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Topamax (topiramate) was originally FDA-approved as a seizure medicine, also called an anticonvulsant. Topiramate is used to treat seizures in adults and children who are at least 2 years old.
Topamax is also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. This medicine will only prevent migraine headaches or reduce the number of attacks. It will not treat a headache that has already begun.
Topamax may also be used for purposes not listed in this medication guide.
Topamax 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.
Topamax can decrease sweating and may cause life-threatening hyperthermia (especially in children). Avoid becoming overheated or dehydrated. Tell your doctor if you have decreased sweating, high fever, and hot dry skin.
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 Topamax suddenly or you could have increased seizures.
You should not use Topamax if you are allergic to topiramate. 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.
To make sure Topamax is safe for you, 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;
an eating disorder;
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 will need to check your progress at regular visits while you are using Topamax. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Do not start or stop taking Topamax 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 Topamax.
Topiramate can pass into breast milk. It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks. Tell your doctor if you are breast-feeding.
Take Topamax max exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Topamax can be taken with or without food.
Do not crush, chew, or break a Topamax tablet. Swallow the tablet whole.
Topamax Sprinkle Capsule can be swallowed whole. Or you may open the capsule and sprinkle the medicine into a spoonful of applesauce or other soft food. Swallow right away without chewing. Do not save the mixture for later use.
Carefully follow the swallowing instructions for your medicine.
Topiramate doses are 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 topiramate, to prevent kidney stones or an electrolyte imbalance.
While using Topamax, you may need frequent blood tests. If you need surgery, tell the surgeon ahead of time that you are using this medicine. Any medical care provider who treats you should know that you take seizure medication.
Do not stop using Topamax 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 Topamax.
Store at cool room temperature away from moisture, light, and high heat. Keep the bottle tightly closed when not in use.
Take the missed dose as soon as you remember. Skip the missed dose if you are more than 6 hours late in taking it. Wait until your next scheduled dose. Do not take extra medicine to make up the missed dose.
Call your doctor for instructions if you miss two or more doses.
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 seizures (convulsions).
Do not drink alcohol. Dangerous side effects or increased seizures may occur.
Avoid becoming overheated or dehydrated in hot weather. Topiramate can decrease sweating and increase body temperature, leading to life-threatening dehydration (especially in children).
Ketogenic or "ketosis" diets that are high in fat and low in carbohydrates can increase the risk of kidney stones. Avoid the use of such diets while you are taking Topamax.
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.
Get emergency medical help if you have signs of an allergic reaction to Topamax: 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, 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 Topamax side effects may include:
fever, weight loss;
numbness or tingling in your arms and legs;
flushing (warmth, redness, or tingly feeling);
headache, dizziness, drowsiness, tired feeling, slow reactions;
mood problems, feeling nervous;
nausea, diarrhea, stomach pain, loss of appetite, indigestion;
cold symptoms such as stuffy nose, sneezing, sore throat; or
changes in your sense of taste.
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.
Taking Topamax with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, opioid pain medication, muscle relaxer, or medicine for anxiety or depression.
Tell your doctor about all your current medicines and any you start or stop using, especially:
birth control pills; or
other seizure medications, such as divalproex (Depakote) or valproic acid (Depakene).
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 interactions are listed in this medication guide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Topamax only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Topamax Sprinkle (www.drugs.com/topamax.html).
Note: This document contains side effect information about topiramate. Some of the dosage forms listed on this page may not apply to the brand name Topamax.
Common side effects of Topamax 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.
