Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Atropine sulfate monohydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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. An anticholinergic is a substance that blocks the neurotransmitter acetylcholine in the central and peripheral nervous system. It is used in emergency situations when the heart beats too slowly, as an antidote to for example organophosphate insecticide or nerve gas poisoning and in mushroom poisoning. It can be used as part of the premedication before general anaesthesia. It can also be used to prevent side effects of other drugs which are used to reverse the effects of muscle relaxants after surgery. Atropine sulfate 3 mg/10 ml solution for injection in pre-filled syringe is used to treat adults only. 2. BEFORE YOU USE ATROPINE SULFATE INJECTION Do not use Atropine sulfate Injection if you:
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 (IV). To reverse effects of muscle relaxants Adults: 0.6-1.2 mg intravenously (IV) with neostigmine. In low heartbeat, heart block or cardiac arrest Adults:
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following information is intended for healthcare professionals only 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. The product should not be used 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) Push on the plunger to free the bung.
3) Twist off the end cap to break the seal.
The side effects depend on the dose you are given and usually disappear when the treatment is discontinued. Rarely an allergic reaction may develop. This may cause skin rashes, severe itching, peeling of the skin, swelling of the face (especially around the lips and eyes), tightening of the throat and difficulty breathing or swallowing, fever, dehydration, shock and fainting. These are all very serious side effects. Tell your doctor immediately if you experience any of these side effects. You may need urgent medical attention. Very common side effects (may affect more than 1 in 10 people)
Do not throw away any medicines via wastewater 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:
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 syringe and blister. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not use Atropine sulfate Injection if you notice visible signs of deterioration.
4) Check the syringe seal (plastic cover to the end cap and seal under end cap) has been completely removed. If not, replace the cap and twist again.
5) Expel the air by gently pushing the plunger.
6) Connect syringe to vascular access device or to needle. Push the plunger 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.
Atropine sulfate 3 mg/10 ml, solution for injection in pre-filled syringe comes as injection containing 3mg / 10ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Atropine sulfate 3 mg/10 ml, solution for injection in pre-filled syringe is atropine sulfate monohydrate.
This leaflet reproduces the patient information leaflet approved for Atropine sulfate 3 mg/10 ml, solution for injection in pre-filled syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Atropine sulfate 3 mg/10 ml, solution for injection in pre-filled syringe is indicated in adults only.
- As a pre-anaesthetic medication: to prevent vagal reactions associated with tracheal intubation and surgical manipulation.
- To limit the muscarinic effects of neostigmine, when given postsurgically to counteract non-depolarising muscle relaxants
- Treatment of hemodynamically compromising bradycardia and/ or atrioventricular block due to excessive vagal tone in emergency situation
- Cardiopulmonary resuscitation: to treat symptomatic bradycardia and AV block.
- As antidote following overdosage or poisoning with acetylcholinesterase-inhibitors e.g. anticholinesterases, organophosphorus, carbamates and muscarinic mushrooms.
Atropine sulfate 3 mg/10 ml, solution for injection in pre-filled syringe must be administered under medical supervision.
Posology:
Pre-anaesthetic medication:
Intravenous administration immediately before surgery.
- Adults:
- 0.3-0.6 mg IV .
In combination with neostigmine to limit its muscarinic effects:
Adults:
0.6-1.2 mg IV
Treatment of hemodynamically compromising bradycardia, atrioventricular block, cardiopulmonary resuscitation:
Adults:
- Sinus bradycardia: 0.5 mg IV, every 2-5 minutes until the desired heart rate is achieved.
- AV block: 0.5 mg IV, every 3-5 minutes (maximum 3 mg)
As an antidote to organophosphates (pesticides, nerve gases), to cholinesterase inhibitors and in muscarinic mushroom poisoning:
Intravenous use.
Adults:
0.5 - 2 mg atropine sulfate depending on the patient's features and response, can be repeated after 5 minutes and subsequently as required, until signs and symptoms disappear (this dose may be exceeded many times).
Dose adjustments
In general, dosage should be adjusted according to patient's response and tolerance.
Dosage to a total maximum dose of 3 mg in adults is usually increased until adverse effects become intolerable; then a slight reduction in dosage generally yields the maximum dosage tolerated by the patient.
Special populations
Caution is advised for patients with renal or hepatic impairment and in elderly (see section 4.4).
Method of administration
Atropine is administered by intravenous injection
Paediatric population
Atropine Sulfate 3 mg/10 ml, solution for injection in pre-filled syringe is not in a presentation suitable for paediatric use, as the graduation scale of the syringe does not permit accurate measurement of the doses for children.
- Hypersensitivity to the active substance or to any of the excipients
- Closed-angle glaucoma
- Risk of urinary retention because of prostatic or urethral disease
- Achalasia of the esophagus, paralytic ileus, and toxic megacolon.
All these contra-indications are however not relevant in life-threatening emergencies (such as bradyarrhythmia, poisoning).
Use with caution in case of:
- Prostatic enlargement
- Renal or hepatic insufficiency
- Cardiac insufficiency, arrhythmias, hyperthyroidism
- Chronic obstructive pulmonary disease, as a reduction in bronchial secretions may lead to the formation of bronchial plugs
- Intestinal atonia in elderly
- Pyloric stenosis
- Fever, or when ambient temperature is high
- In the elderly, more susceptible to adverse effects.
