PRIMIDONE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

McKesson Contract Packaging

INN (nemzetközi neve):

PRIMIDONE

Összetétel:

PRIMIDONE 50 mg

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

PRIMIDONE- PRIMIDONE TABLET
MCKESSON CONTRACT PACKAGING
----------
PRIMIDONE TABLETS, USP
RX ONLY
DESCRIPTION
_Anticonvulsant_
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.
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, acacia, methylcellulose,
magnesium stearate, and sodium starch glycolate.
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