Topiramate 200mg Tablets

Topiramate's exact mechanism is not fully understood but involves multiple actions: blockade of voltage-dependent sodium channels, enhancement of gamma-aminobutyrate (GABA) activity at GABA-A receptors, antagonism of AMPA/kainate glutamate receptors, and inhibition of carbonic anhydrase, particularly isozymes II and IV.

Urgent 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 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, 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.
Numbness or Tingling: Abnormal burning, numbness, or tingling sensations.
Musculoskeletal Symptoms: Bone pain, chest pain, muscle pain or weakness, shakiness, or difficulty walking.
Eye Movement Problems: Inability to control 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 new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes.
Eye Problems: This medication may cause severe eye problems, potentially leading to permanent vision loss if left untreated. Seek medical attention immediately if you experience blurred vision, changes in vision, eye pain, or eye redness.
Liver Problems: Rarely, this medication may cause liver problems, which can be fatal. Contact your doctor immediately if you experience dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellowing of the skin or eyes.
Heat-Related Illness: This medication may cause sweating abnormalities and high body temperatures, potentially leading to hospitalization. Be cautious in hot weather and during physical activity. Seek medical attention immediately if you experience fever or decreased sweating.
Severe Skin Reaction (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis): A severe skin reaction may occur, potentially causing long-term health problems or death. Seek medical attention immediately if you experience 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 significant side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not resolve:

Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Changes in taste
Weight loss
Nervousness or excitability
Dizziness, drowsiness, fatigue, 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 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 they may affect the safety and efficacy of this medication.

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. 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 abruptly stop taking this medication without consulting your doctor, as this may increase your risk of seizures. If you need to discontinue the medication, your doctor will guide you on how to gradually stop taking 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. 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. The risk of metabolic acidosis 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 Risk
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 in children. This medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.

Contraception 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 changes in your menstrual bleeding pattern while taking 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 while taking this medication.

Breastfeeding
If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.

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

• Metformin (increased metformin levels, decreased topiramate levels)
• Lithium (altered lithium levels)
• Hydrochlorothiazide (increased topiramate levels)
• Phenytoin (altered phenytoin and topiramate levels)
• Carbamazepine (decreased topiramate levels)
• Digoxin (decreased digoxin levels)

• Pioglitazone (decreased pioglitazone levels)

• Cognitive slowing/impairment (e.g., word-finding difficulty, memory problems)
• Mood changes (e.g., depression, anxiety, irritability)
• Paresthesia (tingling sensations)
• Symptoms of kidney stones (e.g., flank pain, hematuria)
• Vision changes (e.g., blurred vision, eye pain, sudden decrease in vision)
• Decreased sweating (oligohidrosis) and fever (hyperthermia), especially in children
• Suicidal ideation or behavior

Topiramate can cause fetal harm when administered to a pregnant woman. Increased risk of oral clefts (cleft lip and/or palate), hypospadias, and low birth weight/small for gestational age. Use during pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus. Enrollment in a pregnancy registry is recommended.

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, diarrhea, poor feeding, and irritability.

Increased risk of oligohidrosis (decreased sweating) and hyperthermia (fever), especially in hot weather or during strenuous activity. Also, increased risk of metabolic acidosis. Dosing is weight-based for epilepsy in younger children. Cognitive side effects may be more pronounced.

Start with lower doses and titrate slowly due to potential for decreased renal clearance and increased susceptibility to adverse effects (e.g., cognitive impairment, dizziness, falls). Monitor renal function and serum bicarbonate closely.

• Titrate topiramate slowly to minimize side effects, especially cognitive ones.
• Emphasize adequate hydration (8-10 glasses of water daily) to reduce the risk of kidney stone formation.
• Counsel patients on the potential for cognitive slowing, word-finding difficulties, and mood changes. These are common and often dose-related.
• Monitor for signs of metabolic acidosis, particularly in children and patients with renal impairment.
• Topiramate can cause weight loss, which may be beneficial for some patients but should be monitored.
• Patients should be advised to seek immediate medical attention if they experience sudden vision changes or eye pain due to the risk of acute angle-closure glaucoma.

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

If your symptoms or health issues persist or worsen, it is 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 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.