Topiramate and alcohol both work as depressants on your brain. People taking topiramate should avoid drinking any amount of alcohol when possible. And if you’re taking the extended-release version of topiramate (Trokendi XR), you should avoid alcohol completely within 6 hours of your dose.
- 1 What can happen if I drink alcohol while taking Topamax?
- 2 Can you have a glass of wine with Topamax?
- 3 Can you drink coffee while on Topamax?
- 4 What not to do on Topamax?
- 5 Does Topamax fatigue go away?
- 6 Does Topamax have permanent effects?
- 7 How does Topamax help you stop drinking?
- 8 What does topiramate do to the brain?
- 9 Does caffeine affect topiramate?
- 10 What foods taste bad on Topamax?
- 11 What happens if you don’t drink enough water on Topamax?
Can you drink occasionally on Topamax?
Article at a Glance: – Alcohol is dangerous to mix with topiramate or any other prescription medication. Topamax is known to cause sleepiness and dizziness, so mixing it with alcohol will worsen those symptoms. Alcohol is strictly discouraged while taking this medication.
What can happen if I drink alcohol while taking Topamax?
Topamax (topiramate) is a prescription drug that’s used to:
treat epilepsy in adults and certain children who have any of the following types of seizures:
focal-onset seizures (also known as partial seizures)
primary generalized tonic-clonic seizures
seizures caused by Lennox-Gastaut syndrome
help prevent migraine attacks in adults and some children
Like other drugs, Topamax may have interactions, Some interactions occur because one substance causes another substance to have a different effect than expected. For example, sometimes alcohol, another drug, or a supplement can affect how a drug acts in your body.
- Interactions can also occur if you have certain health conditions.
- Eep reading to learn about Topamax’s possible interactions, including what you should not take with Topamax.
- And for more information about Topamax, including details about its uses, see this article,
- You should avoid drinking alcohol while taking Topamax.
Both alcohol and Topamax reduce activity in your central nervous system, So consuming alcohol with Topamax can increase the risk and severity of certain side effects, such as:
dizzinesssleepiness confusion trouble concentrating, remembering, or speaking
In some cases, drinking alcohol with Topamax could cause serious, life threatening side effects. These include:
respiratory depression (slow, shallow breathing)unconsciousness coma
If you have concerns about drinking alcohol while taking Topamax, talk with your doctor. Before you start taking Topamax, tell your doctor and pharmacist about any prescription, over-the-counter, or other drugs you take. Sharing this information with them may help prevent possible interactions.
(To learn whether Topamax interacts with supplements, herbs, and vitamins, see the “Are there other interactions with Topamax?” section below.) If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist. The chart below lists drugs that may interact with Topamax.
Keep in mind that this chart does not include all drugs that may interact with Topamax. For more information about some of these interactions, see the “Drug interactions explained” section below. Learn more about certain drug interactions that can occur with Topamax.
How many hours does Topamax last?
How long does Topamax stay in your system? Topamax stays in your system for approximately 4 to 5 days after the last dose, but this may vary depending on personal factors, such as your age, weight, dosage, and what other medications you currently take.
- This estimate is based on the half-life of Topamax which is about 21 hours and experts agree that it takes up to 5 half-lives for a drug without active metabolites to be completely removed from the body (a drug’s half-life is the time it takes for 50% of that drug to be removed from the body).
- Topamax does have some metabolites, but these are not considered active and only make up about 5% of an administered dose.
This means it takes 84 to 105 hours for Topamax to leave your body. Topamax should never be stopped suddenly or “cold turkey”, because this may cause you to have an increased risk of seizures, more frequent seizures, or other serious withdrawal symptoms.
This can happen even if you do not take Topamax for epilepsy. Topamax is also approved by the FDA to be used in patients to help prevent migraine headaches. To decrease the risk for seizures or other withdrawal symptoms, your doctor will let you know how to slowly stop taking Topamax. Depending upon the dose you take, it may take several weeks to a few months to slowly discontinue Topamax.
: How long does Topamax stay in your system?
How long is Topamax stay in your system?
How Long Does Topamax (Topiramate) Stay In Your System? – Topamax (topiramate) stays in your system between four and six days after your last dose, depending on your personal factors such as dosage and metabolism. Dosage for topiramate is based on weight but usually starts with one pill per day and gradually increasing to two.
Can you have a glass of wine with Topamax?
Notes for Professionals: Advise patients to avoid alcohol consumption while taking topiramate. Topiramate is a CNS depressant. Concomitant administration of topiramate with alcohol can result in significant CNS depression.
Can I skip a day of Topamax?
Missed Dose – If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. If your next regular dose of Topamax® capsule or tablet or Eprontia™ oral solution is within 6 hours away, wait until then to use the medicine and skip the missed dose.
Can you drink coffee while on Topamax?
Coffee and seizure medicine – If you take antiepileptic drugs to control your seizures, it is important to find out whether caffeine might ‘interact’ with your medication. In relatively small doses, caffeine does not seem to have much of an impact on the effectiveness of most seizure medicines.
Can I drink beer with topiramate?
It’s best not to drink too much alcohol while taking topiramate. It may make you feel sleepy or tired, and alcohol and hangovers can bring on seizures in some people with epilepsy.
What not to do on Topamax?
Avoid the use of a ketogenic or ‘ketosis’ diet (high in fat, low in carbohydrates) while you are taking topiramate. Also avoid activities that could be dangerous if you have an unexpected seizure, such as swimming or climbing in high places.
Why is it better to take Topamax at night?
Advantages of the evening regimen included better early-morning airflow (without significant decline later in the day), more effective symptom control, better patient acceptance, fewer night awakenings, and the obvious convenience of once-daily dosing. –
Does Topamax fatigue go away?
Sleepiness – Treatment with Topamax may cause sleepiness as a side effect. This was one of the most common side effects reported by people taking Topamax to treat epilepsy in studies, Sleepiness was less common in people who took Topamax to help prevent migraine in these studies.
People often need to stop taking Topamax due to the sleepiness that the drug can cause. The risk of sleepiness from Topamax increases with higher doses of the medication. What might help Due to the risk of sleepiness with Topamax, it’s important to avoid certain activities until you know how the drug will affect you.
These activities include driving and operating machinery. It’s possible that sleepiness caused by Topamax will go away on its own. Talk with your doctor if you have sleepiness that’s bothersome to you or doesn’t go away. They may lower your Topamax dose.
Does Topamax have permanent effects?
Topamax (topiramate) is a prescription drug that’s used to treat epilepsy and help prevent migraine headaches. It can cause side effects that range from mild to serious. Examples include hair loss and eye problems. Specifically, Topamax is used in adults and some children to:
treat epilepsy with generalized tonic-clonic seizures, partial onset seizures, or seizures caused by Lennox-Gastaut syndromehelp prevent migraine headaches
The active ingredient in Topamax is topiramate. (An active ingredient is what makes a drug work.) The drug comes as tablets that you swallow and as sprinkle capsules. The sprinkle capsules can be swallowed whole or opened and poured onto food. Keep reading to learn about the common, mild, and serious side effects of Topamax and ways to deal with them.
tingling in the legs and arms loss of appetite weight loss impaired taste (changes in how things taste)trouble with memory
More common side effects in people taking Topamax for epilepsy include:
tingling in the legs and armsloss of appetiteweight loss dizziness sleepiness
Read on to learn about other mild and severe side effects that can happen with Topamax. You may have mild side effects from Topamax. Examples of mild side effects that have been reported with Topamax include:
hair loss *stomach problems* impaired taste (changes in how things taste) loss of appetite weight loss fatigue (low energy) dizziness problems with sleep, such as sleepiness or insomnia (trouble sleeping) fever tingling in your legs and armsspeech problems, such as having trouble thinking of the right words to say numbness slowed mental or physical activity, which can lead to problems such as speaking more slowly than usual upper respiratory infections, such as the common cold
* To learn more about this side effect, see the “Side effects explained” section below. In most cases, these side effects should be temporary. And some may be easily managed, too. But if you have any symptoms that are ongoing or that bother you, talk with your doctor or pharmacist.
And do not stop using Topamax unless your doctor recommends it. Topamax may cause mild side effects other than the ones listed above. See the Topamax prescribing information for details. Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Topamax, visit MedWatch,
Topamax may cause rare but serious side effects. Serious side effects that have been reported with Topamax include:
eye side effects, such as sudden vision changes*severe rash and other serious skin reactions*mood changes* allergic reaction *†severe, negative changes in memory or mood kidney stones high level of acid in the blood, which can cause:
heart palpitations fast breathing stupor (decreased level of consciousness)
high level of ammonia in the blood, which can cause brain swelling decreased sweating, which can cause high body temperature
If you develop serious side effects while taking Topamax, call your doctor right away. If the side effects seem life threatening or if you think you’re having a medical emergency, immediately call 911 or your local emergency number. * To learn more about this side effect, see the “Side effects explained” section below.
† An allergic reaction is possible after using Topamax. But it isn’t clear how often this side effect occurred in studies, Topamax is used to treat certain types of epilepsy in children ages 2 years and older, and to prevent migraine headaches in children ages 12 years and older. Most side effects of Topamax in children are expected to be the same as those in adults.
