Consumer medicine information

Atropt 1%

Atropine sulfate monohydrate

BRAND INFORMATION

Brand name

Atropt 1%

Active ingredient

Atropine sulfate monohydrate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Atropt 1%.

What is in this leaflet

This leaflet answers some common questions about Atropt 1% 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 1% 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 1%

The name of your medicine is Atropt 1% Eye Drops.

The active ingredient is called atropine sulphate monohydrate.

Atropt 1% widens the pupil of the eye and blocks the ability to change the focus of the eye.

Atropt 1% Eye Drops are for use in the eyes only. They should not be taken by mouth.

What is it used for

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.

Your doctor, however, may have prescribed Atropt 1% Eye Drops for another purpose.

Ask your doctor if you have any questions about why Atropt 1% 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 1% Eye Drops are available only on a doctor’s prescription.

Before you use it

When you must not use it

Do not use Atropt 1% Eye Drops if you are allergic to:

  • Atropine or any of the ingredients listed at the end of this leaflet.

Do not use Atropt 1% Eye Drops if you have angle closure glaucoma or a family history of glaucoma.

Atropt 1% like all medicines, should not be used during pregnancy unless your doctor specifically tells you to.

Do not use Atropt 1% Eye Drops after the expiry date printed on the pack. If you use it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.

Do not purchase or use Atropt 1% Eye Drops if the packaging is torn or shows signs of tampering.

Before you start to take it.

You must tell your doctor if you are:

  • allergic to any other medicines or any foods, dyes or preservatives.
  • have glaucoma or a family history of glaucoma
  • wearing contact lenses

Taking other medicines

Tell your doctor if you are taking any other medication, including medicines, creams, ointments or lotions that you buy without a prescription from a pharmacy, supermarket or health food shop.

Do not use in children unless specifically directed to by your doctor.

Your doctor or pharmacist has information on medicines to be careful with or avoid while using Atropt 1%.

How to use it

How to use it

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.

When to use Atropt 1% Eye Drops

Use as directed by your Doctor. Do not use more than the number of drops he/she advises or use them more frequently than directed.

It is important to use Atropt 1% Eye Drops exactly as directed.

If you use less than you should, it may not work as well and your medical condition may not improve.

Using it more frequently than you should may not improve your condition any faster and may cause or increase side effects.

If you forget to use Atropt 1% Eye Drops at the required time.

Use it as soon as you remember and then return to your normal dosing time.

If your next dose is almost due, leave using Atropt 1% Eye Drops until that time.

Do not try to make up for missed doses by using more than one dose at a time.

This may increase the chance of getting an unwanted side effect.

If you have trouble remembering when to use Atropt 1% Eye Drops, ask your pharmacist for some hints.

If you accidentally swallow it:

Immediately phone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think you or anyone else may have swallowed Atropt 1%. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol which has been taken. You may need urgent medical attention.

Keep telephone numbers for these places handy.

While you are using it

Things you must do:

Tell your doctor if you feel Atropt 1% Eye Drops are not helping your condition.

Tell your doctor if, for any reason, you have not used your Atropt 1% Eye Drops as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Always discuss with your doctor any problems or difficulties during or after using Atropt 1% Eye Drops.

Things you must not do:

Do not give Atropt 1% Eye Drops to anyone else even though their symptoms seem similar to yours.

Do not use Atropt 1% for other conditions unless your doctor tells you. Atropt 1% Eye Drops have been prescribed for you for a specific condition.

If you use it for another condition, it may not work or may make the condition worse.

Do not give Atropt 1% Eye Drops to small children.

Things to be careful of:

The pupil dilation will last for up to 12 days. This can make driving or using machinery difficult and possibly hazardous.

While the pupil is dilated you will experience distorted vision, lack of tolerance to bright light or sunlight and possible distortion of your balance. Special care is needed at these times.

Ask your doctor or pharmacist if you are concerned about the length of time you have used Atropt 1% Eye Drops.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while using Atropt 1% Eye Drops.

Atropt 1% Eye Drops helps most people with medical conditions listed in the beginning of this leaflet, but it may have unwanted side effects in some people.

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist any questions you may have.

Common side effects

The most common side effects of Atropt 1% Eye Drops are:

  • temporary blurred vision.
  • burning, stinging, redness or watering of the eyes.

There is a possibility of systemic absorption of Atropt 1% Eye Drops.

If this occurs you may experience flushing, dryness of the skin, rapid and irregular pulse, fever, mental aberrations and loss of neuromuscular coordination.

Atropt 1% Eye Drops may cause other side effects, check with your doctor.

Check with your doctor as soon as possible if you have any problems while using Atropt 1% Eye Drops even if you do not think the problems are connected with the medicine or are not listed on this leaflet.

Do not be alarmed by the list of side effects or their discussion. You may not experience any of them.

After using it

Storage:

Keep Atropt 1% where children cannot reach it. A locked cupboard at least one and a half metres above the floor is a good place to store medicines.

Keep Atropt 1% Eye Drops in a cool, dry place where the temperature stays below 25°C and protect from light.

Do not freeze or refrigerate. Do not store it or any other medicines in a bathroom or near a sink.

Do not leave Atropt 1% Eye Drops in the car or on windowsills.

Discard any of the drops still left after 4 weeks from first using them.

Disposal

If your doctor tells you to stop using Atropt 1% Eye Drops, or they pass their expiry date, ask your pharmacist what to do with any left over.

Product description

What it looks like

Atropt 1% Eye Drops are presented in a plastic dropper bottle with a tamper proof seal.

Atropt 1% Eye Drops contain atropine sulphate in a sterile aqueous base thickened with hypromellose.

The excipients or non-active ingredients are:

Disodium edetate, benzalkonium chloride, hypromellose, boric acid and water for injections.

