Topiramate 25mg Sprinkle Capsules

Manufacturer ZYDUS PHARMACEUTICALS (USA) Active Ingredient Topiramate Sprinkle Capsules(toe PYRE a mate) Pronunciation toe PYRE a mate
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.
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Drug Class
Anticonvulsant; Antimigraine agent
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Pharmacologic Class
Sulfamate-substituted monosaccharide
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Pregnancy Category
Not available
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FDA Approved
Dec 1996
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DEA Schedule
Not Controlled

Overview

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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. The sprinkle capsules can be swallowed whole or opened and sprinkled on soft food.
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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 drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

You can take your medication by swallowing the whole capsule 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 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 almost time for your next dose (less than 6 hours), skip the missed dose and resume your regular dosing 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.
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Lifestyle & Tips

  • Drink plenty of fluids (6-8 glasses of water daily) to help prevent kidney stones and reduce the risk of overheating/decreased sweating.
  • Avoid becoming overheated or dehydrated, especially during exercise or in hot weather.
  • Do not stop taking this medication suddenly, as it can cause seizures to worsen or recur. Always consult your doctor before making any changes.
  • Be aware that this medication may cause drowsiness, dizziness, or vision problems. Avoid driving or operating machinery until you know how it affects you.
  • If you are taking birth control pills, discuss with your doctor as topiramate may make them less effective.

Dosing & Administration

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Adult Dosing

Standard Dose: Epilepsy: Initial 25-50 mg/day, titrate weekly by 25-50 mg/day to target 200-400 mg/day in 2 divided doses. Migraine Prophylaxis: Initial 25 mg/day, titrate 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 for 1 week, then increase by 25-50 mg/week to target 100 mg/day (max 500 mg/day).
Epilepsy (adjunctive): Initial 25-50 mg/day, titrate weekly by 25-50 mg/day to target 200-400 mg/day.
Migraine Prophylaxis: Initial 25 mg/day at night for 1 week, then increase by 25 mg/week to target 100 mg/day in 2 divided doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Epilepsy (adjunctive, â‰Ĩ2 years): Initial 1-3 mg/kg/day, titrate weekly by 1-3 mg/kg/day to target 5-9 mg/kg/day in 2 divided doses. Migraine Prophylaxis (â‰Ĩ12 years): Same as adult.
Adolescent: Epilepsy (adjunctive, â‰Ĩ12 years): Same as adult. Migraine Prophylaxis (â‰Ĩ12 years): Same as adult.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment for CrCl > 70 mL/min.
Moderate: Reduce dose by 50% for CrCl 30-69 mL/min.
Severe: Reduce dose by 50% for CrCl < 30 mL/min.
Dialysis: Topiramate is removed by hemodialysis. A supplemental dose of approximately one-half of the usual daily dose should be administered in divided doses at the beginning and end of the hemodialysis session.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: Use with caution; consider lower starting dose and slower titration.
Severe: Use with caution; consider lower starting dose and slower titration.

Pharmacology

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Mechanism of Action

Topiramate's precise mechanism is not fully understood but involves multiple actions: it blocks voltage-dependent sodium channels, enhances the activity of the neurotransmitter gamma-aminobutyrate (GABA) at some GABA-A receptor subtypes, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits carbonic anhydrase, particularly isozymes II and IV.
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Pharmacokinetics

Absorption:

Bioavailability: 81%
Tmax: 2-4 hours
FoodEffect: Minimal effect on bioavailability; may slightly delay Tmax.

Distribution:

Vd: 0.6-0.8 L/kg
ProteinBinding: 13-17%
CnssPenetration: Yes

Elimination:

HalfLife: 21 hours
Clearance: Approximately 20-30 mL/min in healthy adults
ExcretionRoute: Renal
Unchanged: Approximately 70% (in healthy volunteers)
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Pharmacodynamics

OnsetOfAction: Gradual (requires titration)
PeakEffect: Achieved after several weeks of titration to target dose.
DurationOfAction: Approximately 24 hours (due to long half-life, allowing twice-daily dosing).

