SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Atropine Sulphate Injection BP 600 Micrograms in 1ml

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Atropine Sulphate BP    0.06% w/v

3 PHARMACEUTICAL FORM

Sterile Solution for Injection

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

1.    Drying secretions prior to anaesthesia

2.    Reversal of excessive bradycardia

3.    Indicated with neostigmine for reversal of competitive neuromuscular block.

4.2 Posology and method of administration

Adults

Bradycardia

Management of bradycardia of acute myocardial infarction: Initial dose 300 - 600 micrograms intravenously, the dose may be increased by incremental doses of 100 micrograms up to 1mg if necessary.

Caution is required as atropine may aggravate ischaemia or infarction.

Treatment of bradycardia or asystole due to overdosage with parasympathetic agents 1 - 2mg subcutaneously, intramuscularly or intravenously.

Drying secretions

300 - 600 micrograms subcutaneously or intramuscularly 30 - 60 minutes prior to induction of anaesthesia. Alternatively, 300 - 600 micrograms may be given intravenously immediately prior to induction of anaesthesia.

Reversal of competitive neuromuscular block

0.6 - 1.2mg by slow intravenous injection for control of muscarinic side effects of neostigmine in reversal of competitive neuromuscular block. Atropine should not be given routinely with neostigmine as it may mask signs of overdose.

Children aged 1 year and over

Caution should be exercised in children and reduced doses are necessary.

Drying secretions

20 micrograms/kg (max 600 micrograms) intramuscularly 30 - 60 minutes prior to induction of anaesthesia. This dose should be reduced on hot days or in fever.

Other indications are not recommended for children.

Elderly

Caution should be exercised in the elderly and reduced doses may be required. Routes of administration: Intravenous, intramuscular or subcutaneous injection.

4.3 Contraindications

Known hypersensitivity to atropine, closed angle glaucoma, prostatic enlargement, paralytic ileus or pyloric stenosis, myasthenia gravis, severe ulcerative colitis.

4.4 Special warnings and precautions for use

Atropine Sulphate 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, acute myocardial infarction, hypertension or fever, and when the ambient temperature is high. 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.

Atropine should be given with care to patients with hypertension. Extreme caution is necessary in patients with myasthenia gravis or autonomic neuropathy.

Caution required when atropine is administered systemically to patients with chronic obstructive pulmonary disease, as a reduction in bronchial secretions may lead to the formation of bronchial plugs.

Antimuscarinics may delay gastric emptying, decrease gastric motility and relax the oesophageal sphincter. They should be used with caution in patients whose conditions may be aggravated by these effects e.g. reflux oesophagitis.

4.5 Interaction with other medicinal products and other forms of interaction

The effects of Atropine may be enhanced by the concomitant administration of other drugs with antimuscarinic activity including phenothiazines, amantadine, tricyclic antidepressants, MAOI's, nefopam some antihistamines and disopyramide. Reduced GI motility caused by Atropine may affect the absorption of other drugs such as mexilitine and ketoconazole. Atropine induced dry mouth may prevent dissolution of sublingual preparations such as the nitrates, reducing their effectiveness.

4.6 Pregnancy and lactation

Safety in human pregnancy has not been established although atropine does cross the placenta. Atropine may have antimuscarinic effects in infants. Therefore it is not advisable to administer atropine during pregnancy or breast feeding unless considered essential.

4.7 Effects on ability to drive and use machines

Not applicable as used on sedentary patients.

4.8 Undesirable effects

Common side effects include dryness of the mouth with difficulty in swallowing and talking, thirst, mydriasis with cycloplegia and photophobia, flushing and dryness of skin, transient bradycardia (followed by tachycardia, palpitations and arrhythmias), reduced bronchial secretions, urinary urgency and retention, constipation.

Other reported side effects include anaphylaxis, urticaria and rash occasionally progressing to exfoliation.

Occasionally nausea, vomiting and dizziness. Retrosternal pain may occur due to gastric reflux. Rare occurrences include confusional states and fever.

Atropine may cause raised intra-ocular pressure and mental confusion especially in the elderly.

4.9 Overdose

Symptoms:    Flushing and dryness of the skin (rash may appear on the face and

upper trunk), tachycardia, rapid respiration, hyperpyrexia, CNS stimulation (restlessness, confusion, excitement, paranoid and psychotic reactions, hallucinations and delirium and occasionally seizures and convulsions). Severe overdose may be indicated by CNS depression, coma, circulatory and respiratory failure and death.

Treatment:    Supportive therapy as necessary. Neostigmine or carbachol

antagonise peripheral adverse effects. In children the body surface should be kept moist.

5.1 Pharmacodynamic properties

Atropine is an antimuscarinic alkaloid with both central and peripheral actions. It first stimulates and then depresses the central nervous system and has antispasmodic actions on smooth muscle and reduces secretions, especially salivary and bronchial secretions.

5.2 Pharmacokinetic properties

Rapidly cleared from blood and distributed throughout the body.

Completely metabolised in the liver and excreted in the urine as unchanged drug and metabolites.

Atropine crosses the placenta and traces are found in breast-milk. Atropine crosses the blood brain barrier.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Water for Injections

Sulphuric Acid Nitrogen

6.2    Incompatibilities

Atropine is incompatible with alkaloids, tannic acid and mercury salts.

Shelf life

18 Months

6.4 Special precautions for storage

Store below 25 °C.

Keep container in the outer carton.

6.5 Nature and contents of container

Sterile aqueous solution for injection in Glass (Type I) 1ml prefilled syringes. No needle supplied.

6.6 Special precautions for disposal

Do not use if carton seal is broken or packaging is damaged.

Use once and discard any remaining.

7    MARKETING AUTHORISATION HOLDER

Aurum Pharmaceuticals Ltd

Bampton Road

Harold Hill

Romford

Essex

RM3 8UG

8    MARKETING AUTHORISATION NUMBER(S)

PL 12064/0040

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

01/12/1999 / 13/07/2005

10 DATE OF REVISION OF THE TEXT

15/01/2007