Drugs List

Therapeutic Indications

Uses

Abrasions and ulcers of mouth
Local anaesthetic for gums prior to dental procedures
Temp relief from tenderness, soreness and pain due to wearing dentures
Temp relief of toothache associated with presence of open carious lesions
Temp relief of toothache due to direct exposure of a vital dental pulp

Contraindications

Family history of methaemoglobinaemia
Suspected methaemoglobin reductase deficiency
Methaemoglobinaemia

Precautions and Warnings

Children under 12 years
Breastfeeding
Phenylketonuria
Pregnancy

Some formulations contain aspartame - caution in phenylketonuria
Not all available brands are licensed for all indications
Not all available brands are licensed for use in children under 12 years
Some brands contain Allura Red (E129): may cause allergic reactions
Some formulations contain propylene glycol
Some formulations contain sorbic acid: may cause irritation
Do not use continuously
Only recommended for short term use
Avoid hot liquids
If symptoms persist a doctor or dentist should be consulted
Patients should not exceed recommended dose

Pregnancy and Lactation

Pregnancy

Use benzocaine throat spray with caution in pregnancy.

There is no animal data on the use of benzocaine in pregnancy.

Briggs et al notes that this medicine is not recommended during pregnancy.

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 to 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

Use benzocaine throat spray with caution in breastfeeding.

Hale et al notes there is no animal data on the use of benzocaine in breastfeeding. The oral bioavailability in infants would be less than 35%, as maternal plasma and milk levels do not reach high concentrations.

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

Burning sensation (local)
Contact dermatitis
Erythema
Hypersensitivity reactions
Methaemoglobinaemia
Oedema
Pruritus
Rash
Stinging

Presentation

Oromucosal gel containing benzocaine.

Drugs List

Therapeutic Indications

Uses

Abrasions and ulcers of mouth
Local anaesthetic for gums prior to dental procedures
Temp relief from tenderness, soreness and pain due to wearing dentures
Temp relief of toothache associated with presence of open carious lesions
Temp relief of toothache due to direct exposure of a vital dental pulp

Dosage

Adults

Children

Contraindications

Family history of methaemoglobinaemia
Suspected methaemoglobin reductase deficiency
Methaemoglobinaemia

Precautions and Warnings

Children under 12 years
Breastfeeding
Phenylketonuria
Pregnancy

Some formulations contain aspartame - caution in phenylketonuria
Not all available brands are licensed for all indications
Not all available brands are licensed for use in children under 12 years
Some brands contain Allura Red (E129): may cause allergic reactions
Some formulations contain propylene glycol
Some formulations contain sorbic acid: may cause irritation
Do not use continuously
Only recommended for short term use
Avoid hot liquids
If symptoms persist a doctor or dentist should be consulted
Patients should not exceed recommended dose

Pregnancy and Lactation

Pregnancy

Use benzocaine throat spray with caution in pregnancy.

There is no animal data on the use of benzocaine in pregnancy.

Briggs et al notes that this medicine is not recommended during pregnancy.

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 to 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

Use benzocaine throat spray with caution in breastfeeding.

Hale et al notes there is no animal data on the use of benzocaine in breastfeeding. The oral bioavailability in infants would be less than 35%, as maternal plasma and milk levels do not reach high concentrations.

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

Burning sensation (local)
Contact dermatitis
Erythema
Hypersensitivity reactions
Methaemoglobinaemia
Oedema
Pruritus
Rash
Stinging

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: July 2017.

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Orajel Dental Gel. Church & Dwight UK Limited. Revised April 2015.

Summary of Product Characteristics: Orajel Extra Strength. Church & Dwight UK Limited. Revised April 2015.

Summary of Product Characteristics: Orajel Mouth Gel. Church & Dwight UK Limited. Revised April 2015.

Summary of Product Characteristics: Ultracare Topical Anaesthetic Gel. Optident Ltd. Revised June 2015.