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

Logo Q-MED ADRENALINE INJECTION 1 mg/1 mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

Q-MED ADRENALINE INJECTION 1 mg/1 mL

COMPOSITION:
Each 1 mL contains 1 mg
adrenaline base as tartrate.
Sodium metabisulphite 0,1% m/v as anti-oxidant.

PHARMACOLOGICAL CLASSIFICATION:
A 5.1 Adrenomimetics.

PHARMACOLOGICAL ACTION:
Adrenaline is a sympathomimetic agent. It is a potent stimulator of both alpha and ß adrenergic receptors.

INDICATIONS:
Adrenaline is used for its sympathomimetic properties, such as relieve of bronchial spasm, acute allergy and for cardiovascular resuscitation as well as anaphylactic shock.

CONTRA-INDICATIONS:
Hypertension, arteriosclerosis, aneurysms, cardiovascular diseases such as ischaemic heart disease, arrhythmia or tachycardia and hyperthyroidism.
Anginal pain may be precipitated in patients with angina pectoris. Care is also required in patients with diabetes mellitus or closed-angle glaucoma. It should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane, or other halogenated anaesthetics, as they may induce ventricular fibrillation. An increased risk of arrhythmias may also occur if sympathomimetic agents are given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Adrenaline interacts with monoamine oxidase inhibitors and should not be given to patients receiving such treatment or within 14 days of its termination.

WARNINGS:
The injection is not to be used if its colour is pinkish or darker than slightly yellow or if it contains a precipitate.

DOSAGE AND DIRECTIONS FOR USE:
Bronchial spasm:
By subcutaneous injection.
Adults: 0,1 mL –0,5 mL of a 1 in 1000 aqueous solution (100 to 500 µg).
Children: 0,01 mL per kg body-mass, (10 µg per kg body-mass) to a maximum total dose of 0,5 mL (500 µg).
Acute allergy and anaphylactic shock:
By subcutaneous or preferably intramuscular injection.
Adults: 0,2 mL –0,5 mL of a 1 in 1000 solution. Up to 1 mL may be given and more than one dose may be required.
Cardiovascular resuscitation:
In emergencies a diluted solution is given slowly intravenously. The recommended dose is 0,5 mL to 1 mL, (0,5 mg to 1 mg) diluted 10 times to 5 to 10 mL (1 in 10 000 solutions). Doses may be given every 5 minutes during the prolonged resuscitation effort.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Central adverse effects may be fear; anxiety; restlessness; tremors; insomnia; irritability; confusion; weakness and psychotic states. Cardiac effects are palpitations; cardiac arrest; rapid pulse; anginal pain; hypotension with dizziness and flushing.
Appetite may be reduced, and nausea and vomiting may occur.
Weakness and coldness of the extremities, even with small doses, and especially when given in conjunction with local anaesthetics may occur. Gangrene may follow infiltration into the fingers and toes. Other effects may be, difficulty in micturition; urinary retention; dyspnoea; disturbances of glucose metabolism; sweating and hypersalivation.
Headache is also common.

KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT:
For symptoms see "Side-effects and Special Precautions". Because of the rapid onset and short duration of adrenaline action, the treatment is primarily supportive. Severe toxic reactions should be treated with an immediate injection of rapidly acting alpha-adrenergic blocking agent, such as phentolamine followed by a beta blocker such as propranolol. Rapid acting vasodilator, such as glyceryl trinitrate have also been used.

IDENTIFICATION:
A clear, practically colourless, slightly acid liquid. Gradually turns dark on exposure to light and air.

PRESENTATION:
1 mL amber ampoules in packs of 10 and 100.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER:
30/5.1/0395

ZIMBABWE ONLY PP –Reg .No 98/12.7/3380

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
November 1996
        PAD0051/09/98

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