PRIMIDONE- primidone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

West-ward Pharmaceutical Corp

INN (International Name):

PRIMIDONE

Composition:

PRIMIDONE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 is contraindicated in: - Patients with porphyria and - Patients who are hypersensitive to phenobarbital (see CLINICAL PHARMACOLOGY ).

Product summary:

Primidone Tablets, USP 50 mg are supplied as: white, round, scored tablets; debossed “W” on one side of the tablet, and “8” on one side of the score and “2” on the other side of the score on the other side of the tablet, and are available in:       Bottles of 100 tablets.       Bottles of 500 tablets.       Bottles of 1000 tablets. Primidone Tablets, USP 250 mg are supplied as: white, round, scored tablets; debossed “WW 484” on one side of the tablet, and scored on the other side of the tablet, and are available in:       Bottles of 100 tablets.       Bottles of 1000 tablets. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised December 2011

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

West-ward Pharmaceutical Corp
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MEDICATION GUIDE
MEDICATION GUIDE
Primidone Tablets, USP
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:
1. 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

Summary of Product characteristics

PRIMIDONE- PRIMIDONE TABLET
WEST-WARD PHARMACEUTICAL CORP
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PRIMIDONE TABLETS, USP
REV. 12/11
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.
Each tablet, for oral administration, contains 50 mg or 250 mg
primidone, and the following inactive
ingredients: lactose monohydrate, magnesium stearate, microcrystalline
cellulose, povidone, sodium
lauryl sulfate, sodium starch glycolate, and stearic acid.
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 is contraindicated in:
Patients with porphyria and
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 Tablets, 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 wo