This information is intended for use by health professionals
Atropine Sulfate 600 micrograms Tablets
Atropine sulfate 600 micrograms.
For a full list of excipients, see section 6.1.
Non ulcer dyspepsia
Irritable bowel syndrome
0.6mg - 1.2mg as a single night time dose.
Elderly and Children
Atropine should be used with caution employing a suitably reduced dose.
Atropine is contraindicated in patients with prostatic enlargement, as it may lead to urinary retention.
Atropine should not be used in patients with paralytic ileus or pyloric stenosis.
Atropine is contraindicated in angle-closure glaucoma or in patients with a narrow angle between the iris and the cornea as it may raise intra-ocular pressure and precipitate an acute attack.
Atropine is contra-indicated in myasthenia gravis (except to reduce muscarinic side-effects of anticholinesterases).
Use with caution in patients with urinary retention, acute myocardial infarction, hypertension, conditions associated with tachycardia (including hyperthyroidism, cardiac insufficiency, cardiac surgery), pyrexia and diarrhoea.
Use of atropine in patients with ulcerative colitis may lead to toxic megacolon and ileus.
Increased side effects may be seen in children and the elderly, and in patients with Down's syndrome.
Atropine may aggravate gastro-oesophageal reflux.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Alcohol: Marked impairment of attention can occur with alcohol, sufficient to make driving more hazardous (see 4.7 Effects on Ability to Drive and Use Machinery).
Anti-arrhythmics: Increased antimuscarinic side-effects may occur with disopyramide. The absorption of mexiletine can be delayed by atropine but the extent of absorption is unaltered and no special precautions are necessary.
Anticholinergics: Many drugs have antimuscarinic effects; concomitant use of two or more such drugs can increase side-effects such as dry mouth, urine retention, and constipation; concomitant use can lead to confusion in the elderly.
Antidepressants: Increased antimuscarinic side-effects may occur with tricyclic antidepressants and mono-amine oxidase inhibitors (MAOIs).
Antifungals: The absorption of ketoconazole can be reduced by atropine.
Antihistamines: Increased antimuscarinic side-effects may occur with some antihistamines.
Antipsychotics: Increased antimuscarinic side-effects may occur with phenothiazines and clozapine.
Antivirals and Dopaminergics: Increased antimuscarinic side-effects may occur with amantadine. The absorption of levodopa may possibly be reduced when administered with antimuscarinic agents.
Metoclopramide & domperidone: Possible antagonism of gastrointestinal effects.
Nitrates: The common side-effect of a dry mouth with atropine may result in the failure of sublingual nitrates to dissolve, thereby reducing their effectiveness.
Parasympathomimetics: Possible antagonism of effect of parasympathomimetics.
Phenylephrine: Hypertensive and other serious adverse effects of phenylephrine absorbed from eye drops may be markedly increased by atropine.
Atropine crosses the placenta and traces are found in breast milk. It should therefore only be used with caution.
Atropine may cause visual disturbances, giddiness and staggering. In addition, marked impairment of attention can occur with alcohol (see 4.5 Interactions). If affected, patients should be cautioned against driving a car or operating machinery.
Some of the central effects of atropine seen at toxic doses (see section 4.9) may also occur at therapeutic doses.
Immune system disorders
In rare cases a fever may develop.
Confusional states (particularly in the elderly).
Nervous system disorders
Occasionally giddiness and staggering may occur.
Dilation of the pupils with loss of accommodation and photophobia. Increased intra-ocular pressure. In rare cases, angle-closure glaucoma may develop.
Transient bradycardia, followed by tachycardia, palpitations and arrhythmias.
Respiratory, thoracic and mediastinal disorders
Bronchial secretions may be reduced, with formation of mucous plugs.
Dry mouth with difficulty in swallowing, thirst. Occasionally nausea and vomiting may occur. A reduction in the tone and mobility of the gastro-intestinal tract may lead to constipation. Increased gastric reflux may result in retrosternal pain.
Skin and subcutaneous tissue disorders
Flushing and dryness of the skin. Rashes.
Renal and urinary disorders
Urinary urgency, difficulty or retention.
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
There is considerable variation in susceptibility to atropine; recovery has occurred even after 1g, whereas deaths have been reported from doses of 100mg or less for adults and 10mg for children.
Symptoms of overdose:
In overdose, the peripheral effects become more pronounced such as dilation of pupils, continuing blurred vision, or changes in near vision, severe dryness of mouth, nose or throat, dizziness and drowsiness. Other symptoms such as rapid respiration, increased respiratory rate, difficulty in breathing, increased heartbeat, hypertension, hyperthermia, fever, muscle weakness, inhibition of micturition, nausea and vomiting may occur. A rash may appear on the face, neck or upper trunk, and there may be unusual warmth, dryness or flushing of the skin. Toxic doses also cause CNS stimulation marked by nervousness, restlessness, irritability, confusion, excitement, ataxia, incoordination, slurred speech, paranoid and psychotic reactions, hallucinations and delirium and occasionally seizures. In severe overdose, central stimulation may give way to CNS depression, coma, circulatory and respiratory failure and death.
Treatment of overdose:
If a patient presents within an hour of an overdose of atropine by mouth, the stomach may be emptied (but only if a life-threatening amount has been ingested) or activated charcoal given to reduce absorption. Diazepam may be given to control marked excitement and convulsions. Hypoxia and acidosis should be corrected. If metabolic acidosis persists despite correction of hypoxia and adequate fluid resuscitation consider correction with intravenous sodium bicarbonate. Antiarrhythmics are not recommended if arrhythmias develop. Phenothiazines should not be given as they may exacerbate antimuscarinic effects. Supportive therapy should be given as required.
Atropine is an antimuscarinic agent. These substances are competitive inhibitors of acetylcholine at muscarinic receptors of autonomic effector sites with parasympathetic innervation.
Atropine is readily absorbed from the gastro-intestinal tract and mucous membranes. It is absorbed from the eye and to a lesser extent through intact skin.
It is rapidly cleared from the blood and is distributed through the body, crossing the blood-brain barrier. It is completely metabolised in the liver and is excreted in the urine as unchanged drug and metabolites.
There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections.
Three years in polypropylene/polyethylene containers.
Two years in strip packs.
Do not store above 25°C
Store in the original container
Polyethylene or polypropylene containers with tamper evident closure strips of 28, 30, 56, 60, 84, 90 or 100 tablets.
Strip packs of 28, 30, 56, 60, 84 or 90 tablets.
Wockhardt UK Ltd
Ash Road North
Date of first authorisation: 19/10/1983
Date of latest renewal: 25/05/2002