Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
ATROPINE SULFATE 1 mg/5 ml, solution for injection in pre-filled syringe.
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
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 1 mg/5 ml solution for injection in prefilled syringe is used to treat adults only.
What you need to know before you take it
e ATROPINE SULFATE Do not use ATROPINE SULFATE if you:
- are allergic (hypersensitive) to atropine or any of the other ingredients of this medicine (listed in section 6),
- have urinary difficulties,
- have elevated pressure in your eye (glaucoma),
- have oesophagus disease (achalasia of oesophagus), a blockage in your intestine (paralytic ileus), or acute form of colonic distension (toxic megacolon). These contraindications do not apply in case of lifethreatening emergencies. Warnings and precautions Talk to your doctor before using ATROPINE SULFATE if you have:
- hyperthyroidism,
- prostatic disease,
- heart failure,
- liver or kidney disease,
- some cardiac diseases,
- stomach disease, such as pyloric narrowing,
- chronic bronchitis,
- fever,
- myasthenia gravis (severe muscle weakness),
- heartburn (reflux),
- Or if you are elderly. Other medicines and ATROPINE SULFATE Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
- tricyclic antidepressants,
- some antihistamines,
- medicines for Parkinson's disease,
- phenothiazine, clozapine or neuroleptic drugs (for mental illness),
- quinidine or disopyramide (for heart disease),
- antispasmodic medications (for irritable bowel syndrome). Pregnancy and breastfeeding Pregnancy Limited data from the use of atropine in pregnant women indicate no adverse effects on pregnancy or on the health of the fetus. Atropine crosses the placenta. Intravenous administration of atropine during pregnancy or at term may cause a faster heart rate in the fetus and the mother. This medicine should only be administered during pregnancy after careful consideration of the benefits and risks of the treatment. Breast-feeding Small amounts of atropine may pass into breast milk and may have effects on the infant. Atropine may inhibit the production of breast milk. Your doctor will consider the benefit of breastfeeding against the benefit of the treatment. Breast-feeding should be discontinued if the decision to use the treatment is maintained. However, if it is decided during treatment to continue breast-feeding, your doctor will perform extra examinations on the infant. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Atropine injection may cause confusion or blurred vision. You should not drive or operate machinery after receiving an injection. ATROPINE SULFATE contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i.e. essentially "sodium-free".
How to take it
ATROPINE SULFATE 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 just before induction of anaesthesia or 0.3-0.6 mg IM, 30 to 60 minutes before the anaesthesia. 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:
- Sinus bradycardia (low heartbeat): 0.5 mg IV, every 2-5 minutes until the desired heart rate is achieved.
- AV block (Block the transmission of the contraction between the atrium and the ventricle): 0.5 mg IV, every 3-5 minutes (maximum 3 mg). As an antidote to organophosphorus poisoning (insecticides, or nerve gas), to anticholinesterases and in muscarinic mushroom poisoning: Adults: 0.5-2 mg depending on the patient's features and response, can be repeated after 5 minutes and subsequently as required. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
The following information is intended for healthcare professionals only: The pre-filled syringe is for single patient only. Discard syringe after use. Do not reuse. The content of un-opened and un-damaged blister is sterile, and must not be opened until used. 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.
This injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much atropine. If you think you have been given too much atropine, you feel your heart beating very fast, you are breathing quickly, have a high temperature, feel restless, confused, have hallucinations, or lose co-ordination you must tell the person giving you the injection.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. 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)
- visual disturbances (widening of the pupils, difficulty focussing, blurred vision, inability to tolerate light),
- reduced bronchial secretion,
- dry mouth (difficulty in swallowing and talking, feeling thirsty),
- constipation and heartburn (reflux),
- reduced secretion of gastric acid,
- loss of taste,
- nausea,
- vomiting,
- bloated feeling,
- lack of sweating,
- skin dryness,
- hives,
- rash. Common side effects (may affect up to 1 in 10 people)
- excitement (especially with higher dosages),
- loss of coordination (especially with higher dosages),
- confusion (especially with higher dosages),
- hallucinations (especially with higher dosages),
- overheated body,
- certain heart conditions (rapid heart beat, irregular heart beat, temporary further slowing down of heart beat),
- flushing,
- difficulty in passing urine. Uncommon side effects (may affect up to 1 in 100 people)
- psychotic reactions. Rare side effects (may affect up to 1 in 1,000 people)
- allergic reactions,
- fits (seizures),
- drowsiness. Very rare side effects (may affect up to 1 in 10,000 people)
- severe hypersensitivity reaction,
- irregular heart beat, including ventricular fibrillation,
- chest pain,
- spike in blood pressure. Not known (frequency cannot be estimated from the available data)
- headache,
- restlessness,
- unsteady walking and balance problems,
- sleeplessness.
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.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard By reporting side effects, you can help provide more information on the safety of this medicine.
How to store it
ATROPINE SULFATE Keep this medicine out of the sight and reach of children. Do not use this medicine 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 this medicine if you notice visible signs of deterioration. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What ATROPINE SULFATE contains
- The active substance is atropine sulfate: Each ml of solution for injection contains 0.2 mg atropine sulfate monohydrate, equivalent to 0.17 mg atropine. Each 5 ml syringe contains 1 mg atropine sulfate monohydrate, equivalent to 0.83 mg atropine.
- The other ingredients are: sodium chloride, concentrated hydrochloric acid (for pH adjustment), water for injections. What ATROPINE SULFATE looks like and contents of the pack. This medicinal product is a clear and colourless solution for injection in a sterile 5 ml polypropylene pre-filled syringe. Boxes of 1, 5, 10, 12 and 20 syringes. Not all pack sizes may be marketed. Marketing Authorisation Holder Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 LYON France Manufacturer Laboratoire AGUETTANT Lieu-dit "Chantecaille" 07340 CHAMPAGNE France Distributor AGUETTANT ltd. N°1, Farleigh House Flax Bourton BRISTOL BS48 1UR United Kingdom This leaflet was last revised in 12/2021. Detailed information on this medicinal product is available on the web site of Medicines and Healthcare Products Regulatory Agency (MHRA).
5) Expel the air by gently pushing the plunger.
6) Connect the syringe to vascular access device or needle. Push the plunger to inject the required volume. The needle gauge appropriate for use with the syringe are 23 to 20 gauge for IV administration and 23 to 21 gauge for IM administration.
Frequently asked questions about ATROPINE SULFATE 1 mg/5 ml, solution for injection in pre-filled syringe.
How do I take ATROPINE SULFATE 1 mg/5 ml, solution for injection in pre-filled syringe.?
ATROPINE SULFATE 1 mg/5 ml, solution for injection in pre-filled syringe. comes as injection containing 1mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in ATROPINE SULFATE 1 mg/5 ml, solution for injection in pre-filled syringe.?
The active substance in ATROPINE SULFATE 1 mg/5 ml, solution for injection in pre-filled syringe. is atropine sulfate monohydrate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for ATROPINE SULFATE 1 mg/5 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.
Can I get ATROPINE SULFATE 1 mg/5 ml, solution for injection in pre-filled syringe. without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: atropine sulfate monohydrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Atropine sulfate 1 mg/5 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
4.2. Posology and method of administration
Atropine sulfate 1 mg/5 ml, solution for injection in pre-filled syringe must be administered under medical supervision. Posology:
Pre-anaesthetic medication
Intravenous administration immediately before surgery; if necessary an intramuscular administration 30-60 minutes before surgery is possible. Adults:
0.3 – 0.6 mg IV or IM (1.5 – 3 ml)In combination with neostigmine to limit its muscarinic effects: Adults:
0.6-1.2 mg IV (3 to 6 ml) Treatment of hemodynamically compromising bradycardia, atrioventricular block, cardiopulmonary resuscitation:
Adults:
- Sinus bradycardia: 0.5 mg IV (2.5 ml), every 2-5 minutes until the desired heart rate is achieved.- AV block: 0.5 mg IV (2.5 ml), 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 (2.5 - 10 ml) 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 or intramuscular injection. Paediatric population
The pre-filled syringe is not adapted to the administration in paediatric population; the graduation does not permit accurate measurement.
4.3. Contraindications
- 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 megacolonAll these contra-indications are however not relevant in life-threatening emergencies (such as bradyarrhythmia, poisoning).
4.4. Special warnings and precautions for use
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, who may be more susceptible to its adverse effects - In reflux oesophagitis, as atropine may delay gastric emptying, decrease gastric motility and relax oesophageal sphincterAtropine 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 sodium. Sodium level is lower than 1 mmol per syringe, i.e. 'without sodium'.
4.5. Interaction with other medicinal products and other forms of interaction
Combinations to be taken into account
Other drugs with anticholinergic activity, such as tricyclic antidepressants, some H1-antihistamines, antiparkinsonian drugs, disopyramide, mequitazine, phenothiazines, neuroleptic drugs, atropinic antispasmodics, clozapine and quinidine, because of the risk of potentialisation of atropinic adverse effects (urinary retention, constipation, dry mouth).
4.6. Fertility, pregnancy and lactation
Pregnancy
Data on a limited number of exposed pregnancies indicate no adverse effects of atropine on pregnancy or on the health of the fetus/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.
4.7. Effects on ability to drive and use machines
Atropine may cause confusion or blurred vision and patients should be advised of it.
4.8. Undesirable effects
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.
4.9. Overdose
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 severe 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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- SULFAT DE ATROPINA NORIDEM 1 mg/ml prescriptionATROPINUM · injection / infusion
- SULFAT DE ATROPINA ACCORD 0,1 mg/ml prescriptionATROPINUM · injection / infusion
- SULFAT DE ATROPINA EVOLAN 1 mg/ml prescriptionATROPINUM · injection / infusion
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 →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Atropinum sulfuricum WZFAtropini sulfas · injection / infusion
- Atropine AccordAtropini sulfas · injection / infusion
- Atropinum Sulfuricum DelfarmaAtropini sulfas · injection / infusion
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 about this leaflet
Ask anything about ATROPINE SULFATE 1 mg/5 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.