Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
ETHOSUXIMIDE (UNII: 5SEH9X1D1D) (ETHOSUXIMIDE - UNII:5SEH9X1D1D)
Parke-Davis Div of Pfizer Inc
ETHOSUXIMIDE
ETHOSUXIMIDE 250 mg
ORAL
PRESCRIPTION DRUG
Zarontin is indicated for the control of absence (petit mal) epilepsy.
Zarontin is supplied as: NDC 0071-0237-24: Bottles of 100. Each capsule contains 250 mg ethosuximide. Store at 25° C (77° F); excursions permitted to 15–30° C (59–86° F) [see USP Controlled Room Temperature].
New Drug Application
ZARONTIN- ETHOSUXIMIDE CAPSULE Parke-Davis Div of Pfizer Inc ---------- MEDICATION GUIDE ZARONTIN, (ZĂ RŎN' TĬN) (ETHOSUXIMIDE) CAPSULES, ORAL SOLUTION Read this Medication Guide before you start taking ZARONTIN 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. If you have any questions about ZARONTIN, ask your healthcare provider or pharmacist. What is the most important information I should know about ZARONTIN? Do not stop taking ZARONTIN without first talking to your healthcare provider. Stopping ZARONTIN suddenly can cause serious problems. ZARONTIN can cause serious side effects, including: 1. Rare but serious blood problems that may be life-threatening. Call your healthcare provider right away if you have: • fever, swollen glands, or sore throat that come and go or do not go away • frequent infections or an infection that does not go away • easy bruising • red or purple spots on your body • bleeding gums or nose bleeds • severe fatigue or weakness 2. Drug reactions 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 healthcare provider right away if you have any of these symptoms: • joint pain and swelling • muscle pain • fatigue, weakness • low-grade fever • pain in the chest that is worse with breathing • skin rash • swollen lymph glands • swelling of your face • yellowing of your skin or the white part of your eyes 3. Like other antiepileptic drugs, ZARONTIN 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 • attempts to commit suicide • new or worse depression • new or Preberite celoten dokument
ZARONTIN- ETHOSUXIMIDE CAPSULE PARKE-DAVIS DIV OF PFIZER INC ---------- ZARONTIN® (ETHOSUXIMIDE CAPSULES, USP) DESCRIPTION Zarontin (ethosuximide) is an anticonvulsant succinimide, chemically designated as alpha-ethyl-alpha-methyl-succinimide, with the following structural formula: Each Zarontin capsule contains 250 mg ethosuximide, USP. Also contains: polyethylene glycol 400, NF. The capsule contains D&C yellow No. 10; FD&C red No. 3; gelatin, NF; glycerin, USP; and sorbitol. CLINICAL PHARMACOLOGY Ethosuximide suppresses the paroxysmal three cycle per second spike and wave activity associated with lapses of consciousness which is common in absence (petit mal) seizures. The frequency of epileptiform attacks is reduced, apparently by depression of the motor cortex and elevation of the threshold of the central nervous system to convulsive stimuli. INDICATIONS AND USAGE Zarontin is indicated for the control of absence (petit mal) epilepsy. CONTRAINDICATION Ethosuximide should not be used in patients with a history of hypersensitivity to succinimides. WARNINGS BLOOD DYSCRASIAS: Blood dyscrasias, including some with fatal outcome, have been reported to be associated with the use of ethosuximide; therefore, periodic blood counts should be performed. Should signs and/or symptoms of infection (e.g., sore throat, fever) develop, blood counts should be considered at that point. DRUG-INDUCED IMMUNE THROMBOCYTOPENIA: Drug-induced immune thrombocytopenia (DITP) has been reported with ethosuximide. In the reported cases, the onset of symptoms occurred 1 to 3 weeks after initiation of ethosuximide; one patient had recurrence of symptoms within 1 day of a subsequent re-challenge with the drug. In those cases in which the platelet count was specified, the nadir was 2,000 and 3,000/mm . When DITP is suspected, discontinue Zarontin, monitor serial platelet counts, and treat as appropriate. If possible, assess the presence of drug-dependent antiplatelet antibodies. Avoid future use of Zarontin in patients with history of ethosuximi Preberite celoten dokument