But the following side effects may be more likely to happen in children:
decreased sweating, which can cause high body temperature and may require treatment in a hospitalcough fever ear infections upper respiratory infections, such as the common cold
Also, when Topamax is taken by children, it may cause reduced bone mineral density (BMD), This measurement describes bone strength. Lowered BMD could mean your bones are weakened. Topamax may also affect weight and height in children taking the drug. Specifically, the drug can cause decreased growth in children.
If a child takes Topamax, their doctor will check their growth. Talk with your child’s doctor about your child’s risk of side effects from Topamax. In most cases, side effects from Topamax are temporary. Most side effects tend to go away soon after you start or stop taking the drug. But severe side effects that could lead to long-term problems and permanent damage from Topamax are possible.
For example, Topamax may cause eye side effects,* such as glaucoma, And if untreated, glaucoma could cause blindness, If you have questions about possible long-term side effects of Topamax, talk with your doctor or pharmacist. * To learn more about this side effect, see the “Side effects explained” section below.
How does Topamax help you stop drinking?
WHAT PROBLEM DOES THIS STUDY ADDRESS? – Alcohol-related cues (e.g., visual cues like a beer bottle, a bar, etc.) can play a role in ongoing alcohol use and a return to alcohol use after a period of abstinence. Brain imaging studies show that individuals with alcohol use disorder have enhanced dopamine release (brain chemical that plays a role in pleasure and reward) and brain activation in regions involved in reward processing (e.g., an area called the ventral striatum) when exposed to alcohol-related cues.
Topiramate is an anti-seizure medication that was traditionally prescribed to people for epilepsy and has more recently been investigated for the treatment of alcohol use disorder. Though not yet approved by the FDA, emerging studies suggest that topiramate may be a promising treatment for alcohol use disorder and some currently use it as an off-label treatment for this purpose.
More specifically, topiramate has been shown to reduce heavy drinking – defined differently across studies but indicative of consumption of multiple drinks in a way that increase risk for harm – and/or craving and promote abstinence in clinical trials conducted to date.
- Also, preliminary work suggests its efficacy may be somewhat greater than that of naltrexone and acamprosate (i.e., the most commonly prescribed medications for alcohol use disorder treatment).
- Little research has been conducted to evaluate the brain changes that underlie topiramate’s effects in alcohol use disorder populations.
Characterizing topiramate’s effects on the brain and its relationship to behavior may help further our understanding of how this medication, traditionally used for epilepsy, works for alcohol use disorder to address maladaptive alcohol-related behaviors, which can ultimately guide decisions around FDA approval of topiramate for alcohol use disorder or the development of new drugs with similar neural targets.
It has been hypothesized that topiramate may work by reducing dopamine release in reward-related regions of the brain when alcohol is consumed, or individuals are exposed to alcohol cues. Over time, this decrease in the brain’s response to alcohol might act to decrease the reinforcing/rewarding effects of alcohol, thereby weakening the learned association between alcohol, alcohol cues, and reward, and reducing alcohol cravings and the motivation to drink.
Decreased reward from alcohol and alcohol-related cues (e.g., liquor bottle, bar, alcohol advertisement), in turn, means less drinking over time and fewer negative consequences. To test this hypothesis and better understand how topiramate works, this study examined the effects of topiramate on brain responses to alcohol cues and their relationship to craving and heavy drinking among individuals with alcohol use disorder.
What does topiramate do to the brain?
Abstract – Drug side effects which impair cognition can lead to diminished quality of life and discontinuation of therapy. Topiramate is an antiepileptic drug which elicits cognitive deficits more frequently than other antiepileptic drugs, impairing multiple cognitive domains including language, attention, and memory.
Although up to 40% of individuals taking topiramate may experience cognitive deficits, we are currently unable to predict which individuals will be most severely affected prior to administration. The objective of this analysis was to show the contributions of plasma concentration and working memory capacity in determining the severity of an individual’s topiramate-related cognitive impairment.
Subjects were enrolled in a double-blind, placebo-controlled crossover study during which they received a single dose of either 100, 150, or 200 mg topiramate. Working memory function was assessed using a modified Sternberg working memory task with three memory loads administered four hours after dosing.
After adjusting for differences in working memory capacity, each μg/mL of topiramate plasma concentration was associated with a 3.6% decrease in accuracy for all memory loads. Placebo effects occurred as a function of working memory capacity, with high working memory capacity individuals experiencing less severe placebo-related impairment compared to those with low working memory capacity.
Our results demonstrate that severity of topiramate-related cognitive deficits occurs as a function of both drug exposure and baseline cognitive function. By identifying patient- and exposure-related characteristics which modulate the severity of cognitive side effects, topiramate dosing strategies may be individually tailored in the future to prevent unwanted cognitive impairment.
Does Topamax affect your mood?
Personality or mood changes – Topamax can sometimes cause personality changes that affect the way people behave, react, feel, or interact with others. For example, the drug may cause agitation, aggression, or other behavior problems. Topamax may also cause mood changes, such as anxiety, mood swings, and depression,
- In addition, the medication may raise your risk for suicidal thoughts or behaviors.
- All antiepileptic drugs (medications used to treat seizures due to epilepsy) are known to slightly raise the risk of suicidal thoughts and behaviors.
- Antiepileptic drugs are also called anticonvulsants.) These drugs can increase the risk regardless of what condition they’re treating.
Clinical trials looked at people taking an antiepileptic drug for any condition. The people had about twice the risk of suicidal thoughts or behaviors than people taking a placebo, In these studies, suicidal behavior or thoughts occurred in:
0.43% of people taking an antiepileptic0.24% of people taking a placebo
Symptoms of depression It’s important for you, your friends, and your family to watch for symptoms of depression while you take Topamax. These symptoms can include:
having thoughts about suicide or harming yourselffeeling sad or hopelesshaving trouble sleeping losing interest in usual activitiesfeeling agitated or restlessfeeling anxious or having panic attacks being irritable, aggressive, or violenthaving other changes in your mood or behavior
If you have any symptoms of new or worsening depression while taking Topamax, talk with your doctor right away. They can suggest ways to ease this condition. They may also recommend that you switch to a different medication. If you need to stop taking Topamax, your doctor will explain how to taper off the drug gradually.
- To read more about stopping Topamax treatment, see the ” Topamax withdrawal and dependence ” section below.
- Weight gain (not a side effect) Topamax isn’t known to cause weight gain.
- This side effect wasn’t reported in clinical trials with Topamax.
- However, weight gain has been reported with some anticonvulsant drugs that are in the same class as Topamax.
Topamax can cause weight loss. To read more about this, see the “Topamax for weight loss” section below.
What happens if you don’t drink enough water with topiramate?
Drink plenty of water It’s important because topiramate can increase your body temperature and reduce sweating – especially during hot weather and when you exercise. This can put you at risk of getting dehydrated and can cause kidney stones.
What happens if you don’t drink enough water with Topamax?
What else should I avoid while taking topiramate? – Avoid getting dehydrated. Drink plenty of fluids when taking topiramate. Also, avoid becoming overheated or dehydrated in hot weather. Topiramate can increase body temperature and decrease sweating, leading to life-threatening dehydration (especially in children).
- It is also important to drink plenty of fluids when taking topiramate to decrease your chances of getting kidney stones.
- Topiramate may cause drowsiness, dizziness, blurred vision or impair your thinking or reactions.
- Avoid driving or operating machinery until you know how topiramate will affect you.
- Avoid the use of a ketogenic or “ketosis” diet (high in fat, low in carbohydrates) while you are taking topiramate.
Also avoid activities that could be dangerous if you have an unexpected seizure, such as swimming or climbing in high places. Do not stop taking topiramate or change your dose without first talking to your doctor. Stopping suddenly or changing your dose on your own can cause serious health problems and may cause or worsen seizures.
- All women of childbearing age should talk to their doctors about using other treatments instead of topiramate.
- Talk to your doctor before you become pregnant.
- If you take topiramate during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate.
- These defects can begin early in pregnancy, even before you know you are pregnant.
Also, talk to your doctor about the best form of birth control for you to use. If you are not pregnant or planning to become pregnant, use effective birth control to prevent pregnancy while taking topiramate. It may not be safe to breastfeed a baby while you are using this medicine.
Ask your doctor about any risks. This is not all the information you need to know about topiramate (Topamax) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full patient information for topiramate and discuss this information and any questions you have with your doctor or other health care provider.
Topamax (topiramate) Product Information. Revised 6/2020. Janssen Pharmaceuticals, Inc. Titusville, NJ. Accessed July 15, 2021 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020505s061,020844s052lbl.pdf Topamax (topiramate). Medication Guide. Janssen Pharmaceuticals, Inc. Titusville, NJ. Accessed July 15, 2021 at https://www.janssenlabels.com/package-insert/product-patient-information/TOPAMAX-medication-guide.pdf
Does caffeine affect topiramate?
Abstract – Purpose: Caffeine is the most commonly used central nervous system (CNS) stimulant. The relationship between caffeine, seizures, epilepsy, and antiepileptic drugs (AEDs) is complex and not fully understood. Case reports suggest that caffeine triggers seizures in susceptible people.
