Drugs List

Therapeutic Indications

Uses

Vaginosis - bacterial

Contraindications

None known

Precautions and Warnings

Children under 18 years
Menstruation
Breastfeeding
Haematological disorder
History of haematological disorder
Pregnancy

Contains hydroxybenzoate
Contains propylene glycol: may cause irritation
Symptoms of candidiasis may be exacerbated
May affect results of some laboratory tests
Not licensed for all indications in all age groups
Avoid prolonged use
Advise patient that alcohol ingestion may cause a disulfiram-like reaction
Advise patients to refrain from sexual intercourse during treatment

Pregnancy and Lactation

Pregnancy

Use metronidazole with caution in pregnancy.

Data on a large number (several hundred) of exposed pregnancies indicate no adverse effects of metronidazole on the foetus/newborn child. There have been no formal studies with metronidazole vaginal gel in pregnant women. The manufacturer advises that caution should, therefore, be exercised when prescribing to pregnant women.

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 metronidazole with caution in breastfeeding.

Neither topical nor vaginal metronidazole have been studied during breastfeeding. After vaginal administration, plasma levels are less than 2% of those after a 500mg oral dose. After topical administration, blood levels are about 1% of the peak plasma levels after a 250mg oral dose. Manufacturer advises that caution should be exercised when prescribing to breastfeeding women.

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

"Spotting" bleeding
Abdominal cramps
Allergic reaction
Bloating
Burning sensation
Constipation
Cramp
Decreased appetite
Depression
Diarrhoea
Discolouration of urine
Dizziness
Dry mouth
Dry skin
Erythema
Fatigue
Gastro-intestinal discomfort
Headache
Hypoesthesia
Insomnia
Irritability
Menstrual discomfort
Menstrual disturbances
Metallic taste
Nausea
Paraesthesia
Pelvic discomfort
Pruritus
Skin discomfort
Skin irritation
Skin pain
Stinging
Stomach/abdominal gurgling
Tongue disorder
Urinary tract infections
Urticaria
Vaginal candidiasis
Vaginal discharge
Vaginal irritation
Vaginal numbness
Vomiting
Vulvovaginal burning
Vulvovaginal itching
Vulvovaginal swelling

Presentation

Vaginal gel containing metronidazole.

Drugs List

Therapeutic Indications

Uses

Vaginosis - bacterial

Dosage

Adults

Children

Contraindications

None known

Precautions and Warnings

Children under 18 years
Menstruation
Breastfeeding
Haematological disorder
History of haematological disorder
Pregnancy

Contains hydroxybenzoate
Contains propylene glycol: may cause irritation
Symptoms of candidiasis may be exacerbated
May affect results of some laboratory tests
Not licensed for all indications in all age groups
Avoid prolonged use
Advise patient that alcohol ingestion may cause a disulfiram-like reaction
Advise patients to refrain from sexual intercourse during treatment

Pregnancy and Lactation

Pregnancy

Use metronidazole with caution in pregnancy.

Data on a large number (several hundred) of exposed pregnancies indicate no adverse effects of metronidazole on the foetus/newborn child. There have been no formal studies with metronidazole vaginal gel in pregnant women. The manufacturer advises that caution should, therefore, be exercised when prescribing to pregnant women.

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 metronidazole with caution in breastfeeding.

Neither topical nor vaginal metronidazole have been studied during breastfeeding. After vaginal administration, plasma levels are less than 2% of those after a 500mg oral dose. After topical administration, blood levels are about 1% of the peak plasma levels after a 250mg oral dose. Manufacturer advises that caution should be exercised when prescribing to breastfeeding women.

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

"Spotting" bleeding
Abdominal cramps
Allergic reaction
Bloating
Burning sensation
Constipation
Cramp
Decreased appetite
Depression
Diarrhoea
Discolouration of urine
Dizziness
Dry mouth
Dry skin
Erythema
Fatigue
Gastro-intestinal discomfort
Headache
Hypoesthesia
Insomnia
Irritability
Menstrual discomfort
Menstrual disturbances
Metallic taste
Nausea
Paraesthesia
Pelvic discomfort
Pruritus
Skin discomfort
Skin irritation
Skin pain
Stinging
Stomach/abdominal gurgling
Tongue disorder
Urinary tract infections
Urticaria
Vaginal candidiasis
Vaginal discharge
Vaginal irritation
Vaginal numbness
Vomiting
Vulvovaginal burning
Vulvovaginal itching
Vulvovaginal swelling

Effects on Laboratory Tests

Metronidazole may interfere with certain types of determination of serum chemistry values, such as aspartame aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactic dehydrogenase (LDH), triglycerides and hexokinase glucose. Values of zero may be observed.

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 2018.

Reference Sources

Summary of Product Characteristics: Zidoval. Meda Pharmaceuticals Ltd. Revised March 2018.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 02 July 2018

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: 01 May 2018
Last accessed: 29 June 2018