מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
Primidone (UNII: 13AFD7670Q) (Primidone - UNII:13AFD7670Q)
Bausch Health US, LLC
Primidone
Primidone 50 mg
ORAL
PRESCRIPTION DRUG
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 anticonvulsant therapy. Primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see ACTIONS ).
MYSOLINE Tablets 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. The opposite side is embossed with the letter “M”, in bottles of 100 (NDC 66490-691-10). Modified square, flat faced, beveled edge, compressed white color tablet. One face is debossed (impressed) with “MYSOLINE” and “50” that are divided by a debossed bisect line. The opposite side is embossed with the letter “M”, in bottles of 100 (NDC 66490-690-10). 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. Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Steinbach, MB R5G 1Z7, Canada MYSOLINE is a trademark of Bausch Health Companies Inc. or its affiliates. © 2020 Bausch Health Companies Inc. or its affiliates
New Drug Application
MYSOLINE- PRIMIDONE TABLET Bausch Health US, LLC ---------- MEDICATION GUIDE MYSOLINE (My-so-lean) (primidone tablets, USP), 50 mg and 250 mg Read this Medication Guide before you start taking MYSOLINE 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 MYSOLINE? Like other antiepileptic drugs, MYSOLINE 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 worsening depression • new or worsening anxiety • feeling agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worsening 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 taking MYSOLINE without first talking to a healthcare provider. • Stopping MYSOLINE 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 is MYSOLINE? MYSOLINE is a prescription medicine used alone or with other medicines to treat people with: • generalized t קרא את המסמך השלם
MYSOLINE- PRIMIDONE TABLET BAUSCH HEALTH US, LLC ---------- MYS OLINE (PRIMIDONE TABLETS, USP) 50 MG AND 250 MG RX ONLY ANTICONVULS ANT 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 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. MYSOLINE 50 mg and 250 mg tablets contain the following inactive ingredients: lactose monohydrate, NF; magnesium stearate, NF; methylcellulose, USP; microcrystalline cellulose, NF; purified water, USP; sodium lauryl sulfate, NF; sodium starch glycolate, NF; and talc, USP. MYSOLINE 250 mg tablets also contain ferric oxide yellow, NF. _______________________________________________________________________________ ACTIONS MYSOLINE 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 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 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 MYSOLINE, increase the risk of suicidal thoughts קרא את המסמך השלם