Topiramate 200mg ER Capsules

Topiramate's precise mechanism of action is not fully understood, but it is thought to involve multiple mechanisms: 1) Blockade of voltage-dependent sodium channels, which stabilizes hyperexcited neuronal membranes. 2) Enhancement of gamma-aminobutyrate (GABA)-mediated chloride influx at GABA-A receptors. 3) Antagonism of the AMPA/kainate subtype of glutamate receptors, reducing excitatory neurotransmission. 4) Inhibition of carbonic anhydrase isoenzymes (primarily CA-II and CA-IV), which may contribute to its anticonvulsant and migraine prophylactic effects, as well as its metabolic side effects (e.g., metabolic acidosis).

Serious Side Effects: Seek Medical Help 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 attention right away:

Allergic reactions: 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.
Infections: Fever, chills, severe sore throat, ear or sinus pain, cough, increased sputum production or change in sputum color, painful urination, mouth sores, or wounds that won't heal.
High ammonia levels: Irregular heartbeat, abnormal breathing, confusion, pale skin, slow heartbeat, 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
Loss of appetite
Back pain, abdominal pain, or blood in the urine (may indicate a kidney stone)
Abnormal sensations (burning, numbness, or tingling)
Bone pain
Chest pain
Muscle pain or weakness
Shakiness
Difficulty walking
Uncontrolled eye movements

Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in individuals 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 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 may be fatal. 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 may require hospitalization. Be cautious in hot weather and during physical activity. If you experience a fever or decreased sweating, contact your doctor immediately.

Severe Skin Reactions: A rare but potentially life-threatening skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may 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. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:

Gastrointestinal symptoms: Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Weight changes: Weight loss
Neurological symptoms: 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 is crucial to avoid 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 vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.

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 activities 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 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 metabolic acidosis, a condition characterized by an imbalance of acid in the blood. This risk is higher in children, individuals with kidney problems, breathing difficulties, or diarrhea, and those taking certain medications, undergoing surgery, or following a ketogenic diet. If left untreated, 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 hypothermia (low body temperature), leading to fatigue, 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. This medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.

Birth Control and Pregnancy
Birth control pills and other hormone-based contraceptives 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 menstrual 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 plan to become pregnant, inform your doctor immediately. If you are breastfeeding, discuss the potential risks to your baby with your doctor.

• Oral Contraceptives (decreased efficacy of estrogen-containing OCs)
• 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)
• Phenytoin (may decrease topiramate levels, topiramate may increase phenytoin levels)
• Carbamazepine (may decrease topiramate levels)
• Valproic Acid (increased risk of hyperammonemia with or without encephalopathy)

• Metformin (topiramate may increase metformin levels)
• Lithium (topiramate may increase or decrease lithium levels)
• Hydrochlorothiazide (may increase topiramate levels)
• Pioglitazone (topiramate may decrease pioglitazone levels)
• Amitriptyline (topiramate may decrease amitriptyline levels)
• Digoxin (topiramate may decrease digoxin levels)

• Not available

• Vision changes (e.g., acute myopia, secondary angle-closure glaucoma, blurred vision, eye pain)
• Cognitive changes (e.g., difficulty with concentration, memory, word-finding, confusion, 'Topamax fog')
• Mood or behavioral changes (e.g., depression, anxiety, irritability, suicidal ideation)
• Paresthesias (tingling in extremities)
• Kidney stone symptoms (e.g., flank pain, hematuria, dysuria)
• Decreased sweating or fever (especially in hot weather or during exertion)
• Unexplained fatigue, nausea, vomiting, or abdominal pain (signs of hyperammonemia, especially with valproic acid)

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 possibly other congenital malformations (e.g., hypospadias, cardiovascular malformations) and low birth weight. Use during pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus. Patients should be counseled on the risks and enrolled in a pregnancy registry if applicable.

Topiramate is excreted into human 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 of the infant for adverse effects is recommended.

Approved for adjunctive treatment of partial-onset seizures and primary generalized tonic-clonic seizures in patients 2 years of age and older, and for migraine prophylaxis in adolescents 12 years of age and older. Pediatric patients are at higher risk for oligohidrosis and hyperthermia, and metabolic acidosis. Close monitoring of bicarbonate levels and hydration status is crucial.

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

• Always emphasize the importance of adequate hydration (6-8 glasses of water daily) to minimize the risk of kidney stone formation.
• Counsel patients on the potential for cognitive side effects, often referred to as 'Topamax fog' or 'topiramate brain,' which can include word-finding difficulty, memory issues, and slowed thinking. These often improve with time or dose reduction.
• Stress the importance of slow titration to minimize side effects, especially paresthesias and cognitive issues.
• Educate female patients of childbearing potential about the significant risk of fetal harm, particularly oral clefts, and discuss contraception options or alternative therapies.
• Advise patients to report any sudden vision changes or eye pain immediately, as this could indicate acute angle-closure glaucoma, a medical emergency.
• Topiramate can cause weight loss, which may be beneficial for some patients but should be monitored to prevent excessive or unhealthy weight loss.

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

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 provides crucial information about its use. 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 this medication, don't hesitate 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 details about the medication taken, the amount consumed, and the time it occurred.