Topiramate 15mg Sprinklecapsules
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; Carbonic Anhydrase Inhibitor
Pregnancy Category
D
FDA Approved
Dec 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Topiramate 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 'Sprinkle' capsules can be opened and sprinkled on soft food for easier swallowing.
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, or look into local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's almost time for your next dose (less than 6 hours), skip the missed dose and return to 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, or look into local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's almost time for your next dose (less than 6 hours), skip the missed dose and return to 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 Topiramate affects you, as it can cause dizziness, drowsiness, and vision problems.
- Monitor for changes in body temperature, especially in hot weather or during exercise, as it can impair sweating.
- Maintain a balanced diet and monitor for significant weight changes.
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 25-50 mg/day, titrated weekly by 25-50 mg/day to target 200-400 mg/day in 2 divided doses. Migraine prophylaxis: Initial 25 mg/day at bedtime, titrated weekly by 25 mg/day to target 100 mg/day in 2 divided doses.
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
Epilepsy (monotherapy):
Initial 25 mg/day, titrated weekly by 25-50 mg/day to target 100-400 mg/day in 2 divided doses.
Lennox-Gastaut Syndrome:
Similar to adjunctive epilepsy dosing.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Epilepsy (adjunctive, âĨ2 years): Initial 1-3 mg/kg/day (max 25 mg/day) at bedtime for 1 week, then increase weekly by 1-3 mg/kg/day in 2 divided doses to target 5-9 mg/kg/day. Migraine prophylaxis (âĨ12 years): Initial 25 mg/day at bedtime, titrated weekly by 25 mg/day to target 100 mg/day in 2 divided doses.
Adolescent:
Epilepsy (adjunctive): Initial 25-50 mg/day, titrated weekly by 25-50 mg/day to target 200-400 mg/day in 2 divided doses. Migraine prophylaxis: Initial 25 mg/day at bedtime, titrated weekly by 25 mg/day to target 100 mg/day in 2 divided doses.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for CrCl > 70 mL/min.
Moderate:
For CrCl 30-69 mL/min, reduce dose by 50% and extend dosing interval (e.g., every other day or half daily dose).
Severe:
For CrCl < 30 mL/min, reduce dose by 50% and extend dosing interval (e.g., every other day or half daily dose).
Dialysis:
Topiramate is removed by hemodialysis. A supplemental dose of approximately one-half of the daily dose should be administered at the end of the hemodialysis session.
Hepatic Impairment:
Mild:
No specific adjustment.
Moderate:
Use with caution; slower clearance may occur. Consider lower starting doses and slower titration.
Severe:
Use with caution; slower clearance may occur. Consider lower starting doses and slower titration.
Pharmacology
Mechanism of Action
Topiramate's precise mechanism is not fully understood but involves multiple actions: potentiation of GABA-mediated chloride currents, antagonism of AMPA/kainate glutamate receptors, inhibition of carbonic anhydrase isoenzymes (especially CA-II and CA-IV), and blockade of voltage-dependent sodium channels. These actions collectively contribute to its anticonvulsant and migraine prophylactic effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 81%
Tmax:
Approximately 2-4 hours
FoodEffect:
Food does not significantly affect the extent of absorption, but may delay Tmax.
Distribution:
Vd:
0.6-0.8 L/kg
ProteinBinding:
13-17%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 21 hours
Clearance:
Approximately 20-30 mL/min (renal clearance)
ExcretionRoute:
Primarily renal (unchanged drug)
Unchanged:
Approximately 70% (in healthy volunteers)
Pharmacodynamics
OnsetOfAction:
Days to weeks (due to titration)
PeakEffect:
Weeks (after reaching target dose)
DurationOfAction:
Approximately 24 hours (allows for twice-daily dosing)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 right away:
Allergic reactions: 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.
Infections: Fever, chills, severe sore throat, ear or sinus pain, cough, increased sputum production or change in sputum color, painful urination, mouth sores, or wounds that won't heal.
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
Loss of appetite
Back pain, abdominal pain, or blood in the urine (may indicate a kidney stone)
Abnormal sensations (burning, numbness, or tingling)
Bone pain
Chest pain
Muscle pain or weakness
Shakiness
Difficulty walking
Uncontrolled 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.
Eye Problems: This medication can cause severe eye problems, potentially leading to permanent vision loss if left untreated. If you experience any new eye symptoms such as blurred vision, changes in vision, eye pain, or eye redness, contact your doctor immediately.
Liver Problems: Rarely, this medication can cause liver problems, which can be fatal. If you experience any symptoms such as 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 abnormalities 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 Reactions: A rare but potentially life-threatening skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) can occur. If you experience any symptoms 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 Side Effects
Most people taking this medication do not experience serious side effects, but some may occur. If you experience any of the following side effects and they bother you or do not go away, contact your doctor:
Gastrointestinal symptoms: Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Weight changes: Weight loss
Neurological symptoms: Feeling nervous or excitable, dizziness, sleepiness, tiredness, or weakness
Headache
Flushing
Common cold symptoms
* Joint pain
This is not an exhaustive list of potential 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, 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 right away:
Allergic reactions: 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.
