Drugs List

Therapeutic Indications

Uses

Bruising
Epicondylitis
Sprain

Contraindications

Burns
Children under 16 years
Open wounds
Eczema
Exudative dermatosis
Peptic ulcer
Skin infection
Third trimester of pregnancy

Precautions and Warnings

Allergic disposition
Elderly
Haemorrhagic diathesis
Asthma
Breastfeeding
Cardiac impairment
First trimester of pregnancy
Hepatic impairment
History of peptic ulcer
Inflammatory bowel disease
Renal impairment
Second trimester of pregnancy

Not all available brands are licensed for all indications
Some formulations contain hydroxybenzoate
Some formulations contain propylene glycol
Avoid broken or inflamed skin
Avoid contact with eyes, lips or mouth
Avoid occlusive dressings
Discontinue treatment if rash occurs
Maintain treatment at the lowest effective dose
Advise patient that photosensitivity possible
Advise patient to see doctor if symptoms persist for 7 days with treatment
Avoid direct exposure to sunlight

The possibility of systemic adverse events from application of diclofenac medicated plaster cannot be excluded if the preparation is used on large areas of skin and over a prolonged period.

Pregnancy and Lactation

Pregnancy

Diclofenac is contraindicated in the third trimester of pregnancy.

Use of any NSAID is considered contraindicated during the third trimester of pregnancy.

First trimester exposure to NSAIDs has been associated with an increased risk spontaneous abortions and of birth defects (notably cardiac septal defects). There is conflicting evidence, however, from various studies and the risk appears to be low.

When an NSAID is considered essential, a more established drug such as ibuprofen may be considered. Diclofenac should be used with caution in the first and second trimesters. Schaefer (2015) considers that use of NSAIDs in early pregnancy does not require termination of pregnancy or invasive diagnostic procedures.

Diclofenac is a prostaglandin synthetase inhibitor and may have effects during the second and third trimesters, including pulmonary and cardiac toxicity in the foetus/newborn from the beginning of the sixth month and increases in risk if administration is close to full term. Other effects also include, functional renal injury in the foetus, inhibition of uterine contractions with delayed onset and prolongation of labour, increased possibility of bleeding in mother and child, and increased risk of maternal oedema formation. When used in the perinatal period, necrotising enterocolitis and intraventricular haemorrhages have been reported in very pre-term and very low birth weight infants.

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 sodium with caution in breastfeeding.

No other published information on topical diclofenac has been found although secretion in maternal milk following oral administration is minimal and probably too low to affect the infant (Schaefer 2015).

In limited studies so far available, oral NSAIDs can appear in breast milk in very low concentrations.

When an NSAID is considered necessary during breastfeeding ibuprofen or flurbiprofen would be the drugs of choice although occasional use of diclofenac is permissible.

Not to be applied to the breasts of nursing mothers or on larges areas of skin or for prolonged periods of time in breastfeeding.

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 dermatitis
Anaphylactic reaction
Angioneurotic oedema
Application site reaction
Asthma
Bullous dermatoses
Contact dermatitis
Dermatitis
Dry skin
Eczema
Erythema
Feeling hot
Hypersensitivity reactions
Petechiae
Photosensitivity
Pruritus
Pustular rash
Rash
Urticaria

Presentation

Medicated plaster formulation of diclofenac sodium.

Drugs List

Therapeutic Indications

Uses

Bruising
Epicondylitis
Sprain

Dosage

The maximum daily dose is 2 medicated plasters, even if there is more than one injured area to be treated. Therefore, only one painful area can be treated at a time.

The duration of use should not exceed 7 days.

Adults

Children

Contraindications

Burns
Children under 16 years
Open wounds
Eczema
Exudative dermatosis
Peptic ulcer
Skin infection
Third trimester of pregnancy

Precautions and Warnings

Allergic disposition
Elderly
Haemorrhagic diathesis
Asthma
Breastfeeding
Cardiac impairment
First trimester of pregnancy
Hepatic impairment
History of peptic ulcer
Inflammatory bowel disease
Renal impairment
Second trimester of pregnancy

Not all available brands are licensed for all indications
Some formulations contain hydroxybenzoate
Some formulations contain propylene glycol
Avoid broken or inflamed skin
Avoid contact with eyes, lips or mouth
Avoid occlusive dressings
Discontinue treatment if rash occurs
Maintain treatment at the lowest effective dose
Advise patient that photosensitivity possible
Advise patient to see doctor if symptoms persist for 7 days with treatment
Avoid direct exposure to sunlight

The possibility of systemic adverse events from application of diclofenac medicated plaster cannot be excluded if the preparation is used on large areas of skin and over a prolonged period.

Pregnancy and Lactation

Pregnancy

Diclofenac is contraindicated in the third trimester of pregnancy.

Use of any NSAID is considered contraindicated during the third trimester of pregnancy.

First trimester exposure to NSAIDs has been associated with an increased risk spontaneous abortions and of birth defects (notably cardiac septal defects). There is conflicting evidence, however, from various studies and the risk appears to be low.

When an NSAID is considered essential, a more established drug such as ibuprofen may be considered. Diclofenac should be used with caution in the first and second trimesters. Schaefer (2015) considers that use of NSAIDs in early pregnancy does not require termination of pregnancy or invasive diagnostic procedures.

Diclofenac is a prostaglandin synthetase inhibitor and may have effects during the second and third trimesters, including pulmonary and cardiac toxicity in the foetus/newborn from the beginning of the sixth month and increases in risk if administration is close to full term. Other effects also include, functional renal injury in the foetus, inhibition of uterine contractions with delayed onset and prolongation of labour, increased possibility of bleeding in mother and child, and increased risk of maternal oedema formation. When used in the perinatal period, necrotising enterocolitis and intraventricular haemorrhages have been reported in very pre-term and very low birth weight infants.

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 sodium with caution in breastfeeding.

No other published information on topical diclofenac has been found although secretion in maternal milk following oral administration is minimal and probably too low to affect the infant (Schaefer 2015).

In limited studies so far available, oral NSAIDs can appear in breast milk in very low concentrations.

When an NSAID is considered necessary during breastfeeding ibuprofen or flurbiprofen would be the drugs of choice although occasional use of diclofenac is permissible.

Not to be applied to the breasts of nursing mothers or on larges areas of skin or for prolonged periods of time in breastfeeding.

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 dermatitis
Anaphylactic reaction
Angioneurotic oedema
Application site reaction
Asthma
Bullous dermatoses
Contact dermatitis
Dermatitis
Dry skin
Eczema
Erythema
Feeling hot
Hypersensitivity reactions
Petechiae
Photosensitivity
Pruritus
Pustular rash
Rash
Urticaria

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: September 2018

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.

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.

Summary of Product Characteristics: Flector Tissugel 140mg medicated plaster. Disposable medical equipment Ltd. Revised February 2014.

Summary of Product Characteristics: Voltarol medicated plaster. Novartis Consumer Health. Revised March 2016.

NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 06 September 2018

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Diclofenac Last revised: 09 August 2018
Last accessed: 06 September 2018