Drugs List

Therapeutic Indications

Uses

Acne vulgaris

Dosage

Apply twice daily over the affected areas for a period of 10 to 12 weeks.

Note that the product is only stable for 8 weeks after reconstitution.

Contraindications

None known

Precautions and Warnings

Porphyria

Cross resistance may occur with clindamycin and lincomycin
Avoid contact with eyes
Avoid contact with mucous membranes
Allergic symptoms may recur after treatment has stopped
Discontinue if allergic reaction occurs

Pregnancy and Lactation

Pregnancy

Erythromycin with zinc acetate is considered safe for use in pregnancy.

According to the manufacturer there are no contraindications to the use of erythromycin with zinc acetate topical solution in pregnancy.

Topical erythromycin was found to be only partially (40% to 50%) systemically absorbed in animal studies and excreted in 24 to 72 hours.

The pharmacokinetics in pregnancy are poorly understood, from oral use of erythromycin pregnant vs non-pregnant levels vary greatly (Briggs 2011), maternal and foetal serum levels are low and may also vary, with foetal plasma levels between 5% and 20% of those of the mother (Schaefer 2007). Whilst erythromycin crosses the placenta the concentration is too low to treat most pathogens although foetal tissue levels rise with multiple doses (Briggs 2011).

An association between prenatal macrolide exposure and infant pyloric stenosis remains uncertain.

Erythromycin is considered the macrolide of choice in pregnancy (Schaefer 2007).

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

Erythromycin with zinc acetate is considered safe for use in breastfeeding.

According to the manufacturer there are no contraindications to the use of erythromycin with zinc acetate topical solution whilst breastfeeding.

Topical erythromycin was found to be only partially (40% to 50%) systemically absorbed in animal studies and excreted in 24 to 72 hours. Zinc acetate is not absorbed. Application of topical erythromycin around the nipple may increase the risk of diarrhoea in the infant due to increased oral neonatal ingestion (LactMed, 2018).

Erythromycin is excreted in breast milk. The UK Drugs in Lactation Advisory Service states topical preparations for acne are considered to pose a negligible risk to a breastfeeding infant as long as precautions are taken to avoid contact of the breastfeeding infant with treated areas. Three potential problems exist for the infant: modification of bowel flora, recognised adverse reactions to erythromycin treatment and interference with infection screens (Briggs 2011). Gastrointestinal flora alteration may result in diarrhoea or candidiasis, this and irritability should be monitored for (LactMed, 2018).

A possible connection between erythromycin use during breastfeeding in the neonatal period and infantile pyloric stenosis has been considered but a causal relationship has not been established so far and erythromycin is considered an antibiotic of choice during breastfeeding (Schaefer 2007).

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

Acute generalised exanthematous pustulosis
Burning sensation (local)
Dry skin
Erythema
Hypersensitivity reactions
Irritation (localised)
Pruritus
Skin exfoliation
Slight redness of the skin

Presentation

Topical solution containing (when reconstituted) erythromycin and zinc acetate.

Drugs List

Therapeutic Indications

Uses

Acne vulgaris

Dosage

Apply twice daily over the affected areas for a period of 10 to 12 weeks.

Note that the product is only stable for 8 weeks after reconstitution.

Contraindications

None known

Precautions and Warnings

Porphyria

Cross resistance may occur with clindamycin and lincomycin
Avoid contact with eyes
Avoid contact with mucous membranes
Allergic symptoms may recur after treatment has stopped
Discontinue if allergic reaction occurs

Pregnancy and Lactation

Pregnancy

Erythromycin with zinc acetate is considered safe for use in pregnancy.

According to the manufacturer there are no contraindications to the use of erythromycin with zinc acetate topical solution in pregnancy.

Topical erythromycin was found to be only partially (40% to 50%) systemically absorbed in animal studies and excreted in 24 to 72 hours.

The pharmacokinetics in pregnancy are poorly understood, from oral use of erythromycin pregnant vs non-pregnant levels vary greatly (Briggs 2011), maternal and foetal serum levels are low and may also vary, with foetal plasma levels between 5% and 20% of those of the mother (Schaefer 2007). Whilst erythromycin crosses the placenta the concentration is too low to treat most pathogens although foetal tissue levels rise with multiple doses (Briggs 2011).

An association between prenatal macrolide exposure and infant pyloric stenosis remains uncertain.

Erythromycin is considered the macrolide of choice in pregnancy (Schaefer 2007).

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

Erythromycin with zinc acetate is considered safe for use in breastfeeding.

According to the manufacturer there are no contraindications to the use of erythromycin with zinc acetate topical solution whilst breastfeeding.

Topical erythromycin was found to be only partially (40% to 50%) systemically absorbed in animal studies and excreted in 24 to 72 hours. Zinc acetate is not absorbed. Application of topical erythromycin around the nipple may increase the risk of diarrhoea in the infant due to increased oral neonatal ingestion (LactMed, 2018).

Erythromycin is excreted in breast milk. The UK Drugs in Lactation Advisory Service states topical preparations for acne are considered to pose a negligible risk to a breastfeeding infant as long as precautions are taken to avoid contact of the breastfeeding infant with treated areas. Three potential problems exist for the infant: modification of bowel flora, recognised adverse reactions to erythromycin treatment and interference with infection screens (Briggs 2011). Gastrointestinal flora alteration may result in diarrhoea or candidiasis, this and irritability should be monitored for (LactMed, 2018).

A possible connection between erythromycin use during breastfeeding in the neonatal period and infantile pyloric stenosis has been considered but a causal relationship has not been established so far and erythromycin is considered an antibiotic of choice during breastfeeding (Schaefer 2007).

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

Counselling

Avoid contact with the eyes or mucous membranes.

Note that the product is only stable for 8 weeks after reconstitution.

Side Effects

Acute generalised exanthematous pustulosis
Burning sensation (local)
Dry skin
Erythema
Hypersensitivity reactions
Irritation (localised)
Pruritus
Skin exfoliation
Slight redness of the skin

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: May 2015

Reference Sources

Summary of Product Characteristics: Zineryt. Astellas Pharma Ltd. Revised March 2015.

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.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 14 May 2015.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 14 May 2015.

Summary of Product Characteristics: Zineryt. Astellas Pharma Ltd. Revised September 2018.

UK Drugs in Lactation Advisory Service.
Available at: https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Last accessed: 14 May 2015

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: 31 October 2018
Last accessed: 5 November 2018

The Welsh Medicines Information Centre (WMIC) - Porphyria Information Service.
Available at: https://www.wmic.wales.nhs.uk/porphyria_info.php
Last revised: April 2014

The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.com/languages/UnitedKingdom/s1.php?l=gbr
Last revised: 23 April 2010
Last accessed: 14 May 2015