Consumer medicine information

1. Why am I using ATROPT 1% Eye Drops?

ATROPT 1% eye drops contain the active ingredient atropine (as atropine sulfate monohydrate). ATROPT 1% eye drops are used in eye examinations as well as other circumstances when the pupil is to be widened and/or the accommodation frozen.
For more information, see Section 1. Why am I using ATROPT 1% eye drops? in the full CMI.

2. What should I know before I use ATROPT 1% Eye Drops?

Do not use if you have ever had an allergic reaction to ATROPT 1% or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use ATROPT 1% eye drops? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ATROPT 1% and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use ATROPT 1% Eye Drops?

• Your doctor will advise you on how much and how often you should use ATROPT 1% eye drops.

• Gently pull out the lower eyelid to form a sac. Allow one drop to fall into the sac without touching the eye with the dropper end of the bottle.

• To minimise absorption of the drug other than into the eye, apply gentle pressure to the tear duct for approximately one minute immediately after application.

5. What should I know while using ATROPT 1% eye drops?

6. Are there any side effects?

Common side effects of ATROPT 1% Eye Drops mainly relate to the eye or eye area. These include temporarily blurred vision; burning, stinging, redness, or watering of the eyes; and conjunctivitis (or pink eye). Serious side effects may also occur, mainly if too much of the medication is absorbed into the rest of the body. Signs of this include flushing and dryness of the skin; rapid and irregular pulse; fever, mental aberrations; loss of muscular coordination; dizziness or light-headedness; fatigue or lethargy; shortness of breath; or confusion, disorientation or altered mental state.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Atropine sulfate monohydrate.

2 Qualitative and Quantitative Composition

Atropt 1% eye drops contains atropine sulfate monohydrate (1%) in a sterile ophthalmic solution.
Atropt 1% eye drops contains Benzalkonium chloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Atropt 1% eye drops are a clear or almost clear, odourless, slightly viscous, colourless liquid which foams on shaking.

4 Clinical Particulars

4.9 Overdose

Signs of overdosage are similar to those described as systemic effects (see Section 4.8 Adverse Effects (Undesirable Effects)). Treatment is symptomatic and supportive.
For systemic effects, 0.2 to 1 mg (0.2 mg in children) physostigmine should be administered intravenously, as a dilution containing 1 mg in 5 mL of normal saline. The solution should be injected over a period of not less than 2 minutes. Dosage may be repeated every 5 minutes up to a total dose of 2 mg in children and 6 mg in adults in each 30 minute period. Physostigmine is contraindicated in hypertensive reactions. ECG monitoring is recommended during physostigmine administration.
Excitement may be controlled by diazepam or a short acting barbiturate.
It is recommended that 1 mg of atropine be available for immediate injection if the physostigmine causes bradycardia, convulsion, or bronchoconstriction.
Supportive therapy may require oxygen and assisted respiration; cool water baths for fever, especially in children; and catheterisation for urinary retention. In infants and small children, the body surface should be kept moist.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Studies have not been performed in either animals or humans to evaluate the potential mutagenic effects of atropine.
Carcinogenicity. Studies have not been performed in either animals or humans to evaluate the potential carcinogenic effects of atropine.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Atropine sulfate monohydrate 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 sulfate monohydrate should be protected from light.
Chemical structure. Atropine sulfate monohydrate is both a mydriatic and cycloplegic has the following chemical structure:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSATRSUM.gif It has a molecular formula of (C₁₇H₂₃NO₃)₂.H₂SO₄.H₂O and a molecular weight of 694.8.
CAS number. CAS - 55-48-1 (anhydrous); CAS - 5908-99-6 (monohydrate).

7 Medicine Schedule (Poisons Standard)

Prescription only medicine: S4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ATROPTST.gif