PRIMIDONE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

AvPAK

DCI (Dénomination commune internationale):

PRIMIDONE

Composition:

PRIMIDONE 50 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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, USP is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see  CLINICAL PHARMACOLOGY ).

Descriptif du produit:

Primidone Tablets, USP, 50 mg are supplied as white, round, flat-faced, bevel-edged tablet, debossed "AN" above "44" on one side and cut-bisected on the other side. NDC 50268-686-15 (10 Tablets per card, 5 cards per carton) Primidone Tablets, USP, 250 mg are supplied as white, round, flat-faced, bevel-edged tablet, debossed "AN" bisect "545" on one side and plain on the other side. NDC 50268-687-15 (10 Tablets per card, 5 cards per carton) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispensed in Unit Dose package. For Institutional Use Only. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 06-2016-00 AV Rev. 08/18 (P) AvPAK

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

AvPAK
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MEDICATION GUIDE
Primidone (PRIM-i-done) Tablets, 50 mg and 250 mg
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:
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 primido

Résumé des caractéristiques du produit

PRIMIDONE- PRIMIDONE TABLET
AVPAK
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PRIMIDONE TABLETS, USP
_ANTICONVULSANT_
RX ONLY
DESCRIPTION
Primidone, USP 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.
Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione.
Structural
formula:
Primidone tablets, USP, 50 mg and 250 mg, contain the following
inactive ingredients:
corn starch, lactose monohydrate, magnesium stearate, methyl
cellulose,
microcrystalline cellulose, sodium lauryl sulfate, sodium starch
glycolate.
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, USP 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 emergence or worsening
of depression,
sui