Trokendi for weight loss

Trokendi XR

Topiramate is a seizure medicine, also called an anticonvulsant. Topiramate is used to treat seizures in adults and children who are at least 2 years old. Trokendi XR is for use in adults and children who are at least 6 years old.

Extended-release topiramate has a higher minimum age (at least 10 years old) when used as the child’s only seizure medicine.

Some brands of topiramate are also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. These medicines will only prevent migraine headaches or reduce the number of attacks, but will not treat a headache that has already begun.

Topiramate may also be used for purposes not listed in this medication guide.

Topiramate may cause vision problems that can be permanent if not treated quickly. Call your doctor right away if you have a sudden decrease in vision.

Topiramate can decrease sweating and may cause life-threatening dehydration (especially in children). Avoid becoming overheated or dehydrated. Tell your doctor if you have decreased sweating, high fever, and hot dry skin.

Do not take Trokendi XR within 6 hours of drinking alcohol.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not stop using topiramate suddenly or you could have increased seizures.

You should not use topiramate if you are allergic to it. Do not take Trokendi XR within 6 hours before or 6 hours after drinking alcohol. You should not use extended-release topiramate if you have metabolic acidosis (high levels of acid in your blood) and are also taking metformin for diabetes.

Tell your doctor if you have ever had:

  • glaucoma or other eye problems;
  • diabetes, or metabolic acidosis;
  • kidney disease, kidney stones, or dialysis;
  • lung disease, breathing problems;
  • mood problems, depression, or suicidal thoughts or actions;
  • liver disease;
  • soft or brittle bones (osteoporosis, osteomalacia);
  • a growth disorder; or
  • if you are sick with diarrhea.

Topiramate can increase the level of acid in your blood (metabolic acidosis). This can weaken your bones, cause kidney stones, or cause growth problems in children or harm to an unborn baby. You may need blood tests to make sure you do not have metabolic acidosis, especially if you are pregnant.

Some people have thoughts about suicide while taking an anticonvulsant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking topiramate during pregnancy without your doctor’s advice. Topiramate may increase the risk of low birth weight and cleft lip and/or cleft palate in a newborn. There may be other seizure medicine that can be more safely used during pregnancy. Tell your doctor right away if you become pregnant.

Topiramate can make birth control pills less effective. Use a barrier form of birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy while taking topiramate.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Generic Name: topiramate (toe PYRE a mate)
Brand Names: Qudexy XR Sprinkle, Topamax, Topamax Sprinkle, Trokendi XR

Medically reviewed by P. Thornton, DipPharm Last updated on Jun 12, 2019.

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What is Trokendi XR?

Trokendi XR (topiramate) is a seizure medicine, also called an anticonvulsant.

Trokendi XR is used to help prevent certain types of seizures in adults and children who are at least 6 years old.

Trokendi XR is also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. Topiramate will only prevent migraine headaches or reduce the number of attacks. It will not treat a headache that has already begun.

Important Information

Trokendi XR may cause vision problems that can be permanent if not treated quickly. Call your doctor right away if you have a sudden decrease in vision.

Topiramate may harm an unborn baby. There may be other seizure medicine that can be more safely used during pregnancy. Tell your doctor right away if you become pregnant.

Trokendi XR can increase body temperature and decrease sweating, which may lead to life-threatening dehydration. Tell your doctor if you have decreased sweating, high fever, and hot dry skin.

Trokendi XR can also increase the level of acid in your blood (metabolic acidosis). Tell your doctor if you have irregular heartbeats, shortness of breath, loss of appetite, or trouble thinking.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not stop using Trokendi XR suddenly or you could have increased seizures.

Before taking this medicine

You should not use Trokendi XR if you are allergic to topiramate. Do not take Trokendi XR within 6 hours before or 6 hours after drinking alcohol.

Tell your doctor if you are sick with diarrhea, or if you have ever had:

  • glaucoma or other eye problems;

  • metabolic acidosis (high levels of acid in your blood);

  • kidney disease, kidney stones, or dialysis;

  • lung disease, breathing problems;

  • mood problems, depression, or suicidal thoughts or actions;

  • liver disease;

  • a growth disorder; or

  • soft or brittle bones (osteoporosis, osteomalacia).

