekly. Target: 50-200 mg/day once daily.
Adolescent:
Epilepsy (âĨ6 years): Initial 25 mg once daily for 7 days, then increase by 25-50 mg/day weekly. Target: 100-400 mg/day once daily based on weight (e.g., 5-9 mg/kg/day). Migraine Prophylaxis (âĨ12 years): Initial 25 mg once daily for 7 days, then increase by 25 mg/day weekly. Target: 50-200 mg/day once daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific 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:
Topiramate is removed by hemodialysis. A supplemental dose equal to approximately one-half of the usual daily dose should be administered on hemodialysis days, in divided doses at the beginning and end of the hemodialysis procedure.
Hepatic Impairment:
Mild:
No specific adjustment needed.
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
Topiramate's precise mechanism is not fully understood but involves multiple actions: potentiation of GABA-A receptor activity, antagonism of AMPA/kainate glutamate receptors, inhibition of voltage-gated sodium channels, and weak inhibition of carbonic anhydrase enzymes (especially CA-II and CA-IV). These actions contribute to its anticonvulsant and migraine prophylactic effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 81% (immediate release)
Tmax:
Extended-release: 24 hours (range 4-48 hours)
FoodEffect:
Food does not significantly affect the bioavailability of topiramate ER, but may delay Tmax.
Distribution:
Vd:
0.6-0.8 L/kg
ProteinBinding:
13-17%
CnssPenetration:
Yes
Elimination:
HalfLife:
20-30 hours
Clearance:
Approximately 20-30 mL/min in healthy adults
ExcretionRoute:
Renal (primarily unchanged drug)
Unchanged:
Approximately 70% (in healthy volunteers)
Pharmacodynamics
OnsetOfAction:
Gradual (due to titration and ER formulation)
PeakEffect:
Weeks (after reaching stable dose)
DurationOfAction:
24 hours (due to ER formulation and long half-life)
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an 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.
Signs of 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.
Signs of 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.
Signs of high ammonia levels: irregular heartbeat, abnormal breathing, confusion, pale skin, slow heartbeat, seizures, sweating, vomiting, or twitching.
Unexplained bruising or bleeding.
Confusion, difficulty focusing, or changes in behavior.
Memory problems or loss.
Speech difficulties.
Sleep disturbances.
Balance problems.
Severe dizziness or fainting.
Inability to eat.
Back pain, abdominal pain, or blood in the urine (may indicate a kidney stone).
Abnormal burning, numbness, or tingling sensations.
Bone pain.
Chest pain.
Muscle pain or weakness.
Shakiness.
Difficulty walking.
Inability to control eye movements.
Suicidal thoughts or actions (rarely reported, but may be more likely in people with a history of suicidal thoughts or actions).
New or worsening symptoms of depression, anxiety, restlessness, or mood changes.
Additional Serious Side Effects
This medication may cause severe eye problems, potentially leading to permanent vision loss if left untreated. Seek medical attention immediately if you experience:
Blurred vision or changes in eyesight.
Eye pain or redness.
Rarely, this medication has caused liver problems, which can be life-threatening. Contact your doctor right away if you notice:
Dark urine.
Fatigue.
Decreased appetite.
Upset stomach or stomach pain.
Light-colored stools.
Vomiting.
Yellow skin or eyes.
In rare cases, this medication may cause a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can be life-threatening. Seek medical help immediately if you experience:
Red, swollen, blistered, or peeling skin (with or without fever).
Red or irritated eyes.
Sores in your mouth, throat, nose, or eyes.
Other Side Effects
Most people taking this medication do not experience severe side effects. However, some may encounter mild or moderate side effects, including:
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.
If you experience any side effects that bother you or do not go away, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an 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.
Signs of 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.
Signs of 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.
Signs of high ammonia levels: irregular heartbeat, abnormal breathing, confusion, pale skin, slow heartbeat, seizures, sweating, vomiting, or twitching.
Unexplained bruising or bleeding.
Confusion, difficulty focusing, or changes in behavior.
Memory problems or loss.
Speech difficulties.
Sleep disturbances.
Balance problems.
Severe dizziness or fainting.
Inability to eat.
Back pain, abdominal pain, or blood in the urine (may indicate a kidney stone).
Abnormal burning, numbness, or tingling sensations.
Bone pain.
Chest pain.
Muscle pain or weakness.
Shakiness.
Difficulty walking.
Inability to control eye movements.
Suicidal thoughts or actions (rarely reported, but may be more likely in people with a history of suicidal thoughts or actions).
New or worsening symptoms of depression, anxiety, restlessness, or mood changes.
Additional Serious Side Effects
This medication may cause severe eye problems, potentially leading to permanent vision loss if left untreated. Seek medical attention immediately if you experience:
Blurred vision or changes in eyesight.
