Atropine Sulfate Injection is used:
• As a preoperative medication for the reduction of salivary and bronchial secretions.
• During cardiopulmonary resuscitation to treat sinus bradycardia or asystole.
• For treatment of symptomatic sinus bradycardia induced by drugs or toxic substances such as
pilocarpine, organophosphate pesticides, amanita muscaria mushrooms
• For management of bradycardia of acute myocardial infarction.
• For prevention of cholinergic effects on the heart (e.g. arrhythmias, bradycardia) during
surgery.
• In combination with neostigmine during reversal of effect of non-depolarising muscle
relaxants.

Bradycardia
Adults and the elderly: 0.1 mg incremental doses by the subcutaneous or intravenous routes.
Children: Not recommended for use in bradycardia.
Preoperative medication.
Adults and the elderly: By the intravenous route: 0.3 – 0.6 mg immediately before induction of
anaesthesia. By the intramuscular or subcutaneous route: 0.25 – 0.5 mg, 30-60 minutes before
induction of anaesthesia.
Children:
Premature infants: Up to 0.065 mg;
Children up to 3kg: Up to 0.1 mg;
Children 7-9kg: Up to 0.2 mg;
Children 12-16kg: 0.3 mg;
Children 20-27kg: 0.4 mg;
Children 32kg: 0.5 mg;
Children 41kg: 0.6 mg;
By the intramuscular route 30-60 minutes before induction of anaesthesia.
Alternative dosage statement for children over 1 year:
0.01-0.02 mg/kg 30-60 minutes before induction of anaesthesia..
As an antidote to cholinesterase inhibitors
Adults:
2mg, preferably IV.

Children:
0.05 mg/kg IV or IM.
Repeat dose every 5-10 minutes until signs of atropinisation appear.
As an antidote to organophosphate pesticides and in mushroom poisoning
Adults:
2mg IV or IM.
Children:
0.05 mg/kg IV or IM
Repeat dose every 10-30 minutes until muscarinic signs and symptoms subside.
Reversal of effects of non-depolarizing muscle relaxants
Adults:
0.6 –1.2 mg given IV in conjunction with neostigmine methyl- sulfate.
In cardiopulmonary resuscitation
Adults:
3mg IV once
Children:
0.02 mg/kg IV once
In arrhythmias
Bradycardia, particularly if complicated by hypotension, 0.3 mg IV initially, increasing to 1mg if
necessary.

Atropine sulfate should be used with caution in children, the elderly and those with
Down's syndrome. It should be given with caution to patients with diarrhoea, urinary retention or
fever, and when the ambient temperature is high. Care is required in patients with acute
myocardial infarction as ischaemia, and infarction may be exacerbated in patients with
hypertension.
Caution is also required when using the drug in patients with conditions characterized by
tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and during cardiac surgery.
Paradoxical atrioventricular block or sinus arrest has been reported following administration of
atropine in a few patients after heart transplantation. The use of atropine for therapeutic or
diagnostic procedures in heart transplant patients should be undertaken with extreme caution,
and ECG monitoring and equipment for immediate temporary pacing should be available.
Caution is required when atropine is administered systemically to patients with chronic
obstructive pulmonary disease, as a reduction in bronchial secretions may lead to the formation
of bronchial plugs.
Antimuscarinics such as atropine may delay gastric emptying, decrease gastric motility and relax
the oesophageal sphincter. They should be used with caution in patients whose conditions may
be aggravated by these effects e.g. reflux oesophagitis.

The effects of atropine may be enhanced by the concomitant administration of other drugs with
antimuscarinic activity including phenothiazines, amantadine, tricyclic antidepressants, MAOI's,
some antihistamines and disopyramide.
Reduced GI motility caused by atropine may affect the absorption of other drugs such as
mexilitine and ketoconazole.
Atropine induced dry mouth may prevent dissolution of sublingual preparations such
as the nitrates, reducing their effectiveness.
During anaesthesia, the heart rate responsiveness to IV atropine could be decreased (and not
effectively overcome by a large dose of atropine) when the subject is receiving concomitant
propofol; it could be due to propofol-induced suppression of the sympathetic nervous system.

