Topiramate 100mg Tablets

Topiramate's exact mechanism is not fully understood but involves multiple actions: it blocks voltage-dependent sodium channels, enhances GABA-mediated chloride currents, antagonizes AMPA/kainate glutamate receptors, and inhibits carbonic anhydrase, particularly isozymes II and IV.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an 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.
Signs of too much acid in the blood (acidosis): 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.
Signs of 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.
Signs of 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.
Inability to eat.
Back pain, abdominal pain, or blood in the urine (may indicate a kidney stone).
Abnormal burning, numbness, or tingling sensations.
Bone pain.
Chest pain.
Muscle pain or weakness.
Shakiness.
Difficulty walking.
Uncontrolled eye movements.

Like other medications used to treat seizures, this drug may increase the risk of suicidal thoughts or actions, particularly in individuals with a history of such thoughts or behaviors. 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.

This medication may cause severe eye problems, potentially leading to permanent vision loss if left untreated. If you notice any new eye symptoms, such as blurred vision, changes in vision, eye pain, or eye redness, contact your doctor immediately.

Rarely, this medication has caused liver problems, which can be fatal. If you experience any signs of liver problems, such as dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor right away.

Sweating less and high body temperatures have occurred with this medication, sometimes requiring hospitalization. Be cautious in hot weather and during physical activity. If you experience a fever or decreased sweating, contact your doctor immediately.

A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, potentially causing serious health problems or death. If you notice any signs, 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 Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:

Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.
Changes in taste.
Weight loss.
Feeling anxious or excitable.
Dizziness, drowsiness, fatigue, or weakness.
Headache.
Flushing.
Common cold symptoms.
* Joint pain.

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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 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.

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 alertness. If you need to stop taking this medication, do not do so abruptly without consulting your doctor, as this may increase your risk of seizures. Instead, your doctor will guide you on how to gradually taper off the medication.

Regular blood tests and other laboratory evaluations, as directed by your doctor, are crucial to monitor your health while taking this medication. Additionally, it is recommended to avoid consuming alcohol during treatment.

Before using marijuana, cannabis products, or prescription and over-the-counter medications that may cause drowsiness, discuss the potential risks with your doctor. This medication may cause a condition called metabolic acidosis, which can be more likely in children, individuals with kidney problems, breathing difficulties, or diarrhea. Certain medications, surgery, or a ketogenic diet may also increase this risk. If left untreated, metabolic acidosis can lead to kidney stones, bone problems, or growth issues in children over time.

There is a potential risk of bleeding associated with this medication, which can be life-threatening in some cases. It is crucial to discuss this risk with your doctor. When taken with valproic acid, this medication can cause low body temperature, leading to fatigue, confusion, or even coma. Your doctor should be informed about this potential interaction.

If the patient is a child, this medication should be used with caution, as the risk of certain side effects may be higher in this age group. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Your doctor will discuss the potential risks and benefits with you.

It is essential to note that birth control pills and other hormone-based contraceptives may not be as effective in preventing pregnancy while taking this medication. To minimize the risk of unplanned pregnancy, use an additional form of birth control, such as condoms. If you experience any changes in your menstrual bleeding pattern while taking hormone-based birth control and this medication, inform your doctor.

This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or suspect you may be 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 to prevent pregnancy during treatment.

If you are breastfeeding, inform your doctor, as they will need to discuss the potential risks to your baby and determine the best course of action.

• Valproic acid (increased risk of hyperammonemia with or without encephalopathy)
• Oral contraceptives (decreased efficacy of estrogen-containing contraceptives)
• Metformin (increased metformin levels, decreased topiramate levels)
• Lithium (altered lithium levels, monitor closely)

• Other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide) - increased risk of metabolic acidosis and kidney stone formation
• CNS depressants (e.g., alcohol, benzodiazepines, opioids) - additive CNS depression
• Phenytoin, Carbamazepine (decreased topiramate levels, altered levels of co-administered AEDs)
• Digoxin (decreased digoxin levels)
• Hydrochlorothiazide (increased topiramate levels)

• Pioglitazone (decreased pioglitazone levels)
• Amitriptyline (increased amitriptyline levels)

• Cognitive impairment (e.g., difficulty concentrating, memory problems, word-finding difficulties)
• Mood changes (e.g., depression, anxiety, irritability, suicidal ideation)
• Vision changes (e.g., blurred vision, eye pain, sudden decrease in vision)
• Symptoms of metabolic acidosis (e.g., fatigue, anorexia, rapid breathing, cardiac arrhythmias)
• Symptoms of kidney stones (e.g., flank pain, hematuria)
• Paresthesias (tingling sensation)
• Fever, rash, swollen glands (signs of DRESS syndrome, rare but serious)

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, craniosynostosis, cardiovascular malformations) when used during pregnancy. There is also an increased risk of low birth weight and small for gestational age infants. Neurodevelopmental outcomes are also a concern.

Topiramate is excreted into breast milk. The decision to breastfeed should consider the potential for adverse effects in the infant (e.g., diarrhea, drowsiness, irritability, poor weight gain) versus the benefits of breastfeeding and the mother's need for the drug. Monitoring the infant for adverse effects is recommended.

Topiramate is approved for adjunctive treatment of partial-onset seizures and generalized tonic-clonic seizures in patients ≥2 years of age, and for monotherapy in patients ≥10 years of age. It is also approved for migraine prophylaxis in adolescents ≥12 years of age. Children are more susceptible to metabolic acidosis and oligohidrosis/hyperthermia. Close monitoring of bicarbonate levels and hydration status is crucial.

Use with caution in elderly patients due to a higher likelihood of decreased renal function. Start at the lower end of the dosing range and titrate slowly. Monitor renal function and for adverse effects such as cognitive impairment and metabolic acidosis more closely.

• Always titrate topiramate slowly to minimize side effects, especially cognitive ones.
• Counsel patients on the importance of adequate hydration to reduce the risk of kidney stones and oligohidrosis.
• Warn female patients of childbearing potential about the decreased efficacy of oral contraceptives and the risk of birth defects.
• Monitor for signs of metabolic acidosis (fatigue, rapid breathing) and consider bicarbonate supplementation if severe.
• Be vigilant for acute angle-closure glaucoma, a rare but serious side effect that requires immediate medical attention.
• Patients may experience weight loss, which can be beneficial for some but needs monitoring for others.
• Cognitive side effects (e.g., 'dopamax' effect, word-finding difficulties) are common, especially during titration or at higher doses.

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

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about its safe and effective use. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, it is vital to seek immediate medical attention by calling your local poison control center or visiting the emergency room. When seeking help, be prepared to provide critical information, including the name of the medication taken, the amount consumed, and the time it happened, to ensure you receive the most appropriate care.