Consumer medicine information

Atropine Injection BP

Atropine sulfate monohydrate

BRAND INFORMATION

Brand name

Bridgewest Atropine Injection BP

Active ingredient

Atropine sulfate monohydrate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Atropine Injection BP.

Atropine Injection BP

Atropine Injection BP


 Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.


 1. Why am I given Atropine Injection?

Atropine Injection contains the active ingredient atropine sulfate monohydrate. Atropine Injection is given before anaesthesia to decrease mucus secretions, such as saliva. During anaesthesia and surgery, atropine is used to help keep the heart beat normal. Atropine Injection is also used to block or reverse the adverse effects caused by some medicines and certain types of pesticides.

For more information, see Section 1. Why am I given Atropine Injection? in the full CMI.

 2. What should I know before receiving Atropine Injection?

Do not use if you have ever had an allergic reaction to atropine, or any of the anticholinergic medicines such as hyoscyamine and belladonna.

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 receiving Atropine Injection? in the full CMI.

 3. What if I am taking other medicines?

Some medicines may interfere with Atropine Injection 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 is Atropine Injection given?

Atropine Injection will be given to you by a doctor or nurse as an injection under the skin, into the muscle or directly into the blood stream.

More information can be found in Section 4. How is Atropine Injection given? in the full CMI.

 5. What should I know after receiving Atropine Injection?

Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Atropine Injection affects you. Atropine Injection may cause drowsiness or blurred vision in some people

For more information, see Section 5. What should I know after receiving Atropine Injection? in the full CMI.

 6. Are there any side effects?

Common side effects are blurred vision, dilation of pupils, difficulty in urinating, constipation, fever, flushing, dryness of skin, headache, dizziness, drowsiness and/or weakness, nervousness, restlessness, confusion, unusual excitement shaking and/or tremor, nausea, vomiting, fast and/or irregular heartbeat, loss of taste, dryness of the mouth, nose and throat, thirst.

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.


Atropine Injection BP

Active ingredient(s): atropine sulfate monohydrate


 Consumer Medicine Information (CMI)

This leaflet provides important information about using Atropine Injection. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about receiving Atropine Injection.

Where to find information in this leaflet:

1. Why am I given Atropine Injection?
2. What should I know before receiving Atropine Injection?
3. What if I am taking other medicines?
4. How is Atropine Injection given?
5. What should I know after receiving Atropine Injection?
6. Are there any side effects?
7. Product details

1. Why am I given Atropine Injection?

Atropine Injection contains the active ingredient atropine sulfate monohydrate. Atropine sulfate monohydrate belongs to a group of medicines called antimuscarinic agents.

Atropine Injection is given before anaesthesia to decrease mucus secretions, such as saliva. During anaesthesia and surgery, atropine is used to help keep the heart beat normal. Atropine Injection is also used to block or reverse the adverse effects caused by some medicines and certain types of pesticides.

2. What should I know before receiving Atropine Injection?

Warnings

You must not be given Atropine Injection if:

  • you are allergic to atropine, or have had an unusual reaction to atropine or any of the anticholinergic medicines such as hyoscyamine and belladonna.
    Always check the ingredients to make sure you can use this medicine.
  • you have or have had any medical conditions, especially the following:
    - severe and chronic inflammation of the large intestine and rectum
    - gastrointestinal blockage and/or diseases
    - enlarged prostate
    - urinary tract blockage and/or bladder problems
    - fever, or if you are exposed to very high temperatures
    - glaucoma and/or family history of glaucoma
    - myasthenia gravis (severe muscle weakness)
    - acute bleeding, especially if you have heart problems
    - heart disease
    - high blood pressure due to pregnancy
    - overactive thyroid.

If you are not sure whether any of these apply to you, check with your doctor.

