Brand Name
Celontin
Generic Name
Methsuximide
View Brand Information FDA approval date: February 08, 1957
Classification: Anti-epileptic Agent
Form: Capsule
What is Celontin (Methsuximide)?
Methsuximide is indicated for the control of absence seizures that are refractory to other drugs.
Approved To Treat
Top Global Experts
Save this treatment for later
Not sure about your diagnosis?
Related Clinical Trials
There is no clinical trials being done for this treatment
Related Latest Advances
Brand Information
Celontin (methsuximide)
1DESCRIPTION
Celontin (methsuximide) is an anticonvulsant succinimide, chemically designated as N,2-Dimethyl-2-phenylsuccinimide, with the following structural formula:
Each Celontin capsule contains 300 mg methsuximide, USP. Also contains starch, NF. The capsule contains colloidal silicon dioxide, NF; D&C yellow No. 10; FD&C yellow No. 6; gelatin, NF; and sodium lauryl sulfate, NF.
2CLINICAL PHARMACOLOGY
Methsuximide 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.
3INDICATIONS AND USAGE
Celontin is indicated for the control of absence (petit mal) seizures that are refractory to other drugs.
4CONTRAINDICATIONS
Methsuximide should not be used in patients with a history of hypersensitivity to succinimides.
5ADVERSE REACTIONS
Gastrointestinal System: Gastrointestinal symptoms occur frequently and have included nausea or vomiting, anorexia, diarrhea, weight loss, epigastric and abdominal pain, and constipation.
Hemopoietic System: Hemopoietic complications associated with the administration of methsuximide have included eosinophilia, leukopenia, monocytosis, and pancytopenia with or without bone marrow suppression.
Nervous System: Neurologic and sensory reactions reported during therapy with methsuximide have included drowsiness, ataxia or dizziness, irritability and nervousness, headache, blurred vision, photophobia, hiccups, and insomnia. Drowsiness, ataxia, and dizziness have been the most frequent side effects noted. Psychologic abnormalities have included confusion, instability, mental slowness, depression, hypochondriacal behavior, and aggressiveness. There have been rare reports of psychosis, suicidal behavior, and auditory hallucinations.
Integumentary System: Dermatologic manifestations which have occurred with the administration of methsuximide have included urticaria, Stevens-Johnson syndrome, and pruritic erythematous rashes.
Cardiovascular: Hyperemia.
Genitourinary System: Proteinuria, microscopic hematuria.
Body as a Whole: Periorbital edema.
6OVERDOSAGE
Acute overdoses may produce nausea, vomiting, and CNS depression including coma with respiratory depression. Methsuximide poisoning may follow a biphasic course. Following an initial comatose state, patients have awakened and then relapsed into a coma within 24 hours. It is believed that an active metabolite of methsuximide, N-desmethylmethsuximide, is responsible for this biphasic profile. It is important to follow plasma levels of N-desmethylmethsuximide in methsuximide poisonings. Levels greater than 40 µg/mL have caused toxicity, and coma has been seen at levels of 150 µg/mL.
6.1Treatment
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. Charcoal hemoperfusion may be useful in removing the N-desmethyl metabolite of methsuximide. Forced diuresis and exchange transfusions are ineffective.
7DOSAGE AND ADMINISTRATION
Optimum dosage of Celontin must be determined by trial. A suggested dosage schedule is 300 mg per day for the first week. If required, dosage may be increased thereafter at weekly intervals by 300 mg per day for the three weeks following to a daily dosage of 1.2 g. Because therapeutic effect and tolerance vary among patients, therapy with Celontin must be individualized according to the response of each patient. Optimal dosage is that amount of Celontin which is barely sufficient to control seizures so that side effects may be kept to a minimum.
Celontin may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal).
8HOW SUPPLIED
N 0071-0525-24 (P-D 525)–Celontin Capsules, #1 capsule each containing 300 mg methsuximide; bottles of 100.
9MEDICATION GUIDE
CELONTIN (Suh lŏn' tĭn)
(methsuximide)
(methsuximide)
Capsules
Read this Medication Guide before you start taking CELONTIN 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 CELONTIN, ask your healthcare provider or pharmacist.
What is the most important information I should know about CELONTIN?
Do not stop taking CELONTIN without first talking to your healthcare provider. Stopping CELONTIN suddenly can cause serious problems.
CELONTIN can cause serious side effects, including:
- 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
- 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
- Like other antiepileptic drugs, CELONTIN 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 in 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 CELONTIN without first talking to a healthcare provider.
- Stopping CELONTIN 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 CELONTIN?
CELONTIN is a prescription medicine used to treat absence (petit mal) seizures that have not gotten better with other seizure medicines.
Who should not take CELONTIN?
Do not take CELONTIN if you are allergic to succinimides (methsuximide or ethosuximide) or any of the ingredients in CELONTIN. See the end of this Medication Guide for a complete list of ingredients in CELONTIN.
What should I tell my healthcare provider before taking CELONTIN?
Before you take CELONTIN, tell your healthcare provider if you:
- have or have 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 CELONTIN can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking CELONTIN. You and your healthcare provider will decide if you should take CELONTIN while you are pregnant.
- are breastfeeding or plan to breastfeed. It is not known if CELONTIN can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take CELONTIN.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking CELONTIN 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 each time you get a new medicine.
How should I take CELONTIN?
- Take CELONTIN exactly as prescribed. Your healthcare provider will tell you how much CELONTIN to take.
- Your healthcare provider may change your dose. Do not change your dose of CELONTIN without talking to your healthcare provider.
- If you take too much CELONTIN, call your healthcare provider or your local Poison Control Center right away.
What should I avoid while taking CELONTIN?
- Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking CELONTIN without first discussing this with your healthcare provider. CELONTIN 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 CELONTIN affects you. CELONTIN can slow your thinking and motor skills.
What are the possible side effects of CELONTIN?
- See "What is the most important information I should know about CELONTIN?"
CELONTIN may cause other serious side effects, including:
- Grand mal seizures can happen more often or become worse
The most common side effects of CELONTIN include:
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 CELONTIN. 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 CELONTIN?
- Store CELONTIN at room temperature, between 59°F to 86°F (15°C to 30°C).
- Keep CELONTIN capsules in a dry place.
- Keep CELONTIN out of the light.
- Protect CELONTIN from heat.
- Do not use CELONTIN capsules that if they do not look full or if the contents have melted.
Keep CELONTIN and all medicines out of the reach of children.
General information about CELONTIN
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CELONTIN for a condition for which it was not prescribed. Do not give CELONTIN to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about CELONTIN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CELONTIN that is written for healthcare professionals.
For more information, go to
What are the ingredients in CELONTIN?
Active ingredient: methsuximide
Inactive ingredients: starch, colloidal silicon dioxide NF, D&C yellow No. 10, FD&C yellow No.6, gelatin NF, and sodium lauryl sulfate NF.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
LAB-0404-3.0
10PRINCIPAL DISPLAY PANEL - 300 mg Capsule Bottle Label
Pfizer
ALWAYS DISPENSE WITH MEDICATION GUIDE
Celontin
300 mg
100 Capsules