Safety & Warnings

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BLACK BOX WARNING

Antiepileptic drugs (AEDs), including Topiramate, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
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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 immediate medical attention:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Acidosis (Too Much Acid in the Blood): Confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, upset stomach, vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased sputum production or change in sputum color, painful urination, mouth sores, or a wound that won't heal.
High Ammonia Levels: Irregular heartbeat, abnormal breathing, confusion, pale skin, slow heartbeat, seizures, sweating, vomiting, or twitching.
Unexplained Bleeding or Bruising: Any unusual bruising or bleeding without a known cause.
Neurological Symptoms: Confusion, difficulty focusing, changes in behavior, memory problems, loss of memory, trouble speaking, difficulty sleeping, balance problems, severe dizziness, or fainting.
Kidney Stone Symptoms: Back pain, abdominal pain, or blood in the urine.
Other Severe Symptoms: Burning, numbness, or tingling sensations, bone pain, chest pain, muscle pain or weakness, shakiness, difficulty walking, or uncontrolled eye movements.

Mental Health and Suicidal Thoughts: Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, especially in people with a history of suicidal behavior. If you experience any new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek help right away.

Eye Problems: This medication may cause severe eye problems that can lead 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.

Liver Problems: Rarely, this medication can cause liver problems, which can be life-threatening. 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 right away.

Heat-Related Illness: This medication can cause sweating problems and high body temperatures, which can lead to hospitalization. Be cautious in hot weather and during physical activity. If you experience a fever or decreased sweating, contact your doctor immediately.

Severe Skin Reaction: A rare but potentially life-threatening skin reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis may occur. If you notice 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 do not experience severe 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:

Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Changes in taste
Weight loss
Feeling nervous or excitable
Dizziness, drowsiness, tiredness, or weakness
Headache
Flushing
Common cold symptoms
* Joint pain

This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Sudden decrease in vision or eye pain (could be acute angle-closure glaucoma)
  • Decreased sweating or fever (could be oligohidrosis/hyperthermia)
  • Signs of kidney stones (severe pain in your side or back, blood in urine, painful urination)
  • Signs of metabolic acidosis (unexplained fatigue, loss of appetite, nausea, vomiting, rapid breathing)
  • Changes in mood or behavior, thoughts of self-harm (report immediately)
  • Unusual tingling or numbness in hands or feet
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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 as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.

To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Existing health problems or conditions

Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

To minimize potential risks, do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of seizures. If you need to discontinue this drug, your doctor will provide guidance on how to gradually stop taking it. Additionally, follow your doctor's instructions for regular blood work and other laboratory tests.

While taking this medication, it is recommended that you avoid consuming alcohol. Before using marijuana, cannabis, or prescription or over-the-counter drugs that may cause drowsiness, discuss the potential risks with your doctor.

This medication may cause a condition known as metabolic acidosis, which can be more likely to occur in children, individuals 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 over time.

There is a potential increased risk of bleeding associated with this medication, which can be life-threatening in some cases. Consult your doctor to discuss this risk.

If you are taking valproic acid in combination with this medication, you may be at risk of developing hypothermia, which can cause fatigue, confusion, or coma. Discuss this potential risk with your doctor.

When administering this medication to children, exercise caution, as they may be more susceptible to certain side effects. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult your doctor to discuss this potential risk.

The effectiveness of birth control pills and other hormone-based contraceptives may be reduced when taking this medication. To prevent pregnancy, consider using an additional form of birth control, such as a condom. If you are taking hormone-based birth control and experience any changes in your menstrual bleeding pattern, consult your doctor.

This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or suspect you may be 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, as they will need to discuss potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Convulsions
  • Drowsiness
  • Speech disturbance
  • Blurred vision
  • Double vision
  • Lethargy
  • Ataxia (loss of coordination)
  • Abdominal pain
  • Hypotension (low blood pressure)
  • Agitation
  • Dizziness
  • Depression
  • Metabolic acidosis

What to Do:

Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Oral Contraceptives (decreased efficacy of estrogen-containing OCs)
  • Carbonic Anhydrase Inhibitors (e.g., zonisamide, acetazolamide, dichlorphenamide - increased risk of metabolic acidosis and kidney stones)
  • Valproic Acid (increased risk of hyperammonemia with or without encephalopathy)
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Moderate Interactions

  • CNS Depressants (additive CNS depression)
  • Lithium (altered lithium levels, monitor)
  • Metformin (increased metformin levels, monitor)
  • Phenytoin (altered phenytoin and topiramate levels, monitor)
  • Carbamazepine (altered carbamazepine and topiramate levels, monitor)
  • Hydrochlorothiazide (increased topiramate levels)
  • Pioglitazone (decreased pioglitazone levels)

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

Rationale: Topiramate is primarily renally eliminated; dose adjustment needed in renal impairment.

Timing: Prior to initiation.

