MYSOLINE Tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US, LLC

Λέξεις κλειδιά

66490-690 66490-691

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1. Description

Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. Structural formula: MYSOLINE (primidone) is a white, crystalline, highly stable substance, M.P. 279-284°C. It is poorly soluble in ...

2. Clinical Pharmacology

MYSOLINE raises electro- or chemoshock seizure thresholds or alters seizure patterns in experimental animals. The mechanism(s) of primidones antiepileptic action is not known. Primidone per se has anticonvulsant ...

3. Indications and Usage

MYSOLINE, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other ...

4. Contraindications

Primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see ACTIONS).

5. Warnings

The abrupt withdrawal of antiepileptic medication may precipitate status epilepticus. The therapeutic efficacy of a dosage regimen takes several weeks before it can be assessed. Suicidal Behavior and Ideation ...

6. Precautions

The total daily dosage should not exceed 2 g. Since MYSOLINE therapy generally extends over prolonged periods, a complete blood count and a sequential multiple analysis-12 (SMA-12) test should be made ...

6.2. Information for Patients

Suicidal Thoughts and Behavior Patients, their caregivers, and families should be counseled that AEDs, including MYSOLINE, may increase the risk of suicidal thoughts and behavior and should be advised ...

6.9. Nursing Mothers

There is evidence in mothers treated with primidone that the drug appears in breast milk in substantial quantities. Since tests for the presence of primidone in biological fluids are too complex to be ...

7. Adverse Reactions

The most frequently occurring early side effects are ataxia and vertigo. These tend to disappear with continued therapy, or with reduction of initial dosage. Occasionally, the following have been reported: ...

10. Dosage and Administration

Usual Dosage Patients 8 years of age and older who have received no previous treatment may be started on MYSOLINE according to the following regimen using either 50 mg or scored 250 mg MYSOLINE tablets: ...

11. How Supplied

<u>MYSOLINE Tablets:</u> Modified square, flat faced, beveled edge, compressed light yellow color tablet. One face is debossed (impressed) with MYSOLINE and 250 that are divided by a debossed bisect line. ...

12. Storage and Handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.