País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V)
DIRECT RX
ZONISAMIDE
ZONISAMIDE 100 mg
ORAL
PRESCRIPTION DRUG
Zonisamide capsules USP 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 is available as 100 mg two-piece hard gelatin capsules. The capsules imprinted with codes are printed in black ink. Zonisamide is available in bottles with strengths and capsule description as follows: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature], in a dry place and protected from light. Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Rev: 01/12 Medication Guide Zonisamide Capsules USP 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? Zonisamide capsules may cause serious side effects, including: 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 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: 3. Like other antiepileptic drugs, zonisamide 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: How can I watch for early symptoms of suicidal thoughts and actions? Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Do not stop zonisamide without first talking to a healthcare provider. Stopping zonisamide suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). 4. Zonisamide can increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones and can slow the rate of growth in children. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will: Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with zonisamide. 5. Zonisamide may cause problems with your concentration, attention, memory, thinking, speech, or language. 6. Zonisamide can cause blood cell changes such as reduced red and white blood cell counts. Call your healthcare provider if you develop fever, sore throat, sores in your mouth, or unusual bruising. Zonisamide capsules can have other serious side effects. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you. Be sure to read the section titled “What are the possible side effects of zonisamide capsules?” What is zonisamide? Zonisamide is a prescription medicine that is used with other medicines to treat partial seizures in adults. It is not known if zonisamide is safe or effective in children under 16 years of age. Who should not take zonisamide capsules? Do not take zonisamide capsules if you are allergic to medicines that contain sulfa. What should I tell my healthcare provider before taking zonisamide capsules Before taking zonisamide capsules, tell your healthcare provider about all your medical conditions, including if you: Tell your healthcare provider if you: You and your healthcare provider should decide if you should take zonisamide capsules while you are pregnant. Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements. Zonisamide capsules and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine. How should I take zonisamide capsules? What should I avoid while taking zonisamide capsules? What are the possible side effects of zonisamide capsules? Zonisamide capsules can cause serious side effects including: The most common side effects of zonisamide capsules include: Side effects can happen at any time, but are more likely to happen during the first several weeks after starting zonisamide capsules. Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of zonisamide capsules. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store zonisamide capsules? Keep zonisamide capsules and all medicines out of the reach of children. General Information about the safe and effective use of zonisamide capsules Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use zonisamide for a condition for which it was not prescribed. Do not give zonisamide capsules to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about zonisamide capsules. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about zonisamide capsules that is written for health professionals. For more information, go to www.camberpharma.com or call 1-866-495-8330. What are the ingredients in zonisamide capsules? Active ingredient: zonisamide USP Inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin and colorants. Components of gelatin capsules (For 100 mg: titanium dioxide, gelatin and FDA/E172 red iron oxide). Imprint ink dye (Black SW- 9008/SW-9009) This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Rev: 01/12 Barcode: 228-01-2012
Abbreviated New Drug Application
ZONISAMIDE- ZONISAMIDE CAPSULE DIRECT RX ---------- 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: Serious skin rash that can cause death. Serious allergic reactions that may affect different parts of the body. Less sweating and increase in your body temperature (fever). Suicidal thoughts or actions in some people. Increased level of acid in your blood (metabolic acidosis). Problems with your concentration, attention, memory, thinking, speech, or language. Blood cell changes such as reduced red and white blood cell counts. These serious side effects are described below. 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. 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. 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 provid Leia o documento completo
ZONISAMIDE- ZONISAMIDE CAPSULE DIRECT RX ---------- ZONISAMIDE DESCRIPTION SECTION Zonisamide USP is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide USP, 1,2-benzisoxazole-3-methanesulfonamide. The empirical formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide USP 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 is supplied for oral administration as capsules containing 100 mg zonisamide USP. Each capsule contains the labeled amount of zonisamide USP plus the following inactive ingredients: microcrystalline cellulose, hydrogenated vegetable oil, gelatin and colorants. Components of gelatin capsules (For 100 mg: titanium dioxide, gelatin and FDA/E172 red iron oxide). Imprint ink dye (Black SW- 9008/SW-9009). CLINICAL PHARMACOLOGY SECTION 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 Ca2+ currents), consequently stabilizing neuro Leia o documento completo