Trokendi XR

Topiramate is used alone or with other medications to treat certain types of seizures including primary generalized tonic-clonic seizures (formerly known as a grand mal seizure; seizure that involves the entire body) and partial onset seizures (seizures that involve only one part of the brain). Topiramate is also used with other medications to control seizures in people who have Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays). Topiramate is also used to prevent migraine headaches but not to relieve the pain of migraine headaches when they occur. Topiramate is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.

Pregnancy

Topiramate can cause fetal harm when administered to a pregnant woman; data from pregnancy registries indicate that infants exposed to topiramate in utero have increased risk for cleft lip and/or cleft palate (oral clefts) and for being small for gestational age

In multiple animal species, topiramate demonstrated developmental toxicity, including teratogenicity, in the absence of maternal toxicity at clinically relevant doses

Consider benefits and risks of topiramate when prescribing to women of childbearing potential, particularly when topiramate is considered for a condition not usually associated with permanent injury or death; because of risk of oral clefts to fetus, which occur in first trimester of pregnancy before many women know they are pregnant, all women of childbearing potential should be informed of potential risk to fetus from exposure to topiramate; women who are planning a pregnancy should be counseled regarding relative risks and benefits of topiramate use during pregnancy; alternative therapeutic options should be considered for these patients

Although effect of topiramate on labor and delivery in humans has not been established, development of topiramate-induced metabolic acidosis in mother and/or in fetus might affect fetus’ ability to tolerate labor; metabolic acidosis in pregnancy (due to other causes) can cause decreased fetal growth, decreased fetal oxygenation, and fetal death, and may affect the fetus’ ability to tolerate labor; pregnant patients should be monitored for metabolic acidosis and treated as in nonpregnant state; newborns of mothers treated with topiramate should be monitored for metabolic acidosis because of transfer of topiramate to fetus and possible occurrence of transient metabolic acidosis following birth

Lactation

Topiramate is excreted in human milk; effects of topiramate exposure in breastfed infants are unknown; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for extended release formulation and any potential adverse effects on the breastfed infant from extended release formulation or from the underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of topiramate capsules or tablets, or Qudexy® extended-release capsules for the treatment of seizures in children younger than 2 years of age (when used alone or together with other medicines). Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Trokendi™ extended-release capsules for the treatment of seizures in children younger than 6 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of topiramate capsules, extended-release capsules, or tablets for the prevention of migraine headaches in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of topiramate have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of topiramate in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving topiramate.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Bromazepam
• Buprenorphine
• Butorphanol
• Calcifediol
• Carbinoxamine
• Citalopram
• Codeine
• Desogestrel
• Dienogest
• Dihydrocodeine
• Doxylamine
• Drospirenone
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Fentanyl
• Flibanserin
• Gestodene
• Hydrocodone
• Hydromorphone
• Levonorgestrel
• Levorphanol
• Meperidine
• Mestranol
• Methadone
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nifedipine
• Norethindrone
• Norgestimate
• Norgestrel
• Orlistat
• Oxycodone
• Oxymorphone
• Pentazocine
• Periciazine
• Piperaquine
• Remifentanil
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Tramadol
• Ulipristal
• Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Fosphenytoin
• Ginkgo
• Hydrochlorothiazide
• Phenobarbital
• Phenytoin
• Pioglitazone
• Posaconazole
• Valproic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, history of or
• Eye or vision problems (eg, glaucoma) or
• Mood disorder, history of or
• Metabolic acidosis (too much acid in the blood), or history of or
• Osteoporosis (weak bones)—Use with caution. May make these conditions worse.

• Diarrhea or
• Lung or breathing problems or
• Patients on ketogenic diet—May increase risk for metabolic acidosis.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Patients with metabolic acidosis who are also taking metformin—Should not be used in patients with this condition.

• It is used to treat seizures.
• It is used to prevent migraine headaches.
• It may be given to you for other reasons. Talk with the doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Trokendi XR, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Trokendi XR. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Trokendi XR.

Review Date: October 4, 2017

Trokendi XR® is contraindicated in patients:

• With recent alcohol use ( i.e., within 6 hours prior to and 6 hours after Trokendi XR® use) [see Warnings and Precautions (5.5)]
• With metabolic acidosis who are taking concomitant metformin [see Warnings and Precautions (5.4) and Drug Interactions (7.6)]

Controlled Substance

Trokendi XR® (topiramate) extended-release capsule is not a controlled substance.

Abuse

The abuse and dependence potential of Trokendi XR® has not been evaluated in human studies.

Dependence

Trokendi XR® has not been systematically studied in animals or humans for its potential for tolerance or physical dependence.

100 Capsules

NDC 17772-101-01

Trokendi XR™
(topiramate) extended-release capsules

Once daily.

25 mg

Swallow capsule
whole and intact.
Do not open, crush,
chew, or sprinkle
capsule contents on food.

ATTENTION PHARMACIST: Dispense
the Accompanying Medication Guide
to Each Patient

Supernus®

Rx only

Common side effects of Trokendi XR include: anxiety, ataxia, confusion, diarrhea, diplopia, dizziness, drowsiness, dysphasia, fatigue, lack of concentration, memory impairment, nausea, nervousness, paresthesia, psychomotor disturbance, speech disturbance, depression, visual disturbance, weight loss, dysgeusia, mood changes, and anorexia. Other side effects include: arthralgia, and asthenia. See below for a comprehensive list of adverse effects.

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.

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;

• severe 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.

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

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

Copyright 1996-2018 Cerner Multum, Inc. Version: 16.01.

Medical Disclaimer

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, agitation, depression, double vision, thinking problems, problems with speech or coordination, fainting, and seizure (convulsions).