Upsher-Smith Laboratories, LLC

Qudexy xr

Brand

Generic: Topiramate

ID: 00245107430

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📜 Prescription Required

FORM

Capsule

STRENGTH

100 mg

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TL;DR — Quick Summary

Key facts from the full medication guide below

1 INDICATIONS AND USAGE 1.1 Monotherapy Epilepsy 1.2 Adjunctive Therapy Epilepsy 1.3 Migraine 2 DOSAGE AND ADMINISTRATION

🩺What it's for

QUDEXY XR is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older ( 1.2) Preventive treatment of migraine in patients 12 years of age and older ( 1.3)

💊How to take it

QUDEXY XR initial dose, titration, and recommended maintenance dose varies by indication and age group.

ℹ️Common side effects

Immediate-release topiramate can cause cognitive/neuropsychiatric adverse reactions and therefore these are expected to be caused by QUDEXY XR.

⚠️Serious risks

Acute myopia and secondary angle closure glaucoma: can lead to permanent visual loss; discontinue QUDEXY XR as soon as possible ( 5.1) Visual field defects: consider discontinuation of QUDEXY XR ( 5.2) Oligohydrosis and hyperthermia: monitor decreased sweating and increased body temperature, especially in pediatric patients ( 5.3) Metabolic acidosis: baseline and periodic measurement of serum bicarbonate is recommended; consider dose reduction or discontinuation of QUDEXY XR if clinically…

📋Interactions & cautions

Oral contraceptives: decreased contraceptive efficacy and increased breakthrough bleeding, especially at doses greater than 200 mg per day ( 7.4) Monitor lithium levels if lithium is used with high-dose QUDEXY XR ( 7.7) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

📦Storage & missed dose

QUDEXY XR (topiramate) extended-release capsules should be stored in a tightly closed container at 20 C to 25 C (68 F to 77 F); excursions permitted to 15 C to 30 C (59 F to 86 F) [See USP Controlled Room Temperature]. Protect from moisture.

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QUDEXY XR can cause hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis). This metabolic acidosis is caused by renal bicarbonate loss due to carbonic anhydrase inhibition by QUDEXY XR. QUDEXY XR-induced metabolic acidosis can occur at any time during treatment. Bicarbonate decrements are usually mild to moderate (average decrease of 4 mEq/L at daily doses of 400 mg in adults and at approximately 6 mg/kg/day in pediatric patients); rarely, patients can experience severe decrements to values below 10 mEq/L. Conditions or therapies that predispose patients to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, ketogenic diet or specific drugs) may be additive to the bicarbonate lowering effects of QUDEXY XR. Metabolic acidosis was commonly observed in adult and pediatric patients treated with immediate-release topiramate in clinical trials. The incidence of decreased serum bicarbonate in pediatric trials, for adjunctive treatment of Lennox-Gastaut syndrome or refractory partial-onset seizures was as high as 67% for immediate-release topiramate (at approximately 6 mg/kg/day), and 10% for placebo. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value < 17 mEq/L and 5 mEq/L decrease from pretreatment) in these trials was up to 11%, compared to 2% for placebo. Manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such as fatigue and anorexia, or more severe sequelae including cardiac arrhythmias or stupor. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis and may also result in osteomalacia (referred to as rickets in pediatric patients) and/or osteoporosis with an increased risk for fractures [see Warnings and Precautions (5.9, 5.13)] . A one-year, active-controlled study of pediatric patients treated with immediate-release topiramate demonstrated that topiramate decreased lumbar spine bone mineral density and that this lumbar spine bone mineral density decrease was correlated (using change from baseline for lumbar spine Z score at final visit versus lowest post-treatment serum bicarbonate) with decreased serum bicarbonate, a reflection of metabolic acidosis [see Warnings and Precautions (5.9), Use in Specific Populations (8.4)] . Chronic metabolic acidosis in pediatric patients may also reduce growth rates, which may decrease the maximal height achieved. Long-term, open-label treatment of pediatric patients 1 to 24 months old with intractable partial epilepsy, for up to 1 year, showed reductions from baseline in length, weight, and head circumference compared to age and sex-matched normative data, although these patients with epilepsy are likely to have different growth rates than normal 1 to 24-month old patients. Reductions in length and weight were correlated to the degree of acidosis [see Use in Specific Populations (8.4)] . QUDEXY XR treatment that causes metabolic acidosis during pregnancy can possibly produce adverse effects on the fetus and might also cause metabolic acidosis in the neonate from possible transfer of topiramate to the fetus [see Warnings and Precautions (5.7), Use in Specific Populations (8.1)] .

