Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
PRIMIDONE (UNII: 13AFD7670Q) (PRIMIDONE - UNII:13AFD7670Q)
PD-Rx Pharmaceuticals, Inc.
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 50 mg Tablets, USP are white, round, flat faced, beveled edge, scored tablets debossed "684" above bisect on one side and "O" on the other side. Supplied in: Bottles of 100, NDC 72789-178-01 Bottles of 500, NDC 72789-178-82 Primidone 250 mg Tablets, USP are yellow, round, flat faced, beveled edge, scored tablets debossed "685" above bisect on one side and "O" on the other side. Supplied in: Bottles of 100, NDC 72789-177-01 Bottles of 500, NDC 72789-177-82 Storage 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. Dispense with Medication Guide available at:https://www.oxford-rx.com/med-guides
Abbreviated New Drug Application
PD-Rx Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Primidone Tablets, USP, 50 mg and 250 mg Dispense with Medication Guide available at: https://www.oxford-rx.com/med-guides 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?. 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 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 or actions, your healthcare provider may check for other causes. 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. What are primidone tablets? Primidone tablets are a prescription Citiți documentul complet
PRIMIDONE- PRIMIDONE TABLET PD-RX PHARMACEUTICALS, INC. ---------- PRIMIDONE TABLETS, USP 50 MG AND 250 MG ANTICONVULSANT RX ONLY 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. Primidone 50 mg and 250 mg tablets contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and talc. Primidone 250 mg tablets also contain D&C yellow #10 aluminum lake and FD&C yellow #5 aluminum lake. 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 Citiți documentul complet