PRIMIDONE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

PRIMIDONE (UNII: 13AFD7670Q) (PRIMIDONE - UNII:13AFD7670Q)

Tilgjengelig fra:

Par Pharmaceutical

INN (International Name):

PRIMIDONE

Sammensetning:

PRIMIDONE 50 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 ).

Produkt oppsummering:

Primidone 50 mg Tablets, USP are white, round, flat faced, scored tablets debossed "5130" on one side and "V" on the reverse side and supplied as follows: Primidone 250 mg Tablets, USP are yellow, round, flat faced, scored tablets debossed "5131" on one side and "V" on the reverse side and supplied as follows: 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.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Par Pharmaceutical
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MEDICATION GUIDE
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:
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
or actions, your healthcare provider may check for ot

Preparatomtale

PRIMIDONE- PRIMIDONE TABLET
PAR PHARMACEUTICAL
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PRIMIDONE TABLETS, USP
ANTICONVULS ANT
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 should be
monitored for