Chloral Hydrate Mixture 1g/10mL

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Chloral hydrate

Patient Information leaflet

CHLORAL HYDRATE MIXTURE 
_Chloral Hydrate Mixture 1g/10mL _

CONSUMER MEDICINE INFORMATION 

Chloral Hydrate 1g/10mL 
Page 1 of 5 
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 Mix

Summary of Product characteristics

 
Chloral Hydrate Mixture 1g/10mL 
Page 1 of 5 
_ _
PRODUCT INFORMATION 
CHLORAL HYDRATE MIXTURE 1G/10ML 

NAME OF DRUG:

Chloral hydrate 

DESCRIPTION: 
Chloral hydrate is a 2,2,2- trichloroethane-1,1-diol. 

C
2
H
3
Cl
3
O
2
.  MW = 165.4 
CAS Number = 302-17-0 

Chloral hydrate occurs as colourless, transparent crystals with
an aromatic, penetrating, and 
slightly acrid odour.  It is very soluble in water and freely
soluble in alcohol.  A 10% solution in 
water has a pH of 3.5 to 5.5.  Chloral hydrate volatises slowly on
exposure to air and should be 
stored in airtight containers.

_EXCIPIENTS: _
Sucrose, citric acid anhydrous, sodium citrate, saccharin sodium,
glycerol, methyl 
hydroxybenzoate, ethanol, propylene glycol, peppermint oil, purified
water. 

PHARMACOLOGY:
_ _

Chloral hydrate is a hypnotic and sedative with CNS depressant
properties similar to barbiturates.    
The mechanism of action of the drug is not completely known,
however the CNS depressant 
effects of chloral hydrate are believed to be mainly due to the active
metabolite trichloroethanol. 

PHARMACOKINETICS_:_
_ _
_ _
_ABSORPTION:  _Chloral hydrate is rapidly absorbed from the
gastrointestinal tract and starts to act 
within 30 minutes of oral administration.  The duration of action
is for between 4-8 hours.  Plasma 
concentrations of chloral hydrate (or the major metabolite
trichloroethanol) required for sedative or 
hypnotic effects are unknown. 

_DISTRIBUTION:  _Chloral hydrate is widely distributed throughout
the body, as is the active metabolite 
trichloroethanol.  Both have been detected in the CSF, umbilical
cord blood, foetal blood, and 
amniotic fluid. The active metabolite is 70% to 80% protein bound.
Following therapeutic doses of 
chloral hydrate, only small amounts of the clinically active
metabolite are distributed into breast 
milk. 

_METABOLISM: _Chloral hydrate is rapidly metabolised by the liver,
erythro