Topiramate can increase the level of acid in your blood (metabolic acidosis). This can weaken your bones, cause kidney stones, or cause growth problems in children or harm to an unborn baby. You may need blood tests to make sure you do not have metabolic acidosis, especially if you are pregnant.

Some people have thoughts about suicide while taking an anticonvulsant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking Trokendi XR during pregnancy without your doctor’s advice. Topiramate may increase the risk of low birth weight and cleft lip and/or cleft palate in a newborn. There may be other seizure medicine that can be more safely used during pregnancy. Tell your doctor right away if you become pregnant.

Topiramate can make birth control pills less effective. Use a barrier form of birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy while taking Trokendi XR.

It may not be safe to breastfeed a baby while you are using Trokendi XR. Ask your doctor about any risks.

How should I take Trokendi XR?

Take Trokendi XR exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Trokendi XR can be taken with or without food.

Swallow the tablet whole and do not crush, chew, or break it. The Trokendi XR extended-release capsule must be swallowed whole. Do not break or open.

Carefully follow the swallowing instructions for your medicine.

Topiramate doses are sometimes based on weight in children. Your child’s dose needs may change if the child gains or loses weight.

Drink plenty of liquids while you are taking Trokendi XR, to prevent kidney stones or an electrolyte imbalance.

You will need frequent medical tests. If you need surgery, tell the surgeon ahead of time that you are using topiramate. Any medical care provider who treats you should know that you take seizure medication.

Do not stop using Trokendi XR suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor’s instructions about tapering your dose.

Call your doctor if your seizures get worse or you have them more often while taking Trokendi XR.

Store at cool room temperature away from moisture, light, and high heat.

What happens if I miss a dose?

Take the medicine as soon as you can. Do not take two doses at one time.

Call your doctor if you have missed more than one dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of topiramate can be fatal. Overdose can cause drowsiness, agitation, depression, double vision, thinking problems, problems with speech or coordination, fainting, and seizure (convulsions).

What should I avoid while taking Trokendi XR?

Do not drink alcohol. Dangerous side effects or increased seizures may occur.

Avoid becoming overheated or dehydrated in hot weather. Topiramate can increase body temperature and decrease sweating, leading to life-threatening dehydration (especially in children).

Avoid the use of a ketogenic or “ketosis” diet (high in fat, low in carbohydrates) while you are taking Trokendi XR.

Topiramate may cause blurred vision or impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Also avoid activities that could be dangerous if you have an unexpected seizure, such as swimming or climbing in high places.

Trokendi XR side effects

Get emergency medical help if you have signs of an allergic reaction to Trokendi XR: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening mood symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • vision problems, blurred vision, eye pain or redness, sudden vision loss (can be permanent if not treated quickly);

  • confusion, problems with thinking or memory, trouble concentrating, problems with speech;

  • dehydration symptoms – decreased sweating, high fever, hot and dry skin;

  • signs of a kidney stone – severe pain in your side or lower back, painful or difficult urination;

  • signs of too much acid in your blood – irregular heartbeats, feeling tired, loss of appetite, trouble thinking, feeling short of breath; or

  • signs of too much ammonia in your blood – vomiting, unexplained weakness, feeling like you might pass out.

Common Trokendi XR side effects may include:

  • dizziness, drowsiness, tired feeling, slow reactions;

  • problems with speech or memory;

  • abnormal vision;

  • numbness or tingling in your arms and legs, decreased sensation (especially in the skin);

  • changes in your sense of taste;

  • feeling nervous;

  • nausea, diarrhea, stomach pain, loss of appetite;

  • fever, weight loss; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Trokendi XR?

Using Trokendi XR with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or depression.

Tell your doctor about all your other medicines, especially:

  • acetazolamide;

  • zonisamide;

  • divalproex, valproic acid; or

  • birth control pills.

This list is not complete. Other drugs may interact with topiramate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Trokendi XR only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Consumer resources

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Other brands: Topamax, Qudexy XR, Topiragen

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Related treatment guides

  • Epilepsy
  • Lennox-Gastaut Syndrome
  • Seizure Prevention
  • Seizures

Topiramate may have benefit as a weight-loss drug

Brazilian researchers are presenting the results at The Endocrine Society’s 93rd Annual Meeting in Boston.

