PRIMIDONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

primidone (UNII: 13AFD7670Q) (primidone - UNII:13AFD7670Q)

Available from:

Dr. Reddy's Laboratories Limited

INN (International Name):

primidone

Composition:

primidone 50 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 tablet is contraindicated in:  1) patients with porphyria and  2) patients who are hypersensitive to phenobarbital (see CLINICALPHARMACOLOGY ).

Product summary:

Primidone tablets USP, 50 mg are white to off white, round, flat, beveled edged uncoated tablets debossed “RDY” and “477” on the periphery on one side and break line on other side. They are supplied in bottles of 30’s, 60’s, 100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                                                                    NDC 55111-477-30 Bottles of 60                                                                                    NDC 55111-477-60 Bottles of 100                                                                                  NDC 55111-477-01 Bottles of 500                                                                                  NDC 55111-477-05 Unit Dosage Package of 100 (10 x 10)                                          NDC 55111-477-78 Primidone tablets USP, 250 mg are cream to yellow, round, flat, beveled edged uncoated tablets debossed “RDY” and “476” on the periphery on one side and break line on other side. They are supplied in bottles of 30’s, 60’s, 100’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                                                                    NDC 55111-476-30 Bottles of 60                                                                                    NDC 55111-476-60 Bottles of 100                                                                                  NDC 55111-476-01 Bottles of 500                                                                                  NDC 55111-476-05 Unit Dosage Package of 100 (10 x 10)                                          NDC 55111-476-78 Store at 20°–25° C (68°–77° F) [See USP Controlled Room Temperature]. Dispense in a well-closed container with a child-resistant closure. 

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Dr. Reddy's Laboratories Limited
----------
MEDICATION GUIDE
PRIMIDONE 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 for other causes.
What is primi

Summary of Product characteristics

PRIMIDONE- PRIMIDONE TABLET
DR. REDDY'S LABORATORIES LIMITED
----------
PRIMIDONE TABLETS USP
ANTICONVULS ANT
DESCRIPTION
CHEMICAL NAME: 5-ethyldihydro- 5-phenyl-4,6 (1H, 5H) pyrimidinedione.
Structural formula:
C
H N O
M.W. 218.25
Primidone is a white crystalline powder, M.P. 279-284°C. It is very
slightly soluble in methanol and
methylene dichloride, slightly soluble in alcohol and insoluble in
water. It possesses no acidic
properties, in contrast to its barbiturate analog.
Primidone tablets 50 mg and 250 mg contain the following inactive
ingredients: lactose monohydrate,
magnesium stearate, methyl cellulose, purified water, sodium lauryl
sulphate, sodium starch glycolate
and talc.
Primidone tablets 250 mg also contain yellow iron oxide.
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 tablet is contraindicated in:
12
14
2
2
1) patients with porphyria and
2) patients who are hypersensitive to phenobarbital (see
CLINICALPHARMACOLOGY).
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 a