Antiepileptic drugs (AEDs), including QUDEXY XR increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. Table 4 shows absolute and relative risk by indication for all evaluated AEDs. Table 4: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients with Events per 1,000 Patients Drug Patients with Events per 1,000 Patients Relative Risk: Incidence of Events in Drug Patients/ Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events per 1,000 Patients Epilepsy 1.0 3.4 3.5 2.4 Psychiatric 5.7 8.5 1.5 2.9 Other 1.0 1.8 1.9 0.9 Total 2.4 4.3 1.8 1.9 The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing QUDEXY XR or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

The effectiveness of QUDEXY XR as an adjunctive treatment for adults (18 to 75 years of age) was evaluated in a randomized, international, multi-center, double-blind, parallel-group, placebo-controlled trial in patients with a history of partial-onset seizures, with or without secondary generalization (Study 14). Patients with partial-onset seizures on a stable dose of 1 to 3 AEDs entered into an 8-week baseline period. Patients who experienced at least 8 partial onset seizures, with or without secondary generalization, and no more than 21 consecutive seizure free days during the 8-week baseline phase were randomly assigned to placebo or QUDEXY XR administered once daily in addition to their concomitant AEDs. Following randomization, 249 patients began the double-blind treatment phase, which consisted of an initial 3-week titration period followed by an 8-week maintenance period. During the titration period, patients received QUDEXY XR or placebo beginning at 50 mg once daily; the dose was increased at weekly intervals by 50 mg once daily, or the placebo equivalent, until a final dose of 200 mg once daily was achieved. Patients then entered the maintenance period at the assigned dose of 200 mg once daily, or its placebo equivalent. The percent reduction in the frequency of partial-onset seizure, baseline period compared to the treatment phase, was the primary endpoint. Data was analyzed by the Wilcoxon rank-sum test, with the criteria of statistical significance of p<0.05. The results of the analysis are presented in Table 15. The median percent reduction in seizure rate was 39.5% in patients taking QUDEXY XR (N=124) and 21.7% in patients taking placebo (N=125). This difference was statistically significant. Table 15: Percent Reduction From Baseline in Partial-Onset Seizure Frequency During 11-week Treatment Period in Study 14 Study End Point QUDEXY XR (N=124) Placebo (N=125) Median Percent Reduction from Baseline Statistically Significant by the Wilcoxon rank-sum test 39.5% 21.7% Figure 2 shows the change from baseline during titration plus maintenance (11 weeks) in partial-onset seizure frequency by category for patients treated with QUDEXY XR and placebo. Patients in whom the seizure frequency increased are shown as "worse." Patients in whom the seizure frequency decreased are shown in four categories of reduction in seizure frequency. Figure 2: Proportion of Patients by Category of Seizure Response to QUDEXY XR and Placebo