Check with your doctor if you:

  • have or have had any medical conditions, especially the following:
    - brain damage and/or mental confusion
    - lung diseases
    - liver and/or kidney diseases
    - hormone problems
    - high blood pressure
    - fast heart beat
    - hiatus hernia
    - heart diseases
    - stomach and intestinal problems
    - gastric ulcer, diarrhoea or gastrointestinal infection.
  • take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

3. What if I am taking other medicines?

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

Some medicines and atropine sulfate monohydrate may interfere with each other. These include:

  • medicines to treat irregular heartbeat e.g. disopyramide and quinidine
  • blood "thinning" medicines e.g., heparin, warfarin
  • medicines to treat Parkinson's disease
  • metoclopramide, a medicine to treat nausea and vomiting
  • cisapride, a medicine used in certain stomach problems
  • anticholinergic medicines to prevent travel sickness, relieve stomach cramps or spasms
  • antispasmodics
  • bethanechol, a medicine used in bladder function disorders
  • antihistamines
  • medicines to treat depression such as tricyclic antidepressants
  • medicines used to treat certain mental and emotional conditions
  • ketoconazole, a medicine to treat fungal infections
  • narcotic analgesics to treat severe pain
  • medicines used for glaucoma e.g. pilocarpine, carbachol
  • medicines to treat Alzheimer's disease e.g. rivastigmine and donepezil
  • muscle relaxants used during an operation.

If you are to receive Atropine Injection as a premedication, your doctor will advise if you should continue to take your regular medicines.

Check with your doctor if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Atropine Injection.

4. How is Atropine Injection given?

How much is given

Your doctor will decide what dose and how often you will receive Atropine Injection. The dosage you will be given will depend on your condition, what it is being used for and other factors, such as your age, and whether or not other medicines are being given at the same time.

How is it given

Atropine Injection will be given to you by a doctor or nurse as an injection under the skin, into the muscle or directly into the blood stream.

If you are given too much

This rarely happens as Atropine Injection will be given to you in hospital under the care of a highly trained doctor.

In the unlikely event that you are given too much (an overdose), you may experience some of the effects listed under Section 6. Are there any side effects?

The signs of overdose are dilation of the pupils, difficulty in swallowing, hot dry skin, thirst, dizziness, flushing and inability to pass urine. Rapid breathing, increased heart rate, tremor, fatigue, loss of muscle control, confusion, hallucinations, paranoid, hyperactivity and occasional seizures or convulsions may also occur.

Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns.

5. What should I know after receiving Atropine Injection?

Things you should do

Tell your doctor or nurse if you do not feel well after you have been given Atropine Injection.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Atropine Injection affects you.

Atropine Injection may cause drowsiness or blurred vision in some people.

Looking after your medicine

Atropine Injection is usually stored in the hospital, clinic or at the pharmacy.

Your doctor, pharmacist or nurse is responsible for storing Atropine Injection in a cool dry place, where the temperature stays below 25°C and disposing of any unused product correctly.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Possible side effectsWhat to do
  • blurred vision and/or discomfort in the eyes especially if your eyes are more sensitive to light than normal, dilation of pupils
  • difficulty in urinating
  • constipation
  • fever
  • flushing, dryness of skin
  • skin rash, hives
  • headache, dizziness, drowsiness and/or weakness
  • nervousness, restlessness, confusion, unusual excitement shaking and/or tremor
  • nausea, vomiting
  • fast and/or irregular heart beat
  • loss of taste
  • dryness of the mouth, nose and throat, thirst
Tell your doctor or nurse if you notice any of these side effects or they worry you.

Tell your doctor or nurse if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is only available with a doctor's prescription.

What Atropine Injection contains

Active ingredient
(main ingredient)
  • atropine sulfate monohydrate (600 micrograms in 1 mL or 1200 micrograms in 1 mL)
Other ingredients
(inactive ingredients)
  • sodium chloride
  • water for Injections
It does not contain preservatives.

Tell your doctor if you are allergic to any of these ingredients.

What Atropine Injection looks like

Atropine Injection is a clear, colourless solution in a plastic ampoule.

Atropine Injection BP 600 micrograms in 1 mL is available in packs of 10 or 50 ampoules (Aust R 11302)

Atropine Injection BP 1200 microgram in 1 mL is available in packs of 50 ampoules (Aust R 11303)

* Not all presentations and pack sizes may be marketed.

