Topiramate ER 100mg Capsules

Manufacturer TEVA PHARMACEUTICALS Active Ingredient Topiramate Extended-Release 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 Agent
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Pharmacologic Class
Sulfamate-substituted monosaccharide, Voltage-gated sodium channel blocker, GABA-A receptor potentiator, Carbonic anhydrase inhibitor, AMPA/kainate receptor antagonist
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Pregnancy Category
Not available
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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 ER is an extended-release capsule used to help prevent seizures (epilepsy) and to prevent migraine headaches. It works by affecting several chemicals and electrical signals in the brain.
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How to Use This Medicine

To take this medication correctly, follow your doctor's instructions and read all accompanying information carefully. You can take this medication with or without food. Continue taking it as directed by your doctor or healthcare provider, even if you start feeling better. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids.

When taking this medication, swallow the tablets whole without chewing, opening, or crushing them. Do not sprinkle the medication on your food.

To store this medication properly, keep it at room temperature, away from light and moisture. Avoid storing it in a bathroom.

If you miss a dose, contact your doctor for guidance on what to do next.
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Lifestyle & Tips

  • Stay well-hydrated by drinking plenty of fluids throughout the day to reduce the risk of kidney stones and metabolic acidosis.
  • Avoid or limit alcohol consumption, as it can increase side effects like dizziness and drowsiness.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can lead to increased seizures.
  • Be aware that this medication can cause drowsiness, dizziness, and vision problems, especially when starting or changing doses. Avoid driving or operating machinery until you know how it affects you.
  • Monitor for changes in mood, behavior, or thoughts of self-harm and report them to your doctor immediately.
  • If you are a woman of childbearing potential, discuss effective birth control methods with your doctor, as topiramate can reduce the effectiveness of oral contraceptives and carries risks during pregnancy.

Dosing & Administration

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Adult Dosing

Standard Dose: Epilepsy (adjunctive): Initial 50 mg once daily for 7 days, then increase by 50 mg weekly to target 200-400 mg once daily. Migraine prophylaxis: Initial 25 mg once daily for 7 days, then increase by 25 mg weekly to target 100 mg once daily.
Dose Range: 25 - 400 mg

Condition-Specific Dosing:

epilepsy_adjunctive: Initial 50 mg once daily for 7 days, then increase by 50 mg weekly to target 200-400 mg once daily. Max 600 mg/day.
migraine_prophylaxis: Initial 25 mg once daily for 7 days, then increase by 25 mg weekly to target 100 mg once daily. Max 200 mg/day.
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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 to target 5-9 mg/kg/day (max 400 mg/day). Migraine prophylaxis (â‰Ĩ12 years): Same as adult.
Adolescent: Epilepsy (adjunctive, â‰Ĩ6 years): Same as child. Migraine prophylaxis (â‰Ĩ12 years): Same as adult.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl >70 mL/min)
Moderate: Reduce dose by 50% (CrCl 30-69 mL/min)
Severe: Reduce dose by 50% (CrCl <30 mL/min)
Dialysis: Reduce dose by 50% and administer supplemental dose after hemodialysis (approximately half of the reduced daily dose).

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Topiramate's exact mechanism is not fully understood but involves multiple actions: it blocks voltage-dependent sodium channels, enhances GABA-A receptor activity, antagonizes AMPA/kainate glutamate receptors, and inhibits carbonic anhydrase, particularly isozymes II and IV.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 81% (oral IR, ER similar)
Tmax: Approximately 10-24 hours (Extended-Release)
FoodEffect: Food does not significantly affect the bioavailability of Topiramate ER, but may delay Tmax.

Distribution:

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

Elimination:

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

OnsetOfAction: Days to weeks (due to slow titration)
PeakEffect: Weeks (after reaching target dose)
DurationOfAction: 24 hours (Extended-Release formulation allows once-daily dosing)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

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 help right away:

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.
Other Serious Symptoms: Burning, numbness, or tingling sensations, bone pain, chest pain, muscle pain or weakness, shakiness, difficulty walking, or uncontrolled eye movements.

Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly 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, potentially leading to permanent vision loss if left untreated. Contact your doctor immediately if you experience any new eye symptoms, such as blurred vision, changes in vision, eye pain, or eye redness.

Liver Problems: Rarely, this medication has caused liver problems, which can be fatal. If you experience any symptoms of liver problems, such as dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin and eyes, contact your doctor right away.

Heat-Related Illness: This medication may cause sweating reduction and high body temperatures, potentially leading 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 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 right away.

Other Side Effects

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

Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Changes in taste
Weight loss
Feeling nervous, excitable, dizzy, sleepy, tired, or weak
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 (could indicate acute angle-closure glaucoma)
  • Severe fatigue, loss of appetite, rapid breathing (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, severe restlessness, or thoughts about suicide or harming yourself
  • Fever, decreased sweating (especially in children, risk of hyperthermia)
  • Confusion, memory problems, difficulty concentrating, or word-finding difficulties
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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 allergic reaction you experienced, including any symptoms that occurred.
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.

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.
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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. This will help ensure your safety and prevent any potential interactions with other treatments.

Until you know how this medication affects you, avoid driving and other activities that require alertness. If you need to stop taking this medication, do not do so abruptly without consulting your doctor, as this may increase your risk of seizures. Instead, your doctor will guide you on how to gradually stop taking it.

Regular blood tests and other laboratory checks are crucial, as directed by your doctor, to monitor your health while taking this medication. Additionally, it is recommended to avoid consuming alcohol, especially within 6 hours before or after taking your dose, as this can interact with the medication.

Before using marijuana, cannabis products, or any prescription or over-the-counter medications 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 in children, people with kidney problems, breathing difficulties, or diarrhea. Certain other medications, surgery, or a ketogenic diet can also increase this risk. If left untreated, metabolic acidosis can lead to kidney stones, bone problems, or growth issues in children over time.

There is a potential risk of bleeding associated with this medication, which can be life-threatening in some cases. It is crucial to discuss this risk with your doctor. When taken with valproic acid, this medication can cause a drop in body temperature, leading to fatigue, confusion, or even coma. Therefore, it is essential to consult with your doctor if you are taking valproic acid.

If the patient is a child, this medication should be used with caution, as the risk of certain side effects may be higher in this age group. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Your doctor will discuss the potential risks and benefits with you.

It is also important to note that birth control pills and other hormone-based contraceptives may not be as effective when taking this medication. To prevent pregnancy, consider using an additional form of birth control, such as a condom. If you experience any changes in your menstrual bleeding pattern while taking hormone-based birth control and this medication, inform your doctor.

This medication can harm an unborn baby if taken during pregnancy. If you become pregnant or plan to become pregnant, notify your doctor immediately. If you are able to get pregnant and do not wish to, use a reliable form of birth control to prevent pregnancy while taking this medication.

Finally, if you are breastfeeding, consult 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)
  • Impaired mentation
  • Lethargy
  • Abnormal coordination
  • Stupor
  • Hypotension
  • Abdominal pain
  • Agitation
  • Dizziness
  • Depression
  • Metabolic acidosis
  • Hypokalemia

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Induce emesis or perform gastric lavage if ingestion is recent. Provide supportive care, including hydration. Hemodialysis is an effective means of removing topiramate from the body.

Drug Interactions

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Major Interactions

  • Oral Contraceptives (decreased efficacy of estrogen component)
  • Valproic Acid (increased risk of hyperammonemia with or without encephalopathy)
  • Carbonic Anhydrase Inhibitors (e.g., acetazolamide, zonisamide - increased risk of metabolic acidosis and kidney stones)
  • CNS Depressants (e.g., alcohol, benzodiazepines, opioids - additive CNS depression)
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Moderate Interactions

  • Phenytoin (altered phenytoin and topiramate levels)
  • Carbamazepine (altered carbamazepine and topiramate levels)
  • Digoxin (decreased digoxin levels)
  • Metformin (decreased metformin levels)
  • Lithium (altered lithium levels)
  • Hydrochlorothiazide (increased topiramate levels)
  • Pioglitazone (decreased pioglitazone levels)
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Minor Interactions

  • Amitriptyline (altered amitriptyline levels)
  • Propranolol (altered propranolol levels)

Monitoring

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Baseline Monitoring

Serum Bicarbonate

Rationale: To establish baseline for metabolic acidosis risk.

