INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BEECHAM ATROPINE SULPHATE INJECTION 0,5 mg/mL

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

BEECHAM ATROPINE SULPHATE INJECTION 0,5 mg/mL

COMPOSITION:
Each 1 mL ampoule contains 0,5 mg
atropine sulphate.

PHARMACOLOGICAL CLASSIFICATION:
A. 5.4 Cholinolytics (anticholinergics)

PHARMACOLOGICAL ACTION:
Atropine is an anticholinergic alkaloid which blocks the effects of acetylcholine at muscarine receptors.

INDICATIONS:
Before the induction of general anaesthesia.
In patients with an acute myocardial infarction who have developed a bradycardia or atrioventricular block.
For the treatment of intoxication with cholinesterase inhibitors and for intoxication by Amanita muscaria and other mushroom poisonings where the toxic agent is a muscarine-like compound.

CONTRA-INDICATIONS:
Atropine is contra-indicated in patients with prostatic enlargement, closed angle glaucoma or patients with a narrow angle between the iris and the cornea. It is also contra-indicated in patients suffering from paralytic ileus or pyloric stenosis and in status asthmaticus.

DOSAGE AND DIRECTIONS FOR USE:
Pre-anaesthetic medication to suppress secretions and diminish the risk of vagal inhibition
Children (above 1 year of age) : 0,010 mg –0,020 mg/kg body mass.
Adults : 0,3 mg –0,6 mg S.C. or I.M., about one hour before anaesthesia.
    0,3 mg –0,6 mg I.V., immediately before induction of anaesthesia.
Treatment of
(1) Intoxication by Amanita muscaria or cholinomimetics
  0,5 –1,0 mg I.M. or I.V.
(2) Anticholinesterase poisoning
  Initially, 2 mg –4 mg given intravenously if possible, otherwise intramuscularly, repeated at intervals of 3 to 10 minutes until muscarinic symptoms are controlled, which may require as much as 50 mg.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects of Atropine include dryness of the mouth with difficulty in swallowing, thirst, dilatation of the pupils with loss of accommodation and photophobia, increased intra-ocular pressure, flushing and dryness of the skin, transient bradycardia, followed by tachycardia, with palpitations and arrhythmias, and desire to urinate with the inability to do so, as well as reduction in the tone and motility of the gastro-intestinal tract leading to constipation. Occasionally vomiting, giddiness, and staggering may occur. Retrosternal pain may occur due to increased gastric reflux.

Due to the risk of provoking hyperpyrexia, Atropine should not be given to patients, especially children, when the ambient temperature is high. It should be used with caution in thyrotoxicosis, cardiac insufficiency or failure, and in cardiac surgery, where it may further accelerate the heart-rate.

Persons with Down's Syndrome appear to have an increased susceptibility to the action of Atropine, whereas those with albinism may be resistant.

Effects may be enhanced by concomitant administration of other drugs with anticholinergic properties, such as amantadine, some antihistamines, butyrophenones and phenothiazines, and tricyclic antidepressants.

Atropine should not be given to patients who are being treated with a monoamine-oxidase inhibitor, or within ten days of the discontinuation of such treatment.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Toxic doses are characterised by marked excitement, hallucinations, delirium, tachycardia. rapid or stertorous respiration, mydriasis, hyperpyrexia, dryness of the mouth, urine retention and constipation. A rash may appear on the face and upper trunk. In severe intoxication, depression of the central nervous system may occur with hypertension or with circulatory failure and respiratory depression.

Physostigmine salicylate controls the central and peripheral effects of Atropine, and is used as antidote.

Marked excitement and convulsions may be controlled by diazepam or a short-acting barbiturate. Large doses should be avoided because the central depressant action may coincide with the depression occurring late in Atropine poisoning.

Supportive therapy may require oxygen and assisted respiration, ice-bags or alcohol sponges for hyperpyrexia, especially in children, bladder catheterisation, and the administration of fluids.

CONDITIONS OF REGISTRATION:
None.

IDENTIFICATION:
A clear solution in clear glass ampoules.

PRESENTATION:
BEECHAM ATROPINE SULPHATE INJECTION 0,5 mg/mL in 1 mL clear glass ampoules.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
T/5.4/42.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
BEECHAM PHARMACEUTICALS (PTY) LIMITED
6 Carey Street
Wynberg Ext. 6
2090, Johannesburg.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
02-09-1986.

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