The plasma clearance of oral zonisamide is approximately 0.30 mL/min/kg to 0.35 mL/min/kg in patients not receiving enzyme-inducing antiepilepsy drugs (AEDs). For the liquid form, throw away any unused medication 30 days after opening the bottle. Uses Warnings Before taking Dosage Side effects Interactions What is Zonegran? Steady-state dosing of either ketoconazole (400 mg/day) or cimetidine (1,200 mg/day) had no clinically relevant effects on the single dose pharmacokinetics of zonisamide given to healthy subjects. Children and people exposed to hot weather may be more likely to have this side effect. The abuse and dependence potential of zonisamide has not been evaluated in human studies (see WARNINGS, Cognitive/Neuropsychiatric Adverse Events subsection). Tell your doctor about all other medicines you use. Zonisamide has been administered to 1,598 individuals during all clinical trials, only some of which were placebo-controlled. Rats treated with zonisamide (20 mg/kg, 60 mg/kg or 200 mg/kg) before mating and during the initial gestation phase showed signs of reproductive toxicity (decreased corpora lutea, implantations, and live fetuses) at all doses. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Do not double the dose to catch up. Symptoms of overdose may include: slow/shallow breathing, severe dizziness, loss of consciousness. NDC 72578--042-01 in bottles of 100's capsules with child-resistant closure, NDC 72578-042-05 in bottles of 500's capsules, NDC 72578-042-10 in bottles of 1,000's capsules. The total daily dose was given as twice a day dosing. Newborns of mothers treated with zonisamide should be monitored for metabolic acidosis because of transfer of zonisamide to the fetus and possible occurrence of transient metabolic acidosis following birth. In adults, mean serum bicarbonate reductions ranged from approximately 2 mEq/L at daily doses of 100 mg to nearly 4 mEq/L at daily doses of 300 mg. 100 mg One-time purchase $0.24 Save 30 % on your first AutoShip order and 4 % on all future Autoship orders AutoShip price $0.17 Auto-Ship You May Also Like K9 Advantix II for Dogs Starts at $12.59 Reviews: 149 Capstar Flea Tablets for Dogs and Cats Starts at $35.99 Reviews: 45 Product Overview How to Use? Medicinal forms | Zonisamide | Drugs | BNF | NICE In a series of animal studies, zonisamide did not demonstrate abuse liability and dependence potential. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. The most commonly adverse reactions with zonisamide (an incidence at least 4% greater than placebo) in controlled clinical trials and shown in descending order of frequency were somnolence, anorexia, dizziness, ataxia, agitation/irritability, and difficulty with memory and/or concentration. General supportive care is indicated, including frequent monitoring of vital signs and close observation. The effectiveness of zonisamide as adjunctive therapy (added to other antiepilepsy drugs) has been established in three multicenter, placebo-controlled, double blind, 3-month clinical trials (two domestic, one European) in 499 patients with refractory partial onset seizures with or without secondary generalization. There are no adequate and well-controlled studies in pregnant women. Ask your pharmacist about using those products safely. You may opt-out of email communications at any time by clicking on This is not a complete list of side effects and others may occur. However, serum bicarbonate was studied in three clinical trials for indications which have not been approved: a placebo-controlled trial for migraine prophylaxis in adults, a controlled trial for monotherapy in epilepsy in adults, and an open label trial for adjunctive treatment of epilepsy in pediatric patients (3 years to 16 years). Keep all medical and lab appointments. The lowest embryolethal dose in monkeys was associated with peak maternal plasma zonisamide levels (5 mcg/mL) approximately 0.1 times the highest levels measured in patients at the MRHD. NDC 72578-040-01 in bottles of 100's capsules with child-resistant closure, NDC 72578-040-05 in bottles of 500's capsules. Zonisamide Capsules can increase the level of acid in your blood (metabolic acidosis). Swallow the capsule whole and do not crush, chew, break, or open it. In rats, increased frequencies of malformations (cardiovascular defects) and variations (persistent cords of thymic tissue, decreased skeletal ossification) were observed among the offspring of dams treated with zonisamide (20 mg/kg/day, 60 mg/kg/day, or 200 mg/kg/day) throughout organogenesis at all doses. Metabolic acidosis generally appears to be dose-dependent and can occur at doses as low as 25 mg daily. To do so may increase the chance of side effects. Your dose may need to be gradually decreased. What should I avoid while taking Zonisamide Capsules? Some products that may interact with this drug include: carbonic anhydrase inhibitors (such as acetazolamide), orlistat. There