Infections: Fever, chills, severe sore throat, ear or sinus pain, cough, increased sputum production or change in sputum color, painful urination, mouth sores, or wounds that won't heal.
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
Loss of appetite
Back pain, abdominal pain, or blood in the urine (may indicate a kidney stone)
Abnormal sensations (burning, numbness, or tingling)
Bone pain
Chest pain
Muscle pain or weakness
Shakiness
Difficulty walking
Uncontrolled 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.
Eye Problems: This medication can cause severe eye problems, potentially leading to permanent vision loss if left untreated. If you experience any new eye symptoms such as blurred vision, changes in vision, eye pain, or eye redness, contact your doctor immediately.
Liver Problems: Rarely, this medication can cause liver problems, which can be fatal. If you experience any symptoms such as 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 abnormalities 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 Reactions: A rare but potentially life-threatening skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) can occur. If you experience any symptoms 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 Side Effects
Most people taking this medication do not experience serious side effects, but some may occur. If you experience any of the following side effects and they bother you or do not go away, contact your doctor:
Gastrointestinal symptoms: Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Weight changes: Weight loss
Neurological symptoms: Feeling nervous or excitable, dizziness, sleepiness, tiredness, or weakness
Headache
Flushing
Common cold symptoms
* Joint pain
This is not an exhaustive list of potential 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 (could be acute myopia or secondary angle-closure glaucoma â seek immediate medical attention)
- Decreased sweating or fever (especially in children or during hot weather)
- Persistent fatigue, rapid breathing, loss of appetite, or irregular heartbeat (signs of metabolic acidosis)
- Severe back or side pain, blood in urine (signs of kidney stones)
- New or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, or thoughts of self-harm (report to doctor immediately)
- Unusual bleeding or bruising
- Severe skin rash
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 identify potential interactions between this medication and other substances.
* 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 other medications and health conditions. Never start, stop, or adjust the dose 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 identify potential interactions between this medication and other substances.
* 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 other medications and health conditions. Never start, stop, or adjust the dose 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 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 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 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 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 bleeding pattern while taking hormone-based birth control, consult your doctor. This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or plan to become pregnant, inform your doctor immediately. If you are able to get pregnant and do not wish to become pregnant, use a reliable form of birth control while taking this medication.
Breastfeeding
If you are breastfeeding, consult 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 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 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 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 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 bleeding pattern while taking hormone-based birth control, consult your doctor. This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or plan to become pregnant, inform your doctor immediately. If you are able to get pregnant and do not wish to become pregnant, use a reliable form of birth control while taking this medication.
Breastfeeding
If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Severe drowsiness
- Dizziness
- Blurred vision
- Double vision
- Slurred speech
- Lack of coordination
- Stomach pain
- Nausea
- Vomiting
- Agitation
- Depression
- Hypotension (low blood pressure)
- Metabolic acidosis
- Coma
What to Do:
Seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222. Management is primarily supportive, including gastric lavage, activated charcoal, and hemodialysis (topiramate is dialyzable).
Drug Interactions
Major Interactions
- Oral Contraceptives (estrogen-containing): May decrease efficacy of oral contraceptives, leading to breakthrough bleeding or unintended pregnancy. Consider alternative or additional birth control methods.
- Valproic Acid: Concomitant use has been associated with hyperammonemia with or without encephalopathy. Monitor for symptoms of hyperammonemia.
- Other Carbonic Anhydrase Inhibitors (e.g., Acetazolamide, Zonisamide): Increased risk of metabolic acidosis and kidney stone formation.
- CNS Depressants (e.g., Alcohol, Benzodiazepines, Opioids): Increased risk of CNS depression (drowsiness, dizziness, cognitive impairment).
Moderate Interactions
- Phenytoin, Carbamazepine: May decrease topiramate concentrations. May require topiramate dose adjustment.
- Digoxin: May decrease digoxin levels. Monitor digoxin levels.
- Metformin: Topiramate may decrease metformin clearance. Monitor blood glucose.
- Lithium: May alter lithium levels. Monitor lithium levels.
- Hydrochlorothiazide: May increase topiramate levels. May require topiramate dose adjustment.
Minor Interactions
- Pioglitazone: May decrease pioglitazone levels. Monitor blood glucose.
Monitoring
Baseline Monitoring
Serum Bicarbonate (HCO3)
Rationale: To establish baseline for metabolic acidosis risk.
Timing: Before initiating therapy
Renal Function (CrCl, BUN, Creatinine)
Rationale: Topiramate is primarily renally cleared; dose adjustment needed for impairment.
Timing: Before initiating therapy
Electrolytes (Potassium, Chloride)
Rationale: To assess baseline electrolyte balance.
Timing: Before initiating therapy
Intraocular Pressure (IOP) / Ophthalmologic Exam
Rationale: To establish baseline for acute myopia/secondary angle-closure glaucoma risk.
