البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
PHENOBARBITAL SODIUM
SANDOZ CANADA INCORPORATED
N03AA02
PHENOBARBITAL
120MG
SOLUTION
PHENOBARBITAL SODIUM 120MG
INTRAMUSCULAR
5X1ML
Schedule G (CDSA IV)
BARBITURATES
Active ingredient group (AIG) number: 0105985001; AHFS:
MARKETED
2008-02-29
_Phenobarbital Sodium Injection USP _ _ _ _Page 1 of 21_ _ _ 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 _ _ _ _Page 2 of 21_ _ _ 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 اقرأ الوثيقة كاملة