Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
PRIMIDONE (UNII: 13AFD7670Q) (PRIMIDONE - UNII:13AFD7670Q)
West-ward Pharmaceutical Corp
PRIMIDONE
PRIMIDONE 250 mg
ORAL
PRESCRIPTION DRUG
Primidone Tablets, USP used alone or concomitantly with other anticonvulsants, are indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy. Primidone is contraindicated in: - Patients with porphyria and - Patients who are hypersensitive to phenobarbital (see CLINICAL PHARMACOLOGY ).
Primidone Tablets, USP 50 mg are supplied as: white, round, scored tablets; debossed “W” on one side of the tablet, and “8” on one side of the score and “2” on the other side of the score on the other side of the tablet, and are available in: Bottles of 100 tablets. Bottles of 500 tablets. Bottles of 1000 tablets. Primidone Tablets, USP 250 mg are supplied as: white, round, scored tablets; debossed “WW 484” on one side of the tablet, and scored on the other side of the tablet, and are available in: Bottles of 100 tablets. Bottles of 1000 tablets. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised December 2011
Abbreviated New Drug Application
West-ward Pharmaceutical Corp ---------- MEDICATION GUIDE MEDICATION GUIDE Primidone Tablets, USP Read this Medication Guide before you start taking Primidone Tablets 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. What is the most important information I should know about Primidone Tablets? Do not stop taking Primidone Tablets without first talking to your healthcare provider. Stopping Primidone Tablets suddenly can cause serious problems. Primidone Tablets can cause serious side effects, including: 1. Like other antiepileptic drugs, Primidone Tablets 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 Primidone Tablets without first talking to a healthcare provider. • Stopping Primidone Tablets 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 Olvassa el a teljes dokumentumot
PRIMIDONE- PRIMIDONE TABLET WEST-WARD PHARMACEUTICAL CORP ---------- PRIMIDONE TABLETS, USP REV. 12/11 DESCRIPTION CHEMICAL NAME: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H) pyrimidinedione. Structural formula: Primidone is a white, crystalline, highly stable substance, M.P. 279-284°C. It is poorly soluble in water (60 mg per 100 mL at 37°C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog. Each tablet, for oral administration, contains 50 mg or 250 mg primidone, and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. CLINICAL PHARMACOLOGY Primidone raises electro- or chemoshock seizure thresholds or alters seizure patterns in experimental animals. The mechanism(s) of primidone’s antiepileptic action is not known. Primidone _per se _has anticonvulsant activity as do its two metabolites, phenobarbital and phenylethylmalonamide (PEMA). In addition to its anticonvulsant activity, PEMA potentiates the anticonvulsant activity of phenobarbital in experimental animals. INDICATIONS AND USAGE Primidone Tablets, USP used alone or concomitantly with other anticonvulsants, are indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy. CONTRAINDICATIONS Primidone is contraindicated in: Patients with porphyria and Patients who are hypersensitive to phenobarbital (see CLINICAL PHARMACOLOGY). 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 Antiepileptic drugs (AEDs), including Primidone Tablets, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or wo Olvassa el a teljes dokumentumot