Sponsor

Aspen Pharma Pty Ltd
34-36 Chandos Street,
St. Leonards NSW 2065
Australia

Australian Registration number for Atropt 1% Eye Drops is AUST R 19648.

This leaflet was prepared in August 2020.

Published by MIMS October 2020

BRAND INFORMATION

Brand name

Atropt 1%

Active ingredient

Atropine sulfate monohydrate

Schedule

S4

 

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

4.1 Therapeutic Indications

Atropt 1% eye drops are indicated where it is necessary to dilate the pupil and paralyse accommodation.

4.2 Dose and Method of Administration

Instil one drop into the eye as required for treatment. To minimise the risk of systemic absorption, gentle pressure should be applied to the tear duct for one minute after application.

4.3 Contraindications

Atropt 1% eye drops are contraindicated in the presence of angle closure glaucoma or where angle closure glaucoma is suspected. If used in glaucoma susceptible patients, an estimation of the depth of the angle of the anterior chamber should be performed prior to the initiation of therapy.
Hypersensitivity to any of the ingredients of Atropt 1% eye drops.

4.4 Special Warnings and Precautions for Use

Patients treated prior to ophthalmic examination should be escorted to and from the surgery.
Risk benefit should be considered when the following medical problems exist: keratoconus (atropine may produce fixed dilated pupil), synechiae between the iris and lens.

Use in the elderly.

Geriatric patients are more susceptible to the effects of atropine, thus increasing the potential for systemic side effects.

Paediatric use.

Atropt 1% must not be used in children less than 2 years old as it contains boron which may impair fertility in the future.
Atropine sulfate monohydrate should not be used in children who have previously had severe systemic reaction to atropine. An increased susceptibility to atropine has been reported in infants and young children and in children with blonde hair, blue eyes, Down's syndrome, spastic paralysis, or brain damage; therefore atropine should be used with great caution in these patients.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Anticholinergics.

If significant systemic absorption of ophthalmic atropine occurs, concurrent use of other anticholinergics or medications with anticholinergic activity may result in potentiated anticholinergic effects.

Antiglaucoma agents.

(Cholinergic, long acting, ophthalmic). Concurrent use with atropine may antagonise the antiglaucoma and miotic actions of ophthalmic long acting cholinergic antiglaucoma agents such as echothiophate. Concurrent use with atropine may also antagonise the anti-accommodative convergence effects of these medications when they are used for the treatment of strabismus.

Antimyasthenics, potassium citrate, potassium supplements.

If significant systemic absorption of ophthalmic atropine occurs, concurrent use may increase the chance of toxicity and/or side effects of these systemic medications because of the anticholinergic induced slowing of gastrointestinal motility.

Carbachol, physostigmine or pilocarpine.

Concurrent use with atropine may interfere with the antiglaucoma action of carbachol, physostigmine or pilocarpine. Also, concurrent use may counteract the mydriatic effect of atropine; this counteraction may be used to therapeutic advantage.

CNS depression producing medications.

If significant absorption of systemic atropine occurs, concurrent use of medications having CNS effects, such as antiemetic agents, phenothiazines, or barbiturates, may result in opisthotonos, convulsions, coma, and extrapyramidal symptoms.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available. Excipients containing boron such as boric acid or borate compounds have been shown to cause reduced fertility and effects on embryofoetal development in animal studies and this appears to be dose related. The relevance of this to humans is uncertain.
(Category A)
Atropine sulfate monohydrate may be systemically absorbed after ocular administration, however significant effects on the foetus have not been reported.
Systemically absorbed atropine sulfate monohydrate is distributed into breast milk in very small amounts. It may cause adverse effects, such as rapid pulse, fever, or dry skin, in nursing infants of mothers using ophthalmic atropine.

4.7 Effects on Ability to Drive and Use Machines

No data available.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions have been reported.

Ophthalmic.

Blurred vision, local irritation, follicular conjunctivitis, vascular congestion, oedema, exudate, contact dermatitis, eczematous dermatitis.

Systemic.

Systemic atropine toxicity may be manifest as flushing and dryness of the skin, blurred vision, rapid and irregular pulse, fever, abdominal distension in infants, mental aberration and loss of neuromuscular coordination. Severe systemic reactions to atropine are characterised by hypotension with progressive respiratory depression. Ophthalmic atropine has been associated with cardiac arrhythmias (e.g. atrial fibrillation) in a few patients.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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

5.1 Pharmacodynamic Properties

Mechanism of action.

Atropine is a belladonna alkaloid. Atropine sulfate monohydrate 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 accommodative ciliary muscle of the lens is also blocked. This results in paralysis of accommodation (cycloplegia).
Atropine sulfate monohydrate has a slower onset and more prolonged effects than most other anticholinergics. Maximum mydriatic effect occurs in around 30 to 40 minutes. Maximum cycloplegia takes several hours. Mydriasis usually lasts 7 to 12 days and cycloplegia persists for 14 days or longer. Onset of effects and duration may be prolonged in heavily pigmented eyes.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Atropine is readily absorbed from the gastrointestinal tract; it is also readily absorbed from mucous membranes, the eye, and to some extent through intact skin.

Distribution.

It is rapidly cleared from the blood and is distributed throughout the body. It crosses the blood brain barrier.

Metabolism.

It is incompletely metabolised in the liver.

Excretion.

It is excreted in the urine as unchanged drug and metabolites. A half-life of 4 hours has been reported.

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

6.1 List of Excipients

Atropt 1% eye drops contains: disodium edetate, benzalkonium chloride, hypromellose, boric acid and water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Atropt 1% eye drops 1%: 15 mL PE-dropper bottles fitted with PP tamper evident eye drop cap.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

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:
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