Peripheral effects include tachycardia, decreased production of saliva, sweat, bronchial, nasal, lachrymal and gastric secretions, decreased intestinal motility and inhibition of micturition.

Atropine increases sinus rate and sinoatrial and AV conduction. Usually heart rate is increased but there may be an initial bradycardia.

Atropine inhibits secretions throughout the respiratory tract and relaxes bronchial smooth muscle producing bronchodilatation.

5.2 Pharmacokinetic properties
Following intravenous administration, the peak increase in heart rate occurs within 2 to 4 minutes. Peak plasma concentrations of atropine after intramuscular administration are reached within 30 minutes, although peak effects on the heart, sweating and salivation may occur nearer one hour after intramuscular administration.

Plasma levels after intramuscular and intravenous injection are comparable at one hour. Atropine is distributed widely throughout the body and crosses the blood brain barrier. The elimination half-life is about 2 to 5 hours. Up to 50% of the dose is protein bound. It disappears rapidly from the circulation.

Atropine is metabolised in the liver by oxidation and conjugation to give inactive metabolites.

About 50% of the dose is excreted within 4 hours and 90% in 24 hours in the urine, about 30 to 50% as unchanged drug.

5.3 Preclinical safety data
Not applicable since atropine has been used in clinical practice for many years and its effects in man are well known.

6. Pharmaceutical particulars
6.1 List of excipients
Sodium Citrate Dihydrate

Citric Acid Monohydrate

Sodium Chloride

Water for Injection

6.2 Incompatibilities
None known

6.3 Shelf life
36 months

6.4 Special precautions for storage
Store below 25°C. Protect from light.

6.5 Nature and contents of container
The solution is contained in a USP type I glass vial with an elastomeric closure which meets all the relevant USP specifications. The product is available either as 5, 10 or 30ml.

6.6 Special precautions for disposal and other handling
The container is specially designed for use with the IMS Minijet injector.

7. Marketing authorisation holder
International Medication Systems (UK) Ltd

21 St Thomas Street

Bristol

United Kingdom

BS1 6JS
8. Marketing authorisation number(s)
PL 03265/0013R

9. Date of first authorisation/renewal of the authorisation
20/03/1991

10. Date of revision of the text
August 2016