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 3/2024 MEDICATION GUIDE QUDEXY XR (cue-DEKS-ee ex-arr) (topiramate) Extended-Release Capsules, for oral use What is the most important information I should know about QUDEXY XR? QUDEXY XR may cause eye problems.Serious eye problems include: any sudden decrease in vision with or without eye pain and redness, a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). These eye problems can lead to permanent loss of vision if not treated. You should call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision. QUDEXY XR may cause decreased sweating and increased body temperature (fever).People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition. If you have a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away. QUDEXY XR can increase the level of acid in your blood (metabolic acidosis).If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will: feel tired not feel hungry (loss of appetite) feel changes in heartbeat have trouble thinking clearly Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with QUDEXY XR. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis. Like other antiepileptic drugs, QUDEXY XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood Do not stop QUDEXY XR without first talking to a healthcare provider. Stopping QUDEXY XR suddenly can cause serious problems. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. QUDEXY XR can harm your unborn baby. If you take QUDEXY XR during pregnancy, your baby has a higher risk for birth including cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. Birth defects may happen even in children born to women who are not taking any medicines and do not have other risk factors. There may be other medicines to treat your condition that have a lower chance of birth defects. All women of childbearing age should talk to their healthcare providers about using other possible treatments instead of QUDEXY XR. If the decision is made to use QUDEXY XR, you should use effective birth control (contraception) unless you are planning to become pregnant. You should talk to your healthcare provider about the best kind of birth control to use while you are taking QUDEXY XR. Tell your healthcare provider right away if you become pregnant while taking QUDEXY XR. You and your healthcare provider should decide if you will continue to take QUDEXY XR while you are pregnant. If you take QUDEXY XR during pregnancy, your baby may be smaller than expected at birth. The long-term effects of this are not known. Talk to your healthcare provider if you have any questions about this risk during pregnancy. Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if QUDEXY XR has caused metabolic acidosis during your pregnancy. Pregnancy Registry: If you become pregnant while taking QUDEXY XR, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of QUDEXY XR and other antiepileptic drugs during pregnancy. QUDEXY XR may decrease the density of bones when used over a long period. QUDEXY XR may slow height increase and weight gain in children and adolescents when used over a long period. What is QUDEXY XR? QUDEXY XR is a prescription medicine used: to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years of age and older, with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years of age and older, to prevent migraine headaches in adults and adolescents 12 years of age and older. What should I tell my healthcare provider before taking QUDEXY XR? Before taking QUDEXY XR, tell your healthcare provider about all of your medical conditions, including if you: have or have had depression, mood problems or suicidal thoughts or behavior have kidney problems, kidney stones or are getting kidney dialysis have a history of metabolic acidosis (too much acid in the blood) have liver problems have weak, brittle or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density) have lung or breathing problems have eye problems, especially glaucoma have diarrhea have a growth problem are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet are having surgery are pregnant or plan to become pregnant are breastfeeding or plan to breastfeed. QUDEXY XR passes into breast milk. Breastfed babies may be sleepy or have diarrhea. It is not known if the QUDEXY XR that passes into breast milk can cause other serious harm to your baby. Talk to your healthcare provider about the best way to feed your baby if you take QUDEXY XR. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. QUDEXY XR and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take: Valproic acid (such as DEPAKENE or DEPAKOTE ) any medicines that impair or decrease your thinking, concentration, or muscle coordination birth control that contains hormones (such as pills, implants, patches or injections). QUDEXY XR may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you are using birth control and QUDEXY XR. Ask your healthcare provider if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider. How should I take QUDEXY XR? Take QUDEXY XR exactly as your healthcare provider tells you to. Your healthcare provider may change your dose. Do notchange your dose without talking to your healthcare provider. QUDEXY XR capsules may be swallowed whole or, if you cannot swallow the capsule whole, you may carefully open the QUDEXY XR capsule and sprinkle the medicine on a spoonful of soft food like applesauce. Swallow the food and medicine mixture right away. Do notstore the food and medicine mixture to use later. Do not crush or chew QUDEXY XR before swallowing. Drink plenty fluids during the day. This may help prevent kidney stones while taking QUDEXY XR. If you take too much QUDEXY XR, call your healthcare provider right away or go to the nearest emergency room. QUDEXY XR can be taken before, during, or after a meal. If you miss a single dose of QUDEXY XR, take it as soon as you can. If you have missed more than one dose, you should call your healthcare provider for advice. Do not stop taking QUDEXY XR without talking to your healthcare provider. Stopping QUDEXY XR suddenly may cause serious problems. If you have epilepsy and you stop taking QUDEXY XR suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking QUDEXY XR slowly. Your healthcare provider may do blood tests while you take QUDEXY XR. What should I avoid while taking QUDEXY XR? You should not drink alcohol while taking QUDEXY XR. QUDEXY XR and alcohol can affect each other causing side effects such as sleepiness and dizziness. Do not drive a car or operate machinery until you know how QUDEXY XR affects you. QUDEXY XR can slow your thinking and motor skills and may affect vision. What are the possible side effects of QUDEXY XR? QUDEXY XR may cause serious side effects, including: See " What is the most important information I should know about QUDEXY XR?" High blood ammonia levels.High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting. This has happened when QUDEXY XR is taken with a medicine called valproic acid (DEPAKENE and DEPAKOTE ). Kidney stones.Drink plenty of fluids when taking QUDEXY XR to decrease your chances of getting kidney stones. Low body temperature.Taking QUDEXY XR when you are also taking valproic acid can cause a drop-in body temperature to less than 95 F, or can cause tiredness, confusion, or coma. Effects on thinking and alertness.QUDEXY XR may affect how you think, and cause confusion, problems with concentration, attention, memory, or speech. QUDEXY XR may cause depression or mood problems, tiredness, and sleepiness. Dizziness or loss of muscle coordination. Serious skin reactions. QUDEXY XR may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). QUDEXY XR may also cause a rash with blisters and peeling skin over much of the body that may cause death (toxic epidermal necrolysis). Call your healthcare provider right away if you develop a skin rash or blisters. Call your healthcare provider right away if you have any of the symptoms above. The most common side effects of QUDEXY XR include: tingling of the arms and legs (paresthesia) not feeling hungry weight loss nervousness nausea speech problems tiredness dizziness sleepiness/drowsiness a change in the way foods taste upper respiratory tract infection decreased feeling or sensitivity, especially in the skin slow reactions difficulty with memory fever abnormal vision diarrhea pain in the abdomen Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of QUDEXY XR. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Upsher-Smith Laboratories, LLC at 1-855-899-9180. How should I store QUDEXY XR? Store QUDEXY XR capsules at room temperature between 68 F to 77 F (20 C to 25 C). Keep QUDEXY XR in a tightly closed container. Keep QUDEXY XR dry and away from moisture. Keep QUDEXY XR and all medicines out of the reach of children. General information about the safe and effective use of QUDEXY XR. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use QUDEXY XR for a condition for which it was not prescribed. Do not give QUDEXY XR to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about QUDEXY XR that is written for health professionals. What are the ingredients in QUDEXY XR? Active ingredient:topiramate Inactive ingredients:microcrystalline cellulose, hypromellose 2910, ethylcellulose, diethyl phthalate, titanium dioxide, black iron oxide, red iron oxide and/or yellow iron oxide, black pharmaceutical ink, and white pharmaceutical ink (200 mg only). Distributed by: UPSHER-SMITH LABORATORIES, LLC, Maple Grove, MN 55369 Qudexy is a registered trademark of Upsher-Smith Laboratories, LLC. All other marks are property of their respective owners. This product may be covered by one or more U.S. patent(s). See www.uslpatents.com. For more information, go to www.upsher-smith.com or call UPSHER-SMITH LABORATORIES, LLC at 1-888-650-3789.