Applies to topiramate: oral capsule, oral capsule extended release, oral tablet
Along with its needed effects, topiramate (the active ingredient contained in Topamax) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking topiramate:
More common
Less common
Rare
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking topiramate:
Symptoms of overdose
Some side effects of topiramate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Applies to topiramate: oral capsule, oral capsule extended release, oral tablet
Uncommon (0.1% to 1%): Bradycardia, sinus bradycardia, palpitations, hypotension, orthostatic hypotension, flushing, hot flush
Rare (less than 0.1%): Raynaud's phenomenon
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, oligohidrosis
Postmarketing reports: Bullous skin reactions, pemphigus
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
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
Postmarketing reports: Kidney stones, nephrocalcinosis
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
Rare (less than 0.1%): Hepatitis, hepatic failure, increase in liver enzymes
Postmarketing reports: Hepatic failure including fatalities
Common (1% to 10%): Hypersensitivity
Frequency not reported: Allergic edema, conjunctival edema
Very common (10% or more): Nasopharyngitis
Frequency not reported: Genital moniliasis
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
Postmarketing reports: Hyperammonemia with and without encephalopathy
Metabolic Acidosis:
Generally, topiramate-induced metabolic acidosis occurs early in treatment; however, it can occur any time. Average decreases of serum bicarbonate of 4 mEq/L have been observed in adults receiving 400 mg/day and pediatrics receiving approximately 6 mg/kg/day. Values below 10 mEq/L have been rarely reported. In adult trials for adjunctive treatment of epilepsy, persistent serum bicarbonate decreases to less than 20 meq/L were reported in 32% of patients receiving 400 mg/day versus 1% of placebo-treated patients. In pediatric trials, adjunctive therapy yielded persistent decreases in serum bicarbonate of 67% for doses of approximately 6 mg/kg/day and 10% for placebo. In monotherapy trials for patients 6 to 15 years, the incidence of persistent decreases in serum bicarbonate was 9% for 50 mg per day and 25% for 400 mg per day. In adult migraine trials, persistent decreases in serum bicarbonate occurred in 44%, 39%, 23%, and 7% of patients receiving 200 mg/day, 100 mg/day, 50 mg/day, and placebo, respectively. In adolescent migraine trials, this was 77%, 27%, 30%, and 9% for those receiving 200 mg/day, 100 mg/day, 50 mg/day, and placebo, respectively.
Hyperammonemia:
The incidence of hyperammonemia (above the upper limit of normal) for adolescent patients receiving this drug for migraine prophylaxis was 26%, 14%, and 9% for doses of 100 mg, 50, mg, or placebo, respectively. Hyperammonemia with and without encephalopathy has been reported in the post-marketing period. Hyperammonemia appears to be more common when used concomitantly with valproic acid.
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
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
Most CNS adverse reactions can be classified into 3 categories: cognitive-related dysfunction (e.g. confusion psychomotor slowing, difficulty with concentration/attention, difficulty with memory, speech, or language problems, particularly word-finding difficulties); psychiatric/behavioral disturbances (e.g. depression or mood problems); and somnolence or fatigue. Most were mild to moderate in severity and frequently occurred in isolation. Rapid titration rate and higher initial dose was associated with a higher occurrence.
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
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
Frequency not reported: Hypothermia, hyperthermia (associated with oligohidrosis)
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
Antiepileptic drugs increased the risk of suicidal thoughts or behaviors when taken for any indication. Pooled analyses of 199 placebo-controlled clinical trials of 11 different antiepileptic drugs showed patients on antiepileptics had approximately twice the risk compared to placebo. In these trials (median duration 12 weeks; most less than 24 weeks), the estimated incidence rate of suicidal behavior or ideation was 0.43% compared to 0.24% which represents an increase of approximately 1 case for every 530 patients treated.
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
In clinical trials, 1.5% of adult patients receiving this drug developed kidney stones (approximately 2 to 4 times more than expected). The incidence was higher in men. Kidney stone have been reported in pediatric patients taking this drug for epilepsy or migraine.
Common (1% to 10%): Bronchitis, rhinitis, dyspnea, epistaxis, nasal congestion, rhinorrhea, cough
Uncommon (0.1% to 1%): Dyspnea exertional, paranasal sinus hypersecretion, dysphonia
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Topamax Sprinkle (www.drugs.com/topamax.html).
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