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

Logo CEPACAINE ANAESTHETIC LOZENGES
CEPACAINE ANAESTHETIC LOZENGES BLACKCURRANT FLAVOUR

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

CEPACAINE ANAESTHETIC LOZENGES
CEPACAINE ANAESTHETIC LOZENGES BLACKCURRANT FLAVOUR

COMPOSITION:
Each lozenge contains:
Cetylpyridinium chloride.         1,40 mg
Benzocaine.         10,00 mg

PHARMACOLOGICAL CLASSIFICATION:
A 16.3 Surface Anaesthetics.

PHARMACOLOGICAL ACTION:
Cetylpyridinium chloride is a quaternary ammonium compound which has bactericidal and fungicidal activity. Cetylpyridinium chloride is effective in inhibiting the growth of a broad spectrum of microorganisms normally associated with mouth and throat infections, especially Streptococcus pyogenes, Steptococcus viridans and Staphylococcus aureus, all gram positive cocci. Cetylpyridinium chloride is to a lesser degree effective in inhibiting the gram negative organisms; Haemophilus influenzae, Klebsiella pneumoniae and the yeast Candida albicans. Benzocaine is a mild local anaesthetic.

INDICATIONS:
For the symptomatic relief of sore throat.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
Benzocaine is contra-indicated in patients with low plasma-cholinesterase concentrations or in those receiving anticholinesterases.
Safety in pregnancy and lactation has not been established.
Not recommended for children under 6 years of age.

DOSAGE AND DIRECTIONS FOR USE:
Dissolve one lozenge slowly in the mouth. Use every two hours as needed.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Severe sore throat or sore throat accompanied by high fever or headache or nausea and vomiting, or any sore throat persisting for more than two days, may be serious. In such cases, consult a physician and follow his instructions.
Systemic adverse effects may occur with benzocaine, as a result of the absorption of large amounts through mucous membranes or damaged skin or from highly vascular areas. Excitation of the central nervous system may be manifested by yawning, restlessness, excitement, nervousness, dizziness, tinnitus, nystagmus, blurred vision, nausea and vomiting. Excitation may be transient and followed by depression with drowsiness. respiratory failure and coma. There may be simultaneous effects on the cardiovascular system with myocardial depression and peripheral vasodilation resulting in hypotension and bradycardia, arrhythmias and cardiac arrest may occur.
Idiosyncratic reactions have been reported. Allergic reactions may occur. Benzocaine should be given with caution to patients with epilepsy, impaired cardiac conduction or respiratory function, or with liver damage; patients with myasthenia gravis are particularly susceptible to the effects of local anaesthetics.
Benzocaine is metabolised to para-aminobenzoic acid and can antagonise the action of sulphonamides. Benzocaine may impair swallowing and increase the risk of aspiration.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may cause nausea and vomiting. It has depolarising muscle relaxant properties and toxic symptoms include dyspnoea and cyanosis due to paralysis of the respiratory muscles, possibly leading to asphyxia. Depression of the central nervous system with convulsions, hypotension and coma may occur. Treatment is symptomatic and supportive.       

IDENTIFICATION:
Cepacaine Anaesthetic Lozenges:
Round green hard candy lozenge embossed with the letter "M" on both sides.
Cepacaine Anaesthetic Lozenges Blackcurrant Flavour: Round maroon hard candy lozenge embossed with the letter "M" on both sides.

PRESENTATION:
Blister pack of 16 lozenges.

STORAGE INSTRUCTIONS:
Store in a cool place below 25°C, protected from light and moisture. Keep out of the reach of children.

REGISTRATION NUMBER:
Cepacaine Anaesthetic Lozenges: H/16.3/123
Cepacaine Anaesthetic Lozenges Blackcurrant Flavour: 33/16.3/0493

NAME AND BUSINESS ADDRESS OF APPLICANT:
ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Bryanston, 2152, RSA.
Private Bag X 69, 2021, RSA.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
25 January 2001.

New addition to this site: April 2004
Source: Pharmaceutical Industry

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