- Our systematic review reports on the relationship between caffeine, seizures, and drugs in animal and human studies.
- Quantitative analyses were also done on animal studies regarding the effects of caffeine on AEDs.
- Methods: PubMed was searched for studies assessing the effects of caffeine on seizure susceptibility, epilepsy, and drug interactions in people and in animal models.
To quantify the interaction between AEDs and caffeine, the data of six animal studies were pooled and analyzed using a general linear model univariate analysis or One-way Analysis of Variance (ANOVA). Results: In total, 442 items were identified from which we included 105 studies.
Caffeine can increase seizure susceptibility and protect from seizures, depending on the dose, administration type (chronic or acute), and the developmental stage at which caffeine exposure started. In animal studies, caffeine decreased the antiepileptic potency of some drugs; this effect was strongest in topiramate.
Conclusion: Preclinical studies suggest that caffeine increases seizure susceptibility. In some cases, chronic use of caffeine may protect against seizures. Caffeine lowers the efficacy of several drugs, especially topiramate. It is unclear how these findings in models can be translated to the clinical condition.
How fast will I lose weight on Topamax?
How long will it take to see weight loss results from Topamax + Phentermine? – The amount of time it takes to see weight loss results while taking Topamax and Phentermine can vary depending on individual factors such as metabolism, diet, and exercise habits.
Is 200 mg of Topamax a lot?
My Account Area – 1. Name of the medicinal product Topamax 200 mg film-coated tablets 2. Qualitative and quantitative composition One tablet contains 200 mg of topiramate. Excipients with known effect: also includes lactose monohydrate: One 200 mg tablet contains 43.50 mg lactose monohydrate For the full list of excipients, see section 6.1.3.
Pharmaceutical form Film-coated tablet. Salmon round tablets, 10 mm in diameter, “TOP” on one side, “200” on the other side.4. Clinical particulars 4.1 Therapeutic indications Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.
Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalisation or primary generalised tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome.
- Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options.
- Topiramate is not intended for acute treatment.4.2 Posology and method of administration Posology It is recommended that therapy be initiated at a low dose followed by titration to an effective dose.
Dose and titration rate should be guided by clinical response. It is not necessary to monitor topiramate plasma concentrations to optimise therapy with Topamax. On rare occasions, the addition of topiramate to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome.
- Addition or withdrawal of phenytoin and carbamazepine to adjunctive therapy with Topamax may require adjustment of the dose of Topamax.
- In patients with or without a history of seizures or epilepsy, antiepileptic (AEDs) drugs including topiramate should be gradually withdrawn to minimise the potential for seizures or increased seizure frequency.
In clinical trials, daily dosages were decreased in weekly intervals by 50-100 mg in adults with epilepsy and by 25-50 mg in adults receiving topiramate at doses up to 100 mg/day for migraine prophylaxis. In paediatric clinical trials, topiramate was gradually withdrawn over a 2-8 week period.
- Monotherapy epilepsy General When concomitant AEDs are withdrawn to achieve monotherapy with topiramate, consideration should be given to the effects this may have on seizure control.
- Unless safety concerns require an abrupt withdrawal of the concomitant AED, a gradual discontinuation at the rate of approximately one-third of the concomitant AED dose every 2 weeks is recommended.
When enzyme inducing medicinal products are withdrawn, topiramate levels will increase. A decrease in Topamax (topiramate) dosage may be required if clinically indicated. Adults Dose and titration should be guided by clinical response. Titration should begin at 25 mg nightly for 1 week.
The dosage should then be increased at 1- or 2-week intervals by increments of 25 or 50 mg/day, administered in two divided doses. If the patient is unable to tolerate the titration regimen, smaller increments or longer intervals between increments can be used. The recommended initial target dose for topiramate monotherapy in adults is 100 mg/day to 200 mg/day in 2 divided doses.
The maximum recommended daily dose is 500 mg/day in 2 divided doses. Some patients with refractory forms of epilepsy have tolerated topiramate monotherapy at doses of 1,000 mg/day. These dosing recommendations apply to all adults including the elderly in the absence of underlying renal disease.
- Paediatric population (children over 6 years of age) Dose and titration rate in children should be guided by clinical outcome.
- Treatment of children over 6 years of age should begin at 0.5 to 1 mg/kg nightly for the first week.
- The dosage should then be increased at 1 or 2 week intervals by increments of 0.5 to 1 mg/kg/day, administered in two divided doses.
If the child is unable to tolerate the titration regimen, smaller increments or longer intervals between dose increments can be used. The recommended initial target dose range for topiramate monotherapy in children over 6 years of age is 100 mg/day depending on clinical response, (this is about 2.0mg/kg/day in children 6-16 years).
- Adjunctive therapy epilepsy (partial onset seizures with or without secondary generalisation, primary generalised tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome) Adults Therapy should begin at 25-50 mg nightly for one week.
- Use of lower initial doses has been reported, but has not been studied systematically.
Subsequently, at weekly or bi-weekly intervals, the dose should be increased by 25-50 mg/day and taken in two divided doses. Some patients may achieve efficacy with once-a-day dosing. In clinical trials as adjunctive therapy, 200 mg was the lowest effective dose.
The usual daily dose is 200-400 mg in two divided doses. These dosing recommendations apply to all adults, including the elderly, in the absence of underlying renal disease (see section 4.4). Paediatric population (children aged 2 years and above) The recommended total daily dose of Topamax (topiramate) as adjunctive therapy is approximately 5 to 9 mg/kg/day in two divided doses.
Titration should begin at 25 mg (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response.
- Daily doses up to 30 mg/kg/day have been studied and were generally well tolerated.
- Migraine Adults The recommended total daily dose of topiramate for prophylaxis of migraine headache is 100 mg/day administered in two divided doses.
- Titration should begin at 25 mg nightly for 1 week.
- The dosage should then be increased in increments of 25 mg/day administered at 1-week intervals.
If the patient is unable to tolerate the titration regimen, longer intervals between dose adjustments can be used. Some patients may experience a benefit at a total daily dose of 50 mg/day. Patients have received a total daily dose up to 200 mg/day. This dose may be benefit in some patients, nevertheless, caution is advised due to an increase incidence of side effects.
- Paediatric population Topamax (topiramate) is not recommended for treatment or prevention of migraine in children due to insufficient data on safety and efficacy.
- General dosing recommendations for Topamax in special patient populations Renal impairment In patients with impaired renal function (CL CR ≤ 70 mL/min) topiramate should be administered with caution as the plasma and renal clearance of topiramate are decreased.
Subjects with known renal impairment may require a longer time to reach steady-state at each dose. Half of the usual starting and maintenance dose is recommended (see section 5.2). In patients with end-stage renal failure, since topiramate is removed from plasma by haemodialysis, a supplemental dose of Topamax equal to approximately one-half the daily dose should be administered on haemodialysis days.
The supplemental dose should be administered in divided doses at the beginning and completion of the haemodialysis procedure. The supplemental dose may differ based on the characteristics of the dialysis equipment being used (see section 5.2). Hepatic impairment In patients with moderate to severe hepatic impairment topiramate should be administered with caution as the clearance of topiramate is decreased.
Elderly No dose adjustment is required in the elderly population providing renal function is intact. Method of administration Topamax is available in film-coated tablets and a hard capsule formulation, for oral administration. It is recommended that film-coated tablets not be broken.
The hard capsule formulation is provided for those patients who cannot swallow tablets, e.g. paediatric and the elderly. Topamax can be taken without regard to meals.4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Migraine prophylaxis in pregnancy and in women of childbearing potential if not using a highly effective method of contraception.4.4 Special warnings and precautions for use In situations where rapid withdrawal of topiramate is medically required, appropriate monitoring is recommended (see section 4.2).
As with other AEDs, some patients may experience an increase in seizure frequency or the onset of new types of seizures with topiramate. These phenomena may be the consequence of an overdose, a decrease in plasma concentrations of concomitantly used AEDs, progress of the disease, or a paradoxical effect.
- Adequate hydration while using topiramate is very important.
- Hydration can reduce the risk of nephrolithiasis (see below).
- Proper hydration prior to and during activities such as exercise or exposure to warm temperatures may reduce the risk of heat-related adverse reactions (see section 4.8).
- Women of childbearing potential Topiramate may cause fetal harm and fetal growth restriction (small for gestational age and low birth weight) when administered to a pregnant woman.
The North American Antiepileptic Drug pregnancy registry data for topiramate monotherapy showed an approximate 3-fold higher prevalence of major congenital malformations (4.3%), compared with a reference group not taking AEDs (1.4%). In addition, data from other studies indicate that, compared with monotherapy, there is an increased risk of teratogenic effects associated with the use of AEDs in combination therapy.
Before the initiation of treatment with topiramate in a woman of childbearing potential, pregnancy testing should be performed and a highly effective contraceptive method advised (see section 4.5). The patient should be fully informed of the risks related to the use of topiramate during pregnancy (see sections 4.3 and 4.6).
Oligohydrosis Oligohydrosis (decreased sweating) has been reported in association with the use of topiramate. Decreased sweating and hyperthermia (rise in body temperature) may occur especially in young children exposed to high ambient temperature. Mood disturbances/depression An increased incidence of mood disturbances and depression has been observed during topiramate treatment.
