Econazole cream 1%w/w
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Cream containing econazole nitrate
Drugs List
Therapeutic Indications
Uses
Candidal balanitis
Fungal infection - nails
Fungal infection of skin
Mycotic vulvovaginitis
Dosage
Adults
Fungal infections of the skin:
Apply the cream twice daily to the affected area and rub in gently.
Treatment should be continued until all lesions are healed.
Fungal infections of the nails:
Apply the cream once daily and cover with an occlusive dressing.
Mycotic vulvovaginitis:
One applicator full (approximately 5 g) to be administered intravaginally once daily (at night) for not less than 14 days. The cream should also be applied to the vulva.
In pregnant women, it is recommended that administration takes place without the use of an applicator, or is performed by a physician. Pregnant women should thoroughly wash their hands before self-administering econazole nitrate vaginal cream.
The full 14 days of treatment should be carried out even if symptoms have disappeared.
The sexual partner should also be treated.
Mycotic balanitis:
Apply the cream to the penis, including under the foreskin, once daily for not less than 14 days.
The sexual partner should also be treated.
Elderly
(See Dosage; Adult)
Children
Fungal infections of the skin:
Apply the cream twice daily to the affected area and rub in gently.
Treatment should be continued until all lesions are healed.
Fungal infections of the nails:
Apply the cream once daily and cover with an occlusive dressing.
Mycotic vulvovaginitis:
Children of 16 years and above
One applicator full (approximately 5 g) to be administered intravaginally once daily (at night) for not less than 14 days. The cream should also be applied to the vulva.
In pregnant women, it is recommended that administration takes place without the use of an applicator, or is performed by a physician. Pregnant women should thoroughly wash their hands before self-administering econazole nitrate vaginal cream.
The full 14 days of treatment should be carried out even if symptoms have disappeared.
The sexual partner should also be treated.
Mycotic balanitis:
Children of 16 years and above
Apply the cream to the penis, including under the foreskin, once daily for not less than 14 days.
The sexual partner should also be treated.
Contraindications
None known
Precautions and Warnings
Children under 16 years
Breastfeeding
Eczematous dermatitis
Pregnancy
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Some formulations contain benzoic acid
Avoid contact with eyes
Avoid contact with the mouth
Do not apply on or near breasts
If accidental contact with the eyes occurs, rinse thoroughly with water
Discontinue if hypersensitivity reactions occur
Male & female: Damages latex condoms and diaphragms
Male & female: May inactivate spermicidal contraceptives
Advise patient residue on clothing/bedding may cause fire hazard
Fire hazard: Keep away from naked flames and potential sources of ignition
Pregnancy and Lactation
Pregnancy
The manufacturers recommend that topical econazole nitrate is not used during pregnancy unless the practitioner considers it to be necessary.
It is noted that systemic absorption of econazole is low (less than 10%) after topical application to the intact skin in humans. There are no adequate and well-controlled studies on adverse effects from the use of this cream in pregnant women and no other relevant epidemiological data is available.
Animal studies have shown reproductive toxicity.
It is not known if econazole nitrate crosses the human placenta. The molecular weight (about 445) is low enough, but the amount of drug in the circulation is very low. It is doubtful that clinically significant amounts of econazole reach the embryo or foetus.
No teratogenic effects have been observed in mice, rats, or rabbits following oral and subcutaneous dosing that produced systemic exposures far greater than those obtained in humans.
Schaefer considers econazole as a second choice antimycotic for local therapy while nystatin, clotrimazole, and miconazole are the preferred agents.
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
No reports on the use of econazole in breastfeeding women have been described. Less than 1 % is absorbed after topical application. The very low systemic bioavailability after topical use suggests little, if any, of econazole will be excreted into breast milk. Therefore, it is considered a low risk to the nursing infant.
Avoid application to the nipple area and ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated.
Schaefer considers nystatin and clotrimazole the local antimycotics of choice during breastfeeding; miconazole is also acceptable.
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
Patients being treated for mycotic vulvovaginitis or balanitis should be advised that their sexual partner should also be treated.
Advise patients that to prevent relapse, local antifungal treatment should be continued for 1 to 2 weeks after the disappearance of all signs of infection.
Contact between contraceptive diaphragms or condoms and econazole nitrate cream must be avoided since the rubber may be damaged by econazole nitrate.
Advise patient that spermicidal contraceptives may be inactivated.
Side Effects
Allergic reaction
Angioedema
Application site reaction
Blisters (application site)
Burning sensation
Contact dermatitis
Erythema
Hypersensitivity reactions
Irritation (localised)
Pruritus
Rash
Skin discomfort
Skin exfoliation
Skin pain
Swelling(localised)
Urticaria
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 2014
Reference Sources
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 https://www.medicinescomplete.com Accessed on May 22, 2014.
Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications https://www.medicinescomplete.com Accessed on May 22, 2014.
Summary of Product Characteristics: Pevaryl 1% Topical Cream. Janssen-Cilag Ltd. Revised October 2014.
Summary of Product Characteristics: Gyno-Pevaryl Cream. Janssen-Cilag Ltd. Revised July 2014.
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: December 06, 2013
Last accessed: May 22, 2014
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