Topiramate ER 200mg Sprinkle Caps

Manufacturer UPSHER-SMITH Active Ingredient Topiramate Extended-Release 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; Migraine Prophylaxis
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Pharmacologic Class
Sulfamate-substituted monosaccharide; Voltage-gated sodium channel blocker; GABA-A receptor modulator; AMPA/kainate receptor antagonist; Carbonic anhydrase inhibitor
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Pregnancy Category
Category D
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FDA Approved
Aug 2013
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Topiramate extended-release is a medication used to prevent seizures (epilepsy) and to prevent migraine headaches. It works by affecting certain chemicals and electrical signals in the brain. The extended-release form means you take it once a day.
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How to Use This Medicine

Taking Your Medication

To take this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, as directed. It's essential to continue taking this medication as prescribed by your doctor or healthcare provider, even if you're feeling well.

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, swallow the mixture immediately and do not store it for later use. After taking the medication with food, drink plenty of fluids 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 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 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.
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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 decreased sweating.
  • Avoid activities that may lead to overheating or dehydration, especially in warm weather or during strenuous exercise.
  • Do not stop taking this medication suddenly, as it can cause seizures to worsen. Always consult your doctor before making any changes.
  • Be aware of potential cognitive side effects ('brain fog'); avoid driving or operating machinery until you know how the medication affects you.
  • If you are taking oral contraceptives, be aware that topiramate may make them less effective; consider alternative or additional birth control methods.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 50 mg once daily for 7 days, then increase by 50 mg weekly. Maintenance: 200-400 mg once daily.
Dose Range: 200 - 400 mg

Condition-Specific Dosing:

Epilepsy (Monotherapy): Initial: 50 mg once daily for 7 days, then increase by 50 mg weekly. Maintenance: 400 mg once daily.
Epilepsy (Adjunctive): Initial: 50 mg once daily for 7 days, then increase by 50 mg weekly. Maintenance: 200-400 mg once daily.
Migraine Prophylaxis: Initial: 25 mg once daily for 7 days, then increase by 25 mg weekly. Maintenance: 100 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Epilepsy (Adjunctive, â‰Ĩ6 years): Initial: 25 mg once daily for 7 days, then increase by 25 mg weekly. Maintenance: 5-9 mg/kg/day once daily.
Adolescent: Epilepsy (Adjunctive, â‰Ĩ6 years): Initial: 25 mg once daily for 7 days, then increase by 25 mg weekly. Maintenance: 5-9 mg/kg/day once daily. Migraine Prophylaxis (â‰Ĩ12 years): Initial: 25 mg once daily for 7 days, then increase by 25 mg weekly. Maintenance: 100 mg once daily.
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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: Topiramate is removed by hemodialysis. A supplemental dose equal to approximately one-half of the daily dose should be administered on hemodialysis days. The supplemental dose should be administered in divided doses at the beginning and end of the hemodialysis procedure.

Hepatic Impairment:

Mild: No specific adjustment recommended, but use with caution.
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, potentiates the activity of gamma-aminobutyrate (GABA) at GABA-A receptors, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits carbonic anhydrase, particularly isozymes II and IV. These actions contribute to its anticonvulsant and migraine prophylactic effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 81% (immediate-release); Extended-release formulation provides sustained release.
Tmax: Approximately 24 hours (extended-release); 2 hours (immediate-release)
FoodEffect: Food does not significantly affect the bioavailability of topiramate extended-release, but may delay Tmax.

Distribution:

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

Elimination:

HalfLife: Approximately 20-30 hours (extended-release); 21 hours (immediate-release)
Clearance: Approximately 20-30 mL/min (renal clearance)
ExcretionRoute: Primarily renal (approximately 70% unchanged)
Unchanged: Approximately 70%
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Pharmacodynamics

OnsetOfAction: Gradual, due to titration schedule.
PeakEffect: Achieved after several weeks of titration to target dose.
DurationOfAction: 24 hours (extended-release, once daily dosing)