Suicide/suicide ideation Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo-controlled trials of AEDs has shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for topiramate.
In double blind clinical trials, suicide related events (SREs) (suicidal ideation, suicide attempts and suicide) occurred at a frequency of 0.5% in topiramate treated patients (46 out of 8,652 patients treated) and at a nearly 3-fold higher incidence than those treated with placebo (0.2%; 8 out of 4,045 patients treated).
- Patients therefore should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered.
- Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
- Serious skin reactions Serious skin reactions (Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)) have been reported in patients receiving topiramate (see section 4.8).
It is recommended that patients be informed about the signs of serious skin reactions. If SJS or TEN are suspected, use of Topamax should be discontinued. Nephrolithiasis Some patients, especially those with a predisposition to nephrolithiasis, may be at increased risk for renal stone formation and associated signs and symptoms such as renal colic, renal pain or flank pain.
Risk factors for nephrolithiasis include prior stone formation, a family history of nephrolithiasis and hypercalciuria (see below – Metabolic acidosis and sequelae). None of these risk factors can reliably predict stone formation during topiramate treatment. In addition, patients taking other medicinal products associated with nephrolithiasis may be at increased risk.
Decreased renal function In patients with impaired renal function (CL CR ≤ 70 mL/min) topiramate should be administered with caution as the plasma and renal clearance of topiramate are decreased. For specific posology recommendations in patients with decreased renal function, see section 4.2.
- Decreased hepatic function In hepatically-impaired patients, topiramate should be administered with caution as the clearance of topiramate may be decreased.
- Acute myopia and secondary angle closure glaucoma syndrome A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate.
Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include some or all of the following: myopia, mydriasis, anterior chamber shallowing, ocular hyperaemia (redness), choroidal detachments, retinal pigment epithelial detachments, macular striae, and increased intraocular pressure.
- This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma.
- Symptoms typically occur within 1 month of initiating topiramate therapy.
- In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in paediatric patients as well as adults.
Treatment includes discontinuation of topiramate, as rapidly as possible in the judgment of the treating physician, and appropriate measures to reduce intraocular pressure. These measures generally result in a decrease in intraocular pressure. Elevated intraocular pressure of any aetiology, if left untreated, can lead to serious sequelae including permanent vision loss.
- A determination should be made whether patients with history of eye disorders should be treated with topiramate.
- Visual field defects Visual field defects have been reported in patients receiving topiramate independent of elevated intraocular pressure.
- In clinical trials, most of these events were reversible after topiramate discontinuation.
If visual field defects occur at any time during topiramate treatment, consideration should be given to discontinuing the drug. Metabolic acidosis and sequelae Hyperchloremic, non-anion gap, metabolic acidosis (i.e. decreased serum bicarbonate below the normal reference range in the absence of respiratory alkalosis) is associated with topiramate treatment.
This decrease in serum bicarbonate is due to the inhibitory effect of topiramate on renal carbonic anhydrase. Generally, the decrease in bicarbonate occurs early in treatment although it can occur at any time during treatment. These decreases are usually mild to moderate (average decrease of 4 mmol/l at doses of 100 mg/day or above in adults and at approximately 6 mg/kg/day in paediatric patients).
Rarely, patients have experienced decreases to values below 10 mmol/l. Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhoea, surgery, ketogenic diet, or certain medicinal products) may be additive to the bicarbonate lowering effects of topiramate.
- Chronic, untreated metabolic acidosis increases the risk of nephrolithiasis and nephrocalcinosis, and may potentially lead to osteopenia (see above – Nephrolithiasis).
- Chronic metabolic acidosis in paediatric patients can reduce growth rates.
- The effect of topiramate on bone-related sequelae has not been systematically investigated in adult populations.
For paediatric patients aged 6 to 15 years a one year, open-label study was conducted (see section 5.1). Depending on underlying conditions, appropriate evaluation including serum bicarbonate levels is recommended with topiramate therapy. If signs or symptoms are present (e.g.
- Ussmaul’s deep breathing, dyspnoea, anorexia, nausea, vomiting, excessive tiredness, tachycardia or arrhythmia), indicative of metabolic acidosis, measurement of serum bicarbonate is recommended.
- If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering).
Topiramate should be used with caution in patients with conditions or treatments that represent a risk factor for the appearance of metabolic acidosis. Impairment of cognitive function Cognitive impairment in epilepsy is multifactorial and may be due to the underlying aetiology, due to the epilepsy or due to the anti-epileptic treatment.
There have been reports in the literature of impairment of cognitive function in adults on topiramate therapy which required reduction in dosage or discontinuation of treatment. However, studies regarding cognitive outcomes in children treated with topiramate are insufficient and its effect in this regard still needs to be elucidated.
Hyperammonemia and encephalopathy Hyperammonemia with or without encephalopathy has been reported with topiramate treatment (see section 4.8). The risk for hyperammonemia with topiramate appears dose-related. Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid (see section 4.5).
In patients who develop unexplained lethargy or changes in mental status associated with topiramate monotherapy or adjunctive therapy, it is recommended to consider hyperammonemic encephalopathy and measuring ammonia levels. Nutritional supplementation Some patients may experience weight loss whilst on treatment with topiramate.
It is recommended that patients on topiramate treatment should be monitored for weight loss. A dietary supplement or increased food intake may be considered if the patient is losing weight while on topiramate. Lactose intolerance Topamax tablets contain lactose.
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medication.
- Sodium Each tablet contains less than 1 mmol sodium (23 mg), and is essentially ‘sodium free’.4.5 Interaction with other medicinal products and other forms of interaction Effects of Topamax on other antiepileptic medicinal products The addition of Topamax to other AEDs (phenytoin, carbamazepine, valproic acid, phenobarbital, primidone) has no effect on their steady-state plasma concentrations, except in the occasional patient, where the addition of Topamax to phenytoin may result in an increase of plasma concentrations of phenytoin.
This is possibly due to inhibition of a specific enzyme polymorphic isoform (CYP2C19). Consequently, any patient on phenytoin showing clinical signs or symptoms of toxicity should have phenytoin levels monitored. A pharmacokinetic interaction study of patients with epilepsy indicated the addition of topiramate to lamotrigine had no effect on steady state plasma concentration of lamotrigine at topiramate doses of 100 to 400 mg/day.
In addition, there was no change in steady state plasma concentration of topiramate during or after removal of lamotrigine treatment (mean dose of 327 mg/day). Topiramate inhibits the enzyme CYP2C19 and may interfere with other substances metabolised via this enzyme (e.g., diazepam, imipramin, moclobemide, proguanil, omeprazol).
Effects of other antiepileptic medicinal products on Topamax Phenytoin and carbamazepine decrease the plasma concentration of topiramate. The addition or withdrawal of phenytoin or carbamazepine to Topamax therapy may require an adjustment in dosage of the latter.
|AED Coadministered||AED Concentration||Topamax Concentration|
|↔ = No effect on plasma concentration (≤15% change) ** = Plasma concentrations increase in individual patients ↓ = Plasma concentrations decrease NS = Not studied AED = antiepileptic drug|
Other medicinal product interactions Digoxin In a single-dose study, serum digoxin area under plasma concentration curve (AUC) decreased 12% due to concomitant administration of Topamax. The clinical relevance of this observation has not been established.
When Topamax is added or withdrawn in patients on digoxin therapy, careful attention should be given to the routine monitoring of serum digoxin. Central nervous system depressants Concomitant administration of Topamax and alcohol or other central nervous system (CNS) depressant medicinal products has not been evaluated in clinical studies.
It is recommended that Topamax not be used concomitantly with alcohol or other CNS depressant medicinal products. St John’s Wort (Hypericum perforatum) A risk of decreased plasma concentrations resulting in a loss of efficacy could be observed with co-administration of topiramate and St John’s Wort.
There have been no clinical studies evaluating this potential interaction. Oral contraceptives In a pharmacokinetic interaction study in healthy volunteers with a concomitantly administered combination oral contraceptive product containing 1 mg norethindrone (NET) plus 35 µg ethinyl estradiol (EE), Topamax given in the absence of other medications at doses of 50 to 200 mg/day was not associated with statistically significant changes in mean exposure (AUC) to either component of the oral contraceptive.
In another study, exposure to EE was statistically significantly decreased at doses of 200, 400, and 800 mg/day (18%, 21%, and 30%, respectively) when given as adjunctive therapy in epilepsy patients taking valproic acid. In both studies, Topamax (50-200 mg/day in healthy volunteers and 200-800 mg/day in epilepsy patients) did not significantly affect exposure to NET.
- Although there was a dose dependent decrease in EE exposure for doses between 200-800 mg/day (in epilepsy patients), there was no significant dose dependent change in EE exposure for doses of 50-200 mg/day (in healthy volunteers).
- The clinical significance of the changes observed is not known.
- The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with Topamax.
Patients taking estrogen containing contraceptives should be asked to report any change in their bleeding patterns. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding. Lithium In healthy volunteers, there was an observed reduction (18% for AUC) in systemic exposure for lithium during concomitant administration with topiramate 200 mg/day.
