Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. It may harm them.This Medication Guide summarizes the most important information about MYSOLINE. Your doctor will need to check your progress at regular visits. Stay alert to changes in your mood or symptoms. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. You may report side effects to FDA at 1-800-FDA-1088.Some people have thoughts about suicide while taking primidone. Copy the URL below and paste it into your RSS Reader application.DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. If you contact our Customer Support by one of the methods below, we will be able to assist you in locating the product you are looking for. Mysoline 250mg Tablets 200 Product ID: 2489212. It possesses no acidic properties, in contrast to its barbiturate analog.MYSOLINE 50 mg and 250 mg tablets contain the following inactive ingredients: lactosemonohydrate, NF; magnesium stearate, NF; methylcellulose, USP; microcrystalline cellulose, NF;purified water, USP; sodium lauryl sulfate, NF; sodium starch glycolate, NF; and talc, USP._______________________________________________________________________________MYSOLINE raises electro- or chemoshock seizure thresholds or alters seizure patterns in experimental animals. Do not give MYSOLINE to other people, even if they have the same symptoms that you have. These and, occasionally, other persistent or severe side effects may necessitate withdrawal of the drug. Stop breast-feeding if you notice unusual drowsiness in the nursing baby. Day 10-maintenance: 250 mg t.i.d. Mysoline 250mg Tablets; Unfortunately our full catalog may not be displayed in your state. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. For most adults and children 8 years of age and over, the usual maintenance dosage is three to four 250 mg Mysoline tablets daily in divided doses (250 mg . ; Tell your doctor if you have ever had: Since tests for the presence of primidone in biological fluids are too complex to be carried out in the average clinical laboratory, it is suggested that the presence of undue somnolence and drowsiness in nursing newborns of MYSOLINE-treated mothers be taken as an indication that nursing should be discontinued.Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. Copy the URL below and paste it into your RSS Reader application. It may control grand mal seizures refractory to other anticonvulsant therapy.Primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see The abrupt withdrawal of antiepileptic medication may precipitate status epilepticus. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed.Table 1 shows absolute and relative risk by indication for all evaluated AEDs.The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.Anyone considering prescribing MYSOLINE or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. One face is debossed (impressed) with “MYSOLINE” and “250” that are divided by a debossed bisect line. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.MYSOLINE is a prescription medicine used alone or with other medicines to treat people with:Before you take MYSOLINE, tell your healthcare provider if you:Know the medicines you take. Megaloblastic anemia may occur as a rare idiosyncrasy to MYSOLINE and to other anticonvulsants.