Drugs List

Therapeutic Indications

Uses

Acne vulgaris

Unlicensed Uses

Infantile acne: treatment

Administration

Gel, cream or lotion
Apply topically after washing and drying affected areas (washing improves the efficacy of the preparation).

Wash 5%
Apply the preparation on a wet area to be treated and leave on the skin for 1 to 2 minutes followed by rinsing with water and drying.

Wash 10%
Apply to the affected areas after they have been wetted with clean water. First rinse with warm water, second rinse with cold water. Use clean towel to pat dry.

Contraindications

None known

Precautions and Warnings

Children under 12 years
Breastfeeding
Pregnancy

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 apply retinoids at the same time of day
For topical use only
If accidental contact with the eyes occurs, rinse thoroughly with water
May cause irritation when applied to sensitive skin
Reduce application frequency/temporarily discontinue if irritation occurs
Avoid other topical acne therapies and exfoliants: may cause irritation
Advise patient to avoid exposure to sunlight and UV rays during treatment
Advise patient to consult physician if condition worsens / does not improve
May bleach hair and fabrics
Patients should not exceed recommended dose

Skin reddening and peeling may occur within the first few days after initial use, possibly extending for some weeks. Temporary discontinuation of benzoyl peroxide should resolve these symptoms. Less frequent use, temporary or permanent discontinuation of benzoyl peroxide is indicated for patients prone to severe irritation.

Benzoyl peroxide should be discontinued if swelling or blistering of the skin occurs.

Pregnancy and Lactation

Pregnancy

Use benzoyl peroxide with caution during pregnancy.

The safety of benzoyl peroxide in human pregnancy has not been established. However, it has been used for the treatment of acne vulgaris at concentrations up to 10% for several decades without any associated effects on reproductive function, fertility, embryotoxicity, teratogenicity or peri- and post-natal development.

Manufacturers of benzoyl peroxide cream 4% advise avoiding treatment during the last month of pregnancy.

Schaefer concludes that benzoyl peroxide in therapeutic concentrations may be used topically on a limited area (i.e. the face) to treat acne during pregnancy.

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 benzoyl peroxide with caution during breastfeeding.

No data exists regarding benzoyl peroxide's excretion into breast milk. Only around 5% is absorbed following topical application, it is considered a low risk to the nursing infant.

During breastfeeding, benzoyl peroxide should not be applied on the breasts to avoid accidental transfer 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

Allergic contact dermatitis
Anaphylaxis
Application site reaction
Burning sensation
Contact sensitisation
Dry skin
Erythema at application site
Facial oedema
Facial swelling
Hypersensitivity reactions
Pain at application site
Photosensitivity
Phototoxicity
Pruritus
Rash
Skin discolouration
Skin peeling
Skin tightness

Presentation

Topical formulations containing benzoyl peroxide

Drugs List

Therapeutic Indications

Uses

Acne vulgaris

Unlicensed Uses

Infantile acne: treatment

Dosage

Initiate treatment with lowest strength preparation. Increase strength if more effective symptom control required (if tolerated by the user).

Some manufacturers advise that initial application can be varied at the physician's instructions, according to the patients skin type and to avoid undesirable effects.

Improvement can generally be seen after 4 to 6 weeks of treatment, however longer may be necessary.

Drying or peeling severity may be controlled by modifying dosage schedule.

Adults

Adolescents

Neonates

Administration

Gel, cream or lotion
Apply topically after washing and drying affected areas (washing improves the efficacy of the preparation).

Wash 5%
Apply the preparation on a wet area to be treated and leave on the skin for 1 to 2 minutes followed by rinsing with water and drying.

Wash 10%
Apply to the affected areas after they have been wetted with clean water. First rinse with warm water, second rinse with cold water. Use clean towel to pat dry.

Contraindications

None known

Precautions and Warnings

Children under 12 years
Breastfeeding
Pregnancy

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 apply retinoids at the same time of day
For topical use only
If accidental contact with the eyes occurs, rinse thoroughly with water
May cause irritation when applied to sensitive skin
Reduce application frequency/temporarily discontinue if irritation occurs
Avoid other topical acne therapies and exfoliants: may cause irritation
Advise patient to avoid exposure to sunlight and UV rays during treatment
Advise patient to consult physician if condition worsens / does not improve
May bleach hair and fabrics
Patients should not exceed recommended dose

Skin reddening and peeling may occur within the first few days after initial use, possibly extending for some weeks. Temporary discontinuation of benzoyl peroxide should resolve these symptoms. Less frequent use, temporary or permanent discontinuation of benzoyl peroxide is indicated for patients prone to severe irritation.

Benzoyl peroxide should be discontinued if swelling or blistering of the skin occurs.

Pregnancy and Lactation

Pregnancy

Use benzoyl peroxide with caution during pregnancy.

The safety of benzoyl peroxide in human pregnancy has not been established. However, it has been used for the treatment of acne vulgaris at concentrations up to 10% for several decades without any associated effects on reproductive function, fertility, embryotoxicity, teratogenicity or peri- and post-natal development.

Manufacturers of benzoyl peroxide cream 4% advise avoiding treatment during the last month of pregnancy.

Schaefer concludes that benzoyl peroxide in therapeutic concentrations may be used topically on a limited area (i.e. the face) to treat acne during pregnancy.

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 benzoyl peroxide with caution during breastfeeding.

No data exists regarding benzoyl peroxide's excretion into breast milk. Only around 5% is absorbed following topical application, it is considered a low risk to the nursing infant.

During breastfeeding, benzoyl peroxide should not be applied on the breasts to avoid accidental transfer 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

Allergic contact dermatitis
Anaphylaxis
Application site reaction
Burning sensation
Contact sensitisation
Dry skin
Erythema at application site
Facial oedema
Facial swelling
Hypersensitivity reactions
Pain at application site
Photosensitivity
Phototoxicity
Pruritus
Rash
Skin discolouration
Skin peeling
Skin tightness

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: March 2013

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.

Summary of Product Characteristics: Acnecide 5% w/w Gel. Galderma (UK) Ltd. Revised January 2018.
Summary of Product Characteristics: Acnecide Wash 5% w/w Gel. Galderma (UK) Ltd. Revised January 2018.
Summary of Product Characteristics: Brevoxyl 4% Cream. Stiefel Laboratories (UK) Limited. Revised July 2010.
Summary of Product Characteristics: PanOxyl 10 Acnegel 10% w/w Gel. GlaxoSmithKline Consumer Healthcare. Revised March 2013
Summary of Product Characteristics: PanOxyl 10 Aquagel 10% w/w Gel. GlaxoSmithKline Consumer Healthcare. Revised March 2013
Summary of Product Characteristics: PanOxyl 2.5 Aquagel 2.5% w/w Gel. GlaxoSmithKline Consumer Healthcare. Revised March 2013
Summary of Product Characteristics: PanOxyl 5 Aquagel 5% w/w Gel. GlaxoSmithKline Consumer Healthcare. Revised March 2013
Summary of Product Characteristics: PanOxyl 5 Cream. GlaxoSmithKline Consumer Healthcare. Revised March 2013
Summary of Product Characteristics: PanOxyl 10 Wash 10% Lotion. GlaxoSmithKline Consumer Healthcare. Revised March 2012.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 June 2017

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
Benzoyl Peroxide. Last revised: September 07, 2013.
Last accessed: 26 March 2018