Serum bicarbonate levels

Rationale: Topiramate can cause metabolic acidosis due to carbonic anhydrase inhibition.

Timing: Prior to initiation.

Eye examination (visual acuity, intraocular pressure)

Rationale: Risk of acute myopia and secondary angle-closure glaucoma.

Timing: Prior to initiation, especially if patient has risk factors.

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Routine Monitoring

Serum bicarbonate levels

Frequency: Periodically (e.g., every 3-6 months or as clinically indicated), especially in pediatric patients or those with renal impairment.

Target: Normal range (22-29 mEq/L)

Action Threshold: If persistently low or symptomatic acidosis, consider dose reduction or discontinuation.

Weight

Frequency: Periodically (e.g., monthly initially, then every 3-6 months).

Target: Maintain healthy weight.

Action Threshold: Significant or rapid weight loss may require nutritional support or dose adjustment.

Renal function (BUN, creatinine)

Frequency: Annually or as clinically indicated, especially in elderly or those with risk factors for renal impairment.

Target: Normal range.

Action Threshold: Dose adjustment if CrCl falls below 70 mL/min.

Electrolytes (potassium, chloride)

Frequency: Periodically, especially if metabolic acidosis is present or suspected.

Target: Normal range.

Action Threshold: Address electrolyte imbalances.

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Symptom Monitoring

  • Metabolic acidosis (fatigue, anorexia, nausea, vomiting, hyperventilation, cardiac arrhythmias)
  • Kidney stones (flank pain, hematuria, dysuria)
  • Oligohidrosis/Hyperthermia (decreased sweating, fever, especially in hot weather or during exertion)
  • Acute myopia/Secondary angle-closure glaucoma (sudden decrease in visual acuity, eye pain, redness)
  • Suicidal thoughts or behavior (mood changes, agitation, anxiety, panic attacks, insomnia, irritability, hostility, impulsivity, severe restlessness, hypomania, mania)
  • Cognitive impairment (difficulty with concentration, memory, word finding)
  • Paresthesia (tingling sensation in extremities)

Special Patient Groups

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Pregnancy

Topiramate can cause fetal harm, including oral clefts (cleft lip/palate) and hypospadias. It is recommended to use effective contraception during treatment. If pregnancy occurs, discuss the risks and benefits with your healthcare provider. Enrollment in a pregnancy registry is encouraged.

Trimester-Specific Risks:

First Trimester: Increased risk of oral clefts (cleft lip/palate) and hypospadias. Highest risk during this trimester.
Second Trimester: Potential for reduced fetal growth and low birth weight.
Third Trimester: Potential for reduced fetal growth and low birth weight. Risk of metabolic acidosis in the newborn.
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Lactation

Topiramate is excreted into breast milk. The decision to breastfeed should consider the potential for adverse effects in the infant (e.g., drowsiness, diarrhea, poor feeding, irritability) versus the benefits of breastfeeding and the mother's need for the drug.

Infant Risk: Low to moderate risk. Monitor infant for drowsiness, diarrhea, and adequate weight gain.
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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 adolescents 12 years of age and older. Pediatric patients are at higher risk for oligohidrosis and hyperthermia, and metabolic acidosis.

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Geriatric Use

Start with lower doses and titrate slowly due to potential for decreased renal clearance and increased susceptibility to adverse effects. Monitor renal function and hydration status closely.

Clinical Information

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Clinical Pearls

  • Ensure adequate hydration (2-3 liters of fluid daily) to minimize the risk of kidney stones and oligohidrosis/hyperthermia.
  • Titration is crucial for tolerability; rapid dose increases can lead to significant side effects.
  • Counsel patients on the risk of cognitive slowing ('dopamax' effect) and paresthesias, which often improve with continued use or dose adjustment.
  • Advise female patients of childbearing potential about the risk of fetal harm and the need for effective contraception.
  • Sprinkle capsules can be opened and sprinkled on a spoonful of soft food (e.g., applesauce, pudding) and swallowed immediately without chewing.
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Alternative Therapies

  • For Epilepsy: Valproic acid, Lamotrigine, Levetiracetam, Carbamazepine, Phenytoin, Oxcarbazepine, Zonisamide, Lacosamide.
  • For Migraine Prophylaxis: Beta-blockers (e.g., Propranolol, Metoprolol), Tricyclic antidepressants (e.g., Amitriptyline), CGRP inhibitors (e.g., Erenumab, Fremanezumab, Galcanezumab), OnabotulinumtoxinA (Botox).
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 capsules (generic 25mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.