Topiramate 25mg Tablets

Topiramate's exact mechanism is not fully understood but involves multiple actions: blockade of voltage-dependent sodium channels, enhancement of GABA-A receptor activity (at a non-benzodiazepine site), antagonism of AMPA/kainate glutamate receptors, and inhibition of carbonic anhydrase (primarily isoenzymes II and IV). These actions contribute to its anticonvulsant and migraine prophylactic effects.

Urgent Side Effects: Seek Medical Help Right Away

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 immediate medical attention:

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 changed sputum, 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, changes in behavior, memory problems, loss of memory, trouble speaking, trouble sleeping, balance changes, severe dizziness, or fainting.
Kidney Problems: Back pain, abdominal pain, or blood in the urine, which may indicate a kidney stone.
Other Severe Symptoms: Burning, numbness, or tingling sensations, bone pain, chest pain, muscle pain or weakness, shakiness, difficulty walking, or uncontrolled eye movements.

Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in people 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 may cause severe eye problems, which can lead to permanent vision loss if left untreated. Contact your doctor immediately if you experience 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. If you experience symptoms such as dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin and eyes, contact your doctor right away.

Heat-Related Illness: This medication may cause sweating reduction and high body temperature, which can lead to hospitalization. Be cautious in hot weather and during physical activity. If you experience fever or decreased sweating, contact your doctor immediately.

Severe Skin Reaction: A rare but potentially life-threatening skin reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis may occur. Seek medical help immediately if you experience 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 severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:

Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Changes in taste
Weight loss
Feeling nervous, excitable, dizzy, sleepy, tired, or weak
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 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 identify potential interactions.
* Any existing health problems, as this medication may interact with other medical 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
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 monitor your condition.

Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or prescription or over-the-counter medications that may cause drowsiness, consult your doctor.

Risk of Metabolic Acidosis
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. 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.

Interaction with Valproic Acid
Taking this medication with valproic acid can cause low body temperature, leading to fatigue, confusion, or coma. Consult your doctor if you are taking valproic acid.

Pediatric Use
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 any 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 component)
• Valproic acid (increased risk of hyperammonemia with or without encephalopathy)
• Other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide, dichlorphenamide - increased risk of metabolic acidosis and kidney stones)
• CNS depressants (e.g., alcohol, benzodiazepines, opioids - additive CNS depression)

• Phenytoin (altered phenytoin levels, altered topiramate levels)
• Carbamazepine (decreased topiramate levels)
• Digoxin (decreased digoxin levels)
• Metformin (decreased metformin clearance)
• Lithium (altered lithium levels)
• Hydrochlorothiazide (increased topiramate levels)
• Pioglitazone (decreased pioglitazone exposure)

• Changes in vision (e.g., sudden decrease in vision, eye pain)
• Signs of metabolic acidosis (e.g., fatigue, anorexia, rapid breathing, cardiac arrhythmias)
• Signs of kidney stones (e.g., flank pain, hematuria)
• Decreased sweating or fever (especially in hot weather or during exertion)
• Cognitive changes (e.g., difficulty concentrating, memory problems, word-finding difficulties)
• Mood changes (e.g., depression, anxiety, suicidal thoughts or behavior)
• Unexplained weight loss

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 birth defects (e.g., hypospadias, craniosynostosis, cardiovascular malformations) and lower birth weight/small for gestational age. Use during pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus.

Topiramate is excreted into human milk. The effects on a breastfed infant are unknown, but potential for serious adverse reactions (e.g., diarrhea, drowsiness, poor feeding, metabolic acidosis) exists. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Children, especially those < 2 years of age, are at increased risk for oligohidrosis (decreased sweating) and hyperthermia (fever). Monitor for decreased sweating and elevated body temperature, especially in hot weather or during exertion. Cognitive side effects may be more pronounced in children. Weight monitoring is important due to potential for weight loss.

Start at the low end of the dosing range and titrate slowly due to the greater frequency of decreased renal function and concomitant disease or other drug therapy. Monitor renal function closely.

• Titrate dose slowly to minimize cognitive side effects and improve tolerability.
• Ensure adequate hydration to reduce the risk of kidney stone formation.
• Counsel patients on the risk of acute myopia and secondary angle-closure glaucoma; advise them to seek immediate medical attention for sudden vision changes or eye pain.
• Monitor for signs of metabolic acidosis, especially in patients with predisposing conditions or on other carbonic anhydrase inhibitors.
• Topiramate can cause weight loss, which may be beneficial for some patients but requires monitoring for others, especially children.
• Patients should be warned about the risk of decreased sweating and hyperthermia, particularly in warm environments or during strenuous activity.
• Due to potential for cognitive slowing, advise patients to avoid activities requiring mental alertness until they know how the drug affects them.

• For Epilepsy: Levetiracetam, Lamotrigine, Valproic Acid, Carbamazepine, Oxcarbazepine, Phenytoin, Gabapentin, Pregabalin, Zonisamide, Lacosamide, etc.
• 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, a patient fact sheet that provides crucial information. 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, consult 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.