DailyMed Label: Methsuximide

DailyMed Label: Methsuximide

2023

DailyMed Prescription

Methsuximide

Methsuximide

ANI Pharmaceuticals, Inc.

NDC: 70954-228

NDC: 70954-228

NDC: 70954-228

NDC: 70954-228

NDC: 70954-228

NDC: 70954-228

Methsuximide is an anticonvulsant succinimide, chemically designated as N,2-Dimethyl-2-phenylsuccinimide, with the following structural formula: Each Methsuximide Capsule, USP contains 300 mg methsuximide, USP. Also contains corn starch, colloidal silicon dioxide and magnesium stearate. The capsule shells contain gelatin, purified water, sodium lauryl sulfate, D&C Yellow No.10 and FD&C Yellow No.6. The imprinting ink contains shellac, alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia, black iron oxide, potassium hydroxide and purified water. FDA approved dissolution test specifications differ from USP. structure

Methsuximide is indicated for the control of absence (petit mal) seizures that are refractory to other drugs.

Optimum dosage of methsuximide 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 methsuximide must be individualized according to the response of each patient. Optimal dosage is that amount of methsuximide which is barely sufficient to control seizures so that side effects may be kept to a minimum. Methsuximide may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal).

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

It is recommended that the physician withdraw the drug slowly on the appearance of unusual depression, aggressiveness, or other behavioral alterations. As with other anticonvulsants, it is important to proceed slowly when increasing or decreasing dosage, as well as when adding or eliminating other medication. Abrupt withdrawal of anticonvulsant medication may precipitate absence (petit mal) status. Methsuximide, when used alone in mixed types of epilepsy, may increase the frequency of grand mal seizures in some patients. Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking methsuximide. Instruct patients to take methsuximide only as prescribed. Methsuximide may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a motor vehicle or other such activity requiring alertness; therefore, the patient should be cautioned accordingly. Patients taking methsuximide should be advised of the importance of adhering strictly to the prescribed dosage regimen. Patients should be instructed to promptly contact their physician if they develop signs and/or symptoms suggesting an infection (eg, sore throat, fever). ADVICE TO THE PHARMACIST AND PATIENT: Since methsuximide has a relatively low melting temperature (124° F), storage conditions which may promote high temperatures (closed cars, delivery vans, or storage near steam pipes) should be avoided. Do not dispense or use capsules that are not full or in which contents have melted. Effectiveness may be reduced. Protect from excessive heat (104° F). Patients, their caregivers, and families should be counseled that AEDs, including methsuximide, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see PRECAUTIONS: Pregnancy section). Since methsuximide may interact with concurrently administered antiepileptic drugs, periodic serum level determinations of these drugs may be necessary (eg, methsuximide may increase the plasma concentrations of phenytoin and phenobarbital). To provide information regarding the effects of in utero exposure to methsuximide, physicians are advised to recommend that pregnant patients taking methsuximide enroll in the (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website: http://www.aedpregnancyregistry.org/. See WARNINGS. See DOSAGE AND ADMINISTRATION.

Since methsuximide may interact with concurrently administered antiepileptic drugs, periodic serum level determinations of these drugs may be necessary (eg, methsuximide may increase the plasma concentrations of phenytoin and phenobarbital).

Methsuximide Capsules, USP are supplied as pale yellow colored, size "1" hard gelatin capsules, imprinted 228 on the cap and 300 mg on the body in black ink filled with white to off-white powder with each capsule containing 300 mg methsuximide, USP. NDC 70954-228-10                            Bottles of 100 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].   Protect from light and moisture. Protect from excessive heat 40°C (104°F).   Trademarks are the property of their respective owners.   Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623   Issued:  11/2022 LB4557-00

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.

Methsuximide Capsules, USP 300 mg NDC 70954-228-10 - Bottles of 100 container