Drugs List

Therapeutic Indications

Uses

Topical treatment of mild to moderate acne vulgaris

Dosage

The skin should be washed with a mild cleanser and fully dried before use.

Apply a thin film to the affected area, once daily in the evening.

Contraindications

Children under 12 years

Precautions and Warnings

Atopy
Breastfeeding
History of gastrointestinal disorder
Pregnancy

Avoid administration to eczematous or inflamed 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
Do not apply to broken or denuded skin
If accidental contact with eyes or mucous membranes - rinse with cool water
Reduce frequency of application if skin irritation occurs
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue therapy if marked diarrhoea occurs
Several weeks of treatment may be needed to achieve effect
Usual treatment period is up to 12 weeks
Advise patient on appropriate sun protection methods
Advise patient that the use of topical moisturisers may be necessary
Advise patient to discontinue use if severe or persistent irritation occurs
Avoid excessive exposure to sunlight or sunlamps
Avoid use of abrasive or astringent skin products
Avoid use on sensitive areas of skin
May bleach hair and fabrics

Pregnancy and Lactation

Pregnancy

Use benzoyl peroxide with clindamycin gel with caution during pregnancy.

The manufacturer suggests benzoyl peroxide with clindamycin should be administered with caution during pregnancy with the potential benefit weighed against possible risks. Briggs (2011) suggests clindamycin is compatible with use during pregnancy. Schaefer (2007) suggests that benzoyl peroxide can be used topically on a limited area to treat acne during pregnancy.

There are no adequate data from the use of this formulation in pregnant women. Limited data from use of clindamycin during the first trimester show no adverse effects on pregnancy or on the foetus/newborn. Subcutaneous and oral doses of clindamycin given to rats and mice showed no evidence of impaired fertility or harm to the foetus.

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 and clindamycin gel with caution in breastfeeding.

The manufacturer suggests for use in breastfeeding benefit and possible risks have to be weighed up against each other. The Drugs and Lactation Database (LactMed) suggests infant side effects are unlikely after topical administration of clindamycin however topical administration to the nipple may increase the risk of diarrhoea in the infant.

It is not known whether topically applied benzoyl peroxide or clindamycin is excreted in human breast milk. Following oral and parenteral use, clindamycin is present in human breast milk. Transcutaneous absorption of clindamycin is minimal and infant side-effects are unlikely with topical administration for acne. However, application to the nipple area may increase the risk of diarrhoea in the infant.

Schaefer (2007) suggests topical benzoyl peroxide can be used during breastfeeding. About 5% of benzoyl peroxide is absorbed following topical application, it is considered a low risk to the nursing 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

Abdominal pain
Anaphylaxis
Colitis
Contact dermatitis
Diarrhoea
Dry skin
Erythema
Erythematous rash
Exacerbation of acne
Headache
Hypersensitivity reactions
Local burning
Pain at application site
Paraesthesia
Photosensitivity
Pruritus
Skin discolouration
Skin peeling
Skin reactions
Urticaria

Presentation

Gel containing benzoyl peroxide (as hydrous benzoyl peroxide) and clindamycin (as clindamycin phosphate)

Drugs List

Therapeutic Indications

Uses

Topical treatment of mild to moderate acne vulgaris

Dosage

The skin should be washed with a mild cleanser and fully dried before use.

Apply a thin film to the affected area, once daily in the evening.

Contraindications

Children under 12 years

Precautions and Warnings

Atopy
Breastfeeding
History of gastrointestinal disorder
Pregnancy

Avoid administration to eczematous or inflamed 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
Do not apply to broken or denuded skin
If accidental contact with eyes or mucous membranes - rinse with cool water
Reduce frequency of application if skin irritation occurs
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue therapy if marked diarrhoea occurs
Several weeks of treatment may be needed to achieve effect
Usual treatment period is up to 12 weeks
Advise patient on appropriate sun protection methods
Advise patient that the use of topical moisturisers may be necessary
Advise patient to discontinue use if severe or persistent irritation occurs
Avoid excessive exposure to sunlight or sunlamps
Avoid use of abrasive or astringent skin products
Avoid use on sensitive areas of skin
May bleach hair and fabrics

Pregnancy and Lactation

Pregnancy

Use benzoyl peroxide with clindamycin gel with caution during pregnancy.

The manufacturer suggests benzoyl peroxide with clindamycin should be administered with caution during pregnancy with the potential benefit weighed against possible risks. Briggs (2011) suggests clindamycin is compatible with use during pregnancy. Schaefer (2007) suggests that benzoyl peroxide can be used topically on a limited area to treat acne during pregnancy.

There are no adequate data from the use of this formulation in pregnant women. Limited data from use of clindamycin during the first trimester show no adverse effects on pregnancy or on the foetus/newborn. Subcutaneous and oral doses of clindamycin given to rats and mice showed no evidence of impaired fertility or harm to the foetus.

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 and clindamycin gel with caution in breastfeeding.

The manufacturer suggests for use in breastfeeding benefit and possible risks have to be weighed up against each other. The Drugs and Lactation Database (LactMed) suggests infant side effects are unlikely after topical administration of clindamycin however topical administration to the nipple may increase the risk of diarrhoea in the infant.

It is not known whether topically applied benzoyl peroxide or clindamycin is excreted in human breast milk. Following oral and parenteral use, clindamycin is present in human breast milk. Transcutaneous absorption of clindamycin is minimal and infant side-effects are unlikely with topical administration for acne. However, application to the nipple area may increase the risk of diarrhoea in the infant.

Schaefer (2007) suggests topical benzoyl peroxide can be used during breastfeeding. About 5% of benzoyl peroxide is absorbed following topical application, it is considered a low risk to the nursing 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

Abdominal pain
Anaphylaxis
Colitis
Contact dermatitis
Diarrhoea
Dry skin
Erythema
Erythematous rash
Exacerbation of acne
Headache
Hypersensitivity reactions
Local burning
Pain at application site
Paraesthesia
Photosensitivity
Pruritus
Skin discolouration
Skin peeling
Skin reactions
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: July 2013

Reference Sources

British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

BNF for Children (2012-2013) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Duac Once Daily 10 mg/g + 30 mg/g Gel. Stiefel Laboratories (UK) Ltd. Revised March 2013.
Summary of Product Characteristics: Duac Once Daily 10 mg/g + 50 mg/g Gel. Stiefel Laboratories (UK) Ltd. Revised February 2013.

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
Clindamycin. Last revised: January 31, 2011
Last accessed: July 17, 2013

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: February 10, 2012
Last accessed: July 17, 2013