Qudexy XR

Oral Administration

Can be taken without regard to meals

Trokendi XR

• Swallow capsule whole and intact
• Do not sprinkle on food, chew, or crush

Qudexy XR, Topamax Sprinkle Capsules

• Capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food
• This drug/food mixture should be swallowed immediately and not chewed or crushed
• Do not store drug/food mixture for further use

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty 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, eye pain or redness, sudden vision loss (can be permanent if not treated quickly);
• confusion, slowed thinking, memory problems, 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 side effects may include:

• numbness or tingling in your arms and legs;
• flushing (warmth, redness, or tingly feeling);
• headache, dizziness, drowsiness, tired feeling;
• mood problems, confusion, feeling nervous, problems with thinking or memory;
• changes in your sense of taste;
• nausea, diarrhea, stomach pain, loss of appetite, indigestion, weight loss; or
• rapid back-and-forth movements of the eyes.

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.

Qudexy XR is a prescription medication used to treat seizure disorders. This medication is also approved to prevent migraine headaches. 

Qudexy XR belongs to a group of drugs called anticonvulsants or anti-epileptic drugs. These work by altering the activity of neurotransmitters in the brain.

This medication comes in capsule form and is taken once a day, with or without food. Qudexy XR capsules may be swallowed whole or opened and sprinkled on a spoonful of soft food.

Common side effects of Qudexy XR include loss of appetite, weight loss, fatigue, nervousness, difficulty with memory, difficulty concentrating, cognitive problems, confusion, mood changes, fever, infection, and flushing.

Qudexy XR can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Qudexy XR affects you.

Qudexy XR is part of the drug class:

• Other antiepileptics

If you take too much Qudexy XR, call your local Poison Control Center or seek emergency medical attention right away.

• 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 you have an allergy to topiramate or any other part of Qudexy XR (topiramate extended-release sprinkle capsules).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have high blood acid levels (metabolic acidosis) and are also taking a drug that has metformin in it. Check with your doctor or pharmacist if you are not sure if a drug you take has metformin in it.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Qudexy XR with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach.
• Change in taste.
• Weight loss.
• Not hungry.
• Loose stools (diarrhea).
• Feeling nervous and excitable.
• Dizziness.
• Feeling sleepy.
• Feeling tired or weak.
• Headache.
• Dry mouth.
• Hair loss.
• Flushing.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to topiramate: oral capsule, oral capsule extended release, oral tablet

Cardiovascular

Uncommon (0.1% to 1%): Bradycardia, sinus bradycardia, palpitations, hypotension, orthostatic hypotension, flushing, hot flush
Rare (less than 0.1%): Raynaud's phenomenon[Ref]

Dermatologic

Common (1% to 10%): Alopecia, rash, pruritus
Uncommon (0.1% to 1%): Anhidrosis, hypoesthesia facial, urticaria, erythema, pruritus generalized, rash macular, skin discoloration, dermatitis allergic, swelling face
Rare (less than 0.1%): Stevens-Johnson syndrome, erythema multiforme, skin odor abnormal, periorbital edema, urticaria localized
Frequency not reported: Toxic epidermal necrolysis[Ref]

Gastrointestinal

Very common (10% or more): Nausea, diarrhea
Common (1% to 10%): Vomiting, constipation, abdominal pain upper, dyspepsia, abdominal pain, dry mouth, stomach discomfort, paresthesia oral, gastritis, abdominal discomfort
Uncommon (0.1% to 1%): Pancreatitis, flatulence, gastroesophageal reflux disease, abdominal pain lower, hypoesthesia oral, gingival bleeding, abdominal distension, epigastric discomfort, abdominal tenderness, salivary hypersecretion, oral pain, breath odor, glossodynia[Ref]

Genitourinary

Uncommon (0.1% to 1%): Erectile dysfunction, sexual dysfunction, renal calculus, intermenstrual bleeding, leucorrhoea, menorrhagia, vaginitis, amenorrhea, urinary tract infections, micturition frequency, urinary incontinence, dysuria[Ref]

Hematologic

Common (1% to 10%): Anemia, epistaxis
Uncommon (0.1% to 1%): Leucopenia, thrombocytopenia lymphadenopathy, white blood cell count decreased, eosinophilia
Rare (less than 0.1%): Neutropenia[Ref]

