Phenobarbitone Elixir

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Phenobarbitone

Available from:

Orion Laboratories Pty Ltd T/A Perrigo Australia

Class:

Medicine Registered

Patient Information leaflet

 
PHENOBARBITONE ELIXIR 
_Phenobarbitone 15mg in 5mL  _
_ _
CONSUMER MEDICINE INFORMATION 

IMPORTANT INFORMATION 
ABOUT YOUR MEDICINE   

Phenobarbitone Elixir 15mg/5mL  
Page 1 of 4 

This medicine the doctor has 
prescribed for you is called 
Phenobarbitone Elixir. 

The information in this leaflet 
will answer some of the 
questions you may have about 
Phenobarbitone Elixir.  This 
leaflet does not tell you 
everything.  Your doctor or 
pharmacist has been provided 
with full information and can 
answer any questions you may 
have. 

This leaflet does not replace 
the advice given to you by your 
doctor.  Talk to your doctor or 
pharmacist.    

You should read this leaflet 
before taking Phenobarbitone 
Elixir and keep it in a safe place 
to refer to later. 

WHAT PHENOBARBITONE 
ELIXIR IS USED FOR 

Phenobarbitone Elixir is used to 
treat people with epilepsy.  It is 
a barbiturate which belongs to 
a group of medicines called 
central nervous system 
depressants (medicines that 
cause drowsiness).  Your 
doctor however may have 
prescribed Phenobarbitone 
Elixir for another purpose.  Ask 
you doctor if you have any 
questions about why

Phenobarbitone Elixir has been 
prescribed for you. 

BEFORE TAKING THIS 
MEDICINE 

When deciding to take a 
medicine, the risks of taking the 
medicine must be weighed 
against the good it will do. This 
is a decision you and your 
doctor will make. For 
barbiturates the following 
should be considered: 
_ALLERGIES_: Tell your doctor if 
you have ever had any unusual 
or allergic reactions to 
phenobarbitone or barbiturates, 
or any of the ingredients in 
Phenobarbitone Elixir (see 
PRODUCT DESCRIPTION).  
Symptoms of an allergic 
reaction may include red itchy 
skin rashes, difficulty breathing, 
hay fever, swelling of the face, 
lips, tongue or other parts of 
the body.   Tell your doctor if 
you are allergic to any other 
substances s

Summary of Product characteristics

PRODUCT INFORMATION 
PHENOBARBITONE ELIXIR 15MG/5ML 

NAME OF THE DRUG

Phenobarbitone 

_CHEMICAL STRUCTURE _

DESCRIPTION Phenobarbitone is a barbituric acid derivative.  It
occurs as colourless crystals or 
a white odourless crystalline powder.  Soluble 1 in 1000 of water
and 1 in 10 of alcohol.  It is 
soluble in alcohol, in ether and in solutions of fixed alkali
hydroxides and carbonates, it is 
sparingly soluble in chloroform.  Phenobarbitone is
5-ethyl-5-phenylbarbituric acid and has 
the molecular formula C
12
H
12
N
2
O
3
 and molecular weight 232.2.   

CAS number 50-06-6 

Phenobarbitone Elixir contains 15mg phenobarbitone per 5mL (0.3%w/v)
in a sweetened 
sucrose free base.  It contains butterscotch flavour,
ethanol, glycerol, sorbitol solution (70% 
non-crystallising) and water. 

PHARMACOLOGY 
_ACTIONS  _Phenobarbitone is a non selective
central nervous system depressant with a long 
duration of action.  The mechanism of action of the
barbiturates is not completely known.  
They may act by enhancing and/or mimicking the synaptic action
of gamma-aminobutyric acid 
(GABA).  Barbiturates depress the sensory cortex, decrease motor
activity, alter cerebellar 
function and produce drowsiness, sedation and hypnosis.
Phenobarbitone is reported to have 
anti convulsant activity at sub-hypnotic doses._ _

The anticonvulsant properties are believed to be due to depression of
mono-synaptic and 
poly-synaptic transmission and increasing the threshold for
electrical stimulation of the motor 
cortex. 

PHARMACOKINETICS 
_ABSORPTION  _Phenobarbitone is readily
absorbed (about 70-90% of an oral dose) from the 
gastrointestinal tract.   It is relatively lipid insoluble and may
require up to an hour or longer to 
achieve effective concentrations.  Absorption is increased if
barbiturates are taken well diluted 
or on an empty stomach.  Its duration of action ranges from 10-12
hours. 

_