Qudexy XR Sprinkle

Qudexy XR Sprinkle is used by itself or with other medicines to treat certain types of seizures in adults and children who are at least 2 years old. Some extended-release capsule forms of topiramate are only for adults and children who are at least 6 years old.

Qudexy XR Sprinkle is also used to help prevent migraine headaches in adults and children who are at least 12 years old.

Qudexy XR Sprinkle may also be used for other reasons that are not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may sometimes change your dose. Use the medicine exactly as directed.

You may take Qudexy XR Sprinkle with or without food.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Drink plenty of liquids while you are taking Qudexy XR Sprinkle to help prevent kidney stones.

Some capsules can be swallowed whole or opened and sprinkled on a small amount of soft food. Certain extended-release capsules must be swallowed whole and must not be opened, crushed, chewed, dissolved, or sprinkled on food. Follow the instructions that come with your medicine.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

You may need blood tests before and during treatment with Qudexy XR Sprinkle, and your next dose may be changed based on the results. Your doctor will need to check your progress on a regular basis. Keep all follow-up visits to your doctor.

You should not stop using Qudexy XR Sprinkle suddenly. Follow your doctor's instructions about tapering your dose.

Call your doctor if your symptoms do not improve, or if they get worse.

Store tightly closed at room temperature, away from moisture, heat, and light. Do not allow the liquid medicine to freeze. Throw away any unused liquid medicine 90 days after opening the bottle.

Qudexy XR Sprinkle may cause vision problems that can lead to permanent vision loss. Call your doctor immediately if you experience any eye pain, redness, or changes in your vision.

Qudexy XR Sprinkle may lead to decreased sweating and increased body temperature. Children and people exposed to hot weather may be more likely to experience this side effect.

Some people may have thoughts about suicide while taking Qudexy XR Sprinkle. Inform your doctor right away if you notice any sudden changes in mood or behavior, or if you have thoughts about suicide.

Qudexy XR Sprinkle can reduce bone mineral density, which may increase the risk of developing osteoporosis in children when the medicine is used for long periods of time.

You should not use Qudexy XR Sprinkle if you are allergic to it.

You may not be able to use some extended-release forms of topiramate if you drank alcohol within the past 6 hours or plan to drink alcohol within 6 hours after taking the medicine.

Tell your doctor if you have or have ever had:

• glaucoma or other eye problems;
• high levels of ammonia in your blood;
• metabolic acidosis (high levels of acid in your blood);
• lung disease or breathing problems;
• depression, mood changes, or thoughts or actions of suicide;
• a growth problem;
• diarrhea;
• a planned surgery;
• kidney stones;
• a bone disorder that causes soft or weak bones or low bone mineral density;
• follow a ketogenic diet (high-fat, high-protein, low-carb);
• liver disease; or
• kidney disease (or if you are on dialysis).

Taking Qudexy XR Sprinkle may increase the level of acid in your blood (metabolic acidosis). This can weaken your bones, cause kidney stones, or lead to growth problems in children. Ask your doctor about your individual risk.

Some people may have thoughts about suicide while taking Qudexy XR Sprinkle. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor should decide whether you need Qudexy XR Sprinkle. Taking this medicine during pregnancy may cause birth defects or medical problems in the baby. There may be other medications that are safer to use during pregnancy.

You must use effective birth control while using Qudexy XR Sprinkle. This medicine can make some types of birth control less effective. Ask your doctor about other birth control options.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of topiramate on the baby.

Ask a doctor if it is safe to breastfeed while using Qudexy XR Sprinkle.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Qudexy XR Sprinkle may cause serious side effects. Call your doctor at once if you have:

• changes in your menstrual bleeding;
• a skin rash, no matter how mild;
• dizziness or loss of coordination;
• blurred vision, eye pain or redness, seeing halos around lights, or sudden vision loss (can be permanent if not treated quickly);
• confusion, problems with thinking or memory, trouble concentrating, problems with speech;
• decreased sweating, feeling very hot;
• signs of a kidney stone--pain in your side or lower back, blood in your urine, painful or difficult urination;
• signs of metabolic acidosis--confusion, vomiting, lack of energy, irregular heartbeats; or
• high levels of ammonia in your blood--vomiting, unexplained weakness, feeling like you might pass out, change in your mental state.

Qudexy XR Sprinkle can affect growth in children. Your child's height and weight may be checked often. Tell your doctor if your child is not growing at a normal rate while using Qudexy XR Sprinkle long-term.

Common side effects of Qudexy XR Sprinkle may include:

• dizziness, drowsiness, tiredness, slow reactions;
• problems with speech, memory, or vision;
• numbness, tingling, burning pain 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.

Take the medicine as soon as possible, but skip the missed dose if your next dose is due in less than 6 hours. Do not take two doses at once.

For the extended-release capsule: Contact your doctor for guidance if you miss a dose. Do not take two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. An overdose can be fatal.

Do not drink alcohol. Dangerous side effects could happen. Certain extended-release forms of topiramate must not be taken within 6 hours before or after drinking alcohol.

Avoid getting overheated or dehydrated in hot weather. Qudexy XR Sprinkle can raise body temperature and reduce sweating, which can lead to life-threatening dehydration (especially in children).

Avoid following a ketogenic or "ketosis" diet (high in fat, low in carbohydrates) while you are taking Qudexy XR Sprinkle.

Avoid driving or doing hazardous activities until you know how Qudexy XR Sprinkle will affect you. This medicine may cause dizziness, blurred vision, balance or memory issues, which may impair your reactions or lead to falls, accidents, or serious injuries.

Using Qudexy XR Sprinkle with other medications that cause drowsiness can make you feel more tired. Check with your doctor before taking opioid painkillers, sleeping pills, muscle relaxants, or medicines for anxiety or seizures.

Inform your doctor about all the other medications you are taking, especially:

• hydrochlorothiazide;
• acetazolamide or other eye medications for glaucoma, including eye drops;
• hormonal birth control (like pills, implants, patches, or injections); or
• anticonvulsants (antiepileptics) such as phenytoin, carbamazepine, zonisamide, or valproic acid.

This list is not exhaustive. Other medications may interact with Qudexy XR Sprinkle, including both prescription and over-the-counter drugs, vitamins, and herbal supplements. Not all possible drug interactions are mentioned here.