Drugs List

Therapeutic Indications

Uses

Treatment of vaginitis caused by Candida albicans or other yeasts.

Administration

For vaginal administration.

To be inserted high into the vagina at night regardless of menstruation.

Precautions and Warnings

This product can cause damage to latex condoms and diaphragms.

Patients using spermicidal contraceptives should consult their clinician as vaginal treatment may inactivate the spermicidal contraceptive.

Econazole pessaries should be discontinued if hypersensitivity reactions occur.

Pregnancy (see Pregnancy ).

Male sexual partners should also be treated with econazole cream to prevent re-infection with Candida.

One course of therapy is usually sufficient to treat the infection, however a second course may be necessary.

Pregnancy and Lactation

Pregnancy

Econazole pessaries should only be used during pregnancy if a physician considers it necessary.

As with other agents, the pessaries should not be used in the first trimester of pregnancy unless the physician deems it essential for the welfare of the patients (Briggs, 2011).

It is not know whether econazole nitrate crosses the placenta although the molecular weight (about 445) is low enough for this to be expected. In animal studies, econazole has shown no teratogenic effects but is foetotoxic at high doses. It is not known how significant this is in relation to humans and there is no evidence of increased risk when administered during human pregnancy.

During pregnancy, extra care should be taken in using a vaginal applicator to prevent the possibility of mechanical trauma.

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 14-17 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

No specific information on the effects of vaginal econazole on lactation are available. However low systemic bioavailability after topical use suggests that the quantities of econazole excreted in breast milk would be low. The risk of exposure to nursing infants is therefore considered to be low.

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
Pruritus
Erythema at application site
Rash
Irritation (localised)
Hypersensitivity reactions
Angioedema
Urticaria
Vaginal discomfort

Presentation

Pessaries containing 150mg of econazole nitrate.

Long-acting pessaries containing 150mg econazole nitrate.

Drugs List

Therapeutic Indications

Uses

Treatment of vaginitis caused by Candida albicans or other yeasts.

Dosage

Adults

Elderly

Children

Administration

For vaginal administration.

To be inserted high into the vagina at night regardless of menstruation.

Precautions and Warnings

This product can cause damage to latex condoms and diaphragms.

Patients using spermicidal contraceptives should consult their clinician as vaginal treatment may inactivate the spermicidal contraceptive.

Econazole pessaries should be discontinued if hypersensitivity reactions occur.

Pregnancy (see Pregnancy ).

Male sexual partners should also be treated with econazole cream to prevent re-infection with Candida.

One course of therapy is usually sufficient to treat the infection, however a second course may be necessary.

Pregnancy and Lactation

Pregnancy

Econazole pessaries should only be used during pregnancy if a physician considers it necessary.

As with other agents, the pessaries should not be used in the first trimester of pregnancy unless the physician deems it essential for the welfare of the patients (Briggs, 2011).

It is not know whether econazole nitrate crosses the placenta although the molecular weight (about 445) is low enough for this to be expected. In animal studies, econazole has shown no teratogenic effects but is foetotoxic at high doses. It is not known how significant this is in relation to humans and there is no evidence of increased risk when administered during human pregnancy.

During pregnancy, extra care should be taken in using a vaginal applicator to prevent the possibility of mechanical trauma.

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 14-17 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

No specific information on the effects of vaginal econazole on lactation are available. However low systemic bioavailability after topical use suggests that the quantities of econazole excreted in breast milk would be low. The risk of exposure to nursing infants is therefore considered to be low.

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 the preparation damages latex condoms and diaphragms.

Advise patients that using econazole cream to treat sexual partners at the same time lessens the risk of re-infection.

Advise patients not to use spermicidal contraceptives unless under the guidance of a clinician as they may be inactivated by this preparation.

Side Effects

Burning sensation (local)
Stinging
Pruritus
Erythema at application site
Rash
Irritation (localised)
Hypersensitivity reactions
Angioedema
Urticaria
Vaginal 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 ).

Shelf Life and Storage

Store below 30 degrees C.

Reference Sources

British National Formulary, 63rd Edition (2012) Pharmaceutical Press, London.

BNF for Children (2011-2012) Pharmaceutical Press, London.

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.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Gyno-Pevaryl 150mg Vaginal Pessaries. Janssen-Cilag Ltd. Revised January 2012.

Summary of Product Characteristics: Gyno-Pevaryl 1 Vaginal Pessary. Janssen-Cilag Ltd. Revised January 2012.

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
Econazole Last revised: January 31, 2011
Last accessed: March 20, 2012