- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Cream containing 20% w/w azelaic acid
Gel containing 15% w/w azelaic acid
Topical treatment for acne vulgaris.
Treatment of mild to moderate papular-pustular acne of the facial area.
Topical treatment of papulopustular rosacea.
Not all available formulations are licensed for all indications.
Apply to the affected areas twice daily (morning and evening) and rub in well. Regular use is important.
As a guide 0.5g of gel or cream is sufficient to treat the entire facial area (0.5g = 2.5cm gel/cream).
Patients with sensitive skin should be advised to use the cream only once a day (in the evening) for the first week of treatment and then proceed to twice daily applications.
The duration of use will vary from person to person and also depends on the severity of the acne. In general, a distinct improvement becomes apparent after about 4 weeks. To obtain the best results, the cream should be applied over a period of several months but not for more than 6 months.
Occlusive dressings or wrappings should be avoided.
The duration of treatment will vary from person to person and according to the severity of the skin condition.
Acne: A distinct improvement is usually seen within 4 weeks of commencing treatment. For optimum results azelaic acid gel can be used for several months in accordance with clinical outcome.
If no improvement is seen after 1 month or if exacerbation of symptoms occurs, treatment should be discontinued and an alternative therapeutic option should be considered.
Rosacea: Significant initial therapeutic effects have been observed after 4 weeks. For optimum results azelaic acid gel can be used for several months in accordance with clinical outcome.
If no improvement is seen after 2 months or if exacerbation of symptoms occurs, treatment should be discontinued and an alternative therapeutic option should be considered.
Cream preparation - safety and efficacy not established in patients younger than 12 years old.
Gel preparation - safety and efficacy not established in patients under 18 years old when used to treat papulopustular rosacea or in patients younger than 12 years old when used to treat pustular acne.
For topical administration
Before application, the skin should be thoroughly washed with water alone or, if necessary, with a mild cleansing agent. Wash hands after application.
Children under 12 years old
Precautions and Warnings
Not all available formulations are licensed for all indications.
Pregnancy - see Pregnancy section
Gel preparation - safety and efficacy not established in patients younger than 18 years old when used to treat papulopustular rosacea.
Regular use is important. Before application, the skin should be thoroughly washed with water alone or, if necessary, with a mild cleansing agent. Wash hands after each application.
Avoid contact with the eyes, mouth and/or mucous membranes. If accidental contact with these areas occurs, rinse immediately with copious amounts of water. If eye irritation persists, patients should consult a physician.
In the event of marked skin irritation, either, reduce the amount of cream or gel per application, reduce the frequency of application to once a day, or the temporarily interrupt treatment until the symptoms regress.
Topical formulations of azelaic acid contain benzoic acid and propylene glycol which are mildly irritating to the skin, eyes and mucous membranes.
It is advisable to avoid alcoholic cleansers, tinctures and astringents, abrasives and peeling agents when using the gel formulations for treatment of papulopustular rosacea.
Occlusive dressings or wrappings should be avoided when using the gel formulation.
Pregnancy and Lactation
Caution is advised during pregnancy.
There are no adequate data of the use of topically administered azelaic acid in pregnant women.
Animal studies have not shown any evidence that would suggest any risk to a foetus from use by a pregnant woman.
Schaefer advises that azelaic acid should only be used in pregnancy when absolutely necessary, on small skin surfaces, and preferably not during the first trimester. If used during pregnancy there is no justification for invasive prenatal diagnostics or termination of 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 14-17 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 ).
Ensure that the infant does not come into contact with treated skin.
Azelaic acid is only modestly absorbed via skin (about 4%) and it is rapidly metabolised. Due to its poor penetration into plasma and rapid half-life (45 minutes) it is not likely to pass into milk or produce adverse effects in a breastfed infant. It is considered a low risk to the nursing infant.
Animal studies have not shown teratogenicity.
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
Effects on Ability to Drive and Operate Machinery
Advise patient on the importance of regular use.
Advise patient to wash the skin thoroughly with water alone or, if necessary, with a mild cleansing agent before application.
Advise patient to wash their hands after each application.
Advise patient to consult a physician if eye irritation persists.
Advise patient in the event of marked skin irritation either, reduce the amount of cream or gel per application, reduce the frequency of application to once a day, or the temporarily interrupt treatment until the symptoms regress.
Burning sensation (local)
Erythema at application site
Exacerbation of pre-existing asthma
Pain at application site
Sensation of warmth
Oedema at application site
Ulceration (application site)
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 ).
Shelf Life and Storage
Do not store above 30 degrees C
No special storage conditions.
British National Formulary, 63rd Edition (2012) Pharmaceutical Press, London.
BNF for Children (2011-2012) 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.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: Skinoren Cream. Bayer PLC. Revised November 2011.
Summary of Product Characteristics: Finacea 15% Gel. Bayer PLC. Revised October 2010.
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
Azelaic acid. Last revised: January 31, 2011.
Last accessed: May 22, 2012.
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