Drugs List

Therapeutic Indications

Uses

Relief of pain and inflammation of oropharynx

Contraindications

Children under 18 years
Hereditary fructose intolerance

Precautions and Warnings

Breastfeeding
Pregnancy

Contains ponceau 4R (E124) - may cause allergic reactions
Contains sodium benzoate - mildly irritant to eyes, skin & mucous membranes
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Avoid contact with eyes
Discontinue if irritation or sensitisation occur

Pregnancy and Lactation

Pregnancy

Use diclofenac mouthwash with caution in pregnancy.

Briggs (2015) states that some nonsteroidal anti-inflammatory drugs (NSAIDs) have been associated with congenital malformations, however diclofenac shows a low risk when used in pregnancy as animal studies have not shown any teratogenic effects. The manufacturer suggests diclofenac mouthwash should not be used during pregnancy unless a physician states the potential benefit to the mother outweighs the potential risk to the foetus.

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 diclofenac mouthwash with caution in breastfeeding.

At the time of writing there is limited published information regarding the use of diclofenac in breastfeeding. Briggs (2015) states diclofenac is excreted into breast milk, however can be considered low risk due to its short serum half-life. Hale (2014) also states even long term use of diclofenac would most likely excrete negligible amounts into breast milk. The manufacturer suggests diclofenac mouthwash should not be used during breastfeeding unless a physician states the potential benefit to the mother outweighs the potential risk to the foetus.

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

Cough
Local irritation (prolonged use)

Presentation

Oromucosal formulation of diclofenac

Drugs List

Therapeutic Indications

Uses

Relief of pain and inflammation of oropharynx

Dosage

Adults

Elderly

Additional Dosage Information

Contraindications

Children under 18 years
Hereditary fructose intolerance

Precautions and Warnings

Breastfeeding
Pregnancy

Contains ponceau 4R (E124) - may cause allergic reactions
Contains sodium benzoate - mildly irritant to eyes, skin & mucous membranes
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Avoid contact with eyes
Discontinue if irritation or sensitisation occur

Pregnancy and Lactation

Pregnancy

Use diclofenac mouthwash with caution in pregnancy.

Briggs (2015) states that some nonsteroidal anti-inflammatory drugs (NSAIDs) have been associated with congenital malformations, however diclofenac shows a low risk when used in pregnancy as animal studies have not shown any teratogenic effects. The manufacturer suggests diclofenac mouthwash should not be used during pregnancy unless a physician states the potential benefit to the mother outweighs the potential risk to the foetus.

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 diclofenac mouthwash with caution in breastfeeding.

At the time of writing there is limited published information regarding the use of diclofenac in breastfeeding. Briggs (2015) states diclofenac is excreted into breast milk, however can be considered low risk due to its short serum half-life. Hale (2014) also states even long term use of diclofenac would most likely excrete negligible amounts into breast milk. The manufacturer suggests diclofenac mouthwash should not be used during breastfeeding unless a physician states the potential benefit to the mother outweighs the potential risk to the foetus.

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

Cough
Local irritation (prolonged use)

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: December 2016

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

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

Summary of Product Characteristics: Diclofenac 0.74 mg/ml Mouthwash. Morningside Healthcare Ltd. Revised May 2016.