Drugs List

Therapeutic Indications

Uses

Treatment of acne rosacea
Treatment of malodorous fungating tumours
Gravitational ulcers
Decubitus ulcers

Not all brands are licensed for all indications.

Administration

For topical application.

The areas to be treated in rosacea should be washed with a mild cleanser before application.

For the treatment of malodorous fungating tumours and malodorous gravitational and decubitus ulcers, apply to a clean wound and cover with non-adherent dressing.

Contraindications

Children under 1 year

Precautions and Warnings

Avoid contact with the eyes. If exposed, wash out with plenty of water.

If local irritation occurs, the treatment should be used less frequently or discontinued temporarily and therapy reviewed.

Care should be taken when treating patients with evidence of, or history of blood dyscrasias.

Exposure of treated areas to ultraviolet or strong sunlight should be avoided during treatment.

Patients should avoid alcohol. Absorption of metronidazole following topical application is low but may cause a disulfiram type reaction.

Unnecessary and prolonged use of this medication should be avoided.

Children 1 to 12 years (see 'Children -Dosage' section)

Pregnancy (see ' Pregnancy' section)

Breastfeeding (see 'Lactation' section)

Pregnancy and Lactation

Pregnancy

Use with caution, safety of metronidazole gel in pregnancy has not been adequately established.

Oral metronidazole crosses the placental barrier and rapidly enters the foetal circulation, but human data suggest low risk.

No foetotoxicity was observed after oral metronidazole in either rats or mice.

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

There have been no studies with topical metronidazole during breastfeeding.

After topical administration, blood levels are about 1% of the peak plasma levels after a 250mg oral dose. Therefore the use of metronidazole gel during breastfeeding is unlikely to be of concern.

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

Burning sensation (local)
Stinging
Erythema
Pruritus
Irritation (localised)
Worsening of rosacea
Nausea
Darkening of urine
Lacrimation
Dry skin
Skin pain
Contact dermatitis
Paraesthesia
Dysgeusia (metallic taste)
Hypoesthesia
Hypersensitivity reactions

Presentation

Gel containing metronidazole.

Drugs List

Therapeutic Indications

Uses

Treatment of acne rosacea
Treatment of malodorous fungating tumours
Gravitational ulcers
Decubitus ulcers

Not all brands are licensed for all indications.

Dosage

Adults

Children

Administration

For topical application.

The areas to be treated in rosacea should be washed with a mild cleanser before application.

For the treatment of malodorous fungating tumours and malodorous gravitational and decubitus ulcers, apply to a clean wound and cover with non-adherent dressing.

Contraindications

Children under 1 year

Precautions and Warnings

Avoid contact with the eyes. If exposed, wash out with plenty of water.

If local irritation occurs, the treatment should be used less frequently or discontinued temporarily and therapy reviewed.

Care should be taken when treating patients with evidence of, or history of blood dyscrasias.

Exposure of treated areas to ultraviolet or strong sunlight should be avoided during treatment.

Patients should avoid alcohol. Absorption of metronidazole following topical application is low but may cause a disulfiram type reaction.

Unnecessary and prolonged use of this medication should be avoided.

Children 1 to 12 years (see 'Children -Dosage' section)

Pregnancy (see ' Pregnancy' section)

Breastfeeding (see 'Lactation' section)

Pregnancy and Lactation

Pregnancy

Use with caution, safety of metronidazole gel in pregnancy has not been adequately established.

Oral metronidazole crosses the placental barrier and rapidly enters the foetal circulation, but human data suggest low risk.

No foetotoxicity was observed after oral metronidazole in either rats or mice.

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

There have been no studies with topical metronidazole during breastfeeding.

After topical administration, blood levels are about 1% of the peak plasma levels after a 250mg oral dose. Therefore the use of metronidazole gel during breastfeeding is unlikely to be of concern.

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

None known

Counselling

Use in or near the eyes should be avoided and if accidental contact occurs, the patient should be advised to rinse the eyes thoroughly with water.

Advise patient to avoid exposure of treated areas to ultraviolet light or strong sunlight during treatment.

Patients should be advised to avoid drinking alcohol during treatment.

Advise patients that they may use non-comedogenic and non-astringent cosmetics after treatment with metronidazole gel.

Patients should be advised that if local irritation occurs the treatment should be used less frequently or discontinued temporarily and medical advice sought.

Side Effects

Burning sensation (local)
Stinging
Erythema
Pruritus
Irritation (localised)
Worsening of rosacea
Nausea
Darkening of urine
Lacrimation
Dry skin
Skin pain
Contact dermatitis
Paraesthesia
Dysgeusia (metallic taste)
Hypoesthesia
Hypersensitivity reactions

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 ).

Shelf Life and Storage

Store below 25 degrees C
Do not refrigerate or freeze
Protect the gel from the heat

Further Information

Last Full Review Date: July 2012

Reference Sources

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.

Summary of Product Characteristics: Acea 0.75% w/w Gel. Ferndale Pharmaceuticals Ltd. Revised August 2010.

Summary of Product Characteristics: Metrogel. Galderma (U.K) Ltd. Revised December 2010.

Summary of Product Characteristics: Rozex gel. Galderma (U.K) Ltd. Revised December 2010.

Summary of Product Characteristics: Zyomet gel. Goldshield Pharmaceuticals Ltd. Revised May 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
Metronidazole: Last revised: January 31, 2011
Last accessed: July 25, 2012

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 September 2017