Skip to Content

ATROPINE SULFATE 3 MG/10 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): ATROPINE SULFATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Atropine sulfate
3 mg/10 ml

Solution for injection in pre-filled syringe
(Referred to as Atropine sulfate Injection in this leaflet)
Read all of this leaflet carefully before you start using
this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Atropine sulfate Injection is and what it is used for
2. Before you use Atropine sulfate Injection
3. How to use Atropine sulfate Injection
4. Possible side effects
5. How to store Atropine sulfate Injection
6. Further information.

1. WHAT ATROPINE SULFATE INJECTION IS AND
WHAT IT IS USED FOR
Atropine belongs to a group of medicines known as
anticholinergics.

This medicine is used:
• To prevent slow or irregular heart rate during surgery or
when a doctor places a tube in your windpipe (tracheal
intubation),
• To treat slow heart rate in emergency situations,
• To control the side effects of neostigmine (a medicine
sometimes used after surgery).

Do not use Atropine sulfate Injection if you:
• are allergic (hypersensitive) to atropine or any of the other
ingredients of Atropine sulfate Injection (See section 6.
Further information),
• have elevated pressure in your eye (glaucoma),
• have a risk of urine retention because of a prostate gland
problem or bladder disease,
• suffer from pyloric stenosis (where the stomach cannot
empty properly), paralytic ileus (a disease that causes
severe constipation and bloating caused by inactivity of
your intestines), or if you have severe ulcerative colitis (a
disease of the colon and rectum),
• have myasthenia gravis (extreme tiredness and muscle
weakness),
• are breast-feeding.
Take special care with Atropine sulfate Injection.
Tell your doctor if you have:
• bladder difficulties,
• hyperthyroidism,
• heart failure, irregular heart beat,
• liver or kidney disease,
• chronic bronchitis,
• gastric reflux,
• fever.
Using other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription, especially:
• some antidepressants,
• some antihistamines (e.g., for use in allergy),
• medicines for Parkinson's disease,
• neuroleptics (e.g., for use in mental illness),
• quinidine or disopyramide (e.g., for use in heart disease),
• antispasmodics (e.g., for use in irritable bowel syndrome).
Pregnancy and breast-feeding
Please tell your doctor if you are pregnant or think you may
be pregnant before you are given this medicine.
You should not breast-feed if you are given this medicine.
Driving and using machines
Atropine injection may cause drowsiness or blurred vision.
You should not drive or operate machinery after having been
given this injection.

101246

06/13

It can also be used as an antidote in the following situations:
• Overdose of medicines that block cholinesterase (an
enzyme which destroys acetylcholine),
• Poisoning with organophosphate insecticide or gases,
• Poisoning with mushrooms.

2. BEFORE YOU USE ATROPINE SULFATE
INJECTION

AGUETTANT SYSTEM®
The following information is intended for medical or healthcare professionals only:
Drug name:

Atropine sulfate 3 mg/10 ml

Solution for injection in pre-filled syringe
Incompatibilities:

This medicinal product must not be mixed with other medicinal products.

Administration:

Preoperative medication:
• Adults: 0.3-0.6 mg IV just before induction of anaesthesia.
Cardiopulmonary resuscitation:
• Adults: Sinus bradycardia: 0.5 mg IV, every 2-5 minutes until the desired heart rate is achieved.
Arrhythmias (symptomatic bradycardia, AV conduction block):
• Adults: 0.5 mg IV, every 3-5 minutes (maximum 3 mg).
Reversal of effects of non-depolarising muscle relaxants:
• Adults: 0.6-1.2 mg IV
As an antidote to organophosphates (pesticides, nerve gases):
• Adults: 2 mg IV every 5-10 minutes
Repeat dose until muscarinic signs and symptoms disappear or until signs of atropinisation (tachycardia, mydriasis) appear.
As an antidote to cholinesterase inhibitors and in mushroom poisoning:
• Adults: 0.6-1 mg IV every 2 hours.
Repeat dose until muscarinic signs and symptoms disappear or until signs of atropinisation (tachycardia, mydriasis) appear.
Atropine sulfate Injection is not in a presentation suitable for paediatric use, as the graduation scale on the syringe does not
permit accurate measurement of the doses for children.
Overdose
Symptoms:
Flushing and dryness of the skin, dilated pupils, dry mouth and tongue, tachycardia, rapid respiration, hyperpyrexia,
hypertension, nausea, vomiting. Symptoms of CNS stimulation include restlessness, confusion, hallucinations, paranoid and
psychotic reactions, incoordination, delirium and occasionally convulsions. In severe overdose, CNS depression may occur
with coma, circulatory and respiratory failure and death.
Treatment:
Treatment should be supportive. An adequate airway should be maintained. Diazepam may be administered to control
excitement and convulsions but the risk of CNS depression should be considered.

