PRIMIDONE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Bryant Ranch Prepack

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 ).

製品概要:

NDC: 71335-1158-1: 30 Tablets in a BOTTLE NDC: 71335-1158-2: 90 Tablets in a BOTTLE NDC: 71335-1158-3: 60 Tablets in a BOTTLE

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

Bryant Ranch Prepack
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
www.lannett.com/med-guide/primidone
Primidone Tablets, USP
Read this Medication Guide before you start taking primidone tablets,
USP 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, USP?
Do not stop taking primidone tablets, USP without first talking to
your healthcare provider.
Stopping primidone tablets, USP suddenly can cause serious problems.
Primidone tablets, USP can cause serious side effects, including:
1. Like other antiepileptic drugs, primidone tablets, USP 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, USP without first talking to a
healthcare provider.
•
Stopping primidone tablets, USP 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

製品の特徴

PRIMIDONE- PRIMIDONE TABLET
BRYANT RANCH PREPACK
----------
PRIMIDONE TABLETS, USP
RX ONLY
DESCRIPTION
_Anticonvulsant_
Chemical name: 5-ethyldihydro-5-phenyl-4,6
(1_H_,5_H_)-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 either 50 mg or 250 mg
of primidone. In
addition, each tablet contains the following inactive ingredients:
lactose monohydrate,
methylcellulose, acacia, sodium starch glycolate, and magnesium
stearate.
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 the emergence or worsening
of depression,
suicidal thoughts or b