ORION CHLORAL HYDRATE MIXTURE 1g/10mL bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

chloral hydrate, Quantity: 100 mg/mL

Available from:

Orion Laboratories Pty Ltd T/A Perrigo Australia

INN (International Name):

Chloral hydrate

Pharmaceutical form:

Oral Liquid, solution

Composition:

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

Administration route:

Oral

Units in package:

200mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 19 SEPTEMBER 2003: Chloral Hydrate Mixture is indicated pre-operatively to produce sedation. It is also indicated for short term (not more than 2 weeks) use as a hypnotic to assist in sleep disorders.

Product summary:

Visual Identification: Clear, colourless, syrupy liquid; Container Type: Bottle; 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

Page 1 of 5
CHLORAL HYDRATE MIXTURE
_Chloral Hydrate Mixture 1g/10mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET?
Please read this leaflet
carefully before you take
Chloral Hydrate Mixture.
This leaflet answers some
common questions about
Chloral Hydrate Mixture. It
does not contain all 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 taking
Chloral Hydrate Mixture against
the benefits they expect it will
have for you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the
medicine. You may need to
read it again.
WHAT IS CHLORAL
HYDRATE MIXTURE
USED FOR?
The brand name of your
medicine is Chloral Hydrate
Mixture. The active ingredient
in Chloral Hydrate Mixture is
called chloral hydrate.
Chloral hydrate belongs to a
group of medicines called
sedatives and hypnotics. It is
used short term to treat
insomnia, a condition where
people have difficulty sleeping.
In patients with insomnia,
Chloral Hydrate Mixture
decreases the time it takes to
fall asleep and increases the
length of time spent sleeping.
Chloral Hydrate Mixture is also
used to calm patients down and
make them sleepy before
surgery. If your child is to be
given chloral hydrate before a
dental or medical procedure, it
should only be administered at
the health care facility where
the procedure is to be done.
This will allow the health care
professional to monitor your
child.
Chloral Hydrate mixture
remains active in the body for
many hours and may cause
drowsiness the next day.
Your doctor may have
prescribed Chloral Hydrate
Mixture for another use. Ask
your doctor if you have any
questions about why Chloral
Hydrate Mixture has been
prescribed for you.
In general, sedatives and
hypnotics such as Chloral
Hydrate Mixture should be
taken for short periods only (no
more than 2 weeks).
Continuous long term use is not
recommended unless advised
by your doctor. The use of
C

Summary of Product characteristics

Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION – CHLORAL HYDRATE
MIXTURE (CHLORAL HYDRATE 1G/10ML) ORAL LIQUID, SOLUTION
1
NAME OF THE MEDICINE
Chloral hydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient of Chloral Hydrate Mixture is chloral hydrate
1g/10mL.
Excipients
with
known
effect:
sucrose,
sodium
citrate,
saccharin
sodium,
methyl
hydroxybenzoate, ethanol.
For the full list of excipients, see _Section 6.1 - List of
excipients_.
3
PHARMACEUTICAL FORM
Chloral hydrate mixture 1g/10mL is a clear, colourless, syrupy liquid
in a 200mL bottle.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Chloral Hydrate Mixture is indicated pre-operatively to produce
sedation. It is also indicated for
short term (not more than 2 weeks) use as a hypnotic to assist in
sleep disorders.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dosage of chloral hydrate must be individualised for each patient.
Generally Chloral Hydrate Mixture should be well diluted with water or
another liquid (e.g. fruit
juice, ginger ale) prior to administering. Gastric irritation may be
minimised by diluting the
mixture before administering.
ADULTS:
The usual hypnotic dose is 500mg to 1g given 15-30 minutes before
bedtime, or when used as a
preoperative medication, 30 minutes before surgery.
The maximum daily dose in adults should not exceed 2g.
CHILDREN:
Sedatives should be administered preoperatively to children only at
the health facility, where
appropriate monitoring can be instituted (see _Section 4.4 - Special
Warnings and Precautions for _
_Use_). Monitoring must continue until the child’s level of
consciousness has returned to a state
that meets the approved discharge criteria.
Particular care must be taken in calculating and administering the
proper dose appropriate to
the age and weight of paediatric patients.
Page 2 of 9
The usual hypnotic dose is 30-50 mg/kg or 1.5 g/m2 with a maximum
single dose of 1g (10mL).
As premedication, children have been given chloral hydrate in a dose
of 20-50 mg/kg, to a
maximum single dose of 1g