In healthy subjects, steady state dosing with zonisamide did not affect serum concentrations of ethinylestradiol or norethisterone in a combined oral contraceptive. Zonisamide is used together with other medicines to treat partial seizures in adults and teenagers at least 16 years old. kishore.gadde@duke.edu PMID: 23147455 Less sweating and increase in your body temperature (fever). Zonisamide: View Uses, Side Effects and Medicines Tell your doctor about all other medicines you use. The elimination half-life of zonisamide in red blood cells is approximately 105 hours. Follow your doctor's instructions about tapering your dose. The possibility that these deaths were due to malformations cannot be ruled out. In the presence of food, the time to maximum concentration is delayed; occurring at 4-6 hours, but food has no effect on the bioavailability of zonisamide. Store at 20oC to 25oC (68oF to 77oF) [see USP Controlled Room Temperature]. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. The primary treatment to reverse symptoms is discontinuation of zonisamide as rapidly as possible, according to the judgment of the treating physician. Keep all medications away from children and pets. To enroll, patients can call the toll-free number 1-888-233-2334 (see. problems with mood or thinking (new or worse depression; sudden changes in mood, behavior, or loss of contact with reality, sometimes associated with hearing voices or seeing things that are not really there; feeling sleepy or tired; trouble concentrating; speech and language problems). Last updated on Oct 1, 2022. Measure serum ammonia concentration if signs or symptoms (e.g., unexplained change in mental status, vomiting, or lethargy) of encephalopathy occur. Capsule Oral suspension There can be variation in the licensing of different medicines containing the same drug. Zonisamide treatment causes metabolic acidosis in humans. Zonisamide Capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Zonisamide is a sulfonamide anticonvulsant and a carbonic anhydrase inhibitor. Adults and children 16 years of age and olderAt first, 100 milligrams (mg) once a day. Canada residents can call a provincial poison control center. Selected from data included with permission and copyrighted by First Databank, Inc. These side effects can increase the risk of falling. Behaviors of concern should be reported immediately to healthcare providers (see, Warn patients about the possible development of hyperammonemia with or without encephalopathy. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Zonisamide (Oral Route) Side Effects Oligohidrosis, sometimes resulting in heat stroke and hospitalization, is seen in association with zonisamide in pediatric patients. Rats exposed to zonisamide did not exhibit signs of physical dependence of the CNS-depressant type. In the US - Call your doctor for medical advice about side effects. This Medication Guide has been approved by the U.S. Food and Drug Administration. Chronic, untreated metabolic acidosis may result in osteomalacia (referred to as rickets in pediatric patients) and/or osteoporosis with an increased risk for fracture. Zonisamide - Indications, Dosage, Side Effects and Precautions Since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. The prescriber should be aware that, because of the long half-life of zonisamide, up to two weeks may be required to achieve steady state levels upon reaching a stable dose or following dosage adjustment. Zonisamide works well in children and is well tolerated by most of them. Problems with your concentration, attention, memory, thinking, speech, or language. Suicidal thoughts or actions in some people. Ask a doctor if it is safe to breastfeed while using this medicine. Currently taking (3)100mg capsules at bedtime in addition to 1500mg Keppra 2x daily and 500mg Depakote ER 2x daily. In mice, this dose is approximately equivalent to the maximum recommended human dose (MRHD) of 400 mg/day on a mg/m2 basis. Rash usually occurred early in treatment, with 85% reported within 16 weeks in the U.S. and European studies and 90% reported within two weeks in the Japanese studies. 7. In the first 11 years of marketing in Japan, 38 cases were reported, an estimated reporting rate of about 1 case per 10,000 patient-years of exposure. In vitro binding studies have demonstrated that zonisamide binds to the GABA/benzodiazepine receptor ionophore complex in an allosteric fashion which does not produce changes in chloride flux. In the two U.S. studies, over 80% of patients were Caucasian; 100% of patients in the European study were Caucasian. Your doctor may need to adjust your dose of zonisamide if you are on these medications. It is unknown, however, whether these measures will reduce the risk of stone formation in patients treated with zonisamide. Keep Zonisamide Capsules and all medicines out of the reach of children. Avoid driving or hazardous activity until you know how zonisamide will affect you. Instruct patients to take Zonisamide Capsules only as prescribed. Somnolence and fatigue were frequently reported CNS adverse events during clinical trials with zonisamide. Measure a dose with the supplied measuring device (not a kitchen spoon). The low dose in this study is approximately 1.5 times the MRHD on a mg/m2 basis. Zonisamide (Aurobindo Pharma Limited): FDA Package Insert - MedLibrary.org You can enroll in this registry by calling 1-888-233-2334. Hyperammonemia with encephalopathy has been reported in pediatric patients (see WARNINGS, Hyperammonemia and Encephalopathy subsection). Do not drive, operate heavy machinery, or do other dangerous activities until you know how Zonisamide Capsules affects you. Drinking alcohol with this medicine can cause side effects. Zonisamide Aspire 100mg hard capsules - Patient Information Leaflet Cases of oligohidrosis and hyperpyrexia have been reported (see WARNINGS, Oligohidrosis and Hyperthermia in Pediatric Patients subsection). Although not approved in pediatric patients, sonographic findings consistent with nephrolithiasis were also detected in 8 % of a subset of zonisamide treated pediatric patients who had at least one renal ultrasound prospectively performed in a clinical development program investigating open-label treatment. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. It may harm them. Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and opioid pain relievers (such as codeine). INGREDIENTS AND APPEARANCE. There is little experience with doses greater than 600 mg/day. Ask your doctor if you have any questions. Do not break, crush, or chew it. Zonisamide 100mg Hard Capsules - Summary of Product Characteristics (SmPC) - (emc) Zonisamide 100mg Hard Capsules Active Ingredient: zonisamide Company: Glenmark Pharmaceuticals Europe Ltd See contact details ATC code: N03AX15 About Medicine Prescription only medicine Healthcare Professionals (SmPC) Patient Leaflet (PIL) Heat stroke, requiring hospitalization, was diagnosed in some cases. Acute myopia and secondary angle closure glaucoma have been reported in pediatric patients (see WARNINGS, Acute Myopia and Secondary Angle Closure Glaucoma subsection). What Are Side Effects of Zonegran? Inactive ingredients: FD&C Blue #1, FD&C Red #4, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Drug information provided by: Merative, Micromedex. Once a stable dose is reached, steady state is achieved within 14 days. 1. Stopping suddenly may cause increased seizures. Stopping Zonisamide Capsules suddenly can cause serious problems. The initial dose of zonisamide should be 100 mg daily. See "What is the most important information I should know about Zonisamide Capsules?". Although in most cases these events were of mild to moderate severity, they at times led to withdrawal from treatment. Zonisamide raised the threshold for generalized seizures in the kindled rat model and reduced the duration of cortical focal seizures induced by electrical stimulation of the visual cortex in cats. Liquid medicine: Hospital pharmacies may be able to provide liquid medicine that contains either 10 mg or 8 mg in 1 mL of medicine. Coadministration of multiple dosing of zonisamide up to 400 mg/day with single 50 mg doses of desipramine did not significantly affect the pharmacokinetic parameters of desipramine, a probe drug for CYP2D6 activity. This medication may cause a serious metabolic problem (metabolic acidosis). 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. Older adults may be more sensitive to the side effects of this drug, especially dizziness, lightheadedness, or lack of coordination. It is very important to follow your doctor's dosing instructions exactly. This is not a complete list of side effects and others may occur. Do not stop taking Zonisamide Capsules without talking to your healthcare provider. Therefore, if zonisamide is given concomitantly with another carbonic anhydrase inhibitor, the patient should be monitored for the appearance or worsening of metabolic acidosis (see WARNINGS, Metabolic Acidosis subsection and Hyperammonemia and Encephalopathy subsection and PRECAUTIONS, Drug Interactions subsection). Zonisamide for preventing seizures - Medicines For Children Before taking Zonisamide Capsules, tell your healthcare provider about all your medical conditions, including if you: have or have had depression, mood problems or suicidal thoughts or behavior, have a history of metabolic acidosis (too much acid in your blood), have weak, brittle bones or soft bones (osteomalacia, osteopenia or osteoporosis), are on a diet high in fat called a ketogenic diet. In vitro pharmacological studies suggest that zonisamide blocks sodium channels and reduces voltage-dependent, transient inward currents (T-type Ca2+ currents), consequently stabilizing neuronal membranes and suppressing neuronal hypersynchronization. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Zonisamide 100mg Hard Capsules - Patient Information - medicines Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, has occurred with zonisamide. Take Zonisamide Capsules exactly as prescribed. The rate of occurrence of kidney stones was 28.7 per 1,000 patient-years of exposure in the first six months, 62.6 per 1,000 patient-years of exposure between 6 and 12 months, and 24.3 per 1,000 patient-years of exposure after 12 months of use. In cynomolgus monkeys, administration of zonisamide (10 mg/kg/day or 20 mg/kg/day) to pregnant animals during organogenesis resulted in embryo-fetal deaths at both doses. Symptoms of overdose may include: slow/shallow breathing, severe dizziness, loss of consciousness. ZONEGRAN is supplied for oral administration as capsules containing 25 mg or 100 mg zonisamide. Zonisamide for weight reduction in obese adults: a 1-year randomized controlled trial Authors Kishore M Gadde 1 , Mariko F Kopping , H Ryan Wagner 2nd , Gretchen M Yonish , David B Allison , George A Bray Affiliation 1 Obesity Clinical Trials Program, Duke University Medical Center, Durham, NC 27710, USA. Seizures are involuntary and may cause changes in movement, behavior, or consciousness. Call your health care provider right away if you have: high fever, recurring fever, or long lasting fever. Last updated on Jul 11, 2023. The incidence of a persistent markedly abnormally low serum bicarbonate value was 4 % at doses up to 100 mg daily, was 18% for a wide range of doses up to 600 mg daily, and generally appeared to increase with higher doses. Ask your doctor before stopping the medicine. There were no cases of aplastic anemia and two confirmed cases of agranulocytosis in the U.S., European, or Japanese development programs. Common side effects of zonisamide may include: problems with memory or trouble concentrating; loss of coordination, trouble walking; or. Please address medical inquiries to, drugsafety@vionausa.com orTel. Following multiple dosing, 62% of the radiolabeled dose was recovered in the urine, with 3% in the feces by day 10. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. Generic Zonegran Zonisamide Switch to brand medication info_outlined Used for Epilepsy MORE expand_more Check your prescription Prescription 100mg zonisamide (120 capsules) edit Choose your pharmacy Near boydton, VA CVS $49.81 Harris Teeter $53.68 Walgreens $50.00 Low price Walmart $17.01 Food Lion $19.04 Target $49.81 Kroger $53.68 Zonisamide Oral Reviews and User Ratings: Effectiveness, Ease - WebMD