Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
PRIMIDONE (UNII: 13AFD7670Q) (PRIMIDONE - UNII:13AFD7670Q)
Physicians Total Care, Inc.
PRIMIDONE
PRIMIDONE 50 mg
ORAL
PRESCRIPTION DRUG
Primidone, 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 anticonvulsant therapy. Primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see ACTIONS ).
Primidone Tablets USP, 50 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1301, supplied in bottles of 100, 500 and 1000 tablets. Primidone Tablets USP, 250 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1231, supplied in bottles of 100, 500 and 1000 tablets. Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP with a child-resistant closure. Manufactured by: Lannett Company, Inc. Philadelphia, PA 19136 Made in the USA Revised 11/10, Revision 1 10-916 Distributed by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146
Abbreviated New Drug Application
PRIMIDONE - PRIMIDONE TABLET Physicians Total Care, Inc. ---------- MEDICATION GUIDE PRIMIDONE TABLETS, USP Read this Medication Guide before you start taking primidone tablets, USP 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, USP? Do not stop taking primidone tablets, USP without first talking to your healthcare provider. Stopping primidone tablets, USP suddenly can cause serious problems. Primidone tablets, USP can cause serious side effects, including: 1. Like other antiepileptic drugs, primidone tablets, USP 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, USP without first talking to a healthcare provider. • Stopping primidone tablets, USP 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 o read_full_document
PRIMIDONE - PRIMIDONE TABLET PHYSICIANS TOTAL CARE, INC. ---------- PRIMIDONE TABLETS, USP RX ONLY DESCRIPTION _Anticonvulsant_ 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 either 50 mg or 250 mg of primidone. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, acacia, methylcellulose, magnesium stearate, and sodium starch glycolate. ACTIONS 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, 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 anticonvulsant therapy. CONTRAINDICATIONS Primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see ACTIONS). 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, 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 worsening of depression, suicidal thoughts o read_full_document