- In reflux oesophagitis, as atropine may delay gastric emptying, decrease gastric motility and relax oesophageal sphincter
Atropine should not be given to patients with myasthenia gravis unless given in conjunction with anticholinesterase.
Atropine administration should not delay implementation of external pacing for unstable patients, particularly those with high-degree (Mobitz type II second-degree or third-degree) block.
Antimuscarinics block vagal inhibition of the SA nodal pacemaker and should thus be used with caution in patients with tachyarrhythmias, congestive heart failure or coronary heart disease.
This medicinal product contains 35.4 mg sodium per 10 ml syringe, equivalent to 1.77% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Combinations to be taken into account
Other drugs with anticholinergic activity such as tricyclic antidepressants, some H1- antihistamines, antiparkinsonian drugs (MAOI's), disopyramide, mequitazine, phenothiazine neuroleptic drugs, antispasmodics and quinidine, because of the increased risk of atropinic adverse effects (urinary retention, constipation, dry mouth).
Pregnancy
Data on a limited number of exposed pregnancies indicate no adverse effects of atropine on pregnancy or on the health of the foetus/new-born child.
Animal studies did not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Studies of the pharmacokinetics of atropine in mother and fetus in late pregnancy indicated that atropine rapidly crosses the placental barrier. Intravenous administration of atropine during pregnancy or at term may cause tachycardia in the fetus and the mother.
Atropine should not be used during pregnancy unless clearly necessary.
Breast feeding
Small amounts of atropine may pass into human breast milk. Infants have an increased sensitivity to the anticholinergic effects of atropine. Atropine may inhibit the production of milk, particularly upon repeated use. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from treatment taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. If it is decided during treatment to continue breastfeeding, the child should be monitored for anticholinergic effects.
Fertility
There are no data on effects of this atropine sulfate on fertility in humans. Atropine sulfate reduced fertility in male rats, presumably as a consequence of an inhibitory effect on the transport of sperm and semen during the process of emission.
Atropine may cause drowsiness or blurred vision and patients should be advised of it.
The pattern of adverse effects seen with atropine can mostly be related to their pharmacological actions at muscarinic and, at high doses, nicotinic receptors. Adverse effects are dose-related and usually reversible when therapy is discontinued. The most common effects occurring with relatively small doses are visual disturbances, reduced bronchial secretion, dry mouth, constipation, reflux, flushing, difficulty in micturition and dryness of the skin. Transient bradycardia may develop followed by tachycardia, with palpitations and arrhythmias.
The evaluation of adverse reactions is based on the following definition of frequency:
Very Common: ≥1/10;
Common: ≥1/100 to <1/10;
Uncommon: ≥1/1,000 to <1/100;
Rare: ≥1/10,000 to <1/1,000;
Very rare: <1/10,000;
Not known: cannot be estimated from the available data
Frequency
Very Common
(≥1/10)
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1,000 to <1/100)
Rare
(≥1/10,000 to <1/1,000)
Very Rare
(<1/10,000)
Not known (cannot be estimated from the available data)
System Organ Class
Immune system disorders
Allergic reactions
Anaphylaxis
Nervous system disorders
Excitement, incoordination, mental confusion, and/or hallucinations (especially with higher dosages), hyperthermia
Psychotic reactions
Seizure, drowsiness
Headache, restlessness, ataxia, insomnia
Eye disorders
Visual disturbances (mydriasis, inhibition of accommodation, blurred vision, photophobia)
Cardiac disorders
Tachycardia (arrhythmias, transient exacerbation of bradycardia)
Atrial arrhythmias, ventricular fibrillation, angina, hypertensive crisis
Vascular disorders
Flushing
Respiratory, thoracic and mediastinal disorders
Reduced bronchial secretion
Gastrointestinal disorders
Dryness of the mouth (difficulty in swallowing and talking, thirst), parasympathetic inhibition of gastrointestinal tract (constipation and reflux), inhibition of gastric secretion, loss of taste, nausea, vomiting, bloated feeling
Skin and subcutaneous tissue disorders
Anhidrosis, urticaria, rash
Renal and urinary disorders
Inhibition of the parasympathetic control of the urinary bladder, urinary retention
Special populations
Atropine may cause excitement, incoordination, confusion and/or hallucinations especially in the elderly. An epidemiological study similarly reported lower cognitive performance in elderly patients receiving antimuscarinics.
Patients with Down syndrome may be more susceptible to antimuscarinic effects.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
Symptoms:
Flushing and dryness of the skin, dilated pupils with photophobia, dry mouth and tongue accompanied by a burning sensation, difficulty in swallowing, tachycardia, rapid respiration, hyperpyrexia, nausea, vomiting, hypertension, rash and excitement. Symptoms of CNS stimulation include restlessness, confusion, hallucinations, paranoid and psychotic reactions, incoordination, delirium and occasionally convulsions. In sever overdose, drowsiness, stupor and 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.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Atropine sulfate 3 mg/10 ml, solution for injection in pre-filled syringe. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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