Among more than 3,300 overweight or obese patients, those who took topiramate for at least four months lost 11.8 pounds more on average than individuals who took “dummy” pills, or placebo, found the meta-analysis, a systematic and quantitative review of published studies.

“Topiramate is not an approved drug for the treatment of obesity. Data from individual clinical trials might not be sufficient to support physicians’ decision to prescribe it for this use, and robust evidence of its safety is lacking,” said lead investigator Caroline Kramer, MD, PhD. She is an endocrinologist at Clinic Hospital of Porto Alegre in Brazil.

Currently topiramate is approved as an anti-convulsant for treatment of seizure disorders and for prevention in adults of migraine headaches.

The investigators pooled the research results of 10 randomized, controlled clinical trials (considered the gold standard in scientific research) that evaluated the benefits and adverse effects of topiramate prescribed for weight loss. They analyzed data about the effectiveness of topiramate on weight loss in 3,320 patients and data on adverse effects in 6,620 patients, she said.

According to the analysis, the duration and dosage of treatment affected the weight-loss benefits. Weight loss was higher when the drug was prescribed at doses of 96 to 200 milligrams per day for more than 28 weeks compared with less than 28 weeks, the authors reported. Compared with study subjects who took the placebo, topiramate-treated patients were seven times likelier to lose more than 10 percent of their body weight.

However, the authors found that patients were nearly two times more likely to stop topiramate treatment because of side effects than were those receiving placebo. The most common side effects, according to Kramer, included a burning sensation (paresthesia), typically around the mouth; impaired taste; and psychomotor disturbances, including slower thinking and reduced physical movements. Difficulty concentrating and memory impairment also were increased.

“Topiramate has a substantial effect on weight loss, at least comparable to the weight loss that other anti-obesity drugs induce,” Kramer said. “We have so few pharmacological options for the treatment of obesity that I believe topiramate can be a useful tool together with diet and exercise.”

She said it is important, however, for patients to understand the drug’s known possible side effects and to be aware that it may have uncommon side effects that researchers have not yet observed.

The National Institutes of Health caution that people should use prescription weight-loss medications only if they are at increased risk of health problems because of their excess weight.

General Information

Trokendi XR is an extended release formulation of topiramate, an anticonvulsant.

Trokendi XR is specifically indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures. Trokendi XR is also indicated as adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gastaut syndrome.

Trokendi XR is supplied as a capsule for oral administration. The recommended dose regimen is as follows:
Monotherapy Use
Adults and Pediatrics 10 Years and Older with Partial Onset or Primary Generalized TonicClonic Seizures: 400 mg orally once daily. Titrate Trokendi XR according to the following schedule:
Week 1 50 mg once daily
Week 2 100 mg once daily
Week 3 150 mg once daily
Week 4 200 mg once daily
Week 5 300 mg once daily
Week 6 400 mg once daily
Adjunctive Therapy Use
Adults (17 Years of Age and Older) – Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome: partial onset seizures or Lennox-Gaustaut Syndrome – 200 mg to 400 mg orally once daily; primary generalized tonic-clonic seizures – 400 mg orally once daily. Initiate therapy at 25 mg to 50 mg once daily followed by titration to an effective dose in increments of 25 mg to 50mg every week.
Pediatrics (Ages 6 years to 16 Years) – Partial Onset Seizures, Primary Generalized TonicClonic Seizures, or Lennox-Gastaut Syndrome: approximately 5 mg/kg to 9 mg/kg orally once daily. Begin titration at 25 mg once daily (based on a range of 1 mg/kg/day to 3 mg/kg/day) given nightly for the first week. Subsequently, increase the dosage at 1- or 2­ week intervals by increments of 1 mg/kg to 3 mg/kg to achieve optimal clinical response.

Clinical Results

FDA Approval
The FDA approval of Trokendi XR was based on studies using an immediate-release formulation of topiramate and the demonstration of the pharmacokinetic equivalence of Trokendi XR to immediate-release topiramate through the analysis of concentrations and cumulative AUCs at multiple time points.

