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

Logo Q-MED ATROPINE 0,5 mg Injection
Q-MED ATROPINE 1,0 mg Injection

SCHEDULING STATUS:
S1        0,5 mg/mL
S2        1,0 mg/mL

PROPRIETARY NAME
(and dosage form):

Q-MED ATROPINE 0,5 mg Injection
Q-MED ATROPINE 1,0 mg Injection

COMPOSITION:
Q-Med Atropine 0,5 mg injection contains 0,5 mg of
atropine sulphate per mL.
Q-Med Atropine 1,0 mg injection contains 10 mg of atropine sulphate per mL.

PHARMACOLOGICAL CLASSIFICATION:
A 5 4 Cholinolytics.

PHARMACOLOGICAL ACTION
Atropine sulphate is an antimuscarinic agent. The major action is a competitive antagonism to ACh (acetylcholine) and other muscarinic agonists, the antagonism can therefore be overcome by increasing sufficiently the concentration of ACh at receptor sites of the effector organ. The receptors affected are those on peripheral structures that are either stimulated or inhibited by muscarine, that is, exocrine glands and smooth and cardiac muscle. It crosses the blood-brain barrier. It is incompletely metabolised in the liver and is excreted in the urine as unchanged agent and metabolites. A half-life of about 4 hours has been reported. It disappears rapidly from the blood and is distributed through the entire body. Atropine crosses the placenta and traces appear in milk.

INDICATIONS:
Pre-operatively, to counteract the vagal effects that may frequently occur during anaesthesia and to counteract the unwanted muscarine effects which may accompany reversal of neuromuscular blockade with neostigmine.
Initial treatment of patients with acute myocardial infarction in whom excessive vagal tone causes sinus or nodal bradycardia. Treatment of muscarine toxicity and in poisoning caused by pesticides that are organophosphate cholinesterase inhibitors

CONTRA-INDICATIONS:
Atropine should not be given to patients with closed-angle glaucoma or to patients with a narrow angle between the iris and cornea since it may increase the intra-ocular pressure. It is contra-indicated in patients with prostatic enlargement, in whom it may lead to urinary retention and in those with paralytic ileus or pyloric stenosis. It should not be given to patients with myasthenia gravis, unless it is given to reduce adverse muscarinic effects of an anticholinesterase agent.

WARNINGS:
Atropine should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure, and in cardiac surgery, where it may further accelerate the heart-rate. Care is required in patients with acute myocardial infarction as ischaemia and infarction may be aggravated. Atropine should be given with care to patients with hypertension.

DOSAGE AND DIRECTIONS FOR USE:
Paediatric pre-medication doses are:
Children weighing up to 3 kg: 100 µg subcutaneously
Children weighing 7 to 9 kg: 200 µg
Children weighing 12 to 16 kg: 300 µg
Children weighing 20 to 27 kg: 400 µg
Children weighing 32 kg: 500 µg
Children weighing 41 kg: 600 µg
For pre-medication prior to anaesthesia:
0,3 to 0,6 mg of atropine sulphate may be given by subcutaneous or intramuscular injection, usually in conjunction with 10 to 15 mg of morphine sulphate, about an hour before anaesthesia. Alternatively 0,3 to 0,6 mg may be given intravenously immediately before anaesthesia. In the management of arrhythmias 400 µg to 1 mg is given intravenously, repeated as needed to a total dose of 2 mg. In the treatment of bradycardia following cardiac infarction, atropine sulphate is administered intravenously in initial doses of 0,4 to 1 mg subsequently increased up to 2 mg, according to the needs of the patient.
Atropine sulphate 0,6 -1,2 mg can be given by slow intravenous injection in conjunction with neostigmine methylsulphate to reverse the effects of non-depolarising muscle relaxants. In the treatment of organophosphate poisoning and administered together with pralidoxime, atropine sulphate 2 mg should be given by subcutaneous, intravenous or intramuscular injection and repeated at intervals of 5 to 60 minutes until the patient shows signs of atropine toxicity. Atropinisation should then be maintained throughout the course of pralidoxime treatment, which may continue for 48 hours or more.
Considerably higher doses may be required in the treatment of poisoning due to irreversible anti-cholinesterases such as organo-phosphorous insecticides.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects of atropine includes dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia with palpitations and arrhythmias and difficulty in micturition, as well as reduction in the tone and mobility of the gastro-intestinal tract, leading to constipation. Vomiting, confusion, giddiness and staggering may occur.
Atropine should be used with caution in children and in geriatric patients. In patients with ulcerative colitis its use may lead to ileus or megacolon, and its effects in the lower oesophageal sphincter may exacerbate reflux. Be cautious in giving atropine to any patients with diarrhoea. Due to the risk of provoking hyperpyrexia, atropine should not be given to patients, especially children, when the ambient temperature is high, or in patients with fever. It should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure, and in cardiac surgery or in patients with myocardial infarction or in patients with hypertension.
The effects of atropine may be enhanced by concomitant administration of other agents with anti-muscarinic properties, such as amantadine, some antihistamines, butyrophenones, phenothiazines and tricyclic antidepressants. The reduction in gastric motility caused by atropine may affect the absorption of other agents.

KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT:
See 'Side-effects and Special Precautions'
Toxic doses cause tachycardia, rapid respiration, hyperpyrexia and central nervous system stimulation marked by restlessness, confusion, excitement, paranoid and psychotic reactions, hallucinations and delirium and occasionally seizures or convulsions. A rash may appear on the face or upper trunk. In severe intoxication, central stimulation may give way to central nervous system depression, coma, circulatory and respiratory failure and death.
Treatment: symptomatic and supportive

IDENTIFICATION:
Q-Med Atropine injection is a clear colourless solution filled into clear colourless glass ampoules.

PRESENTATION:
10 x 1 mL clear colourless glass ampoules.

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

REGISTRATION NUMBERS:
0,5 mg/1 mL:        31/5.4/0206
1 mg/1 mL;        31/5.4/0207

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
QUATROMED LIMITED
10 Lindley Street
BETHLEHEM
9701

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 1997
                                PAT 0051/01-98

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996,1997,1998