Topiramate ER 100mg 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 modulator, 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 extended-release is a medication used to prevent seizures (epilepsy) and to prevent migraine headaches. It works by affecting several chemicals in the brain to calm overactive nerve signals. The extended-release form is taken once a day.
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, 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 medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program.
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 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, 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 medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program.
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 further instructions.
Lifestyle & Tips
- Stay well-hydrated to reduce the risk of kidney stones.
- Avoid excessive alcohol consumption, as it can increase side effects like dizziness and drowsiness.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness, drowsiness, and vision problems.
- Monitor for changes in mood or behavior, including thoughts of self-harm, and report them to your doctor immediately.
- Avoid becoming overheated or dehydrated, especially in hot weather or during strenuous activity, as topiramate can reduce sweating.
- If you are taking oral contraceptives, discuss with your doctor as topiramate may reduce their effectiveness.
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 weekly to a target dose of 200-400 mg once daily. Migraine Prophylaxis: Initial 50 mg once daily for 7 days, then increase by 50 mg weekly to a target dose of 100 mg once daily.
Dose Range:
50 - 400 mg
Condition-Specific Dosing:
Epilepsy (monotherapy):
Initial 50 mg once daily for 7 days, then increase by 50 mg weekly to a target dose of 400 mg once daily.
Lennox-Gastaut Syndrome:
Initial 50 mg once daily for 7 days, then increase by 50 mg weekly to a target dose of 200-400 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Epilepsy (adjunctive, âĨ6 years): Initial 25 mg once daily for 7 days, then increase by 25-50 mg weekly to a target dose of 5-9 mg/kg/day once daily. Migraine Prophylaxis (âĨ12 years): Initial 50 mg once daily for 7 days, then increase by 50 mg weekly to a target dose of 100 mg once daily.
Adolescent:
Epilepsy (adjunctive, âĨ6 years): Initial 25 mg once daily for 7 days, then increase by 25-50 mg weekly to a target dose of 5-9 mg/kg/day once daily. Migraine Prophylaxis (âĨ12 years): Initial 50 mg once daily for 7 days, then increase by 50 mg weekly to a target dose of 100 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 50-80 mL/min)
Moderate:
Reduce dose by 50% (CrCl 30-49 mL/min)
Severe:
Reduce dose by 50% (CrCl <30 mL/min)
Dialysis:
Administer 50% of the usual dose on dialysis days, in divided doses at the beginning and end of the hemodialysis session.
Hepatic Impairment:
Mild:
No specific adjustment recommended, but use with caution.
Moderate:
No specific adjustment recommended, but use with caution.
Severe:
No specific adjustment recommended, but use with caution.
Pharmacology
Mechanism of Action
Topiramate's precise mechanism is not fully understood but involves multiple actions: blockade of voltage-dependent sodium channels, enhancement of GABA-A receptor activity (though not directly binding to the benzodiazepine site), antagonism of AMPA/kainate glutamate receptors, and inhibition of carbonic anhydrase (primarily isozymes II and IV). These actions contribute to its anticonvulsant and migraine prophylactic effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 81% (oral)
Tmax:
Extended-release: 24 hours (range 4-48 hours)
FoodEffect:
Food does not significantly affect the bioavailability of the extended-release formulation.
Distribution:
Vd:
0.6-0.8 L/kg
ProteinBinding:
13-17%
CnssPenetration:
Yes
Elimination:
HalfLife:
20-30 hours
Clearance:
Approximately 20-30 mL/min (renal)
ExcretionRoute:
Renal (primarily unchanged drug)
Unchanged:
Approximately 70% (in healthy volunteers)
Pharmacodynamics
OnsetOfAction:
Gradual (due to slow titration)
PeakEffect:
Achieved after reaching steady-state concentrations (typically 4-8 days with once-daily dosing)
DurationOfAction:
24 hours (extended-release formulation)
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while 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.
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in individuals 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.
