Drugs List

Administration

For application to the oral mucosa.

Dentures must be removed prior to application. Leave at least 30 minutes before re-insertion of dentures.

Avoid rinsing of the mouth or eating for 15 minutes after application.

Contraindications

Children under 16 years.
Hypersensitivity to salicylates.

Precautions and Warnings

Each container of solution may only be used by one person.

Frequent application, especially in children, may give rise to salicylate poisoning.

Consult doctor or dentist if symptoms persist for more than 7 days.

Any discolouration which may occur will disappear during normal cleaning of teeth.

Pregnancy (see notes under Pregnancy).

Breastfeeding (see notes under Lactation).

Salicylates may precipitate bronchospasm and induce asthma attacks in susceptible patients.

CSM Warnings

The Commission on Human Medicines (CHM) has advised that topical oral pain relief products containing salicylate salts should not be used in children under 16 years as a cautionary measure, due to the theoretical risk of Reye's syndrome.

Pregnancy and Lactation

Pregnancy

The manufacturer advises caution when prescribing to pregnancy women. Animal studies are insufficient with respect to effects on pregnancy and/or embryonal/foetal development.

A further manufacturer has noted that there is clinical evidence of the safety of salicylates in pregnancy, but that they may prolong bleeding and contribute to maternal and neonatal bleeding. Consequently salicylates are best avoided at term.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

The manufacturer notes that anthranoid glycosides derived from rhubarb may be excreted in breast milk. However, at the therapeutic doses of the medication, it is not known whether these, or salicylic acid are excreted in breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Superficial tooth discolouration
Burning sensation (local)
Allergic reaction
Rash
Urticaria
Bronchospasm
Asthma

Drugs List

Dosage

Adults

Elderly

Children

Adolescents

Administration

For application to the oral mucosa.

Dentures must be removed prior to application. Leave at least 30 minutes before re-insertion of dentures.

Avoid rinsing of the mouth or eating for 15 minutes after application.

Contraindications

Children under 16 years.
Hypersensitivity to salicylates.

Precautions and Warnings

Each container of solution may only be used by one person.

Frequent application, especially in children, may give rise to salicylate poisoning.

Consult doctor or dentist if symptoms persist for more than 7 days.

Any discolouration which may occur will disappear during normal cleaning of teeth.

Pregnancy (see notes under Pregnancy).

Breastfeeding (see notes under Lactation).

Salicylates may precipitate bronchospasm and induce asthma attacks in susceptible patients.

CSM Warnings

The Commission on Human Medicines (CHM) has advised that topical oral pain relief products containing salicylate salts should not be used in children under 16 years as a cautionary measure, due to the theoretical risk of Reye's syndrome.

Pregnancy and Lactation

Pregnancy

The manufacturer advises caution when prescribing to pregnancy women. Animal studies are insufficient with respect to effects on pregnancy and/or embryonal/foetal development.

A further manufacturer has noted that there is clinical evidence of the safety of salicylates in pregnancy, but that they may prolong bleeding and contribute to maternal and neonatal bleeding. Consequently salicylates are best avoided at term.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

The manufacturer notes that anthranoid glycosides derived from rhubarb may be excreted in breast milk. However, at the therapeutic doses of the medication, it is not known whether these, or salicylic acid are excreted in breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Advise patient to consult doctor or dentist if symptoms persist for more than 7 days.

Advise patient that if they wear dentures, to remove them before applying the medication.

Advise patient to avoid rinsing the mouth or eating for 15 minutes after application.

Advise patient that each container of solution may only be used by one person.

Side Effects

Superficial tooth discolouration
Burning sensation (local)
Allergic reaction
Rash
Urticaria
Bronchospasm
Asthma

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: January 2012.

Reference Sources

British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.

BNF for Children (2011-2012) Pharmaceutical Press, London.

MHRA guidance issued 21/04/09 'New advice on oral salicylate gels in under 16s'.

Summary of Product Characteristics for Pyralvex, Meda Pharmaceuticals, revised June 2011.

(Summary of Product Characteristics: Bonjela Gel, Reckitt Benckiser Healthcare (UK) Ltd, revised September 2009).
(Summary of Product Characteristics: Bonjela Cool Mint Gel, Reckitt Benckiser Healthcare (UK) Ltd, revised November 2010).