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DEQUACAINE

Active substance(s): BENZOCAINE / DEQUALINIUM CHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Dequacaine.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 0.25mg dequalinium chloride BP and 10.0mg benzocaine BP.

3

PHARMACEUTICAL FORM
Lozenge.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of severe sore throats.

4.2

Posology and method of administration
Adults and Children over 12 years: One lozenge to be sucked slowly every two hours
as required. Not more than 8 lozenges to be taken in any 24 hours.
Children under 12 years: Not suitable.
Elderly: There is no need for dosage reduction in the elderly.

4.3

Contraindications
Patients hypersensitive to any of the ingredients or to para-aminobenzoic acid and its
derivatives.
Patients with low plasma cholinesterase concentrations.

4.4

Special warnings and precautions for use
Dequacaine should be used with caution in patients with myasthenia gravis.
The label states:
Warning: Do not exceed the stated dose.
Keep all medicines out of the reach of children.
If symptoms persist consult your doctor.

4.5

Interaction with other medicinal products and other forms of interaction
Dequacaine is contraindicated in those patients taking anticholinesterases.
Benzocaine is metabolised to para-aminobenzoic acid and Dequacaine may therefore
antagonise the effects of sulphonamides.

4.6

Pregnancy and lactation
The safety of Dequacaine during pregnancy and lactation has not been established. As
local anaesthetics can cross the placenta, it is recommended that this product is not
taken during pregnancy. No information in the use of this product in lactation is
available and it is recommended that Dequacaine is not taken whilst breast-feeding.

4.7

Effects on ability to drive and use machines
No adverse effects known.

4.8

Undesirable effects
Dequacaine may occasionally cause hypersensitivity reactions.
Methaemoglobinaemia has occasionally been reported following the use of
benzocaine.

4.9

Overdose
Symptoms of overage including yawning, restlessness excitement, nervousness,
dizziness, nystagmus, tinnitus, blurred vision, nausea, vomiting, muscle twitching,
tremors and convulsions. 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, arrythmias and cardiac arrest. May also cause
methaemoglobinaemia.
Treatment consists of essentially of maintaining the circulation and respiration and
controlling convulsions. The circulation may be maintained with infusions of plasma
or suitable electrolyte solutions. Convulsions may be controlled by the intravenous
administration of diazepam. If necessary, suxamethonium together with endotracheal
intubation and artificial respiration may be used if convulsions persist.
Methaemoglobinaemia may be treated by intravenous administration of 1- 4 mg/kg
methylthioninium chloride injection.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Benzocaine is a local anaesthetic of the ester type. Dequalinium chloride is a
quaternary ammonium antiseptic active against many gram-positive and gramnegative bacterial, yeasts and fungi.

5.2

Pharmacokinetic properties
Benzocaine is readily absorbed through mucous membranes and is hydrolysed by
esterases in the plasma and to a lesser extent in the liver.

5.3

Preclinical safety data
There are no preclinical safety data of relevance to the consumer.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium saccharin, levomenthol or racementhol, racemic camphor, sorbitol,
peppermint oil, benzyl alcohol, liquid sugar, liquid glucose, invert syrup.

6.2

Incompatibilities
None.

6.3

Shelf life
2 years.

6.4

Special precautions for storage
Do not store above 30ÂșC.

6.5

Nature and contents of container
PVC/PVDC blister strips sealed with aluminium foil enclosed in cardboard cartons to
give a pack of 24 lozenges.

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0401

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
9.4.1991

10

DATE OF REVISION OF THE TEXT
01/08/2008

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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