PRIMIDONE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Lannett Company, Inc.

INN (International Name):

PRIMIDONE

Sammensætning:

PRIMIDONE 50 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 ).

Produkt oversigt:

Primidone Tablets USP, 50 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1301, supplied in bottles of 100, 500 and 1000 tablets. 100 Tablets                    NDC 0527-1301-01 500 Tablets                    NDC 0527-1301-05 1000 Tablets                   NDC 0527-1301-10 Primidone Tablets USP, 250 mg are available as white, round, flat faced, beveled edge, scored tablets debossed LAN over 1231, supplied in bottles of 100, 500 and 1000 tablets. 100 Tablets                    NDC 0527-1231-01 500 Tablets                    NDC 0527-1231-05 1000 Tablets                   NDC 0527-1231-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP with a child-resistant closure. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 Dispense with Medication Guide available at: www.lannett.com/med-guide/primidone CIB70303E Rev. 06/20

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

Lannett Company, Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
www.lannett.com/med-guide/primidone
Primidone Tablets, USP
Read this Medication Guide before you start taking primidone tablets,
USP 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, USP?
Do not stop taking primidone tablets, USP without first talking to
your healthcare provider.
Stopping primidone tablets, USP suddenly can cause serious problems.
Primidone tablets, USP can cause serious side effects, including:
1. Like other antiepileptic drugs, primidone tablets, USP 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
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.
Do not stop primidone tablets, USP without first talking to a
healthcare provider.
•
Stopping primidone tablets, USP 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

Produktets egenskaber

PRIMIDONE- PRIMIDONE TABLET
LANNETT COMPANY, INC.
----------
PRIMIDONE TABLETS, USP
RX ONLY
DESCRIPTION
_Anticonvulsant_
Chemical name: 5-ethyldihydro-5-phenyl-4,6
(1_H_,5_H_)-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.
Each tablet, for oral administration, contains either 50 mg or 250 mg
of primidone. In addition, each
tablet contains the following inactive ingredients: lactose
monohydrate, methylcellulose, acacia,
sodium starch glycolate, and magnesium stearate.
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 should be
monitored for the emergence or worsening of depression, suicidal
thoughts or