Qudexy XR (Oral)

Topiramate is used by itself or with other medicines to help treat certain types of seizures (for example, partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome). This medicine will not cure epilepsy and will only help control seizures as long as you keep taking it. It is also used to help prevent migraine headaches.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to regularly check how you or your child are doing while using this medicine to ensure it is working correctly. You may need blood and urine tests to look for any unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use effective birth control to prevent pregnancy. If you think you might be pregnant while using this medicine, tell your doctor immediately.

Birth control pills that contain estrogen may not work properly if you take them with topiramate. To prevent pregnancy, use an additional form of birth control (for example, condoms or spermicide) along with your birth control pill. If you have any questions about this, ask your doctor or pharmacist.

This medicine may cause changes in vision, clumsiness or unsteadiness, dizziness, drowsiness, or difficulty with thinking or speaking. Make sure you know how you or your child respond to this medicine before driving, using machines, climbing high places, swimming, or doing anything else that could be dangerous if you are not alert, coordinated, or able to think or see well.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). Using alcohol or other CNS-affecting medicines with topiramate may worsen side effects like dizziness, poor concentration, drowsiness, unusual dreams, and trouble sleeping. Some examples of these medicines are antihistamines or medicines for allergies or colds, sedatives, tranquilizers, sleeping medicines, medicines for depression, medicines for anxiety, prescription pain medicines or narcotics, medicines for attention deficit and hyperactivity disorder, seizure medicines or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Check with your doctor right away if you or your child experience changes in vision or eye pain during and after treatment with this medicine. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

This medicine may cause you to sweat less, which can raise your body temperature. Be extra careful not to overheat during exercise or hot weather while taking this medicine. Overheating can lead to heat stroke, and hot baths or saunas may make you feel dizzy or faint.

Topiramate may cause some people to feel agitated, irritable, or display other unusual behaviors. It may also lead to suicidal thoughts and tendencies or increased depression in some individuals. Make sure the doctor knows if you have difficulty sleeping, get upset easily, experience a sudden increase in energy, or start to act recklessly. Also inform the doctor if you have sudden or intense feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects, inform your doctor immediately.

This medicine may cause nausea, muscle tremors, breathing problems, eating difficulties, a fast heartbeat, restlessness, and stomach pain. Tell your doctor right away if you or your child have any of these symptoms. You may have a serious condition called metabolic acidosis (too much acid in the blood).

This medicine may reduce bone density, which can make your bones weaker. Discuss any concerns about this with your doctor.

This medicine may cause slow growth. For children, the doctor will need to monitor height and weight to ensure proper growth.

Do not suddenly stop using this medicine without consulting your doctor first. Stopping suddenly may cause your seizures to return or increase in frequency. Your doctor may want you or your child to gradually reduce the dosage before stopping completely.

Serious skin reactions (for example, Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur with Topamax® and Eprontia™. Contact your doctor immediately if you experience blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while using this medicine.

Contact your doctor right away if you or your child experience unusual drowsiness, dullness, tiredness, weakness, feelings of sluggishness, mental depression or anxiety, nightmares or unusually vivid dreams, or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.

Contact your doctor immediately if you or your child have sudden back pain, stomach pain, pain while urinating, or bloody or dark urine. These may be symptoms of kidney stones.

Tell your doctor if you or your child's skin feels like it is burning, crawling, itching, or if you have numbness, prickling, "pins and needles," or tingling sensations after using topiramate.

Do not take any other medicines unless you have discussed it with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, the chances of using the drug must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medication, the following should be considered:

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this drug or any other drugs. Additionally inform 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, oral solution, or tablets, or Qudexy® extended-release capsules to treat seizures in children younger than 2 years of age (when used alone or together with other medicines). Nevertheless, children are more likely to have unwanted effects (eg, rickets, slow growth, and increased chance of kidney stones) to this medication. 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 therapy 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, tablets, or oral solution 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. Nevertheless, elderly patients are more likely to have age-related kidney issues, 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 chance when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks before using this medicine while breastfeeding.

Interactions with Medicines

Although certain drugs 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 physician may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially critical that your healthcare professional know if you are using any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following medicines is typically not recommended, but may be required in some cases. If both medications are prescribed together, your physician may change the dose or how frequently you use one or both of the drugs.