- In patients with bipolar disorder, the pharmacokinetics of lithium were unaffected during treatment with topiramate at doses of 200 mg/day; however, there was an observed increase in systemic exposure (26% for AUC) following topiramate doses of up to 600 mg/day.
- Lithium levels should be monitored when co-administered with topiramate.
Risperidone Drug-drug interaction studies conducted under single dose conditions in healthy volunteers and multiple dose conditions in patients with bipolar disorder, yielded similar results. When administered concomitantly with topiramate at escalating doses of 100, 250 and 400 mg/day there was a reduction in risperidone (administered at doses ranging from 1 to 6 mg/day) systemic exposure (16% and 33% for steady-state AUC at the 250 and 400 mg/day doses, respectively).
However, differences in AUC for the total active moiety between treatment with risperidone alone and combination treatment with topiramate were not statistically significant. Minimal alterations in the pharmacokinetics of the total active moiety (risperidone plus 9-hydroxyrisperidone) and no alterations for 9-hydroxyrisperidone were observed.
There were no significant changes in the systemic exposure of the risperidone total active moiety or of topiramate. When topiramate was added to existing risperidone (1-6 mg/day) treatment, adverse events were reported more frequently than prior to topiramate (250-400 mg/day) introduction (90% and 54% respectively).
The most frequently reported AE’s when topiramate was added to risperidone treatment were: somnolence (27% and 12%), paraesthesia (22% and 0%) and nausea (18% and 9% respectively). Hydrochlorothiazide (HCTZ) A drug-drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of HCTZ (25 mg every 24 h) and topiramate (96 mg every 12 h) when administered alone and concomitantly.
The results of this study indicate that topiramate C max increased by 27% and AUC increased by 29% when HCTZ was added to topiramate. The clinical significance of this change is unknown. The addition of HCTZ to topiramate therapy may require an adjustment of the topiramate dose.
The steady-state pharmacokinetics of HCTZ were not significantly influenced by the concomitant administration of topiramate. Clinical laboratory results indicated decreases in serum potassium after topiramate or HCTZ administration, which were greater when HCTZ and topiramate were administered in combination.
Metformin A drug-drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of metformin and topiramate in plasma when metformin was given alone and when metformin and topiramate were given simultaneously. The results of this study indicated that metformin mean C max and mean AUC 0-12h increased by 18% and 25%, respectively, while mean CL/F decreased 20% when metformin was co-administered with topiramate.
Topiramate did not affect metformin t max, The clinical significance of the effect of topiramate on metformin pharmacokinetics is unclear. Oral plasma clearance of topiramate appears to be reduced when administered with metformin. The extent of change in the clearance is unknown. The clinical significance of the effect of metformin on topiramate pharmacokinetics is unclear.
When Topamax is added or withdrawn in patients on metformin therapy, careful attention should be given to the routine monitoring for adequate control of their diabetic disease state. Pioglitazone A drug-drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly.,ss of pioglitazone with no alteration in C max,ss was observed. This finding was not statistically significant. In addition, a 13% and 16% decrease in C max,ss and AUC,ss respectively, of the active hydroxy-metabolite was noted as well as a 60% decrease in C max,ss and AUC,ss of the active keto-metabolite. The clinical significance of these findings is not known. When Topamax is added to pioglitazone therapy or pioglitazone is added to Topamax therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state. Glibenclamide A drug-drug interaction study conducted in patients with type 2 diabetes evaluated the steady-state pharmacokinetics of glibenclamide (5 mg/day) alone and concomitantly with topiramate (150 mg/day). There was a 25% reduction in glibenclamide AUC 24 during topiramate administration. Systemic exposure of the active metabolites, 4- trans -hydroxy-glyburide (M1) and 3- cis -hydroxyglyburide (M2), were also reduced by 13% and 15%, respectively. The steady-state pharmacokinetics of topiramate were unaffected by concomitant administration of glibenclamide. When topiramate is added to glibenclamide therapy or glibenclamide is added to topiramate therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state. Other forms of interactions Agents predisposing to nephrolithiasis Topamax, when used concomitantly with other agents predisposing to nephrolithiasis, may increase the risk of nephrolithiasis. While using Topamax, agents like these should be avoided since they may create a physiological environment that increases the risk of renal stone formation. Valproic acid Concomitant administration of topiramate and valproic acid has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either medicinal product alone. In most cases, symptoms and signs abated with discontinuation of either medicinal product (see section 4.4 and section 4.8). This adverse reaction is not due to a pharmacokinetic interaction. Hypothermia, defined as an unintentional drop in body core temperature to <35°C, has been reported in association with concomitant use of topiramate and valproic acid (VPA) both in conjunction with hyperammonemia and in the absence of hyperammonemia. This adverse event in patients using concomitant topiramate and valproate can occur after starting topiramate treatment or after increasing the daily dose of topiramate. Warfarin Decreased Prothrombin Time/International Normalised Ratio (PT/INR) has been reported in patients treated with topiramate in combination with warfarin. Therefore, INR should be carefully monitored in patients concomitantly treated with topiramate and warfarin. Additional pharmacokinetic drug interaction studies Clinical studies have been conducted to assess the potential pharmacokinetic drug interaction between topiramate and other agents. The changes in C max or AUC as a result of the interactions are summarised below. The second column (concomitant drug concentration) describes what happens to the concentration of the concomitant drug listed in the first column when topiramate is added. The third column (topiramate concentration) describes how the coadministration of a drug listed in the first column modifies the concentration of topiramate.
|Summary of Results from Additional Clinical Pharmacokinetic Drug Interaction Studies|
|Concomitant Drug||Concomitant Drug Concentration a||Topiramate Concentration a|
|Amitriptyline||↔ 20% increase in C max and AUC of nortriptyline metabolite||NS|
|Dihydroergotamine (Oral and Subcutaneous)||↔||↔|
|Haloperidol||↔ 31% increase in AUC of the reduced metabolite||NS|
|Propranolol||↔ 17% increase in C max for 4-OH propranolol (TPM 50 mg q12h)||9% and 16% increase in C max, 9% and17% increase in AUC (40 and 80 mg propranolol q12h respectively)|
|Sumatriptan (Oral and Subcutaneous)||↔||NS|
|Diltiazem||25% decrease in AUC of diltiazem and 18% decrease in DEA, and ↔ for DEM*||20% increase in AUC|
|Flunarizine||16% increase in AUC (TPM 50 mg q12h) b||↔|
|a = % values are the changes in treatment mean C max or AUC with respect to monotherapy ↔ = No effect on C max and AUC (≤15% change) of the parent compound NS = Not studied *DEA = des acetyl diltiazem, DEM = N-demethyl diltiazem b = Flunarizine AUC increased 14% in subjects taking flunarizine alone. Increase in exposure may be attributed to accumulation during achievement of steady state.|
4.6 Fertility, pregnancy and lactation Pregnancy Risk related to epilepsy and AEDs in general Specialist advice should be given to women who are of childbearing potential. The need for treatment with AEDs should be reviewed when a woman is planning to become pregnant. In women being treated for epilepsy, sudden discontinuation of AED therapy should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child. Monotherapy should be preferred whenever possible because therapy with multiple AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics. Risk related to topiramate Topiramate was teratogenic in mice, rats and rabbits (see section 5.3). In rats, topiramate crosses the placental barrier. In humans, topiramate crosses the placenta and similar concentrations have been reported in the umbilical cord and maternal blood. Clinical data from pregnancy registries indicate that infants exposed to topiramate monotherapy have: • An increased risk of congenital malformations (particularly cleft lip/palate, hypospadias, and anomalies involving various body systems) following exposure during the first trimester. The North American Antiepileptic Drug pregnancy registry data for topiramate monotherapy showed an approximate 3-fold higher prevalence of major congenital malformations (4.3%), compared with a reference group not taking AEDs (1.4%). In addition, data from other studies indicate that, compared with monotherapy, there is an increased risk of teratogenic effects associated with the use of AEDs in combination therapy. The risk has been reported to be dose dependent; effects were observed in all doses. In women treated with topiramate who have had a child with a congenital malformation, there appears to be an increased risk of malformations in subsequent pregnancies when exposed to topiramate. • A higher prevalence of low birth weight (<2500 grams)compared with a reference group. • An increased prevalence of being small for gestational age (SGA; defined as birth weight below the 10 th percentile corrected for their gestational age, stratified by sex). The long term consequences of the SGA findings could not be determined. Indication epilepsy It is recommended to consider alternative therapeutic options in women of child bearing potential. If topirmate is used in women of child bearing potential, it is recommended that highly effective contraception be used (see section 4.5), and that the woman is fully informed of the known risks of uncontrolled epilepsy to the pregnancy and the potential risks of the medicinal product to the foetus. If a woman plans a pregnancy, a preconceptional visit is recommended in order to reassess the treatment, and to consider other therapeutic options. In case of administration during the first trimester, careful prenatal monitoring should be performed. Indication migraine prophylaxis Topiramate is contraindicated in pregnancy and in women of childbearing potential if a highly effective method of contraception is not used (see sections 4.3 and 4.5). Breast-feeding Animal studies have shown excretion of topiramate in milk. The excretion of topiramate in human milk has not been evaluated in controlled studies. Limited observations in patients suggest an extensive excretion of topiramate into human milk. Effects that have been observed in breastfed newborns/infants of treated mothers, include diarrhea, drowsiness, irritability and inadequate weight gain. Therefore, a decision must be made whether to suspend breast-feeding or to discontinue/ abstain from topiramate therapy taking into account the benefit of breast-feeding for the child and the benefit of topiramate therapy for the women (see section 4.4). Fertility Animal studies did not reveal impairment of fertility by topiramate (see section 5.3). The effect of topiramate on human fertility has not been established.4.7 Effects on ability to drive and use machines Topamax has minor or moderate influence on the ability to drive and use machines. Topiramate acts on the central nervous system and may produce drowsiness, dizziness or other related symptoms. It may also cause visual disturbances and/or blurred vision. These adverse reactions could potentially be dangerous in patients driving a vehicle or operating machinery, particularly until such time as the individual patient's experience with the medicinal products established.4.8 Undesirable effects The safety of topiramate was evaluated from a clinical trial database consisting of 4,111 patients (3,182 on topiramate and 929 on placebo) who participated in 20 double-blind trials and 2,847 patients who participated in 34 open-label trials, respectively, for topiramate as adjunctive treatment of primary generalised tonic-clonic seizures, partial onset seizures, seizures associated with Lennox-Gastaut syndrome, monotherapy for newly or recently diagnosed epilepsy or migraine prophylaxis. The majority of adverse reactions were mild to moderate in severity. Adverse reactions identified in clinical trials, and during post-marketing experience (as indicated by "*") are listed by their incidence in clinical trials in Table 1. Assigned frequencies are as follows:
|Very common Common Uncommon Rare Not known||≥1/10 ≥1/100 to <1/10 ≥1/1,000 to <1/100 ≥1/10,000 to <1/1,000 cannot be estimated from the available data|
The most common adverse reactions (those with an incidence of >5% and greater than that observed in placebo in at least 1 indication in double-blind controlled studies with topiramate) include: anorexia, decreased appetite, bradyphrenia, depression, expressive language disorder, insomnia, coordination abnormal, disturbance in attention, dizziness, dysarthria, dysgeusia, hypoesthesia, lethargy, memory impairment, nystagmus, paresthesia, somnolence, tremor, diplopia, vision blurred, diarrhoea, nausea, fatigue, irritability, and weight decreased.