are no normative sonographic data available for either the general population or patients with epilepsy. Following a suspected recent overdose, emesis should be induced or gastric lavage performed with the usual precautions to protect the airway. Myopia and secondary angle closure glaucoma usually resolve or improve after discontinuation of zonisamide. Drug class: Carbonic anhydrase inhibitor anticonvulsants. Generic name: zonisamide [zoe-NIS-a-mide] In these studies, either zonisamide or placebo was added to the patient's current AED therapy. Concomitant use of zonisamide, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., topiramate, acetazolamide or dichlorphenamide), may increase the severity of metabolic acidosis and may also increase the risks of hyperammonemia and kidney stone formation. Package insert / product label Drug interactions may change how your medications work or increase your risk for serious side effects. Brand names: Zonegran, Zonisade This design allowed a 100 mg vs. placebo comparison over weeks 1 to 5, and a 200 mg vs. placebo comparison over weeks 2 to 6; the primary comparison was 400 mg (both escalation groups combined) vs. placebo over weeks 8 to 12. Talk to your doctor if you are using marijuana (cannabis). Clinical studies of zonisamide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. However, the dose is usually not more than 400 mg per day. After a single-dose administration, renal clearance of zonisamide is approximately 3.5 mL/min. Zonisamide is used together with other medicines to treat partial seizures in adults and teenagers at least 16 years old. Oligohidrosis, sometimes resulting in heat stroke and hospitalization, is seen in association with zonisamide in pediatric patients. Zonisamide for Dogs: Antiseizure Medicine for Dogs - Epilepsy - VetRxDirect Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Special Senses: Frequent: Amblyopia, tinnitus. Zonisamide: MedlinePlus Drug Information To enroll, patients can call the toll-free number 1-888-233-2334 (see. Pick the price that's right for you Local pharmacy prices Choose a pharmacy to get a coupon In pediatric patients, mean serum bicarbonate reductions ranged from approximately 2 mEq/L at daily doses from above 100 mg up to 300 mg, to nearly 4 mEq/L at daily doses from above 400 mg up to 600 mg. Swallow the capsule whole. 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. Pediatric patients appear to be at an increased risk for zonisamide-associated oligohidrosis and hyperthermia. Zonisamide Capsules can cause blood cell changes such as reduced red and white blood cell counts. Zonisamide (Zonegran) - Side Effects, Interactions, Uses, Dosage, Warnings There is little experience with doses greater than 600 mg/day. Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness), and increased intraocular pressure. include protected health information. clinical symptomatology, sonography, etc. This medicine is a white brown, oblong, capsule imprinted with "100 mg" and "IG228". WebMD does not provide medical advice, diagnosis or treatment. These reactions are reported voluntarily from a population of uncertain size; therefore, it is not possible to estimate their frequency or establish a causal relationship to drug exposure. There were no confirmed cases of SJS or TEN in the U.S., European, or Japanese development programs. However, as a carbonic anhydrase inhibitor, zonisamide may cause metabolic acidosis (see WARNINGS, Metabolic Acidosis subsection). It acts on the central nervous system (CNS) to reduce the number and severity of seizures. Infrequent: Dyspnea. Statistically significant treatment differences favoring zonisamide were seen for doses of 100, 200, and 400 mg/day. There were no cases of aplastic anemia and two confirmed cases of agranulocytosis in the U.S., European, or Japanese development programs. PDF ZONEGRAN - Food and Drug Administration Figure 1 Proportion of Patients Achieving Differing Levels of Seizure Reduction in Zonisamide and Placebo Groups in Studies 2 and 3. Last updated on Jul 11, 2023. Patients, especially pediatric patients, treated with zonisamide should be monitored closely for evidence of decreased sweating and increased body temperature, especially in warm or hot weather. The analyzed stones were composed of calcium or urate salts. Do not share this medicine with another person, even if they have the same symptoms you have. Properly discard this product when it is expired or no longer needed. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. This medicine comes with a Medication Guide. Group 1 was a healthy group with a creatinine clearance ranging from 70 mL/min to 152 mL/min. To prevent kidney stones from forming, drink plenty of liquids while taking this. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. This survey is being conducted by the WebMD marketing sciences department.
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