1. Name of the medicinal product
Atropine Injection BP Minijet

2. Qualitative and quantitative composition
Atropine Sulfate 0.1 mg/ml

3. Pharmaceutical form
Sterile aqueous solution for parenteral administration to humans.

4. Clinical particulars
4.1 Therapeutic indications
Acute myocardial infarction with AV conduction block due to excess vagal tone (Wenkebach Type I, second-degree AV block) and sinus bradycardia, with associated hypotension and increased ventricular irritability.

Atropine can also be used in cardiopulmonary resuscitation for the treatment of sinus bradycardia accompanied by hypotension, hypoperfusion or ectopic arrhythmias.

Parenteral atropine is indicated as an antisialogogue in anaesthetic premedication to prevent or reduce secretions of the respiratory tract.

During anaesthesia, atropine may be used to prevent reflex bradycardia and restore cardiac rate and arterial pressure resulting from increased vagal activity associated with laryngoscopy, tracheal intubation and intra-abdominal manipulation. It may also be administered to block muscarinic effects when neostigmine is used to counteract muscle relaxants such as tubocurarine.

Parenteral atropine is an antidote for cardiovascular collapse following overdose of anticholinesterases; in the treatment of poisoning from organophosphorous insecticides or from chemical warfare 'nerve' gases and in the treatment of mushroom poisoning.

4.2 Posology and method of administration
Adults, children over 12 and the elderly:

Bradyarrhythmias: intramuscular or intravenous, 300 to 600mcg (0.3 to 0.6mg) every four to six hours to a total dose of 2mg.

In cardiac resuscitation, intravenous 500mcg (0.5mg) repeated at 5 minute intervals until the desired heart rate is achieved. In asystole, 3mg may be given intravenously as a once only single dose. If atropine cannot be administered intravenously during resuscitation, 2-3 times the intravenous dose may be administered via an endotracheal tube.

Premedication before anaesthesia: intramuscular or subcutaneous, 300 to 600mcg (0.3 to 0.6mg) 30-60 minutes before surgery or the same dose intravenously immediately before surgery.

To control muscarinic side effects of neostigmine: intravenous, 600 to 1200mcg (0.6 - 1.2mg).

Anticholinesterase poisoning: intramuscular or intravenous, 1 to 2mg repeated every 5 to 60 minutes until signs and symptoms disappear, up to a maximum of 100mg in the first 24 hours.

Children up to the age of 12 years:

The usual intramuscular, intravenous or subcutaneous dose in children is 10mcg/kg (0.01mg/kg), but generally not exceeding 400mcg (0.4mg). If necessary, these doses may be repeated every 4-6 hours.

Cardiac: for advanced cardiac life support: intravenous, 20mcg/kg (0.02mg/kg) with a minimum dose of 10mcg (0.01mg) repeated at 5 minute intervals, to a maximum dose of 100mcg (0.1mg).

Premedication before anaesthesia: intramuscular or subcutaneous; 30-60 minutes before surgery.

Up to 3 kg
 -
 100mcg (0.1mg)
 
7 - 9 kg
 -
 200mcg (0.2mg)
 
12 - 16 kg
 -
 300mcg (0.3mg)
 
Over 20 kg
 -
 as for adults
 

To control the muscarinic side effects of neostigmine: intravenous; neonates, infants and children - 20mcg/kg (0.02mg/kg). Maximum dosage 600mcg.

Antic