ORION DIAZEPAM 10mg/10mL oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

diazepam, Quantity: 1 mg/mL

Available from:

Orion Laboratories Pty Ltd T/A Perrigo Australia

INN (International Name):

Diazepam

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: ethanol; propylene glycol; glycerol; citric acid; sodium citrate dihydrate; purified water; Flavour

Administration route:

Oral

Units in package:

100mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 30 SEPTEMBER 2003: Diazepam is indicated in the management of anxiety disorders and for the short term relief of the symptoms of anxiety. Diazepam is a useful adjunct for the relief of reflux muscle spasm due to local trauma (injury, inflammation) to muscles, bones and joints. It is also indicated in the management of cerebral spasiticity due to upper motor neuron lesions such as cerebral palsy and paraplegia, and spasticity in athetosis and stiff man syndrome. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.

Product summary:

Visual Identification: Clear, colourless, slightly viscous liquid; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1992-11-26

Patient Information leaflet

Diazepam Elixir

10mg/10mL
Page 1 of 4
DIAZEPAM ELIXIR ®
_Diazepam Elixir 10mg/10mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET?
This leaflet answers some
common questions about
Diazepam Elixir. It does not
contain all the available
information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you taking
Diazepam Elixir against the
benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT DIAZEPAM
ELIXIR IS USED FOR:
Diazepam is used for anxiety.
Anxiety or tension associated
with the normal stress of
everyday life usually does not
require treatment with
medicines.
Diazepam is used to relax
muscles.
Diazepam can also be used to
treat trembling, confusional
states or anxiety associated
with alcohol withdrawal. It is
also used to treat panic attacks.
Your doctor, however, may
have prescribed Diazepam
Elixir for another purpose. Ask
your doctor if you have any
questions about why Diazepam
Elixir has been prescribed for
you.
Diazepam Elixir belongs to a
group of medicines called
benzodiazepines. They are
thought to work by their action
on brain chemicals.
In general, benzodiazepines
such as Diazepam Elixir should
be taken for short periods only
(for example 2 - 4 weeks).
Continuous long term use is not
recommended unless advised
by your doctor. The use of
benzodiazepines may lead to
dependence on the medicine.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU TAKE
DIAZEPAM ELIXIR:
_WHEN YOU MUST NOT TAKE _
_DIAZEPAM ELIXIR: _
DO NOT TAKE DIAZEPAM ELIXIR
IF:
1. YOU HAVE AN ALLERGY TO:

Diazepam or any of the
ingredients listed at the end
of this leaflet.

Any other medicine from the
benzodiazepine group of
medicines.
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing,
or difficulty breathing; swe

Summary of Product characteristics

Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION – DIAZEPAM ELIXIR
(DIAZEPAM 10MG/10ML) ORAL LIQUID, SOLUTION
1
NAME OF THE MEDICINE
Diazepam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient of Diazepam Elixir is diazepam 10mg/10mL.
Excipients with known effect: ethanol and sodium citrate dihydrate.
For the full list of excipients, see _Section 6.1 List of excipients_.
3
PHARMACEUTICAL FORM
Diazepam Elixir contains diazepam 10 mg per 10 mL. It is a clear,
colourless to yellow, slightly
viscous liquid with an odour of blackcurrant and is available in a
100mL amber glass bottle.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Diazepam is indicated in the management of anxiety disorders and for
the short term relief of
the symptoms of anxiety. Diazepam is a useful adjunct for the relief
of reflex muscle spasm due
to local trauma (injury, inflammation) to muscles, bones and joints.
It is also indicated in the
management of cerebral spasticity due to upper motor neuron lesions
such as cerebral palsy
and paraplegia, and spasticity in athetosis and stiff man syndrome. In
acute alcohol withdrawal,
diazepam may be useful in the symptomatic relief of acute agitation,
tremor, impending or acute
delirium tremens and hallucinosis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
GENERAL
The lowest dose which can control the symptoms should be used. The
dosage should be
carefully individualised for maximum benefit. Dosage may need to be
reduced in patients with
hepatic or renal disease as the elimination half-life may be prolonged
in this group. Treatment
with benzodiazepines should always be withdrawn gradually. Elderly
patients should be given a
reduced dose. These patients should be checked regularly at the start
of treatment in order to
minimize
the
dosage
and/or
frequency
of
administration
to
prevent
overdose
due
to
accumulation.
In general benzodiazepines should be prescribed for short periods (for
example 2-4 weeks).
Long term use of diazepam is not recommended. There is evidence that
tolerance develops to
the se