This medication may cause severe eye problems, potentially leading to permanent vision loss if left untreated. If you notice any new eye symptoms such as blurred vision, changes in vision, eye pain, or eye redness, contact your doctor immediately.
Rarely, this medication has caused liver problems, which can be fatal. If you experience any signs of liver problems such as dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor immediately.
Sweating less and high body temperatures have occurred with this medication, sometimes requiring hospitalization. Be cautious in hot weather and during physical activity. If you experience a fever or decreased sweating, contact your doctor immediately.
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, potentially causing long-term health problems or death. If you notice any signs such as 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 Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.
Changes in taste.
Weight loss.
Feeling anxious or excitable.
Dizziness, drowsiness, fatigue, or weakness.
Headache.
Flushing.
Common cold symptoms.
* Joint pain.
This is not an exhaustive list of 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 online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while 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.
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in individuals 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.
This medication may cause severe eye problems, potentially leading to permanent vision loss if left untreated. If you notice any new eye symptoms such as blurred vision, changes in vision, eye pain, or eye redness, contact your doctor immediately.
Rarely, this medication has caused liver problems, which can be fatal. If you experience any signs of liver problems such as dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor immediately.
Sweating less and high body temperatures have occurred with this medication, sometimes requiring hospitalization. Be cautious in hot weather and during physical activity. If you experience a fever or decreased sweating, contact your doctor immediately.
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, potentially causing long-term health problems or death. If you notice any signs such as 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 Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.
Changes in taste.
Weight loss.
Feeling anxious or excitable.
Dizziness, drowsiness, fatigue, or weakness.
Headache.
Flushing.
Common cold symptoms.
* Joint pain.
This is not an exhaustive list of 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 online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden decrease in vision or eye pain (signs of acute angle-closure glaucoma)
- Confusion, memory problems, difficulty concentrating, or word-finding difficulties (cognitive side effects)
- Persistent tingling or numbness in hands/feet (paresthesia)
- Unexplained fatigue, weakness, or muscle pain (signs of metabolic acidosis)
- Severe stomach pain, nausea, vomiting, or yellowing of skin/eyes (signs of liver problems, rare)
- Fever, decreased sweating, or hot, dry skin (signs of oligohidrosis/hyperthermia)
- New or worsening depression, anxiety, agitation, or thoughts of self-harm
- Signs of kidney stones (e.g., severe back or side pain, blood in urine, painful urination)
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. This information will help your doctor identify potential interactions.
* Any existing health problems, as this medication may interact with certain 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. This information will help your doctor identify potential interactions.
* Any existing health problems, as this medication may interact with certain 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 activities that require alertness.
Stopping the Medication
Do not suddenly stop taking this medication 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.
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 be higher 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 the 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 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 birth control methods may not be effective in preventing pregnancy while taking this medication. Use an additional form of birth control, such as a condom. 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 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 activities that require alertness.
Stopping the Medication
Do not suddenly stop taking this medication 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.
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 be higher 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 the 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 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 birth control methods may not be effective in preventing pregnancy while taking this medication. Use an additional form of birth control, such as a condom. 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 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)
- Impaired mentation
- Lethargy
- Ataxia (loss of coordination)
- Abdominal pain
- Hypotension
- Palpitations
- Metabolic acidosis
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive; 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 stone formation)
Moderate Interactions
- CNS depressants (additive CNS depression)
- Metformin (topiramate may decrease metformin clearance)
- Lithium (topiramate may decrease lithium levels)
- Hydrochlorothiazide (may increase topiramate levels)
- Pioglitazone (topiramate may decrease pioglitazone levels)
- Phenytoin, Carbamazepine (may decrease topiramate levels)
Monitoring
Baseline Monitoring
Serum bicarbonate
Rationale: To establish baseline for monitoring metabolic acidosis.
Timing: Before initiation
Renal function (CrCl)
Rationale: To determine appropriate dosing and monitor for renal stone risk.
Timing: Before initiation
Eye examination (intraocular pressure)
Rationale: To establish baseline and monitor for acute angle-closure glaucoma.
