Benzoyl peroxide with adapalene topical
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Gel containing benzoyl peroxide with adapalene.
Drugs List
Therapeutic Indications
Uses
Acne vulgaris
Treatment of acne vulgaris when comedones, papules and pustules are present.
Dosage
Early signs of clinical improvement usually appear after 1 to 4 weeks of treatment.
Strength may depend upon patient's severity of condition.
Adults
Apply a thin film of gel to the affected area once daily in the evening to clean and dry skin.
Children
2.5% + 0.1%
Children 9 years and over:Apply a thin film of gel to the affected area once daily in the evening to clean and dry skin.
2.5% + 0.3%
Children 12 years and over:Apply a thin film of gel to the affected area once daily in the evening to clean and dry skin.
Contraindications
Children under 9 years
Pregnancy
Precautions and Warnings
Children aged 9 to 12 years
Breastfeeding
Not all available brands are licensed for use in children under 12 years
Contains propylene glycol: may cause irritation
Avoid administration to eczematous or inflamed skin
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid contact with nostrils or mouth
Cleanse and dry skin before application
Do not apply retinoids at the same time of day
Do not apply to broken or denuded skin
If accidental contact with the eyes occurs, rinse thoroughly with water
Discontinue if hypersensitivity reactions occur
Reduce application frequency/temporarily discontinue if irritation occurs
Female: Ensure adequate contraception during treatment
Avoid excessive exposure to sunlight
Avoid excessive exposure to UV light
May bleach hair and fabrics
Pregnancy and Lactation
Pregnancy
Benzoyl peroxide with adapalene gel is contraindicated during pregnancy.
The manufacturer does not recommend benzoyl peroxide with adapalene gel during pregnancy, nor in women planning a pregnancy. Animal studies by the oral route show reproductive toxicity at high systemic exposure. At the time of writing there is limited human data available. Risks are unknown.
Lactation
Use benzoyl peroxide with adapalene 2.5% + 0.1% gel with caution during breastfeeding.
Benzoyl peroxide with adapalene 2.5% + 0.3% gel is contraindicated during breastfeeding.
The manufacturer advises caution if benzoyl peroxide with adapalene 2.5% + 0.1% gel is used when breastfeeding but that application to the chest is avoided, thus averting contact exposure of the infant. Studies in rats have shown excretion of adapalene in milk after oral or intravenous administration.
The manufacturer advises discontinuing breastfeeding or discontinuing benzoyl peroxide with adapalene 2.5% + 0.3% gel.
At the time of writing there is limited human data available. A risk to the suckling infant cannot be excluded.
Side Effects
Allergic contact dermatitis
Anaphylactic reaction
Blisters (application site)
Burning sensation (local)
Dry skin
Dyspnoea
Eczema
Erythema
Eyelid erythema
Eyelid oedema
Facial swelling
Hyperpigmentation
Hypopigmentation
Irritant dermatitis
Paresthesia (application site)
Photosensitivity
Pruritus
Rash
Scaling of skin
Skin irritation
Skin pain
Sunburn
Throat tightness
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: January 2020
Reference Sources
Summary of Product Characteristics: Epiduo 0.1%/2.5% gel. Galderma (UK) Ltd. Revised June 2019.
Summary of Product Characteristics: Epiduo 0.3%/2.5% gel. Galderma (UK) Ltd. Revised October 2018.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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