Timing: Before initiating therapy (especially if history of eye conditions)
Routine Monitoring
Serum Bicarbonate (HCO3)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated), especially in pediatric patients or those with risk factors for acidosis.
Target: 22-29 mEq/L (adults)
Action Threshold: Persistent decrease below normal range; consider dose reduction or discontinuation if severe or symptomatic.
Renal Function (CrCl, BUN, Creatinine)
Frequency: Annually or as clinically indicated, especially in elderly or those with risk factors for renal impairment.
Target: Normal for age
Action Threshold: Significant decline in CrCl; adjust dose accordingly.
Weight
Frequency: Regularly (e.g., monthly initially, then quarterly)
Target: Stable or within healthy range
Action Threshold: Significant or rapid weight loss; assess nutritional intake and consider dose adjustment.
Electrolytes (Potassium, Chloride)
Frequency: Periodically, especially if metabolic acidosis develops.
Target: Normal range
Action Threshold: Abnormal levels; address underlying cause.
Ophthalmologic Exam
Frequency: If visual symptoms occur (e.g., acute onset of decreased vision, eye pain).
Target: Normal vision/IOP
Action Threshold: Acute myopia or secondary angle-closure glaucoma symptoms; discontinue topiramate immediately.
Symptom Monitoring
- Cognitive impairment (e.g., difficulty concentrating, word-finding difficulties, memory problems)
- Mood changes (e.g., depression, anxiety, irritability)
- Suicidal ideation or behavior
- Visual disturbances (e.g., blurred vision, eye pain, sudden decrease in vision)
- Signs of metabolic acidosis (e.g., fatigue, anorexia, rapid breathing, cardiac arrhythmias)
- Signs of kidney stones (e.g., flank pain, hematuria)
- Decreased sweating or fever (especially in hot weather or during exertion)
- Paresthesias (tingling sensations)
- Dizziness, somnolence
Special Patient Groups
Pregnancy
Topiramate is classified as Pregnancy Category D due to evidence of human fetal risk. It should only be used during pregnancy 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:
Increased risk of oral clefts (cleft lip/palate) and hypospadias. Data also suggest increased risk of low birth weight and small for gestational age.
Second Trimester:
Potential for continued risk of low birth weight and small for gestational age. Risk of metabolic acidosis in the mother, which can affect the fetus.
Third Trimester:
Potential for continued risk of low birth weight and small for gestational age. Risk of metabolic acidosis in the mother, which can affect the fetus. Neonatal withdrawal symptoms have been reported.
Lactation
Topiramate is excreted into breast milk. The American Academy of Pediatrics considers it to have an unknown effect on the nursing infant but may be of concern. Monitor breastfed infants for drowsiness, diarrhea, and poor weight gain. Weigh the benefits of breastfeeding against the potential risks to the infant.
Infant Risk:
L3 (Moderate risk). Potential for infant drowsiness, diarrhea, and metabolic acidosis. Monitor infant closely.
Pediatric Use
Topiramate is approved for adjunctive treatment of partial-onset seizures and generalized tonic-clonic seizures in patients 2 years and older, and for Lennox-Gastaut syndrome in patients 2 years and older. It is approved for migraine prophylaxis in adolescents 12 years and older. Children are at higher risk for oligohidrosis/hyperthermia and metabolic acidosis. Close monitoring of bicarbonate levels and hydration status is crucial.
Geriatric Use
Use with caution in elderly patients due to increased likelihood of decreased renal function. Start with lower doses and titrate slowly. Monitor renal function and for adverse effects such as cognitive impairment, dizziness, and falls more closely.
Clinical Information
Clinical Pearls
- Always titrate Topiramate slowly to minimize side effects, especially cognitive ones.
- Emphasize adequate hydration to patients to reduce the risk of kidney stones and heat-related issues.
- Counsel women of childbearing potential about the risks during pregnancy and the need for effective contraception.
- Be aware of the potential for weight loss, which can be a desired effect for some but needs monitoring for others.
- The sprinkle capsules can be opened and the contents sprinkled on a spoonful of soft food (e.g., applesauce, pudding) and swallowed immediately without chewing. Do not store the mixture for later use.
- Patients should be advised to report any sudden changes in vision or eye pain immediately, as this could indicate acute angle-closure glaucoma, a medical emergency.
Alternative Therapies
- For Epilepsy: Levetiracetam, Lamotrigine, Valproic Acid, Carbamazepine, Oxcarbazepine, Phenytoin, Gabapentin, Pregabalin, Zonisamide, Lacosamide.
- For Migraine Prophylaxis: Propranolol, Timolol, Amitriptyline, Valproic Acid, Erenumab, Fremanezumab, Galcanezumab, Eptinezumab, OnabotulinumtoxinA.
Cost & Coverage
Average Cost:
$30 - $150 per 30 capsules (15mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic); Tier 3 or Non-Formulary (brand)
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, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call the poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.