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Elidel®
(pimecrolimus) Cream 1%
WARNING
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
See also:
Protopic
Drug Uses
Elidel is a prescription medicine you put on your
skin (topical) to treat atopic dermatitis, also known as eczema. Elidel is for
use on the skin only. Elidel is for adults and children age 2 years and older.
You can use Elidel for short or intermittent long periods of treatment.
Intermittent means starting and stopping repeatedly, as directed by your doctor.
You can use it on all affected areas of your skin, including your face and neck.
How Taken
Apply a thin layer of Elidel cream 1% to the
affected skin twice daily and rub in gently and completely. Elidel may be used
on all skin surfaces, including the head, neck. Elidel should be used twice
daily for as long as signs and symptoms persist. Treatment should be
discontinued if resolution of disease occurs. If symptoms persist beyond 6
weeks, the patient should be re-evaluated. The safety of Elidel Cream under
occlusion, which may promote systemic exposure, has not been evaluated. Elidel
cream should not be used with occlusive dressings.
Warnings/Precautions
Do not use Elidel without first talking to your
doctor if you have the congenital skin disorder Netherton's syndrome. Before
using Elidel, tell your doctor if you: have a skin infection; have a disease of
the immune system; or are using any other type of skin product (e.g., cream,
ointment, lotion, etc.). You may not be able to use Elidel, or you may require a
dosage adjustment or special monitoring if you have any of the conditions listed
above. Elidel is in the FDA pregnancy category C. This means that it is not
known whether Elidel will harm an unborn baby. Do not use this medication
without first talking to your doctor if you are pregnant or are planning to
become pregnant during treatment. It is not known whether Elidel passes into
breast milk. Do not use this medication without first talking to your doctor if
you are breast-feeding a baby. Elidel is not approved for use by children
younger than 2 years of age.
Missed Dose
Use the missed dose as soon as you remember. If it
is almost time for the next dose, skip the dose you missed, and use only the
next regularly scheduled dose.
Possible Side Effects
The most common side effