Drugs List

Therapeutic Indications

Uses

Treatment of mild to moderate atopic dermatitis in patients over 3 months of age where topical corticosteroids are either not advisable or not possible. This may include:

- Intolerance to topical corticosteroids

- Lack of effect of topical corticosteroids

- Application to the face and neck where prolonged intermittent treatment with topical corticosteroids may be inappropriate

Administration

For topical application.

Contraindications

Immunosuppression
Malignant and pre-malignant skin lesions
Skin Infection

Children under 3 months of age
Pregnancy ( see Pregnancy )

Precautions and Warnings

Treatment should be initiated by a physician experienced in the diagnosis and topical treatment of atopic dermatitis.

Breastfeeding (see Lactation )

Before commencing treatment with pimecrolimus, clinical infections at treatment sites should be cleared. Patients with atopic dermatitis have an increased risk of skin infections including eczema herpeticum (Kaposi's varicelliform eruption). Treatment with pimecrolimus has been associated with an increase incidence of bacterial infections (including impetigo), herpes simplex virus infection and eczema herpeticum (manifesting as rapid spread of vesicular and erosive lesions). In the presence of herpes simplex skin infection, treatment should be discontinued at the site of infection until the viral infection has cleared.

If discontinued, treatment should be resumed upon first recurrence of signs and symptoms to prevent flares of the disease.

The use of pimecrolimus cream is not recommended where there is a risk of increased systemic absorption including:
Use with occlusive dressings
Use on severely inflamed and/or damaged skin
Patients with erythroderma
Patients with Netherton syndrome

Advice should be given to patients on appropriate sun protection measures, such as minimisation of the time in the sun, use of sunscreen product and covering the skin with appropriate clothing.

Cases of malignancies, such as skin cancers and cutaneous and other types of lymphoma, have been reported in patients using pimecrolimus cream. However, patients with atopic dermatitis treated with pimecrolimus cream have not been found to have significant systemic pimecrolimus levels.

Some cases of lymphadenopathy were reported during clinical studies. In the absence of a clear aetiology or in the presence of acute infectious mononucleosis, patients developing lymphadenopathy during therapy should discontinue treatment with pimecrolimus.

Use of pimecrolimus may cause mild and transient reactions at the site of application, such as a feeling of warmth and/or burning sensation. If the application site reaction is severe, the risk-benefit of treatment should be re-evaluated. The excipients in pimecrolimus (stearyl alcohol, cetyl alcohol and propylene glycol) cream may cause local skin reactions.

Alcohol intolerance, described as flushing, burning itching or swelling at the application site has occurred rarely after the consumption of alcohol by patients using pimecrolimus cream.

Care should be taken to avoid contact with eyes and mucous membranes. If accidentally applied to these areas, the cream should be thoroughly wiped off and/or rinsed off with water.

Pregnancy and Lactation

Pregnancy

Pimecrolimus cream is contraindicated during pregnancy.

At the time of writing, there is no adequate data from the use of pimecrolimus in pregnant women.

Animal studies with dermal application have shown no harmful effects with respect to embryonic / foetal development. Based on the extent of absorption after topical application, the potential risk for humans is considered limited.

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

Pimecrolimus cream should be used with caution in breastfeeding women.

It is not known whether pimecrolimus is excreted in breast milk after topical application. However, based on the minimal extent of pimecrolimus absorption after topical application, the potential risk is considered limited.

Breastfeeding mothers may use pimecrolimus but should not apply cream to the breasts, this will avoid any unintentional oral uptake by the 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

Burning sensation (local)
Application site reaction
Irritation (localised)
Pruritus
Erythema
Skin infection
Furunculosis
Impetigo
Herpes infections
Molluscum contagiosum
Skin papilloma
Rash
Pain
Paraesthesia
Desquamation
Dry skin
Oedema
Exacerbation of symptoms
Alcohol intolerance
Allergic reaction
Urticaria
Folliculitis
Skin carcinoma
Eczema herpeticum
Angioedema
Hypopigmentation
Hyperpigmentation
Anaphylactic reaction
Lymphoma
Lymphadenopathy

Presentation

Cream containing 1% pimecrolimus (1g of cream contains 10mg pimecrolimus)

Drugs List

Therapeutic Indications

Uses

Treatment of mild to moderate atopic dermatitis in patients over 3 months of age where topical corticosteroids are either not advisable or not possible. This may include:

- Intolerance to topical corticosteroids

- Lack of effect of topical corticosteroids

- Application to the face and neck where prolonged intermittent treatment with topical corticosteroids may be inappropriate

Dosage

Treatment should be initiated by a physician experienced in the diagnosis and topical treatment of atopic dermatitis.

Pimecrolimus should not be applied under occlusion. Emollients may be applied immediately after using pimecrolimus.