Timing: Before initiation
Weight
Rationale: To establish baseline and monitor for weight changes.
Timing: Before initiation
Routine Monitoring
Serum bicarbonate
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: 22-29 mEq/L
Action Threshold: <20 mEq/L or symptomatic acidosis
Renal function
Frequency: Annually or as clinically indicated
Target: Normal CrCl
Action Threshold: Significant decline in CrCl
Weight
Frequency: Periodically (e.g., every 3-6 months)
Target: Stable
Action Threshold: Significant or rapid weight loss
Electrolytes (potassium, chloride)
Frequency: Periodically, especially if bicarbonate is low
Target: Normal
Action Threshold: Abnormal values
Symptom Monitoring
- Cognitive impairment (e.g., difficulty concentrating, memory problems, word-finding difficulties)
- Paresthesia (tingling sensation)
- Fatigue, somnolence
- Anorexia, weight loss
- Mood changes, depression, suicidal ideation
- Visual disturbances (e.g., blurred vision, eye pain, sudden decrease in visual acuity - signs of acute myopia/glaucoma)
- Signs of metabolic acidosis (e.g., hyperventilation, fatigue, anorexia)
- Signs of kidney stones (e.g., flank pain, hematuria)
- Signs of oligohidrosis/hyperthermia (e.g., decreased sweating, fever, especially in hot weather or during exertion)
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. Use during pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Increased risk of oral clefts (cleft lip and/or palate) and other major congenital malformations.
Second Trimester:
Potential for continued risk of malformations and growth restriction.
Third Trimester:
Potential for growth restriction and withdrawal symptoms in the neonate if exposed late in pregnancy.
Lactation
Topiramate is excreted in human milk. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother and the potential adverse effects on the breastfed infant (e.g., diarrhea, drowsiness, irritability, poor weight gain). Monitoring the infant for adverse effects is recommended.
Infant Risk:
L3 (Moderately Safe) - Excreted in human milk; monitor infant for drowsiness, poor feeding, diarrhea, and irritability.
Pediatric Use
Approved for adjunctive treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older. Approved for migraine prophylaxis in adolescents 12 years of age and older. Risk of oligohidrosis and hyperthermia is higher in pediatric patients. Monitor for growth and weight changes.
Geriatric Use
Use with caution due to potential for decreased renal clearance and increased susceptibility to side effects, particularly cognitive impairment and metabolic acidosis. Start with lower doses and titrate slowly. Monitor renal function closely.
Clinical Information
Clinical Pearls
- Topiramate ER is designed for once-daily dosing, which can improve adherence compared to immediate-release formulations.
- Patients should be advised to swallow capsules whole or sprinkle the contents on a small amount of soft food (e.g., applesauce) and swallow immediately without chewing.
- Slow titration is crucial to minimize side effects, especially cognitive ones ('topamax fog') and paresthesia.
- Adequate hydration is essential to prevent kidney stone formation, a known side effect.
- Counsel patients on the risk of metabolic acidosis and symptoms to watch for.
- Be aware of the potential for weight loss, which can be a desired effect for some but a concern for others.
- Patients should be warned about the rare but serious risk of acute myopia and secondary angle-closure glaucoma, and instructed to seek immediate medical attention for sudden vision changes or eye pain.
- Consider the interaction with oral contraceptives; advise patients on alternative or additional birth control methods.
Alternative Therapies
- For Epilepsy: Levetiracetam, Lamotrigine, Valproic acid, Carbamazepine, Oxcarbazepine, Phenytoin, Zonisamide, Lacosamide, Pregabalin, Gabapentin.
- For Migraine Prophylaxis: Propranolol, Timolol, Amitriptyline, Venlafaxine, CGRP inhibitors (e.g., Erenumab, Fremanezumab, Galcanezumab), OnabotulinumtoxinA.
Cost & Coverage
Average Cost:
Price varies widely by pharmacy and dosage. For 100mg ER, typically $300-$800+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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 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, consult 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.