AGUETTANT SYSTEM®

Important information about some of the ingredients of
Atropine sulfate Injection:
This medicinal product contains 3.5 mg (0.154 mmol) of
sodium per ml of injection (a total of 35 mg or 1.540 mmol
in 10 ml syringe). This amount must be taken into
consideration by patients on a controlled sodium diet.

3. HOW TO USE ATROPINE SULFATE INJECTION

Your doctor will decide the correct dosage for you and how
and when the injection will be given.
The usual dosages are:
As premedication before anaesthesia: adults 0.3-0.6 mg
intravenously (IV).
In cardiac arrest: adults 3 mg given intravenously (IV).
To reverse effects of muscle relaxants: adults 0.6-1.2 mg
intravenously (IV) with neostigmine.
As an antidote to organophosphorus insecticides:
adults 2 mg intravenously (IV) every 5-10 minutes.
As an antidote to anticholinesterases and in mushroom
poisoning: adults 0.6-1mg IV every 2 hours.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Atropine sulfate Injection can cause side
effects, although not everybody gets them.
• Anaphylaxis (allergic reaction), mild to severe difficulty to
breathe, increased heart rate, mouth and/or face
oedema.
• Slow heart rate followed by a fast or irregular heart rate,
palpitations.
• Confusion, nervous state, especially in the elderly. At
higher doses hallucinations, restlessness, delirium.
• Urinary retention (difficulty in passing urine).
• Dilatation of the pupils with an inability to focus and
sensitivity to light, decrease in lachrymal secretion (tear),
increased eye pressure.
• Flushing state.
• Thickening of bronchial secretions.
• Dry mouth, nausea, vomiting, constipation.
• Dry skin.
• Thirst.

The injection will be given to you by a doctor or nurse, it is
unlikely that you will be given too much. If you think that
you have been given too much, you feel your heart beating
very fast, feel restless, confused, have hallucinations; you
must tell the person giving you the injection.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

5. HOW TO STORE ATROPINE SULFATE
INJECTION

Keep out of the reach and sight of children.
Do not use Atropine sulfate Injection after the expiry date
which is stated on the carton. The expiry date refers to the
last day of that month.
Do not use Atropine sulfate Injection if you notice visible
signs of deterioration.
Medicines should not be disposed of via waste water or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION

What Atropine sulfate Injection contains
- The active substance is atropine sulfate: 0.3 mg in each
ml of solution.
- The other ingredients are: sodium chloride, concentrated
hydrochloric acid (for pH adjustment), water for injections
What Atropine sulfate Injection looks like and contents
of the pack
Each pre-filled syringe contains 3 mg of atropine sulfate in
10 ml of solution for injection.
Boxes of 1, 5, 10, 12, 20, 25, 50 or 100 syringes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
LABORATOIRE AGUETTANT
1, Rue Alexander Fleming
69007 LYON - France
PL 14434/0016
Distributed by:
AGUETTANT LTD
N°1, Farleigh House - Flax Bourton
BRISTOL - BS48 1UR
United Kingdom
This leaflet was last revised in December 2012.

AGUETTANT SYSTEM®
Instructions for use:

Please prepare the syringe carefully as follows.
The pre-filled syringe is for single patient only.
Discard syringe after use. DO NOT REUSE.
The content of unopened and undamaged blister is sterile, and must not be opened until use.
The product should be inspected visually for particles and discoloration prior to administration. Only clear colourless solution
free from particles or precipitates should be used.
Do not use the product if the tamper evident seal on syringe (plastic cover to the end cap) is broken.
The external surface of syringe is sterile until blister is opened.
1) Withdraw the pre-filled syringe from the sterile blister.
2)

2) Push on the plunger to free the bung

4)

4) Check the syringe seal (plastic
cover of the end cap and seal under
end cap) has been completely
removed. If not, replace the cap and
twist again.

5)
3)
3) Twist off the end cap to break the
seals.

5) Expel the air by gently pushing
the plunger.

6) Connect syringe to vascular access device or to needle. Push the plunger carefully to inject the required volume.
The needle gauges appropriate for use with the syringe are 23 to 20 gauges for IV administration.
Any unused product or waste material should be disposed of in accordance with local requirements.

Storage and Shelf life:
36 months

AGUETTANT SYSTEM®

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide