Topiramate 15mg Sprinkle Capsules

Manufacturer AUROBINDO PHARMA 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.
🏷️
Drug Class
Anticonvulsant, Migraine Prophylaxis
🧬
Pharmacologic Class
Sulfamate-substituted monosaccharide
🀰
Pregnancy Category
Category D
βœ…
FDA Approved
Dec 1996
βš–οΈ
DEA Schedule
Not Controlled

Overview

ℹ️

What is this medicine?

Topiramate is a medication used to prevent seizures (epilepsy) and to prevent migraine headaches. It works by affecting certain chemicals in the brain. The sprinkle capsules can be swallowed whole or opened and sprinkled on soft food.
πŸ“‹

How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue taking it even if you feel well. It's essential to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

You can take your medication by swallowing the capsule whole or by sprinkling the contents onto a spoonful of soft food, such as applesauce. However, do not crush or chew the medication before swallowing. If you mix the medication with food, swallow the mixture immediately and do not store it for later use. After taking the medication with food, drink some fluid to ensure the medication is swallowed properly.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed and store all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired 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.
πŸ’‘

Lifestyle & Tips

  • Stay well-hydrated throughout the day to reduce the risk of kidney stones.
  • Avoid or limit alcohol consumption, as it can increase side effects like dizziness and drowsiness.
  • Do not stop taking this medication suddenly, as it can cause seizures. Always consult your doctor before changing your dose.
  • Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness, drowsiness, and vision problems.
  • 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 may cause harm to an unborn baby.

Dosing & Administration

πŸ‘¨β€βš•οΈ

Adult Dosing

Standard Dose: Epilepsy (Adjunctive): 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 at bedtime, 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 at bedtime for 1 week, then increase by 25-50 mg/day weekly to target 100-400 mg/day in 2 divided doses.
Lennox-Gastaut Syndrome: Similar to adjunctive epilepsy dosing.
πŸ‘Ά

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Epilepsy (Adjunctive, β‰₯2 years): Initial 1-3 mg/kg/day (max 25 mg/day) at bedtime for 1 week, then titrate weekly by 1-3 mg/kg/day in 2 divided doses to target 5-9 mg/kg/day. Migraine Prophylaxis (β‰₯12 years): Initial 25 mg at bedtime, titrate weekly by 25 mg/day to target 100 mg/day in 2 divided doses.
Adolescent: Epilepsy (Adjunctive): 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 at bedtime, titrate weekly by 25 mg/day to target 100 mg/day in 2 divided doses.
βš•οΈ

Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl 50-79 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, in divided doses at the beginning and end of the hemodialysis procedure.

Hepatic Impairment:

Mild: Use with caution, consider lower starting dose and slower titration.
Moderate: Use with caution, consider lower starting dose and slower titration.
Severe: Use with caution, consider lower starting dose and slower titration.

Pharmacology

πŸ”¬

Mechanism of Action

Topiramate's precise mechanism is not fully understood, but it is thought to involve 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.
πŸ“Š

Pharmacokinetics

Absorption:

Bioavailability: 81-95%
Tmax: 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: 21 hours
Clearance: 20-30 mL/min (renal clearance)
ExcretionRoute: Renal (primarily unchanged)
Unchanged: 70-80%
⏱️

Pharmacodynamics

OnsetOfAction: Days to weeks (due to titration)
PeakEffect: Weeks (after reaching target dose)
DurationOfAction: 24 hours (allows for once or twice daily dosing)

Safety & Warnings

⚠️

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:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood), such as:
+ Confusion
+ Rapid breathing or heartbeat
+ Abnormal heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness or shortness of breath
+ Feeling extremely tired or weak
Signs of infection, such as:
+ Fever or chills
+ Severe sore throat, ear or sinus pain, or cough
+ Increased sputum production or change in sputum color
+ Painful urination or mouth sores
+ Wounds that won't heal
Signs of high ammonia levels, such as:
+ Abnormal heartbeat or breathing
+ Confusion or pale skin
+ Slow heartbeat or seizures
+ Sweating, vomiting, or twitching
Unexplained bruising or bleeding
Confusion, difficulty focusing, or changes in behavior
Memory problems or loss
Speech difficulties
Sleep disturbances
Balance problems
Severe dizziness or fainting
Inability to eat
Back pain, abdominal pain, or blood in the urine (may indicate a kidney stone)
Abnormal sensations, such as burning, numbness, or tingling
Bone pain or chest pain
Muscle pain or weakness
Shakiness or difficulty walking
Inability to control eye movements
Suicidal thoughts or actions (rarely reported, but may be higher in people with a history of suicidal thoughts or actions)
New or worsening symptoms, such as:
+ Depression
+ Anxiety, restlessness, or irritability
+ Panic attacks or mood changes

Additional Serious Side Effects

This medication may cause rare but serious eye problems, which can lead to permanent vision loss if left untreated. Seek medical attention immediately if you experience:

Blurred vision or changes in eyesight
Eye pain or redness

Liver problems have been reported, sometimes with fatal outcomes. Contact your doctor right away if you notice:

Dark urine
Fatigue
Decreased appetite
Nausea or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes

This medication may also cause sweating reduction and high body temperatures, which can lead to hospitalization. Be cautious in hot weather and during physical activity. Seek medical help if you:

Develop a fever
Experience reduced sweating during activities or in warm temperatures

A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, which can cause serious health problems or death. Seek immediate medical attention if you notice:

Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes

Common Side Effects

Most people experience no side effects or only mild side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention:

Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Changes in taste
Weight loss
Nervousness or excitability
Dizziness, drowsiness, tiredness, or weakness
Headache
Flushing
Common cold symptoms
* Joint pain

Reporting Side Effects

If you experience any side effects, contact your doctor or report them to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • Sudden decrease in vision, eye pain, or redness (could be acute angle-closure glaucoma - seek immediate medical attention)
  • Confusion, memory problems, difficulty concentrating, or word-finding difficulties
  • Tingling or numbness in hands and feet (paresthesias)
  • Unexplained fatigue, loss of appetite, rapid breathing (signs of metabolic acidosis)
  • Severe back or side pain, blood in urine (signs of kidney stones)
  • Fever, vomiting, or changes in mental status (especially if also taking valproic acid - could be hyperammonemia)
  • Any thoughts of self-harm or suicide (seek immediate medical attention)
πŸ“‹

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.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
⚠️

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 your full attention, such as driving, wait until you understand how this drug affects you.

To minimize the risk of seizures, do not abruptly stop taking this medication without first consulting your doctor. If you need to discontinue use, your doctor will guide you on how to gradually stop taking it. Regularly undergo blood tests and other laboratory exams as directed by your doctor.

While taking this medication, avoid consuming alcohol. Additionally, consult your doctor before using marijuana, cannabis, or prescription and over-the-counter drugs that may cause drowsiness.

This medication may increase the risk of developing metabolic acidosis, a condition characterized by an acid imbalance in the blood. This risk is higher in children, individuals with kidney problems, breathing difficulties, or diarrhea. The risk may also be elevated if you take certain 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. Discuss this risk with your doctor.

When taken with valproic acid, this medication can cause hypothermia, leading to fatigue, confusion, or coma. Consult your doctor about this potential interaction.

If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Discuss this with your doctor.

The effectiveness of birth control pills and other hormone-based contraceptives may be reduced when taking this medication. Use an additional form of birth control, such as condoms, to prevent pregnancy. If you experience changes in your menstrual bleeding pattern while taking hormone-based birth control, consult your doctor.

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

If you are breastfeeding, inform your doctor to discuss any potential risks to your baby.
πŸ†˜

Overdose Information

Overdose Symptoms:

  • Convulsions
  • Drowsiness
  • Speech disturbance
  • Blurred vision
  • Diplopia (double vision)
  • Impaired coordination
  • Lethargy
  • Stupor
  • Hypotension
  • Abdominal pain
  • Agitation
  • Dizziness
  • Depression
  • Metabolic acidosis

What to Do:

Call 911 or your local poison control center (1-800-222-1222 in the US) immediately. Induce emesis if recently ingested and patient is conscious. Gastric lavage may be indicated. Provide supportive care, maintain airway, monitor vital signs. Hemodialysis is an effective means of removing topiramate from the body.

Drug Interactions

πŸ”΄

Major Interactions

  • Valproic Acid (VPA): Concomitant use may cause hyperammonemia with or without encephalopathy. Monitor ammonia levels.
  • Oral Contraceptives: Topiramate can decrease the efficacy of estrogen-containing oral contraceptives, leading to breakthrough bleeding and potential pregnancy. Patients should use alternative or additional birth control methods.
  • Carbonic Anhydrase Inhibitors (e.g., Acetazolamide, Zonisamide): Increased risk of metabolic acidosis and kidney stone formation.
🟑

Moderate Interactions

  • CNS Depressants (e.g., Alcohol, Benzodiazepines, Opioids): Increased risk of CNS depression (drowsiness, dizziness).
  • Metformin: Topiramate may decrease metformin exposure. Monitor glycemic control.
  • Lithium: Topiramate may decrease lithium levels. Monitor lithium levels.
  • Hydrochlorothiazide (HCTZ): HCTZ may increase topiramate levels. Dose adjustment of topiramate may be needed.
  • Phenytoin/Carbamazepine: May decrease topiramate levels due to enzyme induction. Topiramate may also increase phenytoin levels.
🟒

Minor Interactions

  • Digoxin: Topiramate may decrease digoxin levels. Monitor digoxin levels.
  • Pioglitazone: Topiramate may decrease pioglitazone exposure. Monitor glycemic control.

