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

Logo Q-MED SUXAMETHONIUM 100 mg/2 mL INJECTION

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

Q-MED SUXAMETHONIUM 100 mg/2 mL INJECTION

COMPOSITION:
Each 2 mL ampoule contains 100 mg
Suxamethonium Chloride dihydrate.

PHARMACOLOGICAL CLASSIFICATION:
A 17.1 Peripherally-acting muscle relaxants.

PHARMACOLOGICAL ACTION:
Suxamethonium chloride is a depolarising, neuromuscular blocking agent. The initial effect is to depolarise the membrane in the same manner as acetylcholine, but more persistently, which results in a brief period of firing manifested by transient muscular fasciculation. This phase is succeeded shortly by paralysis. The degree of muscle relaxation can be altered by a change in the rate of infusion.

INDICATIONS:
It is used as an adjuvant in surgical anaesthesia to obtain relaxation of skeletal muscle, particularly of the abdominal wall, so that operative manipulations are facilitated. With muscular relaxation no longer dependent upon general anaesthesia, a much lighter level of anaesthesia suffices. Muscle relaxation is also of value in various orthopaedic procedures, such as a correction of dislocations and the alignment of fractures. It's used to facilitate laryngoscopy, bronchoscopy and oesophagoscopy, in combination with general anaesthesia.

CONTRA-INDICATIONS:
Suxamethonium chloride is contra-indicated in patients with atypical pseudocholinesterase and should be used with caution in patients with reduced pseudocholinesterase activity which may occur in certain disease states, following exposure to certain drugs, and in pregnancy. It is contra-indicated in patients with burns, massive trauma, renal impairment with a raised plasma-potassium concentration, severe long-lasting sepsis, and severe hyperkalaemia. Patients with a penetrating eye injury or glaucoma or those about to undergo incision of the eyeball in eye surgery should not be given suxamethonium chloride because of the risks from increased intraocular pressure. Suxamethonium chloride produces muscle depolarisation before relaxation and is contra-indicated in patients with bone fractures. It is contra-indicated in patients with a family history of malignant hyperthermia.

DOSAGE AND DIRECTIONS FOR USE:
The usual single dose of suxamethonium chloride for an adult is 20 to 80 mg intravenously. Response varies considerably and doses may be repeated if necessary to a maximum total of 100 mg. An initial test dose of 5 to 10 mg may be given intravenously if increased sensitivity is suspected. When a suitable vein is inaccessible suxamethonium chloride may be given by intramuscular injection, a suggested dose being 2,5 to 4 mg per kg body-weight to a maximum total of 150 mg. While doses of 1 to 2 mg per kg body-weight have been employed in children, it has been recommended that doses of suxamethonium of at least 3 mg per kg body-weight for infants and 2 mg per kg for children are given to compensate for the relative resistance.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Prolonged apnoea may occur in patients with an atypical enzyme or with low enzyme activity. Pseudocholinesterase. Administration of suxamethonium chloride results in transient fasciculations during the onset of depolarising block. Rhabdomyolysis, myoglobinaemia, and myoglobinuria have been reported. A transient rise in intra-gastric pressure may occur secondary to fasciculation of abdominal muscles. Postoperative muscle pain occurs in some patients. A transient increase in intra-ocular pressure often occurs. Depolarisation of skeletal muscle produces an immediate increase in plasma-potassium concentration.
Stimulation of the vagus nerve and parasympathetic ganglia by suxamethonium chloride may be followed by bradycardia, other arrhythmias, and hypotension and may be exacerbated by the raised plasma-potassium concentration; cardiac arrest has been reported. Tachycardia and an increase in blood pressure due to stimulation of sympathetic ganglia have also been reported. Suxamethonium chloride may cause an increase in salivary, bronchial and gastric secretion and other muscarinic effects.
Salivary gland enlargement has occurred. Flushing, skin rash, bronchospasm and shock have been reported. It is implicated in the development of malignant hyperthermia in those patients with a genetic predisposition to the syndrome.
The response to suxamethonium chloride is often unpredictable in patients with neuromuscular disorders and it should be used with great caution in these patients. Caution is also needed if it is given to a patient with cardiac or respiratory disease or who has shown hypersensitivity to any neuromuscular blocker. Hypothermia may enhance the neuromuscular blocking effects of suxamethonium chloride and an increase in body temperature may reduce them. A number of drugs may interact with depolarising muscle relaxants such as suxamethonium. In general, interactions with suxamethonium are potentially more serious in patients with impaired neuromuscular function and in patients with reduced activity of pseudocholinesterase enzyme.

KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT:
Also read Side-Effects and Special Precautions.
Treatment is symptomatic and supportive.
Prolonged apnoea should be treated by assisted respiration with nitrous oxide and oxygen until spontaneous respiration is fully restored.

IDENTIFICATION:
Clear colourless solution in amber glass ampoules.

PRESENTATION:
Pack of 10 x 2 mL ampoules.

STORAGE INSTRUCTIONS:
Store at 2°C to 8°C.
Do not freeze.
Protect from light.
Keep all medicines out of reach of children.

REGISTRATION NUMBER:
29/17.1/0716

NAME AND BUSINESS ADDRESS OF APPLICANT:
QUATROMED LIMITED
10 LINDLEY STREET
BETHLEHEM 9700

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
November 1994        PSU0131/1-96

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