In the long term management of atopic dermatitis, treatment should begin at first appearance of signs and symptoms of atopic dermatitis to prevent flares of the disease.

Treatment should be intermittent, short term and not continuous. If no improvement occurs after 6 weeks, or in case of disease exacerbation, treatment should be discontinued and further therapeutic options considered. Treatment may be used intermittently for up to 12 months.

Adults

Elderly

Children

Administration

For topical application.

Contraindications

Immunosuppression
Malignant and pre-malignant skin lesions
Skin Infection

Children under 3 months of age
Pregnancy ( see Pregnancy )

Precautions and Warnings

Treatment should be initiated by a physician experienced in the diagnosis and topical treatment of atopic dermatitis.

Breastfeeding (see Lactation )

Before commencing treatment with pimecrolimus, clinical infections at treatment sites should be cleared. Patients with atopic dermatitis have an increased risk of skin infections including eczema herpeticum (Kaposi's varicelliform eruption). Treatment with pimecrolimus has been associated with an increase incidence of bacterial infections (including impetigo), herpes simplex virus infection and eczema herpeticum (manifesting as rapid spread of vesicular and erosive lesions). In the presence of herpes simplex skin infection, treatment should be discontinued at the site of infection until the viral infection has cleared.

If discontinued, treatment should be resumed upon first recurrence of signs and symptoms to prevent flares of the disease.

The use of pimecrolimus cream is not recommended where there is a risk of increased systemic absorption including:
Use with occlusive dressings
Use on severely inflamed and/or damaged skin
Patients with erythroderma
Patients with Netherton syndrome

Advice should be given to patients on appropriate sun protection measures, such as minimisation of the time in the sun, use of sunscreen product and covering the skin with appropriate clothing.

Cases of malignancies, such as skin cancers and cutaneous and other types of lymphoma, have been reported in patients using pimecrolimus cream. However, patients with atopic dermatitis treated with pimecrolimus cream have not been found to have significant systemic pimecrolimus levels.

Some cases of lymphadenopathy were reported during clinical studies. In the absence of a clear aetiology or in the presence of acute infectious mononucleosis, patients developing lymphadenopathy during therapy should discontinue treatment with pimecrolimus.

Use of pimecrolimus may cause mild and transient reactions at the site of application, such as a feeling of warmth and/or burning sensation. If the application site reaction is severe, the risk-benefit of treatment should be re-evaluated. The excipients in pimecrolimus (stearyl alcohol, cetyl alcohol and propylene glycol) cream may cause local skin reactions.

Alcohol intolerance, described as flushing, burning itching or swelling at the application site has occurred rarely after the consumption of alcohol by patients using pimecrolimus cream.

Care should be taken to avoid contact with eyes and mucous membranes. If accidentally applied to these areas, the cream should be thoroughly wiped off and/or rinsed off with water.

Pregnancy and Lactation

Pregnancy

Pimecrolimus cream is contraindicated during pregnancy.

At the time of writing, there is no adequate data from the use of pimecrolimus in pregnant women.

Animal studies with dermal application have shown no harmful effects with respect to embryonic / foetal development. Based on the extent of absorption after topical application, the potential risk for humans is considered limited.

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

Pimecrolimus cream should be used with caution in breastfeeding women.

It is not known whether pimecrolimus is excreted in breast milk after topical application. However, based on the minimal extent of pimecrolimus absorption after topical application, the potential risk is considered limited.

Breastfeeding mothers may use pimecrolimus but should not apply cream to the breasts, this will avoid any unintentional oral uptake by the 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

Effects on Ability to Drive and Operate Machinery

No known effect on the ability to drive and use machines.

Counselling

Advise patients on appropriate sun protection measures, such as minimisation of the time in the sun, use of sunscreen product and covering the skin with appropriate clothing.

Advise patient that flushing, burning itching or swelling at the application site may occur after the consumption of alcohol.

Side Effects

Burning sensation (local)
Application site reaction
Irritation (localised)
Pruritus
Erythema
Skin infection
Furunculosis
Impetigo
Herpes infections
Molluscum contagiosum
Skin papilloma
Rash
Pain
Paraesthesia
Desquamation
Dry skin
Oedema
Exacerbation of symptoms
Alcohol intolerance
Allergic reaction
Urticaria
Folliculitis
Skin carcinoma
Eczema herpeticum
Angioedema
Hypopigmentation
Hyperpigmentation
Anaphylactic reaction
Lymphoma
Lymphadenopathy

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

Do not store above 25 degrees C
Do not freeze

Further Information

Last Full Review Date: January 2013

Reference Sources

British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

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

Summary of Product Characteristics: Elidel 1% Cream. Meda Pharmaceuticals Ltd. Revised October 2021.