ATROPINE SULFATE

2 mg/ml, solution for injection in pre-filled syringe must be administered under medical supervision Posology Pre-anaesthetic medication Intravenous administration immediately before surgery; if necessary an intramuscular administration 30-60 minutes before surgery is possible.

5 ml), every 2-5 minutes until the desired heart rate is achieved. 5 ml), every 3-5 minutes (maximum 3 mg) As an antidote to organophosphates (pesticides, nerve gases), to cholinesterase inhibitors and in muscarinic mushroom poisoning: Intravenous use.

5 - 10 ml) depending on the patient's features and response, can be repeated after 5 minutes and subsequently as required, until signs and symptoms disappear (this dose may be exceeded many times). 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 is usually increased until adverse effects become intolerable; then a slight reduction in dosage generally yields the maximum dosage tolerated by the patient. 4). Method of administration Atropine is administered by intravenous injection or intramuscular injection.

Paediatric population The pre-filled syringe is not adapted to the administration in paediatric population; the graduation does not permit accurate measurement.

The pattern of adverse effects seen with atropine can mostly be related to their pharmacological actions at muscarinic and, at high doses, nicotinic receptors. Adverse effects are dose-related and usually reversible when therapy is discontinued.

The most common effects occurring with relatively small doses are visual disturbances, reduced bronchial secretion, dry mouth, constipation, reflux, flushing, difficulty in micturition and dryness of the skin. Transient bradycardia may develop followed by tachycardia, with palpitations and arrhythmias.

The evaluation of adverse reactions is based on the following definition of frequency: Very Common: ≥1/10; Common: ≥1/100 to <1/10; Uncommon: ≥1/1,000 to <1/100; Rare: ≥1/10,000 to <1/1,000; Very rare: <1/10,000; Not known: cannot be estimated from the available data Frequency System Organ Class Very Common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very Rare (<1/10,000) Not known (cannot be estimated from the available data) Immune system disorders Allergic reactions Anaphylaxis Nervous system disorders Excitement, incoordination, mental confusion, and/or hallucinations (especially with higher dosages), hyperthermia Psychotic reactions Seizure, drowsiness Headache, restlessness, ataxia, insomnia Eye disorders Visual disturbances (mydriasis, inhibition of accommodation, blurred vision, photophobia) Cardiac disorders Tachycardia (arrhythmias, transient exacerbation of bradycardia) Atrial arrhythmias, ventricular fibrillation, angina, hypertensive crisis Vascular disorders Flushing Respiratory, thoracic and mediastinal disorders Reduced bronchial secretion Frequency System Organ Class Very Common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very Rare (<1/10,000) Not known (cannot be estimated from the available data) Gastrointestinal disorders Dryness of the mouth (difficulty in swallowing and talking, thirst), parasympathetic inhibition of gastrointestinal tract (constipation and reflux), inhibition of gastric secretion, loss of taste, nausea, vomiting, bloated feeling Skin and subcutaneous tissue disorders Anhidrosis, urticaria, rash Renal and urinary disorders Inhibition of the parasympathetic control of the urinary bladder, urinary retention Special populations Atropine may cause excitement, incoordination, confusion and/or hallucinations especially in the elderly.

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 the 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. e. ‘without sodium’.

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).