• Acepromazine
• Acetazolamide
• Alfentanil
• Alprazolam
• Amitriptyline
• Amobarbital
• Anileridine
• Apixaban
• Aripiprazole
• Aripiprazole Lauroxil
• Asenapine
• Baclofen
• Benperidol
• Benzhydrocodone
• Brinzolamide
• Bromazepam
• Buprenorphine
• Buspirone
• Butabarbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Citalopram
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Codeine
• Cyclobenzaprine
• Daridorexant
• Desogestrel
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Dichlorphenamide
• Dienogest
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Dorzolamide
• Doxylamine
• Droperidol
• Drospirenone
• Enflurane
• Esketamine
• Estazolam
• Estetrol
• Estradiol
• Eszopiclone
• Ethchlorvynol
• Ethinyl Estradiol
• Ethopropazine
• Ethylmorphine
• Ethynodiol
• Etonogestrel
• Fentanyl
• Flibanserin
• Flunitrazepam
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fosphenytoin
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Gestodene
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrochlorothiazide
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Isoflurane
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Lemborexant
• Levocetirizine
• Levonorgestrel
• Levorphanol
• Lithium
• Lofexidine
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Meclizine
• Medroxyprogesterone
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Mestranol
• Metaxalone
• Metformin
• Methadone
• Methazolamide
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Midazolam
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Nifedipine
• Nitrazepam
• Nitrous Oxide
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Olanzapine
• Opium
• Opium Alkaloids
• Orlistat
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenytoin
• Pimozide
• Pioglitazone
• Piperacetazine
• Piperaquine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Quazepam
• Quetiapine
• Ramelteon
• Remifentanil
• Remimazolam
• Remoxipride
• Rivaroxaban
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Segesterone
• Sertindole
• Sodium Oxybate
• Sufentanil
• Sulpiride
• Suvorexant
• Tapentadol
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Tramadol
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Ulipristal
• Valproic Acid
• Venlafaxine
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

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

• Ginkgo
• Phenobarbital
• Posaconazole

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 medications 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 physician may decide not to treat you with this medication, change some of the other medications you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical issues may affect the use of this medication. Make sure you tell your clinician if you have any other medical issues, especially:

• Bone issues (eg, osteoporosis, osteomalacia, osteopenia) or
• 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—Use with caution. May make these conditions worse.

• Diarrhea or
• Lung or breathing issues or
• Patients on ketogenic diet or
• Status epilepticus (prolonged seizure)—May increase chance 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 as well taking metformin—Should not be used in patients with this condition.

• Patients undergoing hemodialysis—Use with caution. The effects of Topamax® or Eprontia™ may be lessened because of its faster removal from the body.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you might need medical attention.

Check with your doctor right away if any of these side effects occur:

More common

• Blurred vision
• burning, prickling, or tingling sensations
• clumsiness or unsteadiness
• confusion
• continuous, uncontrolled back-and-forth or rolling eye movements
• dizziness
• double vision
• drowsiness
• eye redness or pain
• generalized slowing of mental and physical activity
• increased eye pressure
• memory problems
• menstrual changes or pain
• nervousness
• speech or language problems
• trouble concentrating or paying attention
• unusual tiredness or weakness

Less common

• Aggression
• agitation
• chest pain
• chills
• discouragement
• feeling sad or empty
• fever
• irritability
• lack of feeling or emotion
• lessening of sensations or perception
• loss of appetite
• loss of interest or pleasure
• red, irritated, or bleeding gums
• sore throat
• stomach pain
• trouble sleeping
• weight loss

Rare

• Blood in the urine
• difficult or painful urination
• frequent urination
• hearing loss
• itching, skin rash
• loss of bladder control
• lower back or side pain
• nosebleeds
• pale skin
• ringing or buzzing in the ears
• swelling
• trouble breathing

Incidence not known

• Blistering, peeling, or loosening of the skin
• bloating
• bone fractures, especially of the thigh bone
• bone pain, tenderness, or aching
• clay-colored stools
• constipation
• cough
• decrease in height
• diarrhea
• increased rate of breathing
• joint or muscle pain
• muscle weakness
• pain in the back, ribs, arms, or legs
• pain or tenderness in the upper stomach
• red skin lesions, often with a purple center
• sores, ulcers, or white spots in the mouth or on the lips
• yellow eyes or skin

Get emergency help right away if any of these symptoms of overdose occur:

Symptoms of overdose

• Decreased awareness or responsiveness
• dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
• severe sleepiness
• unusual drowsiness, dullness, or feeling sluggish

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also know ways to prevent or reduce some of these side effects. Check with your health care professional if any of these side effects continue, are bothersome, or if you have any questions about them:

More common

• Breast pain in women
• tremors

Less common

• Constipation
• feeling of warmth
• heartburn
• increased sweating
• redness of the face, neck, arms, and sometimes, upper chest

Rare

• Decrease in sexual performance or desire

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Eprontia
• Qudexy XR
• Topamax
• Topiragen
• Trokendi XR

Available Dosage Forms:

• Tablet
• Capsule, Extended Release
• Solution
• Capsule

Therapeutic Class: Anticonvulsant

Chemical Class: Fructopyranose Sulfamate

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Topiramate may be taken with or without food.

Swallow the Trokendi XR™ extended-release capsule whole. Do not open, crush, or chew the capsule.

Measure the Eprontia™ oral solution with a marked measuring spoon, oral syringe, or medicine cup.

Avoid drinking alcohol with Eprontia™, Qudexy® XR, or Topamax®, or avoid for 6 hours before and 6 hours after taking the Trokendi XR™ capsule.

Swallow the tablet whole. Do not break, crush, or chew it. The tablet may taste bitter if it is held in the mouth or chewed.

The Topamax® sprinkle capsule or Qudexy® XR extended-release capsule may be swallowed whole or opened and sprinkled on a small amount (1 teaspoon) of soft food (eg, applesauce). Swallow the food mixture right away without chewing. Do not save for later use.

