Ethosuximide Capsules,USP

DESCRIPTION

DESCRIPTION SECTION

Ethosuximide, USP is an anticonvulsant succinimide, chemically designated as alpha-ethyl-alpha-methyl-succinimide, with the following structural formula: Each ethosuximide capsule intended for oral administration contains 250 mg of ethosuximide, USP and contains the following inactive ingredients: FD&C red # 40 aluminum lake, FD&C yellow # 6 aluminum lake, gelatin, glycerin, light mineral oil, methyl paraben, polyethylene glycol, propyl paraben, and sorbitol. The capsule shell is imprinted with white imprinting ink containing opacode white S-1-7078 as colorant which contains the following inactive ingredients: ammonium hydroxide, isopropyl alcohol, n-butyl acohol, propylene glycol, shellac glaze, simethicon and titanium dioxide.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

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

INDICATIONS & USAGE SECTION

Ethosuximide capsule is indicated for the control of absence (petit mal) epilepsy.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Ethosuximide should not be used in patients with a history of hypersensitivity to succinimides.

WARNINGS

WARNINGS SECTION

PRECAUTIONS

PRECAUTIONS SECTION

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

OVERDOSAGE

OVERDOSAGE SECTION

Acute overdoses may produce nausea, vomiting, and CNS depression including coma with respiratory depression. A relationship between ethosuximide toxicity and its plasma levels has not been established. The therapeutic range of serum levels is 40 mcg/mL to 100 mcg/mL, although levels as high as 150 mcg/mL have been reported without signs of toxicity. Treatment Treatment should include emesis (unless the patient is or could rapidly become obtunded, comatose, or convulsing) or gastric lavage, activated charcoal, cathartics, and general supportive measures. Hemodialysis may be useful to treat ethosuximide overdose. Forced diuresis and exchange transfusions are ineffective.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Ethosuximide capsules are administered by the oral route. The initial dose for patients 3 to 6 years of age is one capsule (250 mg) per day; for patients 6 years of age and older, 2 capsules (500 mg) per day. The dose thereafter must be individualized according to the patient’s response. Dosage should be increased by small increments. One useful method is to increase the daily dose by 250 mg every four to seven days until control is achieved with minimal side effects. Dosages exceeding 1.5 g daily, in divided doses, should be administered only under the strictest supervision of the physician. The optimal dose for most pediatric patients is 20 mg/kg/day. This dose has given average plasma levels within the accepted therapeutic range of 40 to 100 mcg/mL. Subsequent dose schedules can be based on effectiveness and plasma level determinations. Ethosuximide may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal). The optimal dose for most pediatric patients is 20 mg/kg/day.

HOW SUPPLIED

HOW SUPPLIED SECTION

Ethosuximide Capsules USP, 250 mg are clear orange-colored, oblong-shaped, soft gelatin capsules, imprinted "EP138" with white ink and are supplied as follows: NDC 68382-443-01 in bottle of 100 capsules NDC 68382-443-05 in bottle of 500 capsules

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

MF# 0288-01 Manufactured by: Emcure Pharmaceuticals USA Inc. 21-B Cotters Lane East Brunswick, NJ 08816 Distributed by: Zydus Pharmaceuticals USA Inc . Pennington, NJ 08534 Rev : 05/12 Revision Date : 05/30/2012

SPL MEDGUIDE

SPL MEDGUIDE SECTION

Read this Medication Guide before you start taking ethosuximide 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 ethosuximide, ask your healthcare provider or pharmacist. What is the most important information I should know about ethosuximide? Do not stop taking ethosuximide without first talking to your healthcare provider. Stopping ethosuximide suddenly can cause serious problems. Ethosuximide 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 Systematic Lupus Erythematosus. Call your healthcare provider right away if you have any of these symptoms: • joint pain and swelling • muscle pain • fatigue • low-grade fever • pain in the chest that is worse with breathing • unexplained skin rash 3 Like other antiepileptic drugs, ethosuximide 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 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 activity and talking (mania) • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Do not stop ethosuximide without first talking to a healthcare provider. Stopping ethosuximide 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). 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. What is ethosuximide? Ethosuximide is a prescription medicine used to treat absence (petit mal) seizures. Who should not take ethosuximide capsules? Do not take ethosuximide capsules if you are allergic to succinimides (methsuximide or ethosuximide), or any of the ingredients in ethosuximide capsules. See the end of this Medication Guide for a complete list of ingredients in ethosuximide capsules. What should I tell my healthcare provider before taking ethosuximide? Before you take ethosuximide, tell your healthcare provider if you: have or had liver problems have or have had depression, mood problems or suicidal thoughts or behavior have any other medical conditions are pregnant or plan to become pregnant. It is not known if ethosuximide can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking ethosuximide. You and your healthcare provider should decide if you should take ethosuximide while you are pregnant. If you become pregnant while taking ethosuximide, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334. are breastfeeding or plan to breastfeed. It is not known if ethosuximide can pass into breastmilk. You and your healthcare provider should decide how you will feed your baby while you take ethosuximide. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking ethosuximide with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist when you get a new medicine. How should I take ethosuximide? Take ethosuximide exactly as prescribed. Your healthcare provider will tell you how much ethosuximide to take. Your healthcare provider may change your dose. Do not change your dose of ethosuximide without talking to your healthcare provider. If you take too much ethosuximide, call your healthcare provider or your local Poison Control Center right away. What should I avoid while taking ethosuximide? Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking ethosuximide without first talking to your healthcare provider. Ethosuximide taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse. Do not drive, operate heavy machinery, or do other dangerous activities until you know how ethosuximide affects you. ethosuximide can slow your thinking and motor skills. What are the possible side effects of ethosuximide? See "What is the most important information I should know about ethosuximide?" Ethosuximide may cause other serious side effects, including: • Serious allergic reactions. Call your healthcare provider right away if you have any of these symptoms: • skin rash • hives • sores in your mouth • blistering or peeling skin • Changes in thinking, mood, or behavior. Some patients may get abnormally suspicious thoughts, hallucinations (seeing or hearing things that are not there), or delusions (false thoughts or beliefs). • Grand mal seizures can happen more often or become worse Call your healthcare provider right away, if you have any of the symptoms listed above. The most common side effects of ethosuximide include ● nausea or vomiting ● fatigue ● indigestion, stomach pain ● dizziness or lightheadedness ● diarrhea ● unsteadiness when walking ● weight loss ● headache ● loss of appetite ● loss of concentration ● hiccups Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects with ethosuximide. 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 ethosuximide capsules? Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Keep ethosuximide and all medicines out of the reach of children. General information about ethosuximide Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ethosuximide for a condition for which it was not prescribed. Do not give ethosuximide to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about ethosuximide. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ethosuximide that is written for healthcare professionals. Address medical inquiries to, Telephone: 1-877-993-8779 (MedicalAffairs@zydususa.com). What are the ingredients in ethosuximide capsules, USP? Active ingredient: ethosuximide, USP Capsules Inactive ingredients: FD&C red # 40 aluminum lake, FD&C yellow # 6 aluminum lake, gelatin, glycerin, light mineral oil...

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68382-443-01 in bottle of 100 capsules Ethosuximide Capsules USP, 250 mg R x only 100 Capsules ZYDUS