PRIMIDONE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Oxford Pharmaceuticals, LLC

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 ).

Περίληψη προϊόντος:

Primidone 50 mg Tablets, USP are white, round, flat faced, beveled edge, scored tablets debossed "684" above bisect on one side and "O" on the other side. Supplied in: bottles of 100, NDC 69584-684-10 bottles of 500, NDC 69584-684-50 Primidone 250 mg Tablets, USP are yellow, round, flat faced, beveled edge, scored tablets debossed "685" above bisect on one side and "O" on the other side. Supplied in: bottles of 100, NDC 69584-685-10 bottles of 500, NDC 69584-685-50 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. Dispense with Medication Guide available at:https://www.oxford-rx.com/med-guides Manufactured by: OXFORD PHARMACEUTICALS, LLC Birmingham, AL 35211 8200022 Rev 01 01/22                                                                                                                

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

Oxford Pharmaceuticals, LLC
----------
MEDICATION GUIDE
Primidone Tablets, USP, 50 mg and 250 mg
Dispense with Medication Guide available at:
https://www.oxford-rx.com/med-guides
Read this Medication Guide before you start taking primidone tablets
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
tablets?.
Like other antiepileptic drugs, primidone tablets 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
Do not stop primidone tablets without first talking to a healthcare
provider.
•
Stopping primidone tablets 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 are primidone tablets?
Primidone tablets are a prescription

Αρχείο Π.Χ.Π.

PRIMIDONE- PRIMIDONE TABLET
OXFORD PHARMACEUTICALS, LLC
----------
PRIMIDONE TABLETS, USP
50 MG AND 250 MG
ANTICONVULSANT
RX ONLY
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:
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
sodium lauryl sulfate, sodium starch glycolate and talc.
Primidone 250 mg tablets also contain D&C yellow #10 aluminum lake and
FD&C yellow
#5 aluminum lake.
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 any indication