SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Atropine Sulfate Injection BP 400mcg in 1 ml

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Atropine Sulfate 0.04% w/v.

3. Pharmaceutical Form

Solution for injection.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

1.    Bradycardia after myocardial infarction or when caused by beta -adrenoceptor blocking drugs.

2.    To prevent excessive bronchial secretion during the use of general anaesthesia.

By the intramuscular route 30 minutes before induction of anaesthesia.

20 micrograms per kilogram body weight.

4.3 Contra-indications

Prostatic enlargement, use with caution to elderly men. Paralytic ileus and closed angle glaucoma.

4.4 Special Warnings and Precautions for Use

Use with caution in patients with fever, pyloric stenosis, ulcerative colitis, gastro - oesophageal reflex or cardiac insufficiency.

4.5 Interactions with other Medicaments and other forms of Interaction

The effects of Atropine may be enhanced by the concomitant administration of drugs such as drugs with anticholinergics actions such as amantadine, some antihistamines, buterophenones, phenothiazines and tricyclic antidepressants.

The effects of Atropine may be opposed by metoclopramide.

4.6 Pregnancy and Lactation

There is no or inadequate evidence of safety of Atropine in human pregnancy, but the drug has been widely used for many years without apparent ill-consequence. If drug therapy is needed in pregnancy the use of this drug is acceptable.

Use during breast feeding is not recommended.

4.7 Effects on Ability to Drive and Use Machines

Atropine may impair vision and should be used with caution if the patient intends to drive or operate machinery.

Undesirable Effects

Atropine may cause excitement, delirium, dilated pupils, rapid pulse, hot flushes, dry skin, dry mouth and thirst. These may be followed by arrhythmias, difficulty with micturition and constipation. Rarely, fever, confusional states and rashes may occur.

4.9. Overdose

Symptoms Signs of overdosage are those described in section 4.8.

Treatment Symptomatic and supportive treatment should be instituted. If the product has been introduced orally then gastric lavage should be included. In later stages respiratory depression may occur and artificial respiration may be needed. Circulatory failure may occur.

Pharmacological Properties

5.1 Pharmacodynamic Properties Atropine has central and peripheral actions.

Initially the central effects cause restlessness and excitement, but larger doses produce central depression with drowsiness, delirium and coma.

It diminishes the secretions of the salivary and sweat glands and of the bronchial and gastro - intestinal tracts. It increases the heart rate, produces vasodilation, dilates the pupils, paralyses the muscles of accommodation and increases intra - ocular pressure.

5.2    Pharmacokinetic Properties

Atropine is rapidly absorbed from mucous membranes, skin and the gastro -intestinal tract.

It is 50% plasma protein bound.

After 24 hours about 85% of a dose is excreted in the urine.

5.3    Preclinical Safety Data

None stated.

6.1    List of excipients

Sodium Chloride and Water for Injections. The pH may be adjusted using Sodium Hydroxide or Sulphuric Acid.

6.2    Incompatibilities

None known.

6.3    Shelf Life

36 months.

6.4    Special Precautions    for    Storage

None stated.

6.5    Nature and Contents of Container

1 ml in type 1 colourless neutral glass ampoules. Fusion sealed.

Packed into carton of 10 ampoules.

6.6    Instruction for Use/Handling

None stated.

Administrative Data

7. Marketing Authorisation Holder

Macarthys Laboratories Ltd t/a Martindale Pharmaceuticals Bampton Road,

Harold Hill,