Erythromycin + tretinoin topical alcoholic soln 4%+0.025%
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Topical solution containing 4% erythromycin and 0.025% tretinoin.
Drugs List
Therapeutic Indications
Uses
Acne vulgaris
For the treatment of all forms of acne, both non-inflammatory forms with comedones and inflammatory forms with papules and pustules, particularly those associated with a very oily skin.
Dosage
Adults
Apply to the affected areas once or twice daily.
Treatment should continue for 9 to 12 weeks according to the condition of the skin.
A therapeutic improvement may not be observed for several weeks after starting treatment.
Children
(See Dosage; Adult)
Additional Dosage Information
Avoid excessive application as this may result in erythema, drying of the skin and discomfort of the treated area.
There may be a transitory deterioration in acne accompanied by an increase in inflammatory symptoms at the beginning of treatment. If this occurs, therapy should not be interrupted but application frequency may need to be reduced.
Contraindications
Family history of cutaneous epithelioma
Sunburn
Acute eczema
Acute inflammatory dermatosis
History of cutaneous epithelioma
Perioral dermatitis
Pregnancy
Rosacea
Precautions and Warnings
Females of childbearing potential
Breastfeeding
Avoid accumulation of product in skin folds or in angles of the nose
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid contact with nostrils or mouth
Avoid excessive use
If accidental contact with the eyes occurs, rinse thoroughly with water
Extremes of weather may cause irritation
Discontinue if allergic reaction occurs
Discontinue permanently if AGEP is diagnosed
Reduce application frequency/temporarily discontinue if irritation occurs
Several weeks of treatment may be needed to achieve effect
Avoid other topical acne therapies and exfoliants: may cause irritation
Female: Ensure adequate contraception during treatment
Advise patient on appropriate sun protection methods
Advise patient skin irritation may be enhanced by chlorinated or salt water
Advise patient to minimise exposure of treated areas to sunlight/sunlamps
Avoid use of abrasive or astringent skin products
If allergic reaction occurs, discontinue erythromycin with tretinoin topical solution and start symptomatic treatment for allergy. When symptomatic treatment for allergy is stopped, allergic symptoms may reoccur.
Pregnancy and Lactation
Pregnancy
Erythromycin with tretinoin is contraindicated during pregnancy.
The manufacturer recommends treatment is discontinued during pregnancy. Animal studies with high doses of oral tretinoin have shown teratogenic effects. There is also evidence of embryotoxicity where tretinoin has been applied topically.
Lactation
Use erythromycin with tretinoin with caution during breastfeeding.
The manufacturer advises caution if treatment is used when breastfeeding. Tretinoin is poorly absorbed after topical application and is considered a low risk to the nursing infant. Avoid direct contact of the treated skin areas with infant's skin. Erythromycin is unlikely to cause side effects in the infant following topical application. Avoid application to the nipple as may cause diarrhoea in the infant.
Counselling
Advise patient that therapeutic improvement may not be observed for several weeks after starting treatment and that there may be a transitory deterioration in acne accompanied by an increase in inflammatory symptoms at the beginning of treatment. If this occurs, therapy should not be interrupted but application frequency may need to be reduced.
Advise patient that consistent application makes a significant contribution to treatment success.
Advise patient to avoid excessive application as this may result in erythema, dry or uncomfortable skin.
Advise patient to avoid accumulation of product in skin folds or in angles of the nose.
Advise patient to avoid contact with eyes, eyelids, nostrils, mouth or mucous membrane. If accidental contact occurs with the eyes or eyelids, rinse the affected area thoroughly with water.
Advise patient on sun protection methods and to avoid excessive exposure to sunlight and avoid the use of sun lamps during treatment.
Advise the patient that skin irritation may be enhanced by bathing in chlorinated or salt water.
Advise patients to avoid other topical acne therapies and exfoliants as they may cause irritation.
Advise patient to avoid use of abrasive, comedogenic or astringent cosmetics.
Side Effects
Acute generalised exanthematous pustulosis
Allergic contact dermatitis
Burning sensation (local)
Dry skin
Erythema
Inflammation (application site)
Irritation (localised)
Photosensitivity
Skin peeling
Skin pigmentation changes
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 2019
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.
Summary of Product Characteristics: Aknemycin Plus. Almirall Hermal. Revised October 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 03 September 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
Tretinoin Last revised: 03 December 2018
Last accessed: 11 September 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
Erythromycin Last revised: 01 April 2019
Last accessed: 11 September 2019
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