Drugs List

Therapeutic Indications

Uses

Topical treatment of mild to moderate acne vulgaris

Topical treatment of mild to moderate acne vulgaris of the face, chest and back, where comedones, papules and pustules predominate. Cream is best suited for use on dry and fair skin.

Unlicensed Uses

Infantile acne: treatment

Contraindications

Females attempting to conceive
Pregnancy

Precautions and Warnings

Children under 12 years
Females of childbearing potential

Contains parabens
Some formulations contain propylene glycol
Avoid administration to eczematous or inflamed skin
Avoid application to broken skin
Avoid contact with eyes, lips or mouth
Avoid contact with mucous membranes
Breastfeeding: Do not treat the breast area if patient breastfeeding
Do not use over large areas of the body
Dry skin thoroughly before application
Re-evaluate the patient every 3 months following treatment
Pregnancy confirmed: Discontinue this medication
Reduce application frequency/temporarily discontinue if irritation occurs
Female: Ensure adequate contraception during treatment
Advise patient to avoid exposure to sunlight and UV rays during treatment

Pregnancy and Lactation

Pregnancy

Adapalene is contraindicated in pregnancy.

The manufacturer notes that as there is little data available regarding the use of adapalene during pregnancy and absorption through unbroken skin is possible, this product should not be used during pregnancy.

Animal studies have shown that high systemic exposure by the oral route can result in reproductive toxicity, but teratogenic effects have not been noted in two experimental animal species. Available data does not indicate harmful effects on human pregnancy or on the health of the foetus exposed during early pregnancy and it is unknown if adapalene crosses the human placenta, but the molecular weight (about 413) and low plasma concentrations suggest that minimal amounts of drug would be expected to cross the placenta (Briggs et al, 2015). In the case of topical exposure a risk-grounded termination of the pregnancy is not necessarily indicated, but individual consultation should take place and a detailed foetal ultrasound investigation must be offered (Schaeffer et al, 2015).

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

Adapalene is considered safe for use in breastfeeding.

Systemic availability of adapalene from topical application is negligible, therefore the amount found in breast milk should be very low and no effect on the suckling child is anticipated. However, adapalene should not be used on the chest while breastfeeding to avoid contact exposure to the infant.

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

Acne
Contact dermatitis
Dry skin
Erythema
Eye irritation
Eyelid oedema
Irritation (localised)
Local burning
Pruritus
Scaling of skin
Skin exfoliation
Skin pain
Skin photosensitivity
Stinging

Presentation

Topical formulations of adapalene

Drugs List

Therapeutic Indications

Uses

Topical treatment of mild to moderate acne vulgaris

Topical treatment of mild to moderate acne vulgaris of the face, chest and back, where comedones, papules and pustules predominate. Cream is best suited for use on dry and fair skin.

Unlicensed Uses

Infantile acne: treatment

Dosage

Adults

Children

Contraindications

Females attempting to conceive
Pregnancy

Precautions and Warnings

Children under 12 years
Females of childbearing potential

Contains parabens
Some formulations contain propylene glycol
Avoid administration to eczematous or inflamed skin
Avoid application to broken skin
Avoid contact with eyes, lips or mouth
Avoid contact with mucous membranes
Breastfeeding: Do not treat the breast area if patient breastfeeding
Do not use over large areas of the body
Dry skin thoroughly before application
Re-evaluate the patient every 3 months following treatment
Pregnancy confirmed: Discontinue this medication
Reduce application frequency/temporarily discontinue if irritation occurs
Female: Ensure adequate contraception during treatment
Advise patient to avoid exposure to sunlight and UV rays during treatment

Pregnancy and Lactation

Pregnancy

Adapalene is contraindicated in pregnancy.

The manufacturer notes that as there is little data available regarding the use of adapalene during pregnancy and absorption through unbroken skin is possible, this product should not be used during pregnancy.

Animal studies have shown that high systemic exposure by the oral route can result in reproductive toxicity, but teratogenic effects have not been noted in two experimental animal species. Available data does not indicate harmful effects on human pregnancy or on the health of the foetus exposed during early pregnancy and it is unknown if adapalene crosses the human placenta, but the molecular weight (about 413) and low plasma concentrations suggest that minimal amounts of drug would be expected to cross the placenta (Briggs et al, 2015). In the case of topical exposure a risk-grounded termination of the pregnancy is not necessarily indicated, but individual consultation should take place and a detailed foetal ultrasound investigation must be offered (Schaeffer et al, 2015).

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

Adapalene is considered safe for use in breastfeeding.

Systemic availability of adapalene from topical application is negligible, therefore the amount found in breast milk should be very low and no effect on the suckling child is anticipated. However, adapalene should not be used on the chest while breastfeeding to avoid contact exposure to the infant.

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

Counselling

Advise patients if using cosmetics, these should be non-comedogenic and non-astringent.

Side Effects

Acne
Contact dermatitis
Dry skin
Erythema
Eye irritation
Eyelid oedema
Irritation (localised)
Local burning
Pruritus
Scaling of skin
Skin exfoliation
Skin pain
Skin photosensitivity
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: October 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.

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: Differin Cream. Galderma (UK) Ltd. Revised May 2018.

Summary of Product Characteristics: Differin Gel. Galderma (UK) Ltd. Revised May 2018.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 January 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
Last revised: 07 September 2013
Last accessed: 13 October 2016