Topiramate ER 25mg Capsules

The precise mechanisms by which topiramate exerts its anticonvulsant and migraine prophylactic effects are unknown. It is thought to act via multiple mechanisms: blockade of voltage-dependent sodium channels, potentiation of GABA-A receptor activity, antagonism of AMPA/kainate glutamate receptors, and inhibition of carbonic anhydrase (primarily isoenzymes II and IV).

Serious Side Effects: Seek Medical Attention 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 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, or 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 or change in sputum color, painful urination, mouth sores, or a wound that will not heal.
High Ammonia Levels: Irregular heartbeat, abnormal breathing, confusion, pale skin, slow heartbeat, seizures, sweating, vomiting, or twitching.
Unexplained Bleeding or Bruising: Any unexplained bruising or bleeding.
Neurological Symptoms: Confusion, difficulty focusing, or changes in behavior, memory problems or loss, 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.

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

Eye Problems: This medication can cause severe eye problems, which may lead 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 can cause liver problems, which can be fatal. Contact your doctor immediately if you experience any symptoms of liver problems, such as dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin or eyes.

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. Contact your doctor immediately if you experience a fever or decreased sweating during activities or in warm temperatures.

Severe Skin Reaction: A rare but potentially life-threatening skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) can occur. Seek medical help immediately 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.

Other Side Effects

Most people do not experience serious side effects, but some may occur. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:

Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Change 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.

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 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 current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.

Stopping the Medication
Do not suddenly stop taking this medication 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, especially within 6 hours before or after taking it. Additionally, consult your doctor before using marijuana, cannabis, or prescription or over-the-counter medications that may cause drowsiness.

Potential Side Effects
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. Over time, metabolic acidosis can lead to kidney stones, bone problems, or growth issues in children.

Bleeding Risks
This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.

Interactions with Other Medications
Taking this medication with valproic acid can cause low body temperature, leading to fatigue, confusion, or coma. Consult your doctor about this potential interaction.

Special Considerations for Children
If you are a parent or caregiver, use this medication with caution in children, as they may be more susceptible to certain side effects.

Growth Effects in Children and Teens
This medication may affect growth in children and teenagers. Regular growth checks may be necessary, so 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.

Pregnancy and Breastfeeding
This medication may harm an 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 while taking this medication. If you are breastfeeding, discuss the potential risks to your baby with your doctor.

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

• CNS depressants (additive sedation)
• Alcohol (additive CNS depression)
• Lithium (altered lithium levels)
• Phenytoin, Carbamazepine (altered topiramate levels, altered other AED levels)
• Digoxin (decreased digoxin levels)

• Hydrochlorothiazide (increased topiramate levels)

• Cognitive impairment (e.g., difficulty concentrating, memory problems, word-finding difficulties)
• Mood changes (e.g., depression, anxiety, irritability)
• Suicidal ideation or behavior
• Vision changes (e.g., sudden decrease in vision, eye pain, redness)
• Signs of kidney stones (e.g., flank pain, hematuria)
• Signs of metabolic acidosis (e.g., fatigue, anorexia, rapid breathing)
• Hyperammonemia symptoms (e.g., lethargy, vomiting, altered mental status, especially if on valproic acid)
• Oligohidrosis/hyperthermia (especially in children)

Topiramate is associated with an increased risk of oral clefts (cleft lip/palate) and other congenital malformations, as well as low birth weight and potential neurodevelopmental issues. Use during pregnancy should only be considered 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.

Topiramate is excreted into breast milk. The decision to breastfeed should consider the potential for infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Monitor infants for drowsiness, poor feeding, and adequate weight gain.

Children, especially those <6 years old, may be at increased risk for oligohidrosis (decreased sweating) and hyperthermia (fever). Monitor for these symptoms, especially in warm environments. Cognitive side effects may be more pronounced. Growth should be monitored.

Initiate at lower doses and titrate slowly due to potential for decreased renal clearance and increased susceptibility to adverse effects (e.g., dizziness, cognitive impairment, metabolic acidosis). Monitor renal function closely.

• Always titrate topiramate slowly to minimize side effects, especially cognitive ones.
• Emphasize adequate hydration to patients to prevent kidney stone formation.
• Counsel women of childbearing potential about the risks during pregnancy and the need for effective contraception.
• Be aware of the potential for metabolic acidosis and monitor serum bicarbonate levels.
• Topiramate can cause weight loss, which may be a desired effect for some patients but should be monitored.
• Patients should be advised to report any sudden vision changes or eye pain immediately, as this could indicate acute angle-closure glaucoma, a medical emergency.

• For Epilepsy: Levetiracetam, Lamotrigine, Valproic Acid, Carbamazepine, Oxcarbazepine, Phenytoin, Zonisamide, Lacosamide, Pregabalin, Gabapentin.
• For Migraine Prophylaxis: Propranolol, Timolol, Amitriptyline, Venlafaxine, CGRP inhibitors (e.g., Erenumab, Fremanezumab, Galcanezumab), OnabotulinumtoxinA.

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 valuable resource 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, we encourage you to discuss them 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 detailed information, including the medication taken, the amount, and the time it occurred.