Timing: Before initiation

Renal Function (BUN, Creatinine, eGFR)

Rationale: Topiramate is primarily renally cleared; dose adjustment may be needed.

Timing: Before initiation

Weight

Rationale: Topiramate can cause weight loss.

Timing: Before initiation

Intraocular Pressure/Ophthalmic Exam

Rationale: To establish baseline for acute myopia/secondary angle-closure glaucoma risk.

Timing: Before initiation (if clinically indicated or patient has risk factors)

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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 limits

Action Threshold: Significant decline in renal function; consider dose adjustment.

Weight

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

Target: Stable

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

Electrolytes (Potassium, Chloride)

Frequency: Periodically (especially if metabolic acidosis develops)

Target: Normal limits

Action Threshold: Abnormalities; address electrolyte imbalances.

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Symptom Monitoring

  • Cognitive impairment (e.g., difficulty concentrating, memory problems, word-finding difficulties)
  • Mood changes (e.g., depression, anxiety, irritability)
  • Suicidal ideation or behavior
  • Symptoms of metabolic acidosis (e.g., fatigue, anorexia, rapid breathing)
  • Symptoms of kidney stones (e.g., flank pain, hematuria)
  • Acute vision changes (e.g., sudden decrease in vision, eye pain, redness)
  • Paresthesias (tingling sensations)
  • Oligohidrosis/hyperthermia (decreased sweating, increased body temperature)

Special Patient Groups

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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 hypospadias. There is also an increased risk of low birth weight and being small for gestational age.

Trimester-Specific Risks:

First Trimester: Highest risk for oral clefts (cleft lip and/or palate) if exposed during the first trimester.
Second Trimester: Continued risk of fetal growth restriction and other malformations.
Third Trimester: Risk of fetal growth restriction and potential for withdrawal symptoms in the neonate if discontinued abruptly.
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Lactation

Topiramate is excreted into 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 infant.

Infant Risk: L3 (Moderate risk). Monitor breastfed infants for drowsiness, diarrhea, irritability, and poor weight gain. Some infants may experience metabolic acidosis.
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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 6 years of age and older. Approved for migraine prophylaxis in patients 12 years of age and older. Children are at increased risk for oligohidrosis and hyperthermia, and metabolic acidosis. Weight monitoring is important.

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Geriatric Use

Use with caution due to increased likelihood of decreased renal function. Start at the lower end of the dosing range and titrate slowly. Monitor for cognitive side effects and metabolic acidosis more closely.

Clinical Information

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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 metabolic acidosis.
  • Counsel women of childbearing potential about the risk of oral clefts and the need for effective contraception, as topiramate can decrease the efficacy of oral contraceptives.
  • Be vigilant for signs of acute myopia and secondary angle-closure glaucoma, which is a rare but serious side effect requiring immediate medical attention.
  • Monitor serum bicarbonate levels, especially in pediatric patients and those with renal impairment, due to the risk of metabolic acidosis.
  • Patients may experience weight loss; monitor weight regularly.
  • Topiramate can cause cognitive slowing or 'dumbing down' effect, which can be dose-related and may improve with slower titration or dose reduction.
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Alternative Therapies

  • For Epilepsy: Levetiracetam, Lamotrigine, Valproic Acid, Carbamazepine, Oxcarbazepine, Phenytoin, Gabapentin, Pregabalin, Zonisamide, Lacosamide, Brivaracetam.
  • For Migraine Prophylaxis: Propranolol, Timolol, Amitriptyline, Valproic Acid, Erenumab, Fremanezumab, Galcanezumab, Eptinezumab, Rimegepant, Atogepant.
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Cost & Coverage

Average Cost: Varies widely, typically $300-$1000+ per 30 capsules (100mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (generic often Tier 1 or 2, brand Tier 3 or 4)
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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, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

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 detailed information, including the name of the medication taken, the amount, and the time it occurred.