MYSOLINE- primidone tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Bausch Health US, LLC

INN (International Name):

Primidone

Sammensætning:

Primidone 50 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

MYSOLINE, 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 ).

Produkt oversigt:

MYSOLINE Tablets Modified square, flat faced, beveled edge, compressed light yellow color tablet. One face is debossed (impressed) with “MYSOLINE” and “250” that are divided by a debossed bisect line. The opposite side is embossed with the letter “M”, in bottles of 100 (NDC 66490-691-10). Modified square, flat faced, beveled edge, compressed white color tablet. One face is debossed (impressed) with “MYSOLINE” and “50” that are divided by a debossed bisect line. The opposite side is embossed with the letter “M”, in bottles of 100 (NDC 66490-690-10). 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. Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Steinbach, MB R5G 1Z7, Canada MYSOLINE is a trademark of Bausch Health Companies Inc. or its affiliates. © 2020 Bausch Health Companies Inc. or its affiliates

Autorisation status:

New Drug Application

Indlægsseddel

MYSOLINE- PRIMIDONE TABLET
Bausch Health US, LLC
----------
MEDICATION GUIDE
MYSOLINE (My-so-lean)
(primidone tablets, USP), 50 mg and 250 mg
Read this Medication Guide before you start taking MYSOLINE 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 MYSOLINE?
Like other antiepileptic drugs, MYSOLINE 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 MYSOLINE without first talking to a healthcare
provider.
•
Stopping MYSOLINE 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 MYSOLINE?
MYSOLINE is a prescription medicine used alone or with other medicines
to treat people with:
•
generalized t

Produktets egenskaber

MYSOLINE- PRIMIDONE TABLET
BAUSCH HEALTH US, LLC
----------
MYS OLINE
(PRIMIDONE TABLETS, USP)
50 MG AND 250 MG
RX ONLY
ANTICONVULS ANT
DESCRIPTION
Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione.
Structural formula:
MYSOLINE (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.
MYSOLINE 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.
MYSOLINE 250 mg tablets also contain ferric oxide yellow, NF.
_______________________________________________________________________________
ACTIONS
MYSOLINE 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
MYSOLINE, 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 MYSOLINE, increase the risk of
suicidal thoughts