- atropine sulfate
POM: Prescription only medicine
This information is intended for use by health professionals
Atropine Sulfate 1mg in 5ml Solution for injection in pre-filled syringe.
Each 5 ml syringe contains 1 mg Atropine sulfate
Each 1ml of solution for injection contains 0.2 mg Atropine sulphate
For the full list of excipients, see section 6.1.
Solution for injection in pre-filled syringe. Clear and practically particulate free solution pH 3 - 4.5.
Reversal of excessive of bradycardia. The administration is given in the algorithm for the emergency treatment of Peri - arrest arrhythmias produced by European Resuscitation Council's and Resuscitation Council (UK).
Adults and children over 12 years
Initially 0.5mg by intravenous injection and then increments of 0.5mg to a maximum of 3mg.
As for Adults.
Method of administration:
Atropine 1mg in 5ml is administered by intravenous injection.
Hypersensitivity to the active substance or to any of the excipients listed in 6.1
o Closed-angle glaucoma
o Risk of urinary retention because of prostatic or urethral disease
o Myasthenia gravis unless given in conjunction with anticholinesterase
o Breast-feeding (see section 4.6).
o Achalasia of the oesophagus
Use with caution in case of:
Renal or hepatic insufficiency
Cardiac insufficiency, arrhythmias, hyperthyroidism
Chronic obstructive pulrnonary disease, as a reduction in bronchial secretions may lead to the formation of bronchial plugs
Paralytic ileus, intestinal atonia in elderly, toxic megacolon
Fever, or when ambient temperature is high
In the elderly, who are more susceptible to adverse effects.
Combinations to be taken into account
Other medicinal products with anticholinergic activity such as tricyclic antidepressants, some H1-anithistamines, antiparkinsonian medicines, disopyramide, mequitazine, phenothiazines, neuroleptic medicines, atropinic antispasmodics,clozapine and quinidine, because of the risk of potentialisation of atropinic adverse effects (urinary retention, constipation, dry mouth).
Studies in animal have shown a teratogenic effect of atropine in one species with very high doses.
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.
Atropine passes the placenta barrier.
To date, no other epidemiological data are available.
Atropine should not be used during pregnancy unless clearly necessary.
Atropine is excreted in breast milk, and may cause neurological toxicity in the infant. Moreover atropine inhibits lactation.
Breast-feeding is thus contraindicated if atropine should be used.
There are no preclinical fertility data with atropine, and no epidemiological data.
Atropine may cause confusion or blurred vision and patients should be advised of it.
The most commonly reported adverse events are due to the action of atropine on muscarinic and, at high doses, on nicotinic receptors. These effects are dose-related and usually reversible when therapy is discontinued.
Immune system disorders:
Nervousness, confusional state, especially in the elder1y. At higher doses hallucinations, restlessness, and delirium.
Dilatation of the pupils with loss of accommodation and photophobia, decrease in lachrymal secretion, increase in intraocular pressure.
Tachycardia, palpitations, arrhythmias.
Respiratory, thoracic and mediastinal disorders:
Thickening of bronchial secretions.
Dry mouth, nausea, vomiting, and constipation.
Renal and urinary disorders:
Skin and subcutaneous tissue:
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Flushing and dryness of the skin, dilated pupils, dry mouth and tongue, tachycardia, rapid respiration, hyperpyrexia, 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 of overdosage with atropine sulfate injection consists of symptomatic and supportive therapy, control of delirium. General measures include: reduction of body temperature, administration of fluids orally or intravenously, monitoring of ECG or excitement with diazepam, urinary catheterisation to avoid urinary retention. The use of physostigmine as an antidote to atropine is controversial.
Pharmacotherapeutic group: anticholinergic agents.
ATC code: A03BA01.
Atropine is an antimuscarinic agent which competitively antagonises acetylcholine at postganglionic nerve endings, thus affecting receptors in the exocrine glands, smooth muscle, cardiac muscle and the central nervous system.
Peripheral effects include decreased production of saliva, sweat, 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 bronchodilation.
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 1 hour after intramuscular administration.
Plasma levels after intramuscular and intravenous injection are comparable at 1 hour. Atropine is distributed widely throughout the body and crosses the blood brain barrier and the placenta barrier.
The elimination half-life is about 2 to 5 hours. Up to 50% of the dose is protein bound.
Atropine 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 preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC
Water for Injections,
Sulfuric Acid (for pH adjustments),
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. Protect from light.
Sterile aqueous solution for injection in Glass (Type I) 5ml prefilled syringe.
Each syringe is packaged in a lidded blister inside a carton.
No needle is provided with this syringe.
Use once and discard any remaining solution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Aurum Pharmaceuticals Ltd
T/A Martindale Pharma
Date of first authorisation: 13 January 1998