Drugs List

Therapeutic Indications

Uses

Periodontal local anaesthesia

Contraindications

Administration site infection
Children under 18 years
Buccal ulceration
Methaemoglobinaemia

Precautions and Warnings

G6PD deficiency
Hepatic impairment
Pregnancy
Renal impairment
Severe bradycardia
Severe cardiac conduction defects

Avoid contact of product with skin
Avoid contact with eyes
Avoid excessive spread of gel to oro-pharyngeal mucosa
If accidental contact with the eyes occurs, rinse thoroughly with water
Advise patient not to eat or drink until sensation returns

Pregnancy and Lactation

Pregnancy

The manufacturer states that prilocaine with lidocaine gel should not be used during pregnancy unless clearly necessary.

There is no adequate data from the use of this product during human pregnancy.

Animal studies into the effects on pregnancy, embryonic and foetal development, parturition and postnatal development are incomplete. Lidocaine and prilocaine cross the placenta and may be absorbed by foetal tissues. The potential risks for humans is not known.

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

The manufacturer states that breastfeeding may be continued during treatment with prilocaine and lidocaine periodontal gel.

Lidocaine, and probably prilocaine, are excreted in breast milk in small amounts. However, it is unlikely that effects of these substances will affect the breastfeeding infant following administration of this product.

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

Allergic reaction
Anaphylactoid reaction
Application site reaction
Cyanosis
Dizziness
Headache
Irritation with burning (application site)
Laryngeal oedema
Methaemoglobinaemia
Nausea
Numbness
Oedema at application site
Pain at application site
Taste disturbances
Ulceration (application site)
Vesicles

Presentation

Periodontal gel containing prilocaine and lidocaine

Drugs List

Therapeutic Indications

Uses

Periodontal local anaesthesia

Dosage

Adults

Elderly

Children

Additional Dosage Information

Contraindications

Administration site infection
Children under 18 years
Buccal ulceration
Methaemoglobinaemia

Precautions and Warnings

G6PD deficiency
Hepatic impairment
Pregnancy
Renal impairment
Severe bradycardia
Severe cardiac conduction defects

Avoid contact of product with skin
Avoid contact with eyes
Avoid excessive spread of gel to oro-pharyngeal mucosa
If accidental contact with the eyes occurs, rinse thoroughly with water
Advise patient not to eat or drink until sensation returns

Pregnancy and Lactation

Pregnancy

The manufacturer states that prilocaine with lidocaine gel should not be used during pregnancy unless clearly necessary.

There is no adequate data from the use of this product during human pregnancy.

Animal studies into the effects on pregnancy, embryonic and foetal development, parturition and postnatal development are incomplete. Lidocaine and prilocaine cross the placenta and may be absorbed by foetal tissues. The potential risks for humans is not known.

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

The manufacturer states that breastfeeding may be continued during treatment with prilocaine and lidocaine periodontal gel.

Lidocaine, and probably prilocaine, are excreted in breast milk in small amounts. However, it is unlikely that effects of these substances will affect the breastfeeding infant following administration of this product.

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

Allergic reaction
Anaphylactoid reaction
Application site reaction
Cyanosis
Dizziness
Headache
Irritation with burning (application site)
Laryngeal oedema
Methaemoglobinaemia
Nausea
Numbness
Oedema at application site
Pain at application site
Taste disturbances
Ulceration (application site)
Vesicles

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: August 2013

Reference Sources

British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

Summary of Product Characteristics: Oraqix 25/25 mg per g periodontal gel. Dentsply Ltd. March 2008.