Atropt

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Atropine sulfate

Available from:

Aspen Pharma Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

ATROPT
_(At-rop-t)_

_Atropine sulphate (at-rop-een sul-fay-t) 0.5%, 1% _

CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET 

This leaflet answers some 
common questions about 
ATROPT EYE DROPS. 
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 ATROPT 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 ATROPT 

The name of your medicine 
is ATROPT EYE DROPS. 
The active ingredient is 
called atropine sulphate. 

ATROPT widens the pupil of 
the eye and blocks the 
ability to change the focus 
of the eye. 
ATROPT EYE DROPS are for 
use in the eyes only.  They 
should not be taken by 
mouth.  

WHAT IS ATROPT EYE 
DROPS USED FOR 

ATROPT EYE DROPS are used 
in eye examinations as well 
as other circumstances 
when the pupil is to be 
widened and/or the 
accommodation frozen. 
Your doctor, however, may 
have prescribed ATROPT EYE 
DROPS for another purpose. 
Ask your doctor if you have 
any questions about why 
ATROPT EYE DROPS have 
been prescribed for you. 
If you have any concerns, 
you should discuss this with 
your doctor or in his/her 
absence with your 
pharmacist. 
ATROPT EYE DROPS are 
available only on a doctor’s 
prescription. 

BEFORE YOU USE ATROPT 
EYE DROPS 
_ _
_When you must not use it _

Do not use ATROPT EYE 
DROPS if you are allergic to: 
•  Atropine or any of the 
ingredients listed at the 
end of this leaflet. 
Do not use ATROPT EYE 
DROPS if you have angle 
closure glaucoma or a 
family history of glaucoma. 
ATROPT like all medicines, 
should not be used during 
pregnancy unless your 
doctor specifically tells you 
to (CAT

Summary of Product characteristics

ATROPT EYE DROPS- Product Information 

Page 1 of 4 
PRODUCT INFORMATION 

ATROPT EYE DROPS 

NAME OF THE MEDICINE 

ATROPT EYE DROPS

contain atropine sulfate (1%) in a sterile ophthalmic solution.

Atropine  sulphate  is  both  a  mydriatic  and  cycloplegic  and  has  the  following  chemical 
structure: 

2. H
2
SO
4

It  has  a  molecular  formula  of  (C
17
H
23
NO
3
)
2
,H
2
SO
4
,H
2
O  and  a  molecular  weight  of 
694.8.  (CAS - 55-48-1 [anhydrous]; CAS - 5908-99-6
[monohydrate]) 

PHYSICAL AND CHEMICAL PROPERTIES: 
Atropine sulphate exists as odourless, colourless crystals or white crystalline powder.  It 
effloresces  in  dry  air.    It  is  soluble  in  water  (1  in  0.5),  in  boiling  water  (1  in  2.5),  in 
alcohol  (1  in  5),  in  glycerol  (1  in  2.5),  and  is  practically  insoluble  in  chloroform  and 
ether.  A 2% solution  in  water has a pH of 4.5 to  6.2.  Solutions  may be sterilised by 
autoclave.  Atropine sulphate should be protected from light. 

DESCRIPTION 

ATROPT  eye  drops  are  a  clear  or  almost  clear,  odourless,  slightly  viscous,  colourless 
liquid which foams on shaking. 
_The  product  contains  the  following  excipients_:  Disodium  edetate,  benzalkonium 
chloride, hypromellose, boric acid and water - purified. 

PHARMACOLOGY 

ACTIONS: 
Atropine is a belladonna alkaloid.  Atropine sulphate acts in the eye to block the action 
of  acetylcholine,  relaxing  the  cholinergically  innervated  sphincter  muscle  of  the  iris.  
This  results  in  dilation  of  the  pupil  (mydriasis).    The  cholinergic  stimulation  of  the 
OH
O
O
N
H
H
3
C
ATROPT EYE DROPS- Product Information 

Page 2 of 4 
accommodative