Eye pain or redness.
Rarely, this medication has caused liver problems, which can be life-threatening. Contact your doctor right away if you notice:
Dark urine.
Fatigue.
Decreased appetite.
Upset stomach or stomach pain.
Light-colored stools.
Vomiting.
Yellow skin or eyes.
In rare cases, this medication may cause a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can be life-threatening. Seek medical help immediately if you experience:
Red, swollen, blistered, or peeling skin (with or without fever).
Red or irritated eyes.
Sores in your mouth, throat, nose, or eyes.
Other Side Effects
Most people taking this medication do not experience severe side effects. However, some may encounter mild or moderate side effects, including:
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.
If you experience any side effects that bother you or do not go away, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden decrease in vision or eye pain (acute myopia/glaucoma)
- Decreased sweating or fever (oligohidrosis/hyperthermia)
- Persistent fatigue, loss of appetite, rapid breathing (signs of metabolic acidosis)
- Severe back or flank pain, blood in urine (signs of kidney stones)
- Unusual changes in mood or behavior, thoughts of self-harm
- Confusion, lethargy, vomiting (signs of hyperammonemia, especially if also taking valproic acid)
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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 tasks 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 laboratory 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.
Potential Side Effects
This medication may cause metabolic acidosis, a condition characterized by an imbalance of acid in the blood. This risk is higher in children, individuals with kidney problems, breathing difficulties, or diarrhea, and those taking certain medications, undergoing surgery, or following a ketogenic diet. If left untreated, metabolic acidosis can lead to kidney stones, bone problems, or growth issues in children.
Bleeding Risks
This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.
Interactions with Other Medications
Taking this medication with valproic acid can cause hypothermia (low body temperature), leading to fatigue, 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 teenagers, and regular growth checks may be necessary. Discuss this with your doctor.
Birth Control and Pregnancy
Birth control pills and other hormone-based contraceptives may be less 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 menstrual 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 to prevent pregnancy 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 tasks 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 laboratory 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.
Potential Side Effects
This medication may cause metabolic acidosis, a condition characterized by an imbalance of acid in the blood. This risk is higher in children, individuals with kidney problems, breathing difficulties, or diarrhea, and those taking certain medications, undergoing surgery, or following a ketogenic diet. If left untreated, metabolic acidosis can lead to kidney stones, bone problems, or growth issues in children.
Bleeding Risks
This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.
Interactions with Other Medications
Taking this medication with valproic acid can cause hypothermia (low body temperature), leading to fatigue, 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 teenagers, and regular growth checks may be necessary. Discuss this with your doctor.
Birth Control and Pregnancy
Birth control pills and other hormone-based contraceptives may be less 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 menstrual 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 to prevent pregnancy 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)
- Lethargy
- Ataxia (lack of coordination)
- Stupor
- Hypotension
- Abdominal pain
- Agitation
- Dizziness
- Depression
- Metabolic acidosis
- Coma
What to Do:
Call 1-800-222-1222 (Poison Control Center) immediately. Seek emergency medical attention. Induce emesis or perform gastric lavage if ingestion is recent. Provide supportive care, including hydration. Hemodialysis is an effective means of removing topiramate from the body.
Drug Interactions
Major Interactions
- Valproic acid (increased risk of hyperammonemia with or without encephalopathy)
- Oral contraceptives (decreased efficacy of estrogen-containing contraceptives)
- Other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide, dichlorphenamide - increased risk of metabolic acidosis and kidney stones)
- CNS depressants (additive CNS depression with alcohol, benzodiazepines, opioids, etc.)
Moderate Interactions
- Phenytoin (altered phenytoin and topiramate levels)
- Carbamazepine (decreased topiramate levels)
- Digoxin (decreased digoxin levels)
- Metformin (decreased metformin levels, increased topiramate levels)
- Lithium (altered lithium levels)
- Hydrochlorothiazide (increased topiramate levels)
Monitoring
Baseline Monitoring
Serum Bicarbonate (HCO3-)
Rationale: To establish baseline for potential metabolic acidosis.
Timing: Before initiation
Renal Function (SCr, eGFR)
Rationale: Topiramate is primarily renally cleared; dose adjustment needed for impairment.
Timing: Before initiation
Electrolytes (K+, Cl-)
Rationale: To assess baseline electrolyte balance.
Timing: Before initiation
Ophthalmologic exam (visual acuity, intraocular pressure)
Rationale: To establish baseline for potential acute myopia/secondary angle closure glaucoma.
Timing: Before initiation (especially if history of eye conditions)
Weight and Height (especially in children)
Rationale: Topiramate can cause weight loss and impact growth.
