ATROPINE SULFATE

5 mg/5 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. 6 mg per dose), dosage should be adjusted according to the patient’s response and tolerance.

5 mg IV (5ml), every 2-5 minutes until the desired heart rate is achieved. 6 mg). As an antidote to organophosphates (pesticides, nerve gases), to cholinesterase inhibitors and in muscarinic mushroom poisoning: Intravenous use. 5 - 2 mg atropine sulfate (5 - 20 ml), can be repeated after 5 minutes and subsequently every 10-15 minutes as required, until signs and symptoms disappear (this dose may be exceeded many times).

02 mg atropine sulfate/kg body weight possibly repeated several times until signs and symptoms disappear. Dose adjustments In general, dosage should be adjusted according to patient’s response and tolerance. 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.

1). The dosage ranges for the paediatric weight groups as stated below are values for guidance. 6 mg per dose), dosage should be adjusted according to the patient’s response and tolerance. 4). Method of administration Atropine is administered by intravenous injection or intramuscular injection.

5 mg is required.

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) Uncommo n (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very Rare (<1/10,00 0) Not known (cannot be estimated from the available data) Immune system disorders Allergic reactions Anaphylax is Nervous system disorders Excitement, incoordinati on, mental confusion, and/or hallucinatio ns (especially with higher dosages), hyperthermi a Psychotic reactions Seizure, drowsines s Headache, restlessnes s, ataxia, insomnia Eye disorders Visual disturbances (mydriasis, inhibition of accommodati on, blurred vision, photophobia) Cardiac disorders Tachycardia (arrhythmia s, transient exacerbatio n of bradycardia ) Atrial arrhythmia s, ventricular fibrillation , angina, hypertensi ve 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) Uncommo n (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very Rare (<1/10,00 0) Not known (cannot be estimated from the available data) Gastrointestin al disorders Dryness of the mouth (difficulty in swallowing and talking, thirst), parasympathe tic inhibition of gastrointestin al 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 parasympat hetic control of the urinary bladder, urinary retention Paediatric population Infants, children and children with spastic paralysis or brain damage may be more susceptible to antimuscarinic effects.

Special populations Atropine may cause excitement, incoordination, confusion and/or hallucinations especially in the elderly. An epidemiological study similarly reported lower cognitive performance in elderly patients receiving antimuscarinics.

Patients with Down syndrome may be more susceptible to antimuscarinic effects. 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.

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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. 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).