PRIMIDONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

PRIMIDONE

Composition:

PRIMIDONE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Primidone tablets, 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: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see CLINICAL PHARMACOLOGY).

Product summary:

Primidone Tablets USP, 250 mg are scored, round, white tablets imprinted DAN DAN and 5321 supplied in bottles of 100 and 1000. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Manufactured by: Watson Pharma Private Ltd. Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 Revised: April 2016                                                                      190832-3                                                                                                                

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PRIMIDONE- PRIMIDONE TABLET
Actavis Pharma, Inc.
----------
MEDICATION GUIDE
Primidone (prim' i done) Tablets, USP
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:
1. 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

Summary of Product characteristics

PRIMIDONE- PRIMIDONE TABLET
ACTAVIS PHARMA, INC.
----------
PRIMIDONE
TABLETS, USP
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.
Each tablet, for oral administration, contains 250 mg primidone. In
addition, each tablet contains the
following inactive ingredients: colloidal silicon dioxide, docusate
sodium, magnesium stearate,
microcrystalline cellulose, sodium benzoate, 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, 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: 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 emerge