Topiramate ER 50mg Capsules

Topiramate's precise mechanism is not fully understood but involves multiple actions: it blocks voltage-dependent sodium channels, enhances GABA-A receptor activity (potentiating the frequency of chloride channel opening), antagonizes AMPA/kainate glutamate receptors, and inhibits carbonic anhydrase (primarily isoenzymes II and IV). These actions contribute to its anticonvulsant and migraine prophylactic 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, 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 or changed sputum production, 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 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 behaviors, especially in people with a history of suicidal ideation. 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 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. 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 may cause sweating reduction and high body temperatures, potentially leading 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) 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 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 or excitable
Dizziness, drowsiness, tiredness, 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.

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.
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.
* Any existing health problems, as this medication may interact with them.

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 dose of any medication without first consulting your doctor.

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 your full attention. This will help prevent accidents and ensure your safety.

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 guide you on how to gradually reduce the dosage to minimize potential risks.

Regular blood tests and other laboratory checks are crucial while taking this medication. Be sure to follow your doctor's instructions regarding the frequency and type of tests you need to undergo.

It is recommended to avoid consuming alcohol while taking this medication, especially within 6 hours before or after taking your dose. This will help minimize potential interactions and side effects.

Before using marijuana, cannabis products, or prescription or over-the-counter medications that may cause drowsiness, consult your doctor to discuss potential risks and interactions.

This medication may cause a condition called metabolic acidosis, which can be more likely to occur in children, people with kidney problems, breathing difficulties, or diarrhea. Additionally, the risk may be higher if you take certain medications, undergo surgery, or follow a ketogenic diet. Metabolic acidosis can lead to long-term complications, such as kidney stones, bone problems, or growth issues in children.

There is a risk of bleeding associated with this medication, which can be life-threatening in some cases. Discuss this risk with your doctor to understand the potential consequences and necessary precautions.

Taking this medication with valproic acid may cause low body temperature, leading to fatigue, confusion, or even coma. Consult your doctor to discuss this potential interaction and necessary precautions.

When administering this medication to children, exercise caution, as the risk of certain side effects may be higher in this age group. Children and teenagers may require regular growth checks to monitor potential effects on growth and development.

The effectiveness of birth control pills and other hormone-based contraceptives may be reduced while taking this medication. To prevent pregnancy, use an additional form of birth control, such as condoms, in conjunction with your regular birth control method. If you experience any changes in your menstrual bleeding pattern while taking this medication and using hormone-based birth control, consult your doctor.

This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or plan to become pregnant, inform 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, consult your doctor to discuss potential risks to your baby and determine the best course of action.

• 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 unintended pregnancy. Higher estrogen dose or alternative contraception may be needed.
• Other carbonic anhydrase inhibitors (e.g., acetazolamide, zonisamide): Increased risk of metabolic acidosis and kidney stone formation.

• CNS depressants (e.g., alcohol, benzodiazepines, opioids): Additive CNS depression (sedation, dizziness).
• Lithium: Topiramate may decrease lithium levels. Monitor lithium levels.
• Metformin: Topiramate may decrease metformin clearance. Monitor for metformin-related adverse effects.
• Hydrochlorothiazide (HCTZ): HCTZ can increase topiramate plasma concentrations. Dose adjustment of topiramate may be needed.
• Phenytoin/Carbamazepine: May decrease topiramate levels. Topiramate may increase phenytoin levels in some patients.

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

• Cognitive impairment (e.g., difficulty concentrating, word-finding difficulties)
• Mood changes (e.g., depression, anxiety, suicidal ideation)
• Paresthesias (tingling sensation)
• Kidney stone symptoms (e.g., flank pain, hematuria)
• Decreased sweating/hyperthermia
• Acute visual changes or eye pain
• Unexplained fatigue or muscle weakness (signs of acidosis)

Category D. Topiramate can cause fetal harm when administered to a pregnant woman. Increased risk of oral clefts (cleft lip and/or palate) and potentially other major congenital malformations. Also associated with lower birth weight and reduced head circumference.

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. Monitor breastfed infants for drowsiness, poor feeding, and diarrhea.

Use in pediatric patients (2 years and older for epilepsy, 12 years and older for migraine prophylaxis) requires careful dose titration based on weight and close monitoring for adverse effects, particularly cognitive impairment, metabolic acidosis, and growth retardation. Long-term effects on bone health and neurodevelopment should be considered.

Initiate at the lower end of the dosing range due to the greater frequency of decreased renal function. Monitor renal function and for adverse effects (e.g., cognitive impairment, metabolic acidosis) more closely. Consider polypharmacy and potential drug interactions.

• Always titrate topiramate slowly to minimize side effects, especially cognitive ones.
• Emphasize adequate hydration (2-3 liters of fluid daily) to reduce the risk of kidney stones and oligohidrosis/hyperthermia.
• Counsel patients on the risk of metabolic acidosis and symptoms to report.
• For women of childbearing potential, discuss contraception options due to potential oral contraceptive interaction and pregnancy risks.
• Be aware of the 'Topamax tingle' (paresthesias), a common and usually benign side effect.
• Monitor for suicidal ideation, especially at the beginning of treatment or with dose changes.
• Extended-release formulations (ER) are designed for once-daily dosing and should not be crushed or chewed.

• For Epilepsy: Levetiracetam, Lamotrigine, Valproic Acid, Carbamazepine, Oxcarbazepine, Phenytoin, Zonisamide, Lacosamide, Pregabalin, Gabapentin.
• For Migraine Prophylaxis: Propranolol, Timolol, Amitriptyline, Valproic Acid, Erenumab, Fremanezumab, Galcanezumab, Eptinezumab, OnabotulinumtoxinA.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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. Please read this guide carefully and review it again whenever you receive a refill. 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 details about the medication taken, the amount, and the time it occurred.