Monitoring

πŸ”¬

Baseline Monitoring

Serum Bicarbonate (HCO3-)

Rationale: To establish baseline for metabolic acidosis risk.

Timing: Before initiation

Renal Function (SCr, eGFR)

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

Timing: Before initiation

Weight

Rationale: Topiramate can cause weight loss.

Timing: Before initiation

Intraocular Pressure (IOP) / Eye Exam

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

Timing: Before initiation (especially if history of eye conditions)

πŸ“Š

Routine Monitoring

Serum Bicarbonate (HCO3-)

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.

Weight

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

Target: Stable

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

Renal Function (SCr, eGFR)

Frequency: Annually or as clinically indicated (more frequently in elderly or those with risk factors)

Target: Stable

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

Electrolytes (Potassium, Calcium)

Frequency: Periodically (especially if on diuretics or with risk factors for kidney stones)

Target: Normal

Action Threshold: Abnormal levels; investigate cause and manage.

πŸ‘οΈ

Symptom Monitoring

  • Cognitive impairment (e.g., difficulty concentrating, memory problems, word-finding difficulties)
  • Mood changes (e.g., depression, anxiety, suicidal ideation)
  • Vision changes (e.g., blurred vision, eye pain, sudden decrease in vision - signs of acute angle-closure glaucoma)
  • Symptoms of metabolic acidosis (e.g., fatigue, anorexia, rapid breathing, cardiac arrhythmias)
  • Symptoms of kidney stones (e.g., flank pain, hematuria)
  • Paresthesias (tingling sensations)
  • Fever, confusion, vomiting (signs of hyperammonemia, especially with valproic acid)

Special Patient Groups

🀰

Pregnancy

Topiramate should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. It is associated with an increased risk of major congenital malformations, particularly oral clefts (cleft lip/palate) and hypospadias.

Trimester-Specific Risks:

First Trimester: Highest risk for oral clefts (cleft lip/palate) and hypospadias. Risk is dose-dependent.
Second Trimester: Continued risk of fetal growth restriction and potential for other malformations.
Third Trimester: Risk of fetal growth restriction, metabolic acidosis in the neonate, and withdrawal symptoms if discontinued abruptly.
🀱

Lactation

Topiramate is excreted into human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for topiramate, and any potential adverse effects on the breastfed infant from topiramate or from the underlying maternal condition. Monitor infants for drowsiness, poor feeding, and diarrhea.

Infant Risk: Low to moderate risk. Potential for infant drowsiness, diarrhea, and weight loss. Long-term effects on neurodevelopment are unknown.
πŸ‘Ά

Pediatric Use

Dosing is weight-based for epilepsy in children β‰₯2 years. Monitor for growth, weight changes, and cognitive side effects. Increased risk of metabolic acidosis and kidney stones compared to adults. Behavioral and cognitive side effects may be more pronounced.

πŸ‘΄

Geriatric Use

Start with lower doses and titrate slowly due to potential for decreased renal clearance and increased susceptibility to side effects (e.g., cognitive impairment, metabolic acidosis, kidney stones). Monitor renal function closely.

Clinical Information

πŸ’Ž

Clinical Pearls

  • Topiramate sprinkle capsules can be swallowed whole or opened and sprinkled on a spoonful of soft food (e.g., applesauce, pudding) and swallowed immediately without chewing.
  • Patients should be advised to drink plenty of fluids to minimize the risk of kidney stone formation.
  • Cognitive side effects (e.g., 'topamax fog' or 'topiramate stupor') are common, especially during titration, and can be dose-limiting. Slower titration may help mitigate these.
  • Weight loss is a common side effect and can be beneficial for some patients, but should be monitored to prevent excessive loss.
  • Patients should be screened for a history of kidney stones or glaucoma before starting topiramate.
  • Due to the risk of metabolic acidosis, serum bicarbonate levels should be monitored, especially in pediatric patients and those with renal impairment.
πŸ”„

Alternative Therapies

  • For Epilepsy: Levetiracetam, Lamotrigine, Valproic Acid, Carbamazepine, Oxcarbazepine, Phenytoin, Gabapentin, Pregabalin.
  • For Migraine Prophylaxis: Propranolol, Timolol, Amitriptyline, Valproic Acid, Erenumab, Fremanezumab, Galcanezumab, Eptinezumab, Rimegepant, Atogepant.
πŸ’°

Cost & Coverage

Average Cost: $30 - $150 per 30 capsules (15mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
πŸ“š

General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred, as this information is crucial for receiving appropriate care.