Topiramate 50mg Tablets

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

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention right away:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of too much acid in the blood (acidosis), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Abnormal heartbeat
+ Severe stomach pain, upset stomach, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
Signs of high ammonia levels, such as:
+ Abnormal heartbeat
+ Abnormal breathing
+ Confusion
+ Pale skin
+ Slow heartbeat
+ Seizures
+ Sweating
+ Vomiting
+ 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
Inability to control eye movements
Suicidal thoughts or behaviors (this medication may increase the risk of suicidal thoughts or actions, especially in people with a history of suicidal behavior)
New or worsening symptoms of depression, anxiety, or mood changes

Additional Serious Side Effects

Eye problems: This medication may cause severe eye problems that can lead 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 can cause liver problems, which can be life-threatening. Seek medical attention immediately if you experience dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Sweating and heat-related problems: This medication can cause decreased sweating and high body temperatures, which can lead to hospitalization. Be cautious in hot weather and during physical activity. Seek medical attention immediately if you experience fever or decreased sweating.
Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis): This rare but potentially life-threatening condition can cause severe health problems and 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.

Common Side Effects

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Changes in taste
Weight loss
Nervousness or excitability
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Flushing
Common cold symptoms
* Joint pain

Reporting Side Effects

If you experience any side effects that bother you or do not go away, contact your doctor for medical advice. 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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or health problems, so it is crucial to discuss the following with your doctor and pharmacist:
+ All prescription and over-the-counter (OTC) medications you are taking
+ Any natural products or vitamins you are using
+ Existing health problems
* To ensure your safety, carefully review all your medications and health conditions with your doctor before taking this medication. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

To minimize the risk of seizures, do not abruptly stop taking this medication without consulting your doctor. If you need to discontinue use, your doctor will guide you on how to gradually stop taking it. As directed by your doctor, regularly have your blood work and other laboratory tests checked.

While taking this medication, it is recommended to avoid consuming alcohol. Before using marijuana, cannabis, or prescription and over-the-counter drugs that may cause drowsiness, consult with your doctor.

This medication may cause a condition called metabolic acidosis, which can be more likely in children and individuals 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 over time.

There is a potential increased risk of bleeding associated with this medication, which can be life-threatening in some cases. Discuss this with your doctor.

When taken with valproic acid, this medication can cause low body temperature, leading to fatigue, confusion, or coma. Consult with your doctor about this potential interaction.

If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher. In some cases, this medication can affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.

The effectiveness of birth control pills and other hormone-based birth control methods may be reduced 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.

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 to prevent pregnancy while taking this medication.

If you are breastfeeding, inform your doctor, as you will need 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 - increased risk of metabolic acidosis and kidney stones)

• CNS Depressants (additive CNS depression)
• Metformin (topiramate may decrease metformin clearance)
• Lithium (topiramate may decrease lithium levels)
• Phenytoin, Carbamazepine (may decrease topiramate levels; topiramate may increase phenytoin levels)
• Hydrochlorothiazide (may increase topiramate levels)

• Alcohol (additive CNS depression, increased risk of adverse effects)

• Cognitive impairment (e.g., difficulty concentrating, memory problems, word-finding difficulties)
• Mood changes (e.g., depression, anxiety, irritability)
• Vision changes (e.g., blurred vision, eye pain, sudden decrease in vision)
• Symptoms of kidney stones (e.g., flank pain, hematuria)
• Symptoms of metabolic acidosis (e.g., fatigue, anorexia, rapid breathing)
• Decreased sweating or fever (especially in hot weather or during exertion)

Topiramate is classified as Pregnancy Category D. It should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Women of childbearing potential should be advised about the risks and use effective contraception.

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.

Children, especially those under 2 years, may be at higher risk for metabolic acidosis and decreased sweating/hyperthermia. Monitor growth and development. Cognitive side effects may be more pronounced in some children.

Initiate at 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 closely.

• Titrate dose slowly to minimize cognitive side effects and improve tolerability.
• Emphasize adequate hydration to reduce the risk of kidney stones and oligohidrosis/hyperthermia.
• Counsel patients about potential cognitive side effects ('topa-maxed out' or 'topa-fog') which often improve with time or dose adjustment.
• Advise women of childbearing potential about the risk of oral clefts and the need for effective contraception.
• Be aware of the potential for weight loss, which can be beneficial for some patients but problematic for others.
• Monitor for signs of acute angle-closure glaucoma, a rare but serious side effect requiring immediate medical attention.

• For Epilepsy: Levetiracetam, Lamotrigine, Valproic Acid, Carbamazepine, Oxcarbazepine, Phenytoin, Gabapentin, Pregabalin, Zonisamide, Lacosamide, etc.
• For Migraine Prophylaxis: Propranolol, Timolol, Amitriptyline, Venlafaxine, Valproic Acid, CGRP inhibitors (e.g., Erenumab, Fremanezumab, Galcanezumab), Botox.

If your symptoms or health issues persist or worsen, it's 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, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.