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Logo OROCHLOR SPRAY (solution)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

OROCHLOR SPRAY (solution)

COMPOSITION:
Each 100 mL of solution contains:
  Benzocaine 266,625 mg
  Chlorhexidine gluconate solution 1,071425 mL
  Alcohol 96% 30% v/v
Preservative:
  Nipasept 5% m/v
PHARMACOLOGICAL CLASSIFICATION:
A.16.3 Surface anaesthetics.

PHARMACOLOGICAL ACTION:
Chlorhexidine is a bactericidal cationic antiseptic. It acts by destroying the cell membrane and precipitating the cell cytoplasm. It has been shown that chlorhexidine binds on to the hydroxyapatite of tooth enamel, onto the pellicle of the tooth surface and on to salivary mucins. It slowly desorbs from these sites to exert a prolonged bactericidal effect for several hours.
Benzocaine has mild local anaesthetic properties.

INDICATIONS:
Orochlor Spray solution is indicated for temporary relief of pain and discomfort in sore throats due to cold (and accompanying tickling cough). It is also recommended for minor mouth irritations.

CONTRA-INDICATIONS:
Orochlor Spray solution is contra-indicated in patients with a hypersensitivity to local anaesthetics, chlorhexidine gluconate or any of the active ingredients.
Benzocaine is contra-indicated in patients with low plasma-cholinesterase concentrations or in those receiving anticholinesterases.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 4 - 8 sprays every 4 hours with a maximum of 32 sprays a day.
Children 6 - 12 years: 2 - 4 sprays every 4 hours with a maximum of 16 sprays a day.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Local skin sensitivity reactions may occur. Prolonged use may cause discolouration of the teeth.
Taste disturbances and a burning sensation of the tongue may occur initially.
When used in the mouth or throat, Orochlor Spray solution may impair swallowing and increase the risk of aspiration and patients should be cautioned not to eat for at least 60 minutes after the anaesthetic.
The systemic toxicity of benzocaine mainly involves the central nervous system and the cardiovascular system.
Excitation of the CNS may be manifested by restlessness, excitement, nervousness, dizziness, tinnitus, blurred vision, nausea and vomiting, muscle twitching and tremors, and convulsions. Numbness of the tongue and perioral region may appear as an early sign of systemic toxicity. Excitation may occur and may be followed by depression with drowsiness, respiratory failure, and coma. There may be simultaneous effects on the cardiovascular system with myocardial depression and peripheral vasodilatation resulting in hypotension and bradycardia; arrhythmias and cardiac arrest may occur.
It should be given cautiously to patients with epilepsy, impaired cardiac conduction, shock, myasthenia gravis or with liver damage.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Excitation with subsequent depression of the central nervous system.
Methaemoglobinaemia has occurred after absorption of benzocaine.
When systemic reactions occur steps should be taken to maintain the circulation and respiration and to control convulsions. Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear, orange red liquid.

PRESENTATION:
Amber bottles of 100 mL.

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

REGISTRATION NUMBER:
28/16.3/0057

NAME AND BUSINESS ADDRESS OF APPLICANT:
TRIOMED (PTY) LIMITED,
Parc Du Cap Building No. 3
Corner Willie van Schoor Road and Mispel Road
BELVILLE, 7530.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
07/02/1994

        K650

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