Dose adjustments

In general, dosage should be adjusted according to patient's response and tolerance.

Dosage to a total maximum dose of 3 mg in adults and 0.6 mg in children is usually increased until adverse effects become intolerable; then a slight reduction in dosage generally yields the maximum dosage tolerated by the patient.

Paediatric Population

This medicinal product is not appropriate to deliver a dose of less than 0.5 ml and should therefore not be used in neonates for which the body weight is inferior to 3 kg (see section 4.1).

The dosage ranges for the paediatric weight groups as stated below are values for guidance. The usual dose in children is between 0.01-0.02 mg/kg body weight (maximum 0.6 mg per dose), dosage should be adjusted according to the patient's response and tolerance.

Body weight (kg)
 Dose of 0.01 mg/kg body weight

Atropine sulfate 0.5 mg/5 ml Solution for Injection (ml)
 Dose of 0.02 mg/kg body weight

Atropine sulfate 0.5 mg/5 ml Solution for Injection (ml)
 
3 - 5
 0.5 ml
 0.5-1.0 ml
 
5-10
 0.5-1.0 ml
 1.0-2.0 ml
 
10 - 15
 1.0-1.5 ml
 2.0-3.0 ml
 
15 - 20
 1.5-2.0 ml
 3.0-4.0 ml
 
20 - 30
 2.0-3.0 ml
 4.0-6.0 ml
 
30 - 50
 3.0-5.0 ml
 6.0 ml
 

Special populations

Caution is advised for patients with renal or hepatic impairment and in elderly (see section 4.4).

Method of administration

Atropine is administered by intravenous injection or intramuscular injection. Other pharmaceutical forms/strengths may be more appropriate in the cases where a dose above 0.5 mg is required.

4.3 Contraindications
- Hypersensitivity to the active substance or to any of the excipients

- Closed-angle glaucoma

- Risk of urinary retention because of prostatic or urethral disease

- Achalasia of the esophagus, paralytic ileus, and toxic megacolon

All these contra-indications are however not relevant in life-threatening emergencies (such as bradyarrhythmia, poisoning).
4.4 Special warnings and precautions for use
Use with caution in case of:

- Prostatic enlargement

- Renal or hepatic insufficiency

- Cardiac insufficiency, arrhythmias, hyperthyroidism

- Chronic obstructive pulmonary disease, as a reduction in bronchial secretions may lead to the formation of bronchial plugs

- Intestinal atonia in elderly

- Pyloric stenosis

- Fever, or when ambient temperature is high

- In children and elderly, who may be more susceptible to its adverse effects

- In reflux oesophagitis, as atropine may delay gastric emptying, decrease gastric motility and relax oesophageal sphincter

Atropine should not be given to patients with myasthenia gravis unless given in conjunction with anticholinesterase.

Atropine administration should not delay implementation of external pacing for unstable patients, particularly those with high-degree (Mobitz type II second-degree or third-degree) block.

Antimuscarinics block vagal inhibition of the SA nodal pacemaker and should thus be used with caution in patients with tachyarrhythmias, congestive heart failure or coronary heart disease.

This medicinal product contains sodium. S