Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
PRIMIDONE (UNII: 13AFD7670Q) (PRIMIDONE - UNII:13AFD7670Q)
AvPAK
PRIMIDONE
PRIMIDONE 50 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, USP is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see CLINICAL PHARMACOLOGY ).
Primidone Tablets, USP, 50 mg are supplied as white, round, flat-faced, bevel-edged tablet, debossed "AN" above "44" on one side and cut-bisected on the other side. NDC 50268-686-15 (10 Tablets per card, 5 cards per carton) Primidone Tablets, USP, 250 mg are supplied as white, round, flat-faced, bevel-edged tablet, debossed "AN" bisect "545" on one side and plain on the other side. NDC 50268-687-15 (10 Tablets per card, 5 cards per carton) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispensed in Unit Dose package. For Institutional Use Only. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 06-2016-00 AV Rev. 08/18 (P) AvPAK
Abbreviated New Drug Application
AvPAK ---------- MEDICATION GUIDE Primidone (PRIM-i-done) Tablets, 50 mg and 250 mg Read this Medication Guide before you start taking primidone 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? Do not stop taking primidone without first talking to your healthcare provider. Stopping primidone suddenly can cause serious problems. Primidone can cause serious side effects, including: Like other antiepileptic drugs, primidone 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 without first talking to a healthcare provider. • Stopping primidone 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. What is primido Կարդացեք ամբողջական փաստաթուղթը
PRIMIDONE- PRIMIDONE TABLET AVPAK ---------- PRIMIDONE TABLETS, USP _ANTICONVULSANT_ RX ONLY DESCRIPTION Primidone, USP 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. Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. Structural formula: Primidone tablets, USP, 50 mg and 250 mg, contain the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, methyl cellulose, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate. 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, USP is contraindicated in: 1) patients with porphyria and 2) 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, 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, sui Կարդացեք ամբողջական փաստաթուղթը