Side Effects

Adverse events associated with the use of Topamax XR may include, but are not limited to, the following:

  • paresthesia
  • anorexia
  • weight decrease
  • fatigue
  • dizziness
  • somnolence
  • nervousness
  • psychomotor slowing
  • difficulty with memory
  • difficulty with concentration/attention
  • cognitive problems
  • confusion
  • mood problems
  • fever
  • infection
  • flushing

Mechanism of Action

Trokendi XR is an extended release formulation of topiramate, an anticonvulsant. The precise mechanisms by which topiramate exerts its anticonvulsant effects are unknown; however, preclinical studies have revealed four properties that may contribute to topiramate’s efficacy for epilepsy. Electrophysiological and biochemical evidence suggests that topiramate, at pharmacologically relevant concentrations, blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme.

Additional Information

For additional information regarding Trokendi XR or seizure disorders, please visit the TrokendiXR web page.

Starting New Patients

WARNINGS & PRECAUTIONS

  • A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. Symptoms can include acute onset of decreased visual acuity and/or ocular pain, myopia, anterior chamber shallowing, ocular hyperemia, and increased intraocular pressure. Symptoms typically occur within 1 month of initiating topiramate therapy. The primary treatment to reverse symptoms is discontinuation of Trokendi XR as rapidly as possible. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.
  • Visual field defects (independent of elevated intraocular pressure) have been reported in patients receiving topiramate. In clinical trials, most events were reversible after topiramate discontinuation. If problems occur at any time during topiramate treatment, consider discontinuation of the drug.
  • Oligohydrosis resulting in hospitalization has been reported in some cases in association with topiramate use. The majority of reports have been in pediatric patients. Patients, especially pediatric patients, should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when Trokendi XR is prescribed with other drugs that predispose patients to heat-related disorders.
  • Hyperchloremic, non-anion gap, metabolic acidosis has been reported in adults and pediatric patients treated with topiramate. This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of topiramate on carbonic anhydrase. Conditions that predispose patients to acidosis may be additive to the bicarbonate lowering effects of topiramate. Although Trokendi XR is not approved for children under 6 years of age, a study of topiramate as adjunctive treatment in patients under 2 produced metabolic acidosis of a notably greater magnitude than in older children and adults. Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate. The incidence of persistent decreases in serum bicarbonate in placebo-controlled trials with immediate-release topiramate for adults for prophylaxis of migraine was higher than in the epilepsy controlled trials, and higher in adolescents than adults.
  • In vitro data show that, in the presence of alcohol, the pattern of topiramate release from Trokendi XR capsules is significantly altered. Alcohol use should be completely avoided within 6 hours prior to and 6 hours after Trokendi XR administration.
  • Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED, including Trokendi XR for any indication, should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Anyone prescribing Trokendi XR must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Many illnesses for which antiepileptic drugs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during Trokendi XR treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
  • Immediate-release topiramate can cause, and therefore Trokendi XR is expected to cause cognitive/neuropsychiatric adverse reactions. In adults, the most frequent of these can be classified into three general categories: cognitive-related dysfunction, psychiatric/behavioral disturbances, and somnolence or fatigue.
  • Topiramate can cause fetal harm when administered to a pregnant woman. Use during pregnancy and data from pregnancy registries indicate that infants exposed to topiramate in utero can have increased risk of cleft lip and/or cleft palate, and for being small for gestational age. Trokendi XR should only be used during pregnancy if the potential benefit outweighs the potential risk. Patients should be informed of the potential hazard to the fetus. Diarrhea and somnolence have been reported in breastfed infants whose mothers receive topiramate.
  • Antiepileptic drugs, including Trokendi XR, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency.
  • Hyperammonemia with and without encephalopathy has been observed in post-marketing reports in patients who were taking topiramate with or without concomitant valproic acid (VPA); hyperammonemia appears more common when used concomitantly with VPA. Although Trokendi XR is not indicated for use in infants or toddlers, topiramate with concomitant VPA produced a dose-related increase in hyperammonemia in this population.
  • The concomitant use of Trokendi XR with any other drug producing metabolic acidosis, or potentially in patients on a ketogenic diet, may increase the risk of kidney stone formation and should therefore be avoided.
  • Hypothermia has been reported in association with topiramate use with concomitant valproic acid (VPA) both in the presence and in the absence of hyperammonemia. Consideration should be given to stopping topiramate or valproate in patients who develop hypothermia; clinical management should include examination of blood ammonia levels.
  • Topiramate is a CNS depressant. Concomitant administration of topiramate with other CNS depressant drugs can result in significant CNS depression. Patients should be watched carefully when Trokendi XR is coadministered with other CNS depressant drugs.

