PHENOBARBITAL SODIUM INJECTION, USP SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

PHENOBARBITAL SODIUM

Verfügbar ab:

SANDOZ CANADA INCORPORATED

ATC-Code:

N03AA02

INN (Internationale Bezeichnung):

PHENOBARBITAL

Dosierung:

120MG

Darreichungsform:

SOLUTION

Zusammensetzung:

PHENOBARBITAL SODIUM 120MG

Verabreichungsweg:

INTRAMUSCULAR

Einheiten im Paket:

5X1ML

Verschreibungstyp:

Schedule G (CDSA IV)

Therapiebereich:

BARBITURATES

Produktbesonderheiten:

Active ingredient group (AIG) number: 0105985001; AHFS:

Berechtigungsstatus:

MARKETED

Berechtigungsdatum:

2008-02-29

Fachinformation

_Phenobarbital Sodium Injection USP _
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_Page 1 of 21_
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PRESCRIBING INFORMATION
PHENOBARBITAL SODIUM INJECTION USP
30 mg/ml, 120 mg/ml
THERAPEUTIC CLASSIFICATION
Anticonvulsant, Hypnotic, Sedative
(Barbiturate)
Sandoz Canada Inc.
145 Jules-Léger
Date of Revision: February 26, 2015
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 179559
_Phenobarbital Sodium Injection USP _
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_Page 2 of 21_
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PHENOBARBITAL SODIUM INJECTION USP
THERAPEUTIC CLASSIFICATION
Anticonvulsant, Hypnotic, Sedative
(Barbiturate)
PHARMACOLOGY
Phenobarbital, like many other barbiturates, is a nonselective central
nervous system (CNS)
depressant, capable of producing all degrees of depression from mild
sedation and hypnosis to
general anesthesia, deep coma and death. The extent of CNS depression
varies with the route of
administration, dose and pharmacokinetic characteristics of the
particular barbiturates. Patient
specific factors such as age, physical or emotional state and the
concomitant use of other drugs
will also affect response.
The mechanism of action of phenobarbital is not completely known.
Phenobarbital may act by
enhancing and/or mimicking the synaptic action of gamma-aminobutyric
acid (GABA), an
inhibitory neurotransmitter. The sedative-hypnotic action of
phenobarbital may be due to an
inhibition of conduction in the reticular formation resulting in a
decrease in the number of
impulses reaching the cerebral cortex.
Anticonvulsant activity may result from a reduction in CNS synaptic
transmission and an
increase in the threshold for electrical stimulation of the motor
cortex. Phenobarbital is the only
barbiturate with anticonvulsant activity at subhypnotic doses.
The therapeutic index of barbiturates, such as phenobarbital, is
narrow. Therefore, the use of
phenobarbital is almost always accompanied by some degree of
impairment of cognitive
function. Supratherapeutic doses lead to marked mental and motor
impairment. In some patients
(especially children and the elderly), drowsiness may be paradoxically
preceded by tr