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BONJELA

Active substance(s): CETALKONIUM CHLORIDE / CHOLINE SALICYLATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Bonjela Teething Gel.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient Lidocaine hydrochloride1 Cetalkonium chloride
1

%w/w 0.33 0.01

Specification BP HSE

Equivalent to 0.27% w/w of Lidocaine base.

3.

PHARMACEUTICAL FORM Water soluble viscous gel.

4. 4.1

CLINICAL PARTICULARS Therapeutic Indications For the relief of pain and discomfort associated with infant teething.

4.2

Posology and Method of Administration Topical application to the gums. Infants children: and young Apply a small amount of Bonjela Teething Gel with a clean little finger to the affected area and rub in gently. Repeat every three hours if necessary. Not recommended for infants under two months. Not intended for adult use.

Adults and elderly:

4.3

Contra-Indications Known hypersensitivity to anaesthetics of the amide type.

4.4

Special Warnings and Special Precautions for Use To be used with caution in patients with hepatic or cardiac dysfunction. Label warnings: Do not use more than every 3 hours. Do not exceed the stated dose. Not recommended for infants under two months. Keep out of reach of children. If symptoms persist consult your doctor.

4.5

Interaction with other Medicinal Products and other Forms of Interaction Concurrent use of either cimetidine or propranolol increases the risk of Lidocaine toxicity. Lidocaine is antagonised by those diuretics which cause hypokalaemia.

4.6

Pregnancy and Lactation Not applicable.

4.7

Effects on Ability to Drive and Use Machines Not applicable.

4.8

Undesirable Effects There have been a few cases of contact dermatitis and methaemoglobinaemia.

4.9

Overdose The toxic effects of Lidocaine are directly related to blood concentrations. Symptoms are dizziness, cyanosis due to methaemoglobinaemia, fall of blood pressure, muscular tremors, convulsions, coma, irregular and weak breathing, cardiac standstill and bronchial spasm. Removal of the ingested drug by induced emesis followed by activated charcoal is only useful if the patient is seen within 30 minutes of ingestion. The airway must be maintained and

artificial respiration with oxygen given until convulsions or depression are controlled and blood pressure and pulse return to normal. Convulsions can be controlled with diazepam (0.1mg/kg i.v.) or succinylcholine chloride (10-50mg i.v. slowly). Perform artificial respiration with oxygen until convulsions are controlled and continue giving oxygen until blood pressure and pulse return to normal. Adequate arterial oxygen saturation must be maintained. If convulsions are not continuous the administration of oxygen may be sufficient to maintain the patient until the blood level of Lidocaine falls. Do not give stimulants. The methaemoglobinaemia can be treated by methylene blue (1%, 0.1 ml/kg, i.v. over ten minutes). Treat fall in blood pressure by postural means (head down, feet raised, supine position) or with i.v. saline or blood transfusion if shock threatens. The critical period does not exceed one hour. Suppression of pharyngeal sensation with concomitant effects on swallowing may theoretically result from excessive topical oral use of Bonjela Teething Gel. Such an effect has been reported in an adult who gargled and swallowed 5 ml of a 2% Lidocaine hydrochloride solution (equivalent to 100mg of Lidocaine).However, assuming proportionality of body surface area and pharyngeal surface area, this dose would be equivalent to a single dose of 5.4 g of Bonjela Teething Gel for a three month old child. It is most unlikely, even with misuse or excessive application of Bonjela Teething Gel, that the large amounts of Lidocaine hydrochloride or cetalkonium chloride required to produce clinically-relevant toxic effects would be reached. In the event of overdose, use should be discontinued and a doctor consulted.

5. 5.1.

PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties Lidocaine hydrochloride is an established local anaesthetic agent which produces tissue insensitivity by virtue of its ability to impede the inward flux of sodium ions, thus preventing transmission of the nerve impulse. Cetalkonium chloride is a quatemary ammonium antimicrobial agent, being bactericidal towards both gram positive and gram negative organisms but with preference for the former.

5.2.

Pharmacokinetic Properties

Lidocaine is highly lipophilic resulting in rapid passage through mucous membranes, which is confirmed by human studies showing a Tmax of approximately 50 minutes following application of a 2% solution to the intact oral mucosa. Metabolism is virtually complete by the hepatic route, undergoing three transformations, oxidative-n-dealkylation, hydrolysis and hydroxylation. In neonates a T of 3-5 hours has been reported following intrathecal administration of Lidocaine to the mother; the elimination following topical application to the oral mucosa is likely to be of the same order.

5.3.

Pre-clinical Safety Data No preclinical findings of relevance have been reported.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Ethanol 96%, glycerol, hypromellose 4500, sodium cyclamate 1969, banana flavour and purified water.

6.2.

Incompatibilities None known.

6.3.

Shelf-Life Two years.

6.4.

Special Precautions for Storage Store below 25C.

6.5

Nature and contents of container
Internally lacquered collapsible aluminium tube with membrane seal fitted with a polyethylene wadless cap. Pack sizes: 10g, 15g and 15 g plus teether.

6.6.

Instructions for Use, Handling and Disposal Apply a small amount of gel with a clean little finger to the affected area and rub in gently.

7.

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

8.

MARKETING AUTHORISATION NUMBER(S) PL 00063/0048.

9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION 24 April 1995.

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DATE OF REVISION OF THE TEXT
26/11/2012

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Source: Medicines and Healthcare Products Regulatory Agency

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