Hepatic

Rare (less than 0.1%): Hepatitis, hepatic failure, increase in liver enzymes[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity
Frequency not reported: Allergic edema, conjunctival edema[Ref]

Immunologic

Very common (10% or more): Nasopharyngitis
Frequency not reported: Genital moniliasis[Ref]

Metabolic

Very common (10% or more): Weight decreased
Common (1% to 10%): Anorexia, decreased appetite, weight increased
Uncommon (0.1% to 1%): Metabolic acidosis, hypokalemia, increased appetite, polydipsia
Rare (less than 0.1%): Acidosis hyperchloremic, blood bicarbonate decreased[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, muscle spasms, myalgia, muscle twitching, muscular weakness, musculoskeletal chest pain
Uncommon (0.1% to 1%): Joint swelling, musculoskeletal stiffness, flank pain, muscle fatigue
Rare (less than 0.1%): Limb discomfort[Ref]

Nervous system

Very common (10% or more): Paraesthesia, somnolence, dizziness
Common (1% to 10%): Disturbance in attention, memory impairment, amnesia, cognitive disorder, mental impairment, psychomotor skills impaired, convulsion, coordination abnormal, tremor, lethargy, hypethesia, nystagmus, dysgeusia, balance disorder, dysarthria, intention tremor, sedation
Uncommon (0.1% to 1%): 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, dysesthesia, hypogeusia, stupor, clumsiness, aura, ageusia, dysgraphia, dysphasia, neuropathy peripheral, presyncope, dystonia, formication
Rare (less than 0.1%): Apraxia, circadian rhythm sleep disorder, hyperesthesia, hyposmia, anosmia, essential tremor, akinesia, unresponsive to stimuli[Ref]

Ocular

Common (1% to 10%): Vision blurred, diplopia, visual disturbance
Uncommon (0.1% to 1%): Visual acuity reduced, scotoma, myopia, abnormal sensation in eye, dry eye, photophobia, blepharospasm, lacrimation increased, photopsia, mydriasis, presbyopia
Rare (less than 0.1%): Blindness unilateral, blindness transient, glaucoma, accommodation disorder, altered visual depth perception, scintillating scotoma, eyelid edema, night blindness, amblyopia
Frequency not reported: Angle closure glaucoma, maculopathy, eye movement disorder[Ref]

Other

Very common (10% or more): Fatigue
Common (1% to 10%): Vertigo, tinnitus, ear pain pyrexia, asthenia, irritability, gait disturbance, feeling abnormal, malaise
Uncommon (0.1% to 1%): Deafness, deafness unilateral, deafness neurosensory, ear discomfort, hearing impaired, hyperthermia, thirst, influenza like illness, sluggishness, peripheral coldness, feeling drunk, feeling jittery, tandem gait test abnormal
Rare (less than 0.1%): Face edema, calcinosis, learning disability[Ref]

Psychiatric

Very common (10% or more): Somnolence (15%), memory loss (10%), depression
Common (1% to 10%): Depression, difficulty with concentration/attention, anxiety psychomotor slowing, altered mood, confusion, cognitive difficulty, bradyphrenia, decreased libido, expressive language disorder, disorientation, aggression, aggression, anger, abnormal behavior
Uncommon (0.1% to 1%): Suicidal ideation, suicide attempt, hallucination, psychotic disorder, hallucination auditory, hallucination visual, apathy, lack of spontaneous speech, sleep disorder, affect lability, restlessness, crying, dysphemia, euphoria, paranoia, perseveration, panic attack, tearfulness, reading disorder, flat affect, thinking abnormal, listlessness, middle insomnia, distractibility, early morning awakening, panic reaction, elevated mood
Rare (less than 0.1%): Mania, panic disorder, feelings of despair, hypomania[Ref]

Renal

Common (1% to 10%): Nephrolithiasis, pollakiuria, dysuria
Uncommon (0.1% to 1%): Calculus urinary, urinary incontinence, hematuria, incontinence, micturition urgency, renal colic, renal pain
Rare (less than 0.1%): Calculus ureteric, renal tubular acidosis[Ref]

Respiratory

Common (1% to 10%): Bronchitis, rhinitis, dyspnea, epistaxis, nasal congestion, rhinorrhea, cough
Uncommon (0.1% to 1%): Dyspnea exertional, paranasal sinus hypersecretion, dysphonia[Ref]

Some side effects of Qudexy XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

LactMed Record Number

390

Last Revision Date

20150602

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Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.