PRIMIDONE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Amneal Pharmaceuticals of New York LLC

INN (Medzinárodný Name):

PRIMIDONE

Zloženie:

PRIMIDONE 50 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 ).

Prehľad produktov:

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. They are available as follows: Bottles of 100:                         NDC 53746-544-01 Bottles of 500:                         NDC 53746-544-05 Bottles of 1000:                       NDC 53746-544-10 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. They are available as follows: Bottles of 100:                         NDC 53746-545-01 Bottles of 500:                         NDC 53746-545-05 Bottles of 1000:                       NDC 53746-545-10 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 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 THE REACH OF CHILDREN. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2022-05

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Amneal Pharmaceuticals of New York LLC
----------
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?
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) seiz

Súhrn charakteristických

PRIMIDONE- PRIMIDONE TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
PRIMIDONE TABLETS, USP (50 MG AND 250 MG)
RX ONLY
_Anticonvulsant_
DESCRIPTION
Primidone, USP is a white, crystalline, highly stable substance, M.P.
279 to 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 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 e