Country: United States
Language: English
Source: NLM (National Library of Medicine)
ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V)
Aidarex Pharmaceuticals LLC
ORAL
PRESCRIPTION DRUG
Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Zonisamide capsules are contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide. The abuse and dependence potential of zonisamide capsules has not been evaluated in human studies (see WARNINGS, Cognitive/Neuropsychiatric Adverse Events subsection). In a series of animal studies, zonisamide did not demonstrate abuse liability and dependence potential. Monkeys did not self-administer zonisamide in a standard reinforcing paradigm. Rats exposed to zonisamide did not exhibit signs of physical dependence of the CNS-depressant type. Rats did not generalize the effects of diazepam to zonisamide in a standard discrimination paradigm after training, suggesting that zonisamide does not have abuse potential of the benzodiazepine-CNS depressant type.
Zonisamide capsules are available as 100 mg two-piece hard gelatin capsules. Zonisamide capsules are available in bottles of 60 with strengths and colors as follows: Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature], in a dry place and protected from light. Manufactured by: Wockhardt Limited Mumbai, India. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Repackaged By: Aidarex Pharmaceuticals, LLC. Corona, CA 92880 Rev.190810
Abbreviated New Drug Application
ZONISAMIDE- ZONISAMIDE CAPSULE Aidarex Pharmaceuticals LLC ---------- MEDICATION GUIDE Zonisamide Capsules Read this Medication Guide before you start taking zonisamide capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about zonisamide capsules? 1. Zonisamide capsules may cause a serious skin rash that can cause death. These serious skin reactions are more likely to happen when you begin taking zonisamide capsules within the first 4 months of treatment but may occur at later times. 2. Zonisamide capsules may cause you to sweat less and to increase your body temperature (fever). You may need to be hospitalized for this. You should watch for decreased sweating and fever, especially when it is hot and especially in children taking zonisamide capsules. Call your health care provider right away if you have: • a skin rash • high fever, recurring fever, or long lasting fever • less sweat than normal 3. Like other antiepileptic drugs, zonisamide capsules 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 • attempt 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 • 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 attentio Read the complete document
ZONISAMIDE- ZONISAMIDE CAPSULE AIDAREX PHARMACEUTICALS LLC ---------- PRODUCT INFORMATION ZONISAMIDE CAPSULES RX ONLY DESCRIPTION Zonisamide capsule is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The empirical formula is C H N O S with a molecular weight of 212.23. Zonisamide is a white powder, pKa = 10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is: Zonisamide capsules are supplied for oral administration as capsules containing 25 mg, 50 mg and 100 mg zonisamide. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, sodium lauryl sulfate, hydrogenated vegetable oil, colloidal silicon dioxide, sodium starch glycolate, talc, gelatin, titanium dioxide. For 100 mg D&C red # 28, D&C yellow # 10, and FD&C # yellow 6 and for 50 mg contains FD&C red # 40, FD&C yellow # 5, and FD&C Blue # 1. CLINICAL PHARMACOLOGY MECHANISM OF ACTION: The precise mechanism(s) by which zonisamide exerts its antiseizure effect is unknown. Zonisamide demonstrated anticonvulsant activity in several experimental models. In animals, zonisamide was effective against tonic extension seizures induced by maximal electroshock but ineffective against clonic seizures induced by subcutaneous pentylenetetrazol. 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. Furthermore, zonisamide suppressed both interictal spikes and the secondarily generalized seizures produced by cortical application of tungstic acid gel in rats or by cortical freezing in cats. The relevance of these models to human epilepsy is unknown. Zonisamide may produce these effects through action at sodium and calcium channels. _In vitro_ pharmacological studies suggest that zonisamide Read the complete document