Drink extra water with this medicine to help prevent kidney stones.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release capsules): For seizures (taken with other medicines): Adults—At first, 25 to 50 milligrams (mg) once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 400 mg per day. Children— Qudexy®: Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 25 milligrams (mg) once a day in the evening. Your doctor may adjust the dose as needed. However, the dose is usually not more than 5 to 9 mg per kilogram (kg) of body weight per day. Children younger than 2 years of age—Use is not recommended. Trokendi™: Children 6 years of age and older—At first, 25 milligrams (mg) once a day in the evening. Your doctor may adjust the dose as needed. However, the dose is usually not more than 5 to 9 mg per kilogram (kg) of body weight per day. Children younger than 6 years of age—Use is not recommended. For seizures (taken alone): Qudexy®: Adults and children 10 years of age and older—At first, 50 milligrams (mg) once a day. Your doctor may increase the dose as needed. However, the dose is usually not more than 400 mg per day. Children 2 to 10 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 25 mg once a day, in the evening. Your doctor may increase the dose as needed and tolerated. However, the dose is usually not more than 400 mg per day. Children younger than 2 years of age—Use and dose must be determined by your doctor. Trokendi™: Adults and children 10 years of age and older—At first, 50 milligrams (mg) once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 400 mg per day. Children younger than 10 years of age—Use and dose must be determined by your doctor. For migraine headaches: Adults and children 12 years of age and older—At first, 25 milligrams (mg) once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 100 mg per day. Children younger than 12 years of age—Use and dose must be determined by your doctor.
• For oral dosage forms (capsules or tablets): For seizures (taken with other medicines): Adults and children 17 years of age and older—At first, 25 or 50 milligrams (mg) once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 400 mg per day. Children 2 to 16 years of age—Dose is based on body weight and must be determined by your child's doctor. The starting dose is usually 25 milligrams (mg) once a day in the evening. The doctor may adjust the dose as needed. Children younger than 2 years of age—Use and dose must be determined by your doctor. For seizures (taken alone): Adults and children 10 years of age and older—At first, 50 milligrams (mg) per day, taken in 2 divided doses. Your doctor may adjust the dose as needed. However, the dose is usually not more than 400 mg per day. Children 2 to 9 years of age—Dose is based on body weight and must be determined by your child's doctor. The starting dose is usually 25 mg once a day in the evening. The doctor may adjust the dose as needed. However, the dose is usually not more than 250 to 400 mg per day. Weighing more than 38 kilograms (kg)—250 to 400 mg per day taken in 2 divided doses. Weighing 32 to 38 kg—250 to 350 mg per day taken in 2 divided doses. Weighing 23 to 31 kg—200 to 350 mg per day taken in 2 divided doses. Weighing 12 to 22 kg—200 to 300 mg per day taken in 2 divided doses. Weighing 11 kg or less—150 to 250 mg per day taken in 2 divided doses. Children younger than 2 years of age—Use and dose must be determined by your doctor. For migraine headaches: Adults and children 12 years of age and older—At first, 25 milligrams (mg) once a day in the evening. Your doctor may adjust the dose as needed. However, the dose is usually not more than 100 mg per day. Children younger than 12 years of age—Use and dose must be determined by your doctor.
• For oral dosage forms (solution): For seizures (taken with other medicines): Adults and children 17 years of age and older—At first, 25 or 50 milligrams (mg) once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 400 mg per day. Children 2 to 16 years of age—Dose is based on body weight and must be determined by your child's doctor. The starting dose is usually 25 milligrams (mg) once a day in the evening. The doctor may adjust the dose as needed. Children younger than 2 years of age—Use and dose must be determined by your doctor. For seizures (taken alone): Adults and children 10 years of age and older—At first, 50 milligrams (mg) per day, taken in 2 divided doses. Your doctor may adjust the dose as needed. However, the dose is usually not more than 400 mg per day. Children 2 to 9 years of age—Dose is based on body weight and must be determined by your child's doctor. The starting dose is usually 25 mg once a day in the evening. The doctor may adjust the dose as needed. However, the dose is usually not more than 250 to 400 mg per day. Weighing more than 38 kilograms (kg)—250 to 400 mg per day taken in 2 divided doses. Weighing 32 to 38 kg—250 to 350 mg per day taken in 2 divided doses. Weighing 23 to 31 kg—200 to 350 mg per day taken in 2 divided doses. Weighing 12 to 22 kg—200 to 300 mg per day taken in 2 divided doses. Weighing 11 kg or less—150 to 250 mg per day taken in 2 divided doses. Children younger than 2 years of age—Use and dose must be determined by your doctor. For migraine headaches: Adults and children 12 years of age and older—At first, 25 milligrams (mg) once a day in the evening. Your doctor may adjust the dose as needed. However, the dose is usually not more than 100 mg per day. Children younger than 12 years of age—Use and dose must be determined by your doctor.

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.

If you miss more than 1 dose of Topamax® capsule or tablet orEprontia™ oral solution, contact your doctor for instructions about how to restart it.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused Eprontia™ oral solution 60 days after first opening.

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