PHENOBARBITONE ASPEN_PHENOBARBITONE INJECTION
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
14-05-2024
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Active ingredient:
Phenobarbitone; Phenobarbitone sodium
Available from:
Aspen Pharma Pty Ltd
Class:
Medicine Registered
Summary of Product characteristics
Phenobarbitone Injection/ Phenobarbitone Aspen Tablets - PI
Page 1 of 15
PRODUCT INFORMATION
NAME OF THE MEDICINE
PHENOBARBITONE INJECTION
contains phenobarbitone sodium 219 mg (equivalent to phenobarbitone 200 mg) per 1 mL
ampoule.
PHENOBARBITONE ASPEN TABLETS
contain phenobarbitone 30 mg per tablet.
DESCRIPTION
PHENOBARBITONE presents as colourless crystals or a white odourless crystalline powder.
It
may exhibit polymorphism. It is soluble 1 in 1000 of water and
1 in 10 of alcohol; sparingly
soluble in chloroform; soluble in ether. A saturated solution in
water has a pH of about 5.
PHENOBARBITONE SODIUM is a white, odourless, hygroscopic powder,
granules or flakes. It is
very soluble in water and soluble in alcohol,
practically insoluble in chloroform and ether. A
10% solution in water has a pH of not more than
10.2. Store in airtight containers.
PHENOBARBITONE (CAS -50–06–6) has the following chemical structure:
N
N
O
H
O
O
H
Et
(phenobarbitone base)
Its molecular formula is C
12
H
12
N
2
O
3
. The molecular weight is 232.2.
PHENOBARBITONE SODIUM (CAS -57-30-7) has the following chemical
structure:
Its molecular formula is C
12
H
11
N
2
NaO
3
. The molecular weight is 254.2.
N
N
Et
O
ONa
O
H
Phenobarbitone Injection/ Phenobarbitone Aspen Tablets - PI
Page 2 of 15
PHENOBARBITONE INJECTION contains the following excipients: ethanol, propylene glycol,
water for injections
.
PHENOBARBITONE ASPEN TABLETS contain the following excipients: lactose, acacia, starch-
wheat, magnesium stearate.
PHARMACOLOGY
ACTIONS
Phenobarbitone is a long acting barbiturate used as a sedative-hypnotic and
as an
anticonvulsant in the treatment of epilepsy.
Recent studies have suggested that the sedative-hypnotic and
anticonvulsant effec
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