|Table 1: Topiramate Adverse Reactions|
|System Organ Class||Very common||Common||Uncommon||Rare||Not known|
|Infections and infestations||nasopharyngitis*|
|Blood and lymphatic system disorders||anaemia||leucopenia, thrombocytopenia lymphadenopathy, eosinophilia||neutropenia*|
|Immune system disorders||hypersensitivity||allergic oedema*|
|Metabolism and nutrition disorders||anorexia, decreased appetite||metabolic acidosis, hypokalaemia, increased appetite, polydipsia||acidosis hyperchloraemic, hyperammonemia*, hyperammonemic encephalopathy*|
|Psychiatric disorders||depression||bradyphrenia, insomnia, expressive language disorder, anxiety, confusional state, disorientation, aggression, mood altered, agitation, mood swings, depressed mood, anger, abnormal behaviour||suicidal ideation, suicide attempt, hallucination, psychotic disorder, hallucination auditory, hallucination visual, apathy, lack of spontaneous speech, sleep disorder, affect lability, libido decreased, restlessness, crying, dysphemia, euphoric mood, paranoia, perseveration, panic attack, tearfulness, reading disorder, initial insomnia, flat affect, thinking abnormal, loss of libido, listless, middle insomnia, distractibility, early morning awakening, panic reaction, elevated mood||mania, panic disorder, feeling of despair*, hypomania|
|Nervous system disorders||paraesthesia, somnolence dizziness||disturbance in attention, memory impairment, amnesia, cognitive disorder, mental impairment, psychomotor skills impaired, convulsion, coordination abnormal, tremor, lethargy, hypoaesthesia, nystagmus, dysgeusia, balance disorder, dysarthria, intention tremor, sedation,||depressed level of consciousness, grand mal convulsion, visual field defect, complex partial seizures, speech disorder, psychomotor hyperactivity, syncope, sensory disturbance, drooling, hypersomnia, aphasia, repetitive speech, hypokinesia, dyskinesia, dizziness postural, poor quality sleep, burning sensation, sensory loss, parosmia, cerebellar syndrome, dysaesthesia, hypogeusia, stupor, clumsiness, aura, ageusia, dysgraphia, dysphasia, neuropathy peripheral, presyncope, dystonia, formication||apraxia, circadian rhythm sleep disorder, hyperaesthesia, hyposmia, anosmia, essential tremor, akinesia, unresponsive to stimuli|
|Eye disorders||vision blurred, diplopia, visual disturbance||visual acuity reduced, scotoma, myopia*, abnormal sensation in eye*, dry eye, photophobia, blepharospasm, lacrimation increased, photopsia, mydriasis, presbyopia||blindness unilateral, blindness transient, glaucoma, accommodation disorder, altered visual depth perception, scintillating scotoma, eyelid oedema*, night blindness, amblyopia||angle closure glaucoma*, maculopathy*, eye movement disorder*, conjunctival oedema*, uveitis|
|Ear and labyrinth disorders||vertigo, tinnitus, ear pain||deafness, deafness unilateral, deafness neurosensory, ear discomfort, hearing impaired|
|Cardiac disorders||bradycardia, sinus bradycardia, palpitations|
|Vascular disorders||hypotension, orthostatic hypotension, flushing, hot flush||Raynaud’s phenomenon|
|Respiratory, thoracic and mediastinal disorders||dyspnoea, epistaxis, nasal congestion, rhinorrhoea, cough*||dyspnoea exertional, paranasal sinus hypersecretion, dysphonia|
|Gastrointestinal disorders||nausea, diarrhoea||vomiting, constipation, abdominal pain upper, dyspepsia, abdominal pain, dry mouth, stomach discomfort, paraesthesia oral, gastritis, abdominal discomfort||pancreatitis, flatulence, gastrooesophageal reflux disease, abdominal pain lower, hypoaesthesia oral, gingival bleeding, abdominal distension, epigastric discomfort, abdominal tenderness, salivary hypersecretion, oral pain, breath odour, glossodynia|
|Hepatobiliary disorders||hepatitis, hepatic failure|
|Skin and subcutaneous tissue disorders||alopecia, rash, pruritus||anhidrosis, hypoaesthesia facial, urticaria, erythema, pruritus generalised, rash macular, skin discolouration, dermatitis allergic, swelling face||Stevens-Johnson syndrome* erythema multiforme*, skin odour abnormal, periorbital oedema*, urticaria localised||toxic epidermal necrolysis*|
|Musculoskeletal and connective tissue disorders||arthralgia, muscle spasms, myalgia, muscle twitching, muscular weakness, musculoskeletal chest pain||joint swelling*, musculoskeletal stiffness, flank pain, muscle fatigue||limb discomfort*|
|Renal and urinary disorders||nephrolithiasis, pollakiuria, dysuria, nephrocalcinosis*||calculus urinary, urinary incontinence, haematuria, incontinence, micturition urgency, renal colic, renal pain||calculus ureteric, renal tubular acidosis*|
|Reproductive system and breast disorders||erectile dysfunction, sexual dysfunction|
|General disorders and administration site conditions||fatigue||pyrexia, asthenia, irritability, gait disturbance, feeling abnormal, malaise||hyperthermia, thirst, influenza like illness*, sluggishness, peripheral coldness, feeling drunk, feeling jittery||face oedema|
|Investigations||weight decreased||weight increased*||crystal urine present, tandem gait test abnormal, white blood cell count decreased, Increase in liver enzymes||blood bicarbonate decreased|
|Social circumstances||learning disability|
|* identified as an advserse reaction from postmarketing spontaneous reports. Its frequency was calculated based on the incidence in clinical trials, or was calculated if the event did not occur in clinical trials.|
Congenital malformations and fetal growth restrictions (see section 4.4 and section 4.6). Paediatric population Adverse reactions reported more frequently (≥2-fold) in children than in adults in double-blind controlled studies include: • Decreased appetite • Increased appetite • Hyperchloraemic acidosis • Hypokalaemia • Abnormal behaviour • Aggression • Apathy • Initial insomnia • Suicidal ideation • Disturbance in attention • Lethargy • Circadian rhythm sleep disorder • Poor quality sleep • Lacrimation increased • Sinus bradycardia • Feeling abnormal • Gait disturbance.
Adverse reactions that were reported in children but not in adults in double-blind controlled studies include: • Eosinophilia • Psychomotor hyperactivity • Vertigo • Vomiting • Hyperthermia • Pyrexia • Learning disability. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose Signs and symptoms Overdoses of topiramate have been reported.
- Signs and symptoms included convulsions, drowsiness, speech disturbances, blurred vision, diplopia, impaired mentation, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression.
- The clinical consequences were not severe in most cases, but deaths have been reported after overdoses with multiple medicinal products including topiramate.
Topiramate overdose can result in severe metabolic acidosis (see section 4.4). Treatment In the event of overdose, topiramate should be discontinued and general supportive treatment given until clinical toxicity has been diminished or resolved. The patient should be well hydrated.
