PRIMIDONE tablet

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

Primidone (UNII: 13AFD7670Q) (Primidone - UNII:13AFD7670Q)

Disponibbli minn:

Oceanside Pharmaceuticals

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 ).

Sommarju tal-prodott:

Primidone, USP Tablets Each square-shaped, scored, yellow tablet, identified by "MYSOLINE 250" and an embossed M, contains 250 mg of primidone, in bottles of 100 (NDC 68682-690-10) Each square-shaped, scored, white tablet, identified by "MYSOLINE 50" and an embossed M, contains 50 mg of primidone, in bottles of 100 (NDC 68682-691-10) Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA Manufactured by: Piramal Enterprises Limited Plot No. 67-70, Sector II, Dist. Dhar Pithampur, Madhya Pradesh 454775 India Mysoline is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. © Valeant Pharmaceuticals North America LLC

L-istatus ta 'awtorizzazzjoni:

New Drug Application Authorized Generic

Fuljett ta 'informazzjoni

PRIMIDONE- PRIMIDONE TABLET
Oceanside Pharmaceuticals
----------
MEDICATION GUIDE
Primidone (prim-i-done), USP 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?
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

Karatteristiċi tal-prodott

PRIMIDONE- PRIMIDONE TABLET
OCEANSIDE PHARMACEUTICALS
----------
PRIMIDONE, USP TABLETS
50 MG AND 250 MG
RX ONLY
ANTICONVULS ANT
DESCRIPTION
Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-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.
Primidone 50 mg and 250 mg tablets contain the following inactive
ingredients: lactose monohydrate,
NF; magnesium stearate, NF; methylcellulose, USP; microcrystalline
cellulose, NF; purified water,
USP; sodium lauryl sulfate, NF; sodium starch glycolate, NF; and talc,
USP.
Primidone 250 mg tablets also contain ferric oxide yellow, NF.
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 a