PRIMIDONE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

AvKARE

INN (International Name):

PRIMIDONE

Sammensetning:

PRIMIDONE 50 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 ).

Produkt oppsummering:

Primidone Tablets, USP, 50 mg are supplied as white, round, flat-faced, bevel-edged tablets, debossed “AN” above “44” on one side and cut-bisected on the other side. They are available as follows: Bottles of 100: NDC 42291-509-01 Bottles of 500: NDC 42291-509-50 Primidone Tablets, USP, 250 mg are supplied as white, round, flat-faced, bevel-edged tablets, debossed “AN” bisect “545” on one side and plain on the other side. They are available as follows: Bottles of 100: NDC 42291-511-01 Bottles of 500: NDC 42291-511-50 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F- 86°F). [See USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. 12-2021-03 AV 01/23

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

PRIMIDONE- PRIMIDONE TABLET
AvKARE
----------
SPL MEDGUIDE SECTION
What is the most important information I should know about primidone?
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 worsening depression
new or worsening anxiety
feeling agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worsening 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
Do not stop taking 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.
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.
What is primidone?
Primidone is a prescription medicine used alone or with other
medicines to treat people with:
generalized tonic-clonic (grand mal) seizures
complex partial (psychomotor) seizures
partial (focal) epileptic seizures
Who should not take primidone?
Do not take primidone if you:
have a genetic disorder called porphyria
are allergic to phenobarbital
What should I tell my healthcare provider before taking primidone?
Before you take primidone, tell your healthcare provider if you:
have or hav

Preparatomtale

PRIMIDONE- PRIMIDONE TABLET
AVKARE
----------
PRIMIDONE TABLETS, USP
50MG AND 250MG
RX ONLY
Anticonvulsant
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 mechanisms(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 emergence or worsening
of depression,
s