Who manufactures and distributes Atropine Injection

Bridgewest Perth Pharma Pty Ltd
15 Brodie Hall Drive
Bently WA 6102
Telephone: 1800 161 156
safety@lumacina.com

This leaflet was prepared in September 2023.

Published by MIMS November 2023

BRAND INFORMATION

Brand name

Bridgewest Atropine Injection BP

Active ingredient

Atropine sulfate monohydrate

Schedule

S4

 

1 Name of Medicine

Atropine sulfate monohydrate.

2 Qualitative and Quantitative Composition

Atropine Injection BP is a sterile, isotonic, preservative free solution containing 600 micrograms of atropine sulfate monohydrate in 1 mL or 1200 micrograms of atropine sulfate monohydrate in 1 mL.

3 Pharmaceutical Form

Solution for injection.
Clear, colourless solution.

4 Clinical Particulars

4.9 Overdose

There is considerable patient variability in the susceptibility to atropine. Atropine overdosage is characterised by both peripheral and central symptoms. Toxic doses cause dilated pupils, difficulty in swallowing, hot dry skin, thirst, dizziness, vasodilation, urinary retention, tachycardia, rapid respiration, hyperpyrexia, and central nervous system stimulation marked by restlessness, tremor, fatigue, ataxia, confusion, excitement, paranoid psychotic reactions, delirium, hallucinations and occasionally seizures or convulsions. A rash may appear on the face or upper trunk. In severe toxicity, CNS stimulation may give way to CNS depression, coma, circulatory and respiratory failure and death. following paralysis and coma. In addition to tachycardia, cardiac manifestations may include ECG abnormalities (e.g. ventricular arrhythmias, extrasystoles) resulting from enhanced re-entrant excitation secondary to reduced conduction velocity. Widening of the QRS complex, prolongation of the QT interval and ST segment depression may also be seen.
Treatment. Symptomatic and supportive therapy should be provided. Close monitoring, including ECG monitoring, is recommended. Fluid therapy and other standard treatments for shock should be administered. Hyperthermia should be treated with cold packs, mechanical cooling devices or sponging with tepid water. Maintenance of adequate airway is essential, with respiratory assistance if necessary. Urinary catheterisation may be required if the patient is comatose. If photophobia occurs, the patient may be kept in a dark room.
The use of physostigmine as an antidote for atropine poisoning is controversial due to the potential for physostigmine to produce severe adverse effects, e.g. seizures, asystole. The use of physostigmine should be reserved for treatment of patients with extreme delirium or agitation, patients with repetitive seizures, patients with severe sinus tachycardia or supraventricular tachycardia or unresponsive extreme hyperthermia in patients who fail to respond to alternative therapy. Physostigmine should not be used to treat cardiac conduction defects or ventricular tachyarrhythmias. IV propranolol may be useful for treatment of supraventricular tachyarrhythmias unresponsive to physostigmine or where physostigmine is contraindicated.
Relative contraindications to the use of physostigmine include asthma, gangrene, cardiovascular disease and mechanical obstruction of the gastrointestinal or genitourinary tract. In such patients physostigmine should only be used where a life threatening emergency occurs.
Diazepam may be administered to control excitement, delirium or other symptoms of acute psychosis. Phenothiazines should be avoided since these may exacerbate antimuscarinic effects.
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 undertaken in either animals or humans to evaluate the mutagenic potential of atropine.
Carcinogenicity. Studies have not been undertaken in either animals or humans to evaluate the potential of atropine.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Atropine sulfate monohydrate is bis (1R,3r,5S) -3-[(RS) -(3-hydroxy-2- phenylpropionyl)oxy]-8-methyl-8- azabicyclo[3.2.1]octane sulfate. It appears as colourless crystals or a white crystalline powder. It is very soluble in water, freely soluble in alcohol and practically insoluble in ether.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSATRSUM.gif Molecular formula: (C17H23NO3)2,H2SO4,H2O.
Molecular weight: 695.
CAS number. 5908-99-6.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine - S4.

Summary Table of Changes

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