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

Logo INTRAMED ATROPINE SULPHATE INJECTION 10 mg/10 mL

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

INTRAMED ATROPINE SULPHATE INJECTION 10 mg/10 mL

COMPOSITION:.
Atropine Sulphate 10 mg in 10 mL.

PHARMACOLOGICAL CLASSIFICATION:
A 5.4 –Cholinolytics (Anticholinergics)

PHARMACOLOGICAL ACTION:
Atropine Sulphate is a parasympatholytic agent with central and peripheral actions. Intravenous atropine effectively antagonises the effects of muscarinic sites of the anticholinesterase (organophosphores and carbamates) agents.

INDICATIONS:
Intramed Atropine Sulphate Injection 10 mg/10 mL is used for treatment of organophosphore and carbamate (anticholinesterase) poisoning only.

CONTRA-INDICATIONS:
See warnings.

WARNINGS:
Atropine should not be given to patients with prostatic enlargement, close-angel glaucoma or a narrow angel between the iris and the cornea. Caution must be observed in administering atropine to patients with coronary insufficiency or cardiac failure. Tachycardia may result from vagal inhibition and induce angina of effort in patients with coronary heart disease. Atropine is also contraindicated in patients with paralytic ileus, or pyloric stenosis.

DOSAGE AND DIRECTIONS FOR USE:
When treating organophosphore and carbamate poisoning an intravenous line should be inserted and atropine should be started as soon as possible since it is the most important part of therapy. The initial adult dose of intravenous atropine is 2 mg (administered slowly over 2 minutes). If there is no effect after 15 minutes, this dose can be repeated. Up to 5mg every 15 minutes may be necessary in severe cases.
The initial intravenous dose in children is 0,05 mg/kg body mass.
The maintenance dose is in the range of 0,02 to 0,05 mg/kg body mass, as necessary.
The endpoint of treatment is the absence of excessive bronchial secretion.
When the patient improves the atropine can be tapered off, usually after 24 hours. Close observation during this stage is essential as rebound effects of organophosphore and carbamate toxicity (as a result of their lipid solubility) may occur. It is important not to stop atropine therapy abruptly.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects include dryness of the mouth with difficultly in swallowing, thirst, dilation of the pupils with loss of accommodation and photophobia, raised intra-ocular pressure, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, flushing and dryness of the skin, a desire to urinate with the inability to do so, as well as reduction in the tone and motility of the gastrointestinal tract, leading to constipation. Occasionally vomiting, giddiness and staggering may occur. Hypersensitivity to atropine is not uncommon and occurs as conjunctivitis or a skin rash.
Retrosternal pain due to gastric reflux may occur.
Atropine sulphate must be used with caution in patients with fever, tachycardia due to thyrotoxicosis, cardiac insufficiency or failure and cardiac surgery. Patients with Down's syndrome are more susceptible and patients with albinism are less susceptible to the actions of atropine. Mental confusion may occur, especially in the elderly.
The effects of atropine may be enhanced by the concomitant administration of other drugs with parasympatholytic properties, such as some antihistamines, phenothiazines, tricyclic antidepressants and other agents such as butyrophenones.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Toxic doses of atropine cause tachycardia, rapid or stertorous respiration, hyperpyrexia, restlessness, confusion and excitement and hallucinations passing into delirium. In severe intoxication, depression of the central nervous system may occur with circulatory failure and respiratory depression. Treatment of toxic effects is symptomatic and supportive.

IDENTIFICATION:
A clear colourless solution in 10 mL clear ampoules.

PRESENTATION:
Containers with 10 ampoules.

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

REGISTRATION NUMBER:
W/5.4/151

NAME AND BUSINESS ADDRESS OF APPLICANT:
Intramed (Pty) Ltd
6 Gibaud Road
Port Elizabeth
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1989 12-078/1-95
  Tradepak PE

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2004