Timing: Before initiation
Routine Monitoring
Serum Bicarbonate (HCO3-)
Frequency: Periodically, especially during titration and if symptoms of acidosis occur.
Target: 22-29 mEq/L
Action Threshold: <20 mEq/L or symptomatic acidosis; consider dose reduction or discontinuation.
Renal Function (SCr, eGFR)
Frequency: Annually or as clinically indicated.
Target: Normal for age
Action Threshold: Significant decline in eGFR; adjust dose accordingly.
Weight
Frequency: Regularly, especially in children and adolescents.
Target: Stable or healthy BMI
Action Threshold: Significant or rapid weight loss; assess nutritional intake.
Electrolytes (K+, Cl-)
Frequency: Periodically, especially if signs of electrolyte imbalance.
Target: Normal ranges
Action Threshold: Abnormal values; investigate cause and manage.
Intraocular Pressure (IOP) and Visual Acuity
Frequency: If visual symptoms occur.
Target: Normal
Action Threshold: Acute onset of decreased visual acuity or ocular pain; refer to ophthalmologist immediately.
Suicidal ideation/behavior
Frequency: Regularly, especially during initial therapy and dose changes.
Target: Absence of ideation/behavior
Action Threshold: Emergence or worsening of suicidal thoughts/behavior; immediate clinical assessment and intervention.
Symptom Monitoring
- Cognitive impairment (e.g., difficulty concentrating, memory problems, word-finding difficulties)
- Paresthesia (tingling sensation)
- Fatigue/Somnolence
- Nausea/Diarrhea
- Anorexia/Weight loss
- Mood changes/Irritability
- Acute onset of decreased visual acuity or ocular pain (potential glaucoma)
- Decreased sweating/Fever (potential oligohidrosis/hyperthermia)
- Signs of metabolic acidosis (e.g., hyperventilation, fatigue, anorexia, cardiac arrhythmias)
- Signs of kidney stones (e.g., flank pain, hematuria)
- Signs of hyperammonemia (e.g., lethargy, vomiting, altered mental status, especially if on valproic acid)
Special Patient Groups
Pregnancy
Topiramate can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate an increased risk of oral clefts (cleft lip and/or palate) and possibly other congenital malformations (e.g., hypospadias, craniosynostosis, cardiovascular malformations) and adverse neurodevelopmental outcomes (e.g., autism spectrum disorder, intellectual disability). Use during pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus. Women of childbearing potential should be advised about the risks and the need for effective contraception.
Trimester-Specific Risks:
First Trimester:
Highest risk for major congenital malformations, particularly oral clefts. Risk of hypospadias and craniosynostosis also noted.
Second Trimester:
Potential for continued risk of neurodevelopmental effects; less data on structural malformations compared to first trimester.
Third Trimester:
Potential for continued risk of neurodevelopmental effects; risk of preterm birth and low birth weight.
Lactation
Topiramate is excreted into human milk. The effects on a breastfed infant are unknown. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Monitor breastfed infants for diarrhea, drowsiness, irritability, and poor weight gain.
Infant Risk:
Low to moderate risk. Monitor for adverse effects.
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. Approved for migraine prophylaxis in patients 12 years of age and older. Monitor for weight loss, decreased sweating, hyperthermia, and metabolic acidosis. Cognitive side effects may be more pronounced in children.
Geriatric Use
Use with caution due to increased likelihood of decreased 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.
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.
- Adequate hydration is crucial to minimize the risk of kidney stones and oligohidrosis/hyperthermia.
- Patients should be warned about the potential for cognitive slowing, often referred to as 'dopamax' effect, which can impact daily activities and school/work performance.
- Titration is essential to minimize side effects. Do not stop abruptly due to risk of increased seizure frequency.
- Counsel women of childbearing potential on the teratogenic risks and the need for highly effective contraception, as topiramate can reduce the efficacy of oral contraceptives.
- Be vigilant for signs of acute angle-closure glaucoma (sudden vision loss, eye pain) and metabolic acidosis (fatigue, rapid breathing).
Alternative Therapies
- For Epilepsy: Levetiracetam, Lamotrigine, Valproic acid, Carbamazepine, Oxcarbazepine, Zonisamide, Lacosamide, Phenytoin, Gabapentin, Pregabalin.
- For Migraine Prophylaxis: Propranolol, Timolol, Amitriptyline, Venlafaxine, CGRP inhibitors (e.g., Erenumab, Fremanezumab, Galcanezumab), OnabotulinumtoxinA.
Cost & Coverage
Average Cost:
$300 - $1000+ per 30 capsules (150mg ER)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand ER formulations); Tier 1 (for generic IR formulations)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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 reporting the overdose, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.