PHENOBARBITONE INJECTION

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phenobarbital sodium, Quantity: 219 mg/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

phenobarbital (phenobarbitone) sodium

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: propylene glycol; ethanol; water for injections

Administration route:

Intramuscular, Intravenous

Units in package:

1mL x 5

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of grand mal and psychomotor epilepsy; sedation

Product summary:

Visual Identification: A clear, colourless solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-11-04

Patient Information leaflet

Phenobarbitone Injection- Consumer Medicine Information
Page 1 of 4
PHENOBARBITONE INJECTION
_phenobarbital (phenobarbitone) sodium _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Phenobarbitone Injection. It does
not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using it
against the benefits they expect it
will have.
IF YOU HAVE ANY CONCERNS ABOUT
THE USE OF THIS MEDICINE ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT PHENOBARBITONE
INJECTION IS USED FOR
The active ingredient is called
phenobarbital (phenobarbitone)
sodium_. _
It belongs to a group of medicines
called barbiturates, which act by
inducing sleep and stopping
convulsions.
Phenobarbitone Injection is used
for treatment of grand mal and
psychomotor epilepsy and
sedation.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
PHENOBARBITONE INJECTION HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
it for another purpose.
Phenobarbitone Injection is
available only with a doctor’s
prescription.
The use of barbiturates may lead
to dependence on this medicine.
BEFORE IT IS GIVEN
_WHEN IT MUST NOT BE USED _
PHENOBARBITONE INJECTION
SHOULD NOT BE USED IF YOU ARE
ALLERGIC TO:

phenobarbital
(phenobarbitone) sodium

any of the other ingredients
listed at the end of this leaflet

any other barbiturate.
Some of the symptoms of an
allergic reaction may include red,
itchy skin rashes; difficulty
breathing; hay fever; swelling of
the face or throat or faintness.
DO NOT USE IF YOU HAVE OR HAVE
HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS:

porphyria (a rare blood
pigment disorder)

severe anaemia (a disease of
the blood with reduced
number of red blood cells) if it
is due to folate deficiency

uncontrolled severe asthma

severe respiratory depression

uncontrolled diabetes

Summary of Product characteristics

PHENOBARBITONE INJECTION - PI
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
PHENOBARBITONE INJECTION
PHENOBARBITAL (PHENOBARBITONE) SODIUM
1.
NAME OF THE MEDICINE
phenobarbital (phenobarbitone) sodium.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHENOBARBITONE INJECTION contains phenobarbital (phenobarbitone)
sodium 219 mg
(equivalent to phenobarbitone 200 mg) per 1 mL ampoule.
Excipients include ethanol. For the full list of excipients, see
section 6.1: List of excipients.
3.
PHARMACEUTICAL FORM
PHENOBARBITONE INJECTION is a clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of grand mal and psychomotor epilepsy; sedation.
4.2
DOSE AND METHOD OF ADMINISTRATION
PHENOBARBITONE INJECTION is for single use in one patient only.
Discard any residue.
PHENOBARBITONE INJECTION has been administered by intramuscular (IM)
or slow
intravenous (IV) injection.
Intravenous administration requires a delivery of a diluted (1/10)
solution in water for
injections at a rate not exceeding 60 mg/minute to reduce the risk of
significant respiratory
depression and circulatory collapse. Extravasation of solution,
especially if concentrated, may
cause tissue damage. Adequate provisions for supporting respiration
and circulation should be
present if the intravenous route is contemplated.
The subcutaneous route should be avoided as it may cause tissue
necrosis.
Phenobarbitone
dosage
reduction
is
recommended
in
the
elderly
and
in
patients
with
decreased renal or hepatic function.
The solution should be inspected for discolouration or the presence of
particulate matter.
The
sponsor
recommends
that
PHENOBARBITONE
INJECTION
be
given
by
the
intramuscular (IM) route.
PHENOBARBITONE INJECTION - PI
Page 2 of 19
The following dosage regimen is a guide only.
ANTICONVULSANT
_Adults _
Intramuscular, 100 to 300 mg, repeated if necessary up to a total dose
of 600 mg during a 24
hour period.
_Paediatric _
Initial – Intramuscular 10 to 20 mg per kg body weight as a single
loading dose.
Maintenance – Intramuscular 1