Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V)
Zydus Pharmaceuticals (USA) Inc.
ZONISAMIDE
ZONISAMIDE 25 mg
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 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, 25 mg are white to off white granular powder filled in size '4' hard gelatin capsules with pink colored cap printed with "ZA-31" in black ink and white colored body printed with "25 mg" in black ink, which are supplied as follows. NDC 68382-212-01 in bottles of 100's capsules NDC 68382-212-05 in bottles of 500's capsules Zonisamide capsules, 50 mg are white to off white granular powder filled in size '3' hard gelatin capsules with pink colored cap printed with "ZA-32" in black ink and white colored body printed with "50 mg" in black ink, which are supplied as follows. NDC 68382-213-01 in bottles of 100's capsules NDC 68382-213-05 in bottles of 500's capsules Zonisamide capsules, 100 mg are white to off white granular powder filled in size '1' hard gelatin capsules with pink colored cap printed with "ZA-33" in black ink and white colored body printed with "100 mg" in black ink, which are supplied as follows. NDC 68382-214-01 in bottles of 100's capsules NDC 68382-214-05 in bottles of 500's capsules NDC 68382-214-10 in bottles of 1,000's capsules Store at 20o C to 25o C (68o F to 77o F) [see USP Controlled Room Temperature]. Keep in dry place and protect from light. Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779. Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 09/20
Abbreviated New Drug Application
ZONISAMIDE- ZONISAMIDE CAPSULE Zydus Pharmaceuticals (USA) Inc. ---------- MEDICATION GUIDE Zonisamide (zoe nis' a mide) Capsules What is the most important information I should know about zonisamide? Zonisamide 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 may cause a serious skin rash that can cause death. These serious skin reactions are more likely to happen when you begin taking zonisamide within the first 4 months of treatment but may occur at later times. 2. Zonisamide 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 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. Call your health care provider right away if you have: • high fever, recurring fever, or long lasting fever • less sweat than normal 4. Zonisamide may cause eye problems. Serious eye problems include: • sudden decrease in vision with Przeczytaj cały dokument
ZONISAMIDE- ZONISAMIDE CAPSULE ZYDUS PHARMACEUTICALS (USA) INC. ---------- ZONISAMIDE CAPSULES 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 to off white crystalline 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 contain 25 mg or 50 mg or 100 mg zonisamide. Each capsule contains the inactive ingredients FD&C Blue #1, FD&C Red #4, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. The capsule is printed with black pharmaceutical ink. 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 blocks sodium channels and reduces voltage- dependent, transient inward currents (T-type Ca currents), consequently stabilizing neuronal membranes and suppressing neuronal hypersynchronization. _In vitro _binding studi Przeczytaj cały dokument