Topiramate 50mg Capsules

Topiramate's precise mechanism is not fully understood but involves multiple actions: it blocks voltage-dependent sodium channels, enhances the activity of the neurotransmitter gamma-aminobutyrate (GABA) at GABA-A receptors, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits carbonic anhydrase, particularly isozymes II and IV.

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 discolored 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 unusual bruising or bleeding that doesn't have a clear cause.
Neurological Symptoms: Confusion, difficulty focusing, changes in behavior, memory problems, loss of memory, trouble speaking, difficulty sleeping, balance problems, severe dizziness, or fainting.
Kidney Stone Symptoms: Back pain, abdominal pain, or blood in the urine.
Other Severe 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 tendencies. 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 that can 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 life-threatening. 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 can lead to hospitalization. Be cautious in hot weather and during physical activity. If you experience a fever or don't sweat during activities or in warm temperatures, contact your doctor immediately.

Severe Skin Reaction: A rare but potentially life-threatening skin reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis can occur. 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, seek medical help right away.

Other Side Effects

Most people don't 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 don't go away:

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 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 you have, 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 other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor. Always consult with your doctor and pharmacist to confirm that it is safe to take this medication in conjunction with your other medications and health conditions.

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 tasks 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 Testing
Follow your doctor's instructions for regular blood work and other laboratory tests.

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 with 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 with 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.

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 with your doctor.

Pregnancy and Breastfeeding
This medication may harm the 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.

• Valproic acid (VPA): Concomitant use has been associated with hyperammonemia with or without encephalopathy. Monitor for symptoms.
• Oral contraceptives: Topiramate can decrease the efficacy of estrogen-containing oral contraceptives, leading to breakthrough bleeding and potential pregnancy. Patients should be advised to use alternative or additional birth control methods.

• Other CNS depressants (e.g., alcohol, benzodiazepines, opioids): May cause additive CNS depression (drowsiness, dizziness).
• Carbonic anhydrase inhibitors (e.g., acetazolamide, zonisamide): May increase the risk of metabolic acidosis and kidney stone formation.
• Phenytoin, Carbamazepine: May decrease topiramate plasma concentrations.
• Metformin: Topiramate may increase metformin plasma concentrations.
• Lithium: Topiramate may decrease lithium levels.
• Hydrochlorothiazide: May increase topiramate plasma concentrations.

• Pioglitazone: Topiramate may decrease pioglitazone plasma concentrations.
• Amitriptyline: Topiramate may decrease amitriptyline levels.

• Cognitive slowing (e.g., difficulty with concentration, memory, word finding)
• Paresthesia (tingling sensation)
• Fatigue, somnolence
• Mood changes, depression, suicidal ideation
• Symptoms of metabolic acidosis (e.g., fatigue, anorexia, rapid breathing)
• Symptoms of kidney stones (e.g., flank pain, hematuria)
• Symptoms of oligohidrosis/hyperthermia (e.g., decreased sweating, fever, especially in children)
• Sudden decrease in visual acuity, eye pain, or redness (signs of acute myopia/secondary angle closure glaucoma)
• Breakthrough bleeding or unexpected pregnancy (for women on oral contraceptives)

Topiramate is classified as Pregnancy Category D due to evidence of human fetal risk. It is associated with an increased risk of oral clefts (cleft lip/palate) and potentially other congenital malformations (e.g., hypospadias, low birth weight). Use during pregnancy should only be considered if the potential benefit outweighs the potential risk to the fetus.

Topiramate is excreted into breast milk. The American Academy of Pediatrics considers it to be of unknown effect on the nursing infant but may be of concern. Monitor breastfed infants for drowsiness, diarrhea, and poor weight gain. Weigh the benefits of breastfeeding against the potential risks to the infant.

Topiramate is approved for epilepsy in children 2 years and older and for migraine prophylaxis in adolescents 12 years and older. Children are at higher risk for oligohidrosis (decreased sweating) and hyperthermia (fever), especially in warm environments. Close monitoring of body temperature and hydration is crucial.

Use with caution in elderly patients, as they may be more susceptible to adverse effects, particularly cognitive impairment, dizziness, and metabolic acidosis. Renal function often declines with age, necessitating dose adjustments based on creatinine clearance. Start with lower doses and titrate slowly.

• Always titrate topiramate slowly to minimize side effects, especially cognitive ones.
• Counsel patients on the importance of adequate hydration to prevent kidney stones.
• Warn female patients about the potential for decreased efficacy of oral contraceptives and advise on alternative birth control.
• Be vigilant for signs of metabolic acidosis (e.g., fatigue, rapid breathing) and monitor serum bicarbonate levels.
• Educate patients about the risk of acute myopia and secondary angle closure glaucoma, emphasizing the need for immediate ophthalmologic evaluation if visual symptoms occur.
• Topiramate can cause significant weight loss, which may be a desired or undesired effect depending on the patient.

• For Epilepsy: Levetiracetam, Lamotrigine, Valproic acid, Carbamazepine, Oxcarbazepine, Phenytoin, Gabapentin, Pregabalin, Zonisamide, Lacosamide, Brivaracetam.
• 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's 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 provides important information for patients. Please read this guide carefully and review it again each time you receive a refill. 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, and the time it occurred.