- Haemodialysis has been shown to be an effective means of removing topiramate from the body.
- Other measures may also be taken at the physician’s discretion.5.
- Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: antiepileptics, other antiepileptics ATC code: N03AX11.
- Topiramate is classified as a sulfamate-substituted monosaccharide.
The precise mechanism by which topiramate exerts its antiseizure and migraine prophylaxis effects are unknown. Electrophysiological and biochemical studies on cultured neurons have identified three properties that may contribute to the antiepileptic efficacy of topiramate.
- Action potentials elicited repetitively by a sustained depolarisation of the neurons were blocked by topiramate in a time-dependent manner, suggestive of a state-dependent sodium channel blocking action.
- Topiramate increased the frequency at which γ-aminobutyrate (GABA) activated GABA A receptors, and enhanced the ability of GABA to induce a flux of chloride ions into neurons, suggesting that topiramate potentiates the activity of this inhibitory neurotransmitter.
This effect was not blocked by flumazenil, a benzodiazepine antagonist, nor did topiramate increase the duration of the channel open time, differentiating topiramate from barbiturates that modulate GABA A receptors. Because the antiepileptic profile of topiramate differs markedly from that of the benzodiazepines, it may modulate a benzodiazepine-insensitive subtype of GABA A receptor.
Topiramate antagonised the ability of kainate to activate the kainate/AMPA (α -amino-3-hydroxy-5-methylisoxazole-4-propionic acid) subtype of excitatory amino acid (glutamate) receptor, but had no apparent effect on the activity of N-methyl-D-aspartate (NMDA) at the NMDA receptor subtype. These effects of topiramate were concentration-dependent over a range of 1 µM to 200 µM, with minimum activity observed at 1 µM to 10 µM.
In addition, topiramate inhibits some isoenzymes of carbonic anhydrase. This pharmacologic effect is much weaker than that of acetazolamide, a known carbonic anhydrase inhibitor, and is not thought to be a major component of topiramate’s antiepileptic activity.
In animal studies, topiramate exhibits anticonvulsant activity in rat and mouse maximal electroshock seizure (MES) tests and is effective in rodent models of epilepsy, which include tonic and absence-like seizures in the spontaneous epileptic rat (SER) and tonic and clonic seizures induced in rats by kindling of the amygdala or by global ischaemia.
Topiramate is only weakly effective in blocking clonic seizures induced by the GABA A receptor antagonist, pentylenetetrazole. Studies in mice receiving concomitant administration of topiramate and carbamazepine or phenobarbital showed synergistic anticonvulsant activity, while combination with phenytoin showed additive anticonvulsant activity.
- In well-controlled add-on trials, no correlation has been demonstrated between trough plasma concentrations of topiramate and its clinical efficacy.
- No evidence of tolerance has been demonstrated in man.
- Absence seizures Two small one arm studies were carried out with children aged 4-11 years old (CAPSS-326 and TOPAMAT-ABS-001).
One included 5 children and the other included 12 children before it was terminated early due to lack of therapeutic response. The doses used in these studies were up to approximately 12 mg/kg in study TOPAMAT-ABS-001 and a maximum of the lesser of 9 mg/kg/day or 400 mg/day in study CAPSS-326.
- These studies do not provide sufficient evidence to reach conclusion regarding efficacy or safety in the paediatric population.
- Monotherapy Treatment in Patients 6 to 15 Years Old with New or Recent Epilepsy A one year, open-label study in paediatric patients aged 6 to 15 years including 63 subjects with recent or new onset of epilepsy was conducted to assess the effects of topiramate (28 subjects) versus levetiracetam on growth, development, and bone mineralisation.
Continued growth was observed in both treatment groups but the topiramate group showed statistically significant reductions in mean annual change from baseline in body weight and bone mineral density compared to the levetiracetam group. A similar trend was also observed for height and height velocity but were not statistically significant.
Growth-related changes were not clinically significant nor treatment limiting. Other confounding factors cannot be excluded.5.2 Pharmacokinetic properties The film-coated tablet and hard capsule formulations are bioequivalent. The pharmacokinetic profile of topiramate compared to other AEDs shows a long plasma half-life, linear pharmacokinetics, predominantly renal clearance, absence of significant protein binding, and lack of clinically relevant active metabolites.
Topiramate is not a potent inducer of drug metabolising enzymes, can be administered without regard to meals, and routine monitoring of plasma topiramate concentrations is not necessary. In clinical studies, there was no consistent relationship between plasma concentrations and efficacy or adverse events.
- Absorption Topiramate is rapidly and well absorbed.
- Following oral administration of 100 mg topiramate to healthy subjects, a mean peak plasma concentration (C max ) of 1.5 µg/ml was achieved within 2 to 3 hours (T max ).
- Based on the recovery of radioactivity from the urine the mean extent of absorption of a 100 mg oral dose of 14 C-topiramate was at least 81%.
There was no clinically significant effect of food on the bioavailability of topiramate. Distribution Generally, 13 to 17% of topiramate is bound to plasma protein. A low capacity binding site for topiramate in/on erythrocytes that is saturable above plasma concentrations of 4 µg/ml has been observed.
The volume of distribution varied inversely with the dose. The mean apparent volume of distribution was 0.80 to 0.55 l/kg for a single dose range of 100 to 1200 mg. An effect of gender on the volume of distribution was detected, with values for females circa 50% of those for males. This was attributed to the higher percent body fat in female patients and is of no clinical consequence.
Biotransformation Topiramate is not extensively metabolised (~20%) in healthy volunteers. It is metabolised up to 50% in patients receiving concomitant antiepileptic therapy with known inducers of drug metabolising enzymes. Six metabolites, formed through hydroxylation, hydrolysis and glucuronidation, have been isolated, characterised and identified from plasma, urine and faeces of humans.
- Each metabolite represents less than 3% of the total radioactivity excreted following administration of 14 C-topiramate.
- Two metabolites, which retained most of the structure of topiramate, were tested and found to have little or no anticonvulsant activity.
- Elimination In humans, the major route of elimination of unchanged topiramate and its metabolites is via the kidney (at least 81% of the dose).
Approximately 66% of a dose of 14 C-topiramate was excreted unchanged in the urine within four days. Following twice a day dosing with 50 mg and 100 mg of topiramate the mean renal clearance was approximately 18 ml/min and 17 ml/min, respectively. There is evidence of renal tubular reabsorption of topiramate.
This is supported by studies in rats where topiramate was co-administered with probenecid, and a significant increase in renal clearance of topiramate was observed. Overall, plasma clearance is approximately 20 to 30 ml/min in humans following oral administration. Linearity/non-linearity Topiramate exhibits low intersubject variability in plasma concentrations and, therefore, has predictable pharmacokinetics.
The pharmacokinetics of topiramate are linear with plasma clearance remaining constant and area under the plasma concentration curve increasing in a dose-proportional manner over a 100 to 400 mg single oral dose range in healthy subjects. Patients with normal renal function may take 4 to 8 days to reach steady-state plasma concentrations.
- The mean C max following multiple, twice a day oral doses of 100 mg to healthy subjects was 6.76 µg/ml.
- Following administration of multiple doses of 50 mg and 100 mg of topiramate twice a day, the mean plasma elimination half-life was approximately 21 hours.
- Use with other AEDs Concomitant multiple-dose administration of topiramate, 100 to 400 mg twice a day, with phenytoin or carbamazepine shows dose proportional increases in plasma concentrations of topiramate.
Renal impairment The plasma and renal clearance of topiramate are decreased in patients with moderate and severe impaired renal function (CL CR ≤ 70 ml/min). As a result, higher steady-state topiramate plasma concentrations are expected for a given dose in renal-impaired patients as compared to those with normal renal function.
In addition, patients with renal impairment will require a longer time to reach steady-state at each dose. In patients with moderate and severe renal impairment, half of the usual starting and maintenance dose is recommended. Topiramate is effectively removed from plasma by haemodialysis. A prolonged period of hemodialysis may cause topiramate concentration to fall below levels that are required to maintain an anti-seizure effect.
To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate may be required. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialysed.
Hepatic Impairment Plasma clearance of topiramate decreased a mean of 26% in patients with moderate to severe hepatic impairment. Therefore, topiramate should be administered with caution in patients with hepatic impairment. Elderly population Plasma clearance of topiramate is unchanged in elderly subjects in the absence of underlying renal disease.
Paediatric population (pharmacokinetics, up to 12 years of age) The pharmacokinetics of topiramate in children, as in adults receiving add-on therapy, are linear, with clearance independent of dose and steady-state plasma concentrations increasing in proportion to dose.
- Children, however, have a higher clearance and a shorter elimination half-life.
- Consequently, the plasma concentrations of topiramate for the same mg/kg dose may be lower in children compared to adults.
- As in adults, hepatic enzyme inducing AEDs decrease the steady-state plasma concentrations.5.3 Preclinical safety data In nonclinical studies of fertility, despite maternal and paternal toxicity as low as 8 mg/kg/day, no effects on fertility were observed, in male or female rats with doses up to 100 mg/kg/day.
