Drugs List

Therapeutic Indications

Uses

Treatment of actinic keratoses

Contraindications

Children under 18 years
Open wounds
Exfoliative dermatitis
Skin infection
Third trimester of pregnancy

Precautions and Warnings

Predisposition to haemorrhage
Asthma
Breastfeeding
Cardiac impairment
First trimester of pregnancy
Gastrointestinal haemorrhage
Hepatic impairment
History of gastrointestinal bleeding
History of peptic ulcer
Peptic ulcer
Recent intracranial haemorrhage
Renal impairment
Second trimester of pregnancy

NSAIDs may provoke or exacerbate asthma
Contains benzyl alcohol
Avoid contact with diseased or inflamed skin
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid occlusive dressings
Breastfeeding: Do not treat the breast area if patient breastfeeding
Not for use in open wounds
Not to be applied to infected skin
Prolonged use over a large area may cause systemic absorption
Prolonged continuous use increases the risk of systemic toxicity
Discontinue if irritation or sensitisation occur
Discontinue if patient is attempting to conceive
Discontinue treatment if rash occurs
Avoid excessive exposure to sunlight

Pregnancy and Lactation

Pregnancy

Diclofenac sodium is contraindicated during the 3rd trimester of pregnancy but may be used with caution during the 1st and 2nd trimester.

The manufacturer advises if diclofenac gel is used during the first and second trimesters, the dose should be kept low, less than 30% of the body surface, and the duration of treatment as short as possible, not longer than 3 weeks. Animal studies indicate reproductive toxicity. Diclofenac is known to cross the human placenta. 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.

Lactation

Use diclofenac sodium with caution during breastfeeding.

The manufacturer advises that diclofenac gel should not be applied to the breast area, nor elsewhere on large areas of skin or for a prolonged period of time because this would increase the risk of oral absorption by the infant. Measurable amounts of diclofenac would not be expected in maternal milk following the recommended therapeutic dose in breastfeeding mothers.

Side Effects

Abdominal pain
Alopecia
Angioneurotic oedema
Application site reaction
Asthma
Blistering
Bullous dermatoses
Conjunctivitis
Contact dermatitis
Dermatitis
Diarrhoea
Discolouration of hair
Dry skin
Eczema
Erythema
Eye pain
Facial oedema
Gastro-intestinal haemorrhage
Haemorrhage
Hyperaesthesia
Hypersensitivity reactions
Hypertonia
Inflammation (application site)
Irritation (localised)
Lacrimation disorder
Maculopapular rash
Nausea
Oedema
Pain
Paraesthesia
Photosensitivity
Pruritus
Pustular rash
Rash
Renal failure
Scaling of skin
Seborrhoea
Skin hypertrophy
Skin tingling
Skin ulcer
Urticaria
Vesiculo-bullous reactions

Presentation

Gel containing 3% w/w diclofenac sodium.

Drugs List

Therapeutic Indications

Uses

Treatment of actinic keratoses

Dosage

Adults

Contraindications

Children under 18 years
Open wounds
Exfoliative dermatitis
Skin infection
Third trimester of pregnancy

Precautions and Warnings

Predisposition to haemorrhage
Asthma
Breastfeeding
Cardiac impairment
First trimester of pregnancy
Gastrointestinal haemorrhage
Hepatic impairment
History of gastrointestinal bleeding
History of peptic ulcer
Peptic ulcer
Recent intracranial haemorrhage
Renal impairment
Second trimester of pregnancy

NSAIDs may provoke or exacerbate asthma
Contains benzyl alcohol
Avoid contact with diseased or inflamed skin
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid occlusive dressings
Breastfeeding: Do not treat the breast area if patient breastfeeding
Not for use in open wounds
Not to be applied to infected skin
Prolonged use over a large area may cause systemic absorption
Prolonged continuous use increases the risk of systemic toxicity
Discontinue if irritation or sensitisation occur
Discontinue if patient is attempting to conceive
Discontinue treatment if rash occurs
Avoid excessive exposure to sunlight

Pregnancy and Lactation

Pregnancy

Diclofenac sodium is contraindicated during the 3rd trimester of pregnancy but may be used with caution during the 1st and 2nd trimester.

The manufacturer advises if diclofenac gel is used during the first and second trimesters, the dose should be kept low, less than 30% of the body surface, and the duration of treatment as short as possible, not longer than 3 weeks. Animal studies indicate reproductive toxicity. Diclofenac is known to cross the human placenta. 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.

Lactation

Use diclofenac sodium with caution during breastfeeding.

The manufacturer advises that diclofenac gel should not be applied to the breast area, nor elsewhere on large areas of skin or for a prolonged period of time because this would increase the risk of oral absorption by the infant. Measurable amounts of diclofenac would not be expected in maternal milk following the recommended therapeutic dose in breastfeeding mothers.

Side Effects

Abdominal pain
Alopecia
Angioneurotic oedema
Application site reaction
Asthma
Blistering
Bullous dermatoses
Conjunctivitis
Contact dermatitis
Dermatitis
Diarrhoea
Discolouration of hair
Dry skin
Eczema
Erythema
Eye pain
Facial oedema
Gastro-intestinal haemorrhage
Haemorrhage
Hyperaesthesia
Hypersensitivity reactions
Hypertonia
Inflammation (application site)
Irritation (localised)
Lacrimation disorder
Maculopapular rash
Nausea
Oedema
Pain
Paraesthesia
Photosensitivity
Pruritus
Pustular rash
Rash
Renal failure
Scaling of skin
Seborrhoea
Skin hypertrophy
Skin tingling
Skin ulcer
Urticaria
Vesiculo-bullous reactions

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 2019

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.

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

Summary of Product Characteristics: Solacutan 3% gel. Mibe Pharma UK Ltd. Revised August 2018.

Summary of Product Characteristics: Solaraze 3% gel. Almirall Ltd. Revised January 2019.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 13 September 2019

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: 31 October 2018
Last accessed: 13 September 2019