国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V)
Preferred Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Zonisamide is contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide. The abuse and dependence potential of zonisamide 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 25 mg, 50 mg and 100 mg two-piece hard gelatin capsules. The capsules are printed in black with product code on cap and body “258”, “259” and “260”, respectively. Dosage strength Capsule color Pack NDC# 100 mg White opaque body with light swedish orange opaque cap. Bottle of 30’s with Child Resistant Cap. 68788-7438-03 Bottle of 60’s with Child Resistant Cap. 68788-7438-06 Bottle of 90’s with Resistant Cap 68788-7438-09 Bottle of 100’s with Resistant Cap. 68788-7438-01 Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature], in a dry place and protected from light.
Abbreviated New Drug Application
ZONISAMIDE- ZONISAMIDE CAPSULE Preferred Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Zonisamide (zoe nis’ a mide) Capsules What is the most important information I should know about Zonisamide Capsules? Zonisamide capsules may cause serious side effects, including: 1. Serious skin rash that can cause death. 2. Serious allergic reactions that may affect different parts of the body. 3. Less sweating and increase in your body temperature (fever). 4. Serious eye problems 5. Suicidal thoughts or actions in some people. 6. Increased level of acid in your blood (metabolic acidosis). 7. Problems with your concentration, attention, memory, thinking, speech, or language. 8. Blood cell changes such as reduced red and white blood cell counts. These serious side effects are described below. 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 can cause other types of allergic reactions or serious problems that may affect different parts of the body such as your liver, kidneys, heart, or blood cells. You may or may not have a rash with these types of reactions. These reactions can be very serious and can cause death. Call your health care provider right away if you have: • fever • severe muscle pain • rash • swollen lymph glands • swelling of your face • unusual bruising or bleeding • weakness, fatigue • yellowing of your skin or the white part of your eyes 3. 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: • high fever, recurring fever, or long lasting fever • less sweat than normal 4. Zonisamide capsules may cause eye p 阅读完整的文件
ZONISAMIDE- ZONISAMIDE CAPSULE PREFERRED PHARMACEUTICALS, INC. ---------- ZONISAMIDE CAPSULES, FOR ORAL ADMINISTRATION RX ONLY DESCRIPTION Zonisamide 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 molecular 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 (0.8 mg/mL) and 0.1 N HCl (0.5 mg/mL). The chemical structure is: Zonisamide is supplied for oral administration as capsules containing 25 mg, 50 mg or 100 mg zonisamide, USP. Each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin, and titanium dioxide. In addition, individual empty hard gelatin capsule shell contains: 50 mg : Black iron oxide. 100 mg : FD&C Blue #1 and FD&C Red #40. The imprinting ink contains black iron oxide, shellac glaze, propylene glycol and also contains either FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & C Yellow No.10 or strong ammonia solution and potassium hydroxide. 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 unkn 阅读完整的文件