Drugs List

Therapeutic Indications

Uses

Mycotic vulvovaginitis

For the treatment of mycotic vulvovaginitis and superinfections due to gram-positive bacteria.

Administration

For insertion into the vagina or topical administration to the vulva.

Treatment can continue during menstruation.

Contraindications

Children under 18 years

Precautions and Warnings

Breastfeeding
Pregnancy

Discontinue if hypersensitivity reactions occur
Discontinue if local irritation occurs
Male & female: Damages latex condoms and diaphragms
Male & female: Ensure adequate contraception during treatment

If the patient's partner is also infected, appropriate therapy should be initiated.

Miconazole nitrate vaginal cream contains benzoic acid and butylated hydroxyanisole, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

Pregnancy and Lactation

Pregnancy

Use miconazole nitrate vaginal cream with caution during pregnancy.

Small amounts of miconazole nitrate are absorbed from the vagina.

The manufacturer advises miconazole nitrate vaginal cream should be used in the first trimester of pregnancy only if, in the judgement of the physician, the potential benefits outweigh the possible risks.

Topical miconazole has been used in several clinical trials for the treatment of vaginal candidiasis without evidence of foetal harm. However, one study for the treatment of vaginitis during the first trimester did find a significant increased risk of spontaneous abortion. It is advisable to avoid the use of miconazole in the first trimester until further data is available (Briggs 2015).

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 miconazole nitrate vaginal cream with caution during breastfeeding.

It is not known whether miconazole nitrate is excreted in milk.

The manufacturer advises caution should be exercised with using miconazole nitrate vaginal cream during breastfeeding.

Miconazole has poor oral bioavailaibilty and is unlikely to pose a risk to the breastfed infant.

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

Abdominal pain
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Burning sensation (local)
Dysmenorrhoea
Dysuria
Facial swelling
Genital pruritus
Headache
Hypersensitivity reactions
Irritation (localised)
Nausea
Pruritic rash
Pruritus
Rash
Rosacea
Urinary tract infections
Urticaria
Vaginal discharge
Vaginal haemorrhage
Vaginal pain
Vulvovaginal discomfort

Presentation

Vaginal cream containing miconazole nitrate.

Drugs List

Therapeutic Indications

Uses

Mycotic vulvovaginitis

For the treatment of mycotic vulvovaginitis and superinfections due to gram-positive bacteria.

Dosage

Adults

Administration

For insertion into the vagina or topical administration to the vulva.

Treatment can continue during menstruation.

Contraindications

Children under 18 years

Precautions and Warnings

Breastfeeding
Pregnancy

Discontinue if hypersensitivity reactions occur
Discontinue if local irritation occurs
Male & female: Damages latex condoms and diaphragms
Male & female: Ensure adequate contraception during treatment

If the patient's partner is also infected, appropriate therapy should be initiated.

Miconazole nitrate vaginal cream contains benzoic acid and butylated hydroxyanisole, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

Pregnancy and Lactation

Pregnancy

Use miconazole nitrate vaginal cream with caution during pregnancy.

Small amounts of miconazole nitrate are absorbed from the vagina.

The manufacturer advises miconazole nitrate vaginal cream should be used in the first trimester of pregnancy only if, in the judgement of the physician, the potential benefits outweigh the possible risks.

Topical miconazole has been used in several clinical trials for the treatment of vaginal candidiasis without evidence of foetal harm. However, one study for the treatment of vaginitis during the first trimester did find a significant increased risk of spontaneous abortion. It is advisable to avoid the use of miconazole in the first trimester until further data is available (Briggs 2015).

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 miconazole nitrate vaginal cream with caution during breastfeeding.

It is not known whether miconazole nitrate is excreted in milk.

The manufacturer advises caution should be exercised with using miconazole nitrate vaginal cream during breastfeeding.

Miconazole has poor oral bioavailaibilty and is unlikely to pose a risk to the breastfed infant.

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

Advise patients that latex contraceptives such as condoms and diaphragms may be damaged by miconazole nitrate vaginal cream and consequently their efficacy may be reduced. Alternative precautions should therefore be adopted while using this product.

Advise patients that their partners may also require treatment.

Side Effects

Abdominal pain
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Burning sensation (local)
Dysmenorrhoea
Dysuria
Facial swelling
Genital pruritus
Headache
Hypersensitivity reactions
Irritation (localised)
Nausea
Pruritic rash
Pruritus
Rash
Rosacea
Urinary tract infections
Urticaria
Vaginal discharge
Vaginal haemorrhage
Vaginal pain
Vulvovaginal discomfort

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: November 2018

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: Gyno-Daktarin 20mg/g Cream. Janssen-Cilag Ltd. Revised October 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
Miconazole Last revised: 31 October 2018
Last accessed: 23 November 2018