Atropine sulfate crosses the placenta. There is insufficient evidence to establish the safety of
atropine in human pregnancy. It should therefore be used during pregnancy only if considered
essential by the physician.
Atropine sulfate is excreted in breast milk, and infants of nursing mothers may exhibit some
effects of the drug. Infants are usually very sensitive to the effects of anticholinergic drugs.
Atropine should therefore only be used during breast feeding if considered essential by the
physician.

Atropine sulfate may cause drowsiness or blurred vision and patients should be used advised
accordingly.

The most commonly reported adverse events are due to the action of atropine on muscarinic and,
at high doses, nicotinic receptors. These effects are dose-related and usually reversible when
therapy is discontinued.
Immune system disorders:
Anaphylaxis.
Nervous system/ Psychiatric disorders:
Dizziness, confusional states, especially in the elderly. At higher doses hallucinations,
restlessness, delirium.
Eye disorders:
Dilatation of the pupils with loss of accommodation and photophobia, raised intraocular
pressure.
Cardiac disorders:
Transient bradycardia followed by tachycardia, palpitations, arrhythmias.
There have been reports of paradoxical atrioventricular block, especially after heart
transplantation (see section 4.4 Special warnings and precautions for use).
Vascular disorders:
Flushing.
Respiratory disorders:

Reduced bronchial secretion may result in the formation of thick bronchial plugs which are
difficult to eject from the respiratory tract (see section 4.4 Special warnings and precautions for
use).
Gastrointestinal disorders:
Dry mouth with difficulty in swallowing, nausea, vomiting, constipation. Inhibition of gastric
secretion, retrosternal pain due to gastric reflux.
Skin & subcutaneous tissue disorders:
Dry skin, urticaria, rashes, skin exfoliation.
Renal & urinary disorders:
Difficulty with micturition.
General disorders:
Thirst, fever.
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.

Symptoms
Flushing and dryness of the skin, dilated pupils, dry mouth and tongue, tachycardia, rapid
respiration, hyperpyrexia, hypertension, nausea, vomiting. A rash may appear on the face or
upper trunk. 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 central
nervous system depression should be considered. Hypoxia and acidosis should be corrected.
Antiarrhythmic drugs are not recommended if dysrhythmias occur.

Pharmacotherapeutic group: anticholinergic agents
ATC code: A03BA01
Mechanism of action
Atropine is an antimuscarinic agent which competitively antagonizes acetylcholine at
postganglionic nerve endings, thus affecting receptors of the exocrine glands, smooth muscle,
cardiac muscle and the central nervous system.
Pharmacodynamic effects
Peripheral effects include tachycardia, decreased production of saliva, sweat, bronchial, nasal,
lachrymal and gastric secretions, decreased intestinal motility and inhibition of micturition.
Atropine increases sinus rate and sinoatrial and AV conduction. Usually heart rate is increased
but there may be an initial bradycardia.
Atropine inhibits secretions throughout the respiratory tract and relaxes bronchial smooth muscle
producing bronchodilatation.

Following intravenous administration, the peak increase in heart rate occurs within 2 to 4
minutes. Peak plasma concentrations of atropine after intramuscular administration are reached
within 30 minutes, although peak effects on the heart, sweating and salivation may occur nearer
one hour after intramuscular administration.
Plasma levels after intramuscular and intravenous injection are comparable at one hour. Atropine
is distributed widely throughout the body and crosses the blood brain barrier. The elimination
half-life is about 2 to 5 hours. Up to 50% of the dose is protein bound. It disappears rapidly from
the circulation.
It is incompletely metabolised in the liver and is excreted in the urine as unchanged drug and
metabolites. About 50% of the dose is excreted within 4 hours and 90% in 24 hours.

There are no pre-clinical data of relevance to the prescriber which are additional to that already
included in other sections of the SPC.

Water for Injections

Atropine sulfate injection is reported to be physically incompatible with bromides, iodides,
alkalis, noradrenaline bitartrate, metaraminol bitartrate and sodium bicarbonate. A haze or
precipitate may form within 15 minutes when atropine sulfate is mixed with methohexital
sodium solutions.

Store below 25C.
Keep container in the outer packaging.
Keep out of the sight and reach of children

Sterile aqueous solution for injection in plastic ampoule.
Supplied in: 1ml plastic ampoule.

Do not use if seal on outer packaging is broken or packaging is damaged.
Use once.
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.