Indications

1.As a preoperative medication for the reduction of salivary and bronchial secretions.

2.During cardiopulmonary resuscitation to treat sinus bradycardia or asystole.

3.For treatment of symptomatic sinus bradycardia induced by drugs or toxic substances such as pilocarpine, organophosphate pesticides, amanita muscaria mushrooms.

4.For management of bradycardia of acute myocardial infarction.

5.For prevention of cholinergic effects on the heart (e.g. arrhythmias, bradycardia) during surgery.

6.In combination with neostigmine during reversal of effect of non-depolarising muscle relaxants.

Dosage and Administration

Usage: I.M./I.V./S.C.

1.Pre-oeprativemedication

By the intramuscular route 30-60 minutes before induction of anaesthesia.

Alternative dosage statement for children over 1 year:

10-20 micrograms/kg 30-60 minutes before induction of anaesthesia..

2.As an antidote to cholinesterase inhibitors

Adults:2mg, preferably IV.

Children:50 micrograms/kg IV or IM.

Repeat dose every 5-10 minutes until signs of atropinisation appear.

Precautions & Warning:

1.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.

2.Caution is also required when using the drug in patients with conditions characterised 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.

Contraindications:

1.Hypersensitivity to Atropine Sulfate or to any of the excipients.

2.Known hypersensitivity to the drug, closed-angle glaucoma, prostatic enlargement, myasthenia gravis (unless given in conjunction with anticholinesterase), paralytic ileus or pyloric stenosis and severe ulcerative colitis.

Adverse Reactions:

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.

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 trac.

Drug interactions:

1.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.

2.Reduced GI motility caused by atropine may affect the absorption of other drugs such as mexilitine and ketoconazole.

Storage instructions:

Protect from light, seal tightly, and store at a temperature not exceeding 30°C.