In preclinical studies, topiramate has been shown to have teratogenic effects in the species studied (mice, rats and rabbits). In mice, fetal weights and skeletal ossification were reduced at 500 mg/kg/day in conjunction with maternal toxicity. Overall numbers of fetal malformations in mice were increased for all drug-treated groups (20, 100 and 500 mg/kg/day).
- In rats, dosage-related maternal and embryo/fetal toxicity (reduced fetal weights and/or skeletal ossification) were observed down to 20 mg/kg/day with teratogenic effects (limb and digit defects) at 400 mg/kg/day and above.
- In rabbits, dosage-related maternal toxicity was noted down to 10 mg/kg/day with embryo/fetal toxicity (increased lethality) down to 35 mg/kg/day, and teratogenic effects (rib and vertebral malformations) at 120 mg/kg/day.
The teratogenic effects seen in rats and rabbits were similar to those seen with carbonic anhydrase inhibitors, which have not been associated with malformations in humans. Effects on growth were also indicated by lower weights at birth and during lactation for pups from female rats treated with 20 or 100 mg/kg/day during gestation and lactation.
In rats, topiramate crosses the placental barrier. In juvenile rats, daily oral administration of topiramate at doses up to 300 mg/kg/day during the period of development corresponding to infancy, childhood, and adolescence resulted in toxicities similar to those in adult animals (decreased food consumption with decreased body weight gain, centrolobullar hepatocellular hypertrophy).
There were no relevant effects on long bone (tibia) growth or bone (femur) mineral density, preweaning and reproductive development, neurological development (including assessments on memory and learning), mating and fertility or hysterotomy parameters.
- In a battery of in vitro and in vivo mutagenicity assays, topiramate did not show genotoxic potential.6.
- Pharmaceutical particulars 6.1 List of excipients Core tablet: Lactose Monohydrate Pregelatinized Maize Starch Microcrystalline Cellulose Sodium Starch Glycolate (Type A) Magnesium Stearate Film-coating: OPADRY ® Pink 1, Carnauba Wax 1 OPADRY ® contains: Hypromellose Macrogol Polysorbate 80 And as colourants, titanium dioxide E171 and iron oxide red E172 6.2 Incompatibilities Not applicable.6.3 Shelf life 3 years.6.4 Special precautions for storage Do not store above 25°C.
Blisters: Store in the original package to protect the tablets from moisture. Bottles: Store in the original package and keep the bottle tightly closed to protect the tablets from moisture.6.5 Nature and contents of container Opaque plastic bottle with tamper-evident closure containing 20, 28, 30, 50, 56, 60 or 100 tablets: bundle pack comprising 200 (2 x 100) tablets.
In each bottle, there is a desiccant canister which should not be swallowed. Blister pack of an aluminium/aluminium foil in strips. Pack sizes of 10, 20, 28, 30, 50, 56, 60 or 100 tablets: bundle pack comprising 200 (2 x 100) tablets. Individual (alu/alu) blister strips are packed inside a folding box.
Not all pack sizes may be marketed 6.6 Special precautions for disposal and other handling No special requirements.7. Marketing authorisation holder Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UK 8. Marketing authorisation number(s) PL 00242/0304 9.
What foods taste bad on Topamax?
How does Topamax help me lose weight? Topamax works in multiple ways to help you lose weight, but you must change your behavior in response to those effects. In non-technical terms, it works on neurons in the brain to (1) decrease the addictiveness of food and also to (2) make you feel full sooner.
- It is great for people who are addicted to carbs, because it removes the pleasure you get from carbs.
- When that happens, you need to stop eating the carbs you no longer enjoy.
- It has been known to make foods like soda taste flat and wine/beer taste bad.
- You can get drunk, but you no longer get a happy buzz.
They did a one-year study of alcoholics joining AA who were seriously trying to quit drinking and the ones who took Topamax did a significantly better job of staying clean and sober than the alcoholics who took placebo. Also, you get full on much less food.
- When that happens, you need to stop eating, because if you keep eating, you will feel bad reflux.
- What are some side-effects? Many patients experience side-effects from this medicine.
- Patients can have side-effects that are very annoying, but they usually slowly go away over a period of 2-5 weeks while you continue the medicine.
You can prevent most side-effects by taking Euphasia two capsules twice daily to chase away the side-effects. Euphasia is available at our office. Sometimes, the side-effects don’t lessen and you must discontinue the Topamax entirely, and then the side-effects do go away.
- You may experience numbness/tingling of your fingers or toes, drowsiness, fatigue, and loss of appetite.
- You may temporarily experience difficulty concentrating, memory difficulties, difficulty finding the right word, diarrhea, constipation, mood disturbances/improvements, or sleep disturbance.
- Less commonly, Topamax can cause kidney stones, reflux if you overeat, or upper respiratory infections.
If any of these happen, please let us know so we can discuss the risks and benefits of continuing the Topamax. If any vision changes happen, which is very rare, seek medical attention immediately. Don’t become pregnant while taking Topamax because Topamax is known to cause birth defects.
This handout is not a substitute for the FDA’s handout, so please read the entire FDA insert. What results have you seen at The Institute? One patient said, “Dr. Marlowe, this is the first time I have been able to drive past the ‘Hot Now’ Krispy Kreme sign.” He lost more than 70 lbs on Topamax. Another said, “I haven’t had a soft drink in 6 months.
Yesterday, I tried a Coke and it tasted TERRIBLE – like river water. That medicine is great.” Another said, “This is WONDERFUL. I didn’t know what it felt like to never have a migraine. I’ve had them my whole life. Now I know what it feels like to be free.” Yet another, “My head felt funny.
- I felt disoriented.
- I didn’t know where I was for a few seconds.
- My tongue felt heavy.
- It was awful.” Someone else, “People said I slurred my words.” A different patient, “I couldn’t say the word I knew – words were always on the tip of my tongue.” Or: “I can’t remember stuff and I was foggy, but it was worth it and I tell my friends who I send to Dr.
Marlowe to stick with Topamax, because I went from 210 to 155 lbs.” How do I take Topamax? Take one pill at bedtime for 10 days. The next 10 days, take one in the morning and one at night. The next 10 days, take one in the morning and two at night. If you develop mild side-effects, continue increasing the dose.
- If the side-effects are tolerable, don’t increase the dose, but start the Euphasia described above.
- If the side-effects are intolerable, please discontinue the Topamax and call our office.
- If the side-effects create an emergency, call 911.
- Why don’t you just prescribe Qsymia ? Qsymia is the combination of phentermine and Topamax into one pill.
I rarely prescribe it. First, if you need lower or higher doses of phentermine or Topamax, you can’t do it with Qsymia, The doses are not adjustable. When Topamax and phentermine are separate pills, we can adjust either one. Second, Qsymia is far more expensive and could cost you 10 times as much.
What happens if you don t drink enough water while taking Topamax?
Drink plenty of water It’s important because topiramate can increase your body temperature and reduce sweating – especially during hot weather and when you exercise. This can put you at risk of getting dehydrated and can cause kidney stones.
What happens if you don’t drink enough water on Topamax?
Kidney stones – Topamax can raise the risk of developing kidney stones, In clinical trials, kidney stones were reported in an average of 1.5% of adults who took Topamax for epilepsy, depending on the dose. Topamax was compared with a placebo in some studies.
It’s not known how many people experienced kidney stones. However, people treated with Topamax had 2 to 4 times more kidney stones than people in the general population. It’s not known how many people who took Topamax for migraine may have had kidney stones during clinical trials. Kidney stones were also reported in children taking Topamax for epilepsy or migraine, though it’s not known how often this occurred.
Symptoms of kidney stones Symptoms of kidney stones can include:
pain in your back or abdomenburning feeling or pain when urinating blood in your urine, which may turn your urine pink, red, or brown nausea or vomiting fever
If you have any of these symptoms while taking Topamax, call your doctor right away. You may need treatment to help your body get rid of any kidney stones. During Topamax treatment It’s important to drink plenty of fluids while you take Topamax. This can reduce your risk for developing kidney stones.
Do you have to take Topamax every day?
Topamax (topiramate) is a brand-name drug that’s prescribed for migraine headaches and certain kinds of seizures. Topamax comes as oral tablets and capsules filled with sprinkles. It’s typically taken once or twice daily. Topamax is FDA-approved to treat the following in adults and children ages 2 years and older:
partial-onset seizures primary generalized tonic-clonic seizures seizures due to Lennox-Gastaut syndrome
Topamax is also approved to help prevent migraine headaches in adults and in children ages 12 years and older. Topamax belongs to a drug class called anticonvulsants, Topamax is available in a generic version. Keep reading for specific information about the dosage of Topamax, including its strengths and how to take it.
- For a comprehensive look at Topamax, see this article,
- Note: This article describes typical dosages for Topamax provided by the drug’s manufacturer.
- When taking Topamax, always follow the dosage prescribed by your doctor.
- Topamax’s dosage is different for each person.
- The usual dosage for treating seizures may be different than the dosage for preventing migraine headaches.
Be sure to take the dosage prescribed by your doctor.
How long does 25 mg of Topamax stay in your system?
How do you flush Topamax out of your system? – Topamax takes time to leave your body, so there isn’t a way to flush it out of your system. Once you stop taking the drug, you’ll need to wait until it’s cleared from your body. This usually takes about 5 days.