Trokendi XR™ (Topiramate)

Trokendi XR™ (topiramate) is indicated for the prophylaxis of migraine in patients 12 years of age and older. It is taken by mouth as prophylactic therapy to reduce migraine frequency. For those with frequent migraine attacks or migraine that do not respond to acute treatment, preventive medications can be important.

Trokendi XR is an extended-release formulation of topiramate, the same medication in Topamax®.

What are the ingredients in Trokendi XR?

The active ingredient in Trokendi XR is topiramate.

How does Trokendi XR work?

The precise way Trokendi XR works to prevent migraine is unknown. It is thought that the medication blocks sodium channels and increases the activity of neurotransmitters in the brain. This likely inhibits some of the receptors in nerve cells, which reduce electrical activity and contribute to the development of migraine.

What are the possible side effects of Trokendi XR?

Many clinical trials evaluated the safety and efficacy of Trokendi XR. The most common side effects experienced by those taking Trokendi XR include:

  • Hypoesthesia
  • Taste disturbances
  • Numbness or tingling in the fingers and toes (paresthesia)
  • Anorexia
  • Weight loss
  • Diarrhea
  • Abdominal pain
  • Nausea
  • Upper respiratory infections
  • Speech and memory difficulties

This is not an exhaustive list of all potential side effects of Trokendi XR. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Trokendi XR, contact your doctor or healthcare provider immediately.

Things to note about Trokendi XR

Trokendi XR capsules are taken by mouth with water or other liquids. Trokendi XR is taken once a day for effectiveness in reducing the frequency of migraine. The extended release capsules supply a steady stream of medication over 24 hours. The medication is generally most effective after 1 month of use. Before starting Trokendi XR talk with your doctor if you:

  • Have a history of hypersensitivity to topiramate
  • Have used alcohol within 6 hours prior to use or plan to use alcohol within 6 hours after dosing
  • Have acute myopia and secondary angle closure glaucoma
  • Have visual field defects
  • Have a history of oligohydrosis (decreased sweating) and hyperthermia (fever)
  • Have a history metabolic acidosis
  • Have taken antiepileptic drugs
  • Have taken other carbonic anhydrase inhibitors
  • Have taken valproic acid
  • Have taken anti-depressants
  • Have a history of depression or suicidal ideation
  • Have a history of kidney stones
  • Have a history of weak, brittle or soft bones
  • Have lung or breathing problems
  • Are planning on having surgery
  • Are on a high fat diet/low carbohydrate diet
  • Are pregnant or planning to get pregnant. Topiramate can cause fetal harm when administered to a pregnant woman.

Individuals with the above conditions should be monitored closely while taking Trokendi XR.

Dosing Information

The initial dose of Trokendi XR titration, and recommended maintenance dose, varies by indication and age group. Extended-release capsules come in 4 strengths: 25 mg, 50 mg, 100 mg, and 200 mg.

The recommended total daily dose of Trokendi XR as treatment for prevention of migraine in patients 12 years of age and older is 100 mg once daily. Trokendi XR is generally titrated according to the following schedule:

  • Week 1: 25 mg once daily
  • Week 2: 50 mg once daily
  • Week 3: 75 mg once daily
  • Week 4: 100 mg once daily

A physician will guide the dose and titration rate, based on individual medical circumstances, and clinical outcomes. Longer intervals between dose adjustments can be used.

Trokendi XR capsules can be taken with or without food. Capsules should be swallowed whole. Do not open and sprinkle on food, chew, or crush the medication.

Do not suddenly stop taking Trokendi XR without talking to your doctor, as serious complications can arise.

Keep track of when you have migraine attacks and when you take Trokendi XR so you can monitor its effectiveness, and communicate with your doctor about how the medication is working for you.

Before taking Trokendi XR make sure to tell your doctor about all the medicines you take, including prescription and nonprescription, vitamins, and herbal supplements. Trokendi XR and other medicines may impact each other, causing side effects.

Because Trokendi XR can cause dizziness, weakness, and drowsiness, do not drive a car, use machinery, or do anything requiring you to be fully alert when taking this medication.

For additional details, read the full prescribing information of Trokendi XR.

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