Safety & Warnings

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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 immediately or seek emergency 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 or discolored sputum, painful urination, mouth sores, or a wound that won't heal.
High Ammonia Levels: Irregular heartbeat, abnormal breathing, confusion, pale skin, slow heartbeat, seizures, sweating, vomiting, or twitching.
Unexplained Bleeding or Bruising: Any unusual bruising or bleeding.
Neurological Symptoms: Confusion, difficulty focusing, changes in behavior, memory problems, loss of memory, speech difficulties, sleep disturbances, balance problems, severe dizziness, or fainting.
Kidney Stone Symptoms: Back pain, abdominal pain, or blood in the urine.
Nerve Problems: Abnormal burning, numbness, or tingling sensations.
Musculoskeletal Symptoms: Bone pain, chest pain, muscle pain or weakness, shakiness, or difficulty walking.
Eye Movement Problems: Inability to control eye movements.
Suicidal Thoughts or Actions: Like other seizure medications, this drug may increase the risk of suicidal thoughts or behaviors, especially in people with a history of such thoughts or actions. Contact your doctor immediately if you experience new or worsening symptoms like depression, anxiety, restlessness, irritability, panic attacks, or mood changes.
Eye Problems: 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, changes in vision, eye pain, or eye redness.
Liver Problems: Rarely, this medication has caused liver problems, which can be fatal. Contact your doctor immediately if you experience dark urine, fatigue, decreased appetite, stomach pain, nausea, vomiting, pale stools, or yellowing of the skin or eyes.
Heat-Related Illness: This medication may cause sweating problems, leading to high body temperatures, especially in hot weather or during physical activity. Be cautious and seek medical attention if you experience fever or decreased sweating.
Severe Skin Reaction (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis): A rare but potentially life-threatening skin reaction may occur, causing severe health problems or death. Seek medical attention immediately if you experience red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.

Other Side Effects

Most people experience no side effects or only mild side effects when taking this medication. However, if you experience any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Changes in taste
Weight loss
Nervousness or excitability
Dizziness, drowsiness, fatigue, 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.
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Seek Immediate Medical Attention If You Experience:

  • Sudden decrease in vision or eye pain (signs of acute angle-closure glaucoma)
  • Tingling in arms or legs (paresthesia)
  • Feeling tired, weak, or confused (signs of metabolic acidosis)
  • Nausea, vomiting, loss of appetite
  • Kidney stone symptoms (severe pain in your side or back, blood in urine)
  • Decreased sweating or fever (especially in children)
  • Mood changes, depression, thoughts of self-harm
  • Unexplained weight loss
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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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.

To ensure your safety, it is crucial to verify that this medication can be taken in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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 lab tests to ensure your safety while taking this medication.

Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, cannabis, or prescription or over-the-counter medications that may cause drowsiness.

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 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 tiredness, confusion, or coma. Consult your doctor if you are taking valproic acid.

Special Considerations for Children
If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. This medication may affect growth in children and teens, and regular growth checks may be necessary. Discuss this with your doctor.

Birth Control and Pregnancy
Birth control pills and other hormone-based birth control methods may not be effective 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. If you are breastfeeding, inform your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Convulsions
  • Drowsiness
  • Speech disturbance
  • Blurred vision
  • Diplopia (double vision)
  • Lethargy
  • Ataxia (loss of coordination)
  • Abdominal pain
  • Agitation
  • Dizziness
  • Depression
  • Metabolic acidosis
  • Hypokalemia
  • Hypotension

What to Do:

Seek immediate medical attention or call 911. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

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Major Interactions

  • Valproic acid (increased risk of hyperammonemia with or without encephalopathy)
  • Oral contraceptives (decreased efficacy of estrogen-containing contraceptives)
  • Carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide, dichlorphenamide - increased risk of metabolic acidosis and kidney stones)
  • Metformin (increased metformin levels, decreased topiramate levels)
  • Lithium (increased lithium levels)
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Moderate Interactions

  • Phenytoin (altered levels of both drugs)
  • Carbamazepine (decreased topiramate levels)
  • Digoxin (decreased digoxin levels)
  • Hydrochlorothiazide (increased topiramate levels)
  • Pioglitazone (decreased pioglitazone levels)
  • Amitriptyline (increased amitriptyline levels)
  • CNS depressants (additive CNS depression with alcohol, benzodiazepines, opioids)

Monitoring

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Baseline Monitoring

Serum Bicarbonate

Rationale: To establish baseline and monitor for metabolic acidosis.

Timing: Before starting treatment

Renal Function (BUN, Creatinine, eGFR)

Rationale: Topiramate is primarily renally excreted; assess baseline function.

Timing: Before starting treatment

Electrolytes (especially Potassium)

Rationale: To assess baseline and monitor for imbalances, particularly with CA inhibition.

Timing: Before starting treatment

Intraocular Pressure (IOP)

Rationale: To establish baseline and monitor for acute angle-closure glaucoma.

Timing: Before starting treatment (if clinically indicated or patient at risk)

Weight

Rationale: Topiramate can cause weight loss.

Timing: Before starting treatment

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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; consider dose reduction or discontinuation.

Renal Function (BUN, Creatinine)

Frequency: Annually or as clinically indicated

Target: Normal range

Action Threshold: Significant decline in eGFR; consider dose adjustment.

Weight

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

Target: Stable or desired range

Action Threshold: Significant or rapid weight loss; assess nutritional status.

Electrolytes

Frequency: Periodically (e.g., annually or as clinically indicated)

Target: Normal range

Action Threshold: Significant abnormalities; address underlying cause.

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Symptom Monitoring

  • Cognitive impairment (difficulty concentrating, memory problems, word-finding difficulties)
  • Paresthesia (tingling sensations)
  • Fatigue, somnolence
  • Mood changes, depression, suicidal ideation
  • Vision changes (blurred vision, eye pain, sudden decrease in vision)
  • Signs of metabolic acidosis (fatigue, anorexia, nausea, vomiting, hyperventilation)
  • Signs of kidney stones (flank pain, hematuria)
  • Decreased sweating, fever (especially in children)
  • Unexplained weight loss

Special Patient Groups

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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. Increased risk of oral clefts (cleft lip/palate) and hypospadias has been observed.

Trimester-Specific Risks:

First Trimester: Increased risk of major congenital malformations, particularly oral clefts (cleft lip/palate) and hypospadias. Risk appears to be dose-dependent.
Second Trimester: Potential for fetal growth restriction and low birth weight.
Third Trimester: Potential for fetal growth restriction and low birth weight. Risk of metabolic acidosis in the neonate.
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Lactation

Topiramate is excreted into human breast milk. The decision to breastfeed while taking topiramate should consider the potential for serious adverse reactions in the breastfed infant (e.g., diarrhea, drowsiness, irritability, poor weight gain) versus the benefits of breastfeeding and the mother's need for the drug. Monitoring the infant for adverse effects is recommended.

Infant Risk: L3 (Moderate risk) - Potential for infant adverse effects; monitor infant for drowsiness, poor feeding, diarrhea, and irritability. Consider therapeutic drug monitoring in the infant if concerns arise.
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Pediatric Use

Approved for adjunctive treatment of partial-onset seizures or primary generalized tonic-clonic seizures in patients 6 years and older, and for migraine prophylaxis in patients 12 years and older. Children are at increased risk for oligohidrosis and hyperthermia, especially in warm environments. Monitor for decreased sweating and fever.

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Geriatric Use

Use with caution in elderly patients, as they may be more susceptible to adverse effects, particularly cognitive impairment and metabolic acidosis. Renal clearance of topiramate is decreased in elderly patients, necessitating careful dose titration and potential dose reduction based on renal function.

Clinical Information

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Clinical Pearls

  • Always titrate topiramate slowly to minimize side effects, especially cognitive ones.
  • Counsel patients on the importance of adequate hydration to prevent kidney stones and reduce the risk of oligohidrosis/hyperthermia.
  • Be vigilant for signs of metabolic acidosis (fatigue, anorexia, hyperventilation) and monitor serum bicarbonate levels.
  • Warn patients about potential vision changes (acute myopia/secondary angle-closure glaucoma) and advise immediate medical attention if they occur.
  • Topiramate can cause weight loss, which can be a desired effect for some, but monitor for excessive or unhealthy weight loss.
  • For patients on oral contraceptives, advise using an alternative or additional non-hormonal birth control method due to potential decreased efficacy of hormonal contraceptives.
  • The sprinkle capsules can be swallowed whole or opened and sprinkled on a small amount of soft food (e.g., applesauce) and swallowed immediately without chewing.
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Alternative Therapies

  • Other antiepileptic drugs (e.g., Levetiracetam, Lamotrigine, Valproic Acid, Carbamazepine, Oxcarbazepine, Zonisamide, Gabapentin, Pregabalin)
  • Other migraine prophylactic agents (e.g., Beta-blockers like Propranolol, Tricyclic antidepressants like Amitriptyline, CGRP inhibitors, OnabotulinumtoxinA)
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Cost & Coverage

Average Cost: Varies widely, typically $300-$800+ per 30 capsules (200mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (preferred brand/non-preferred brand) for extended-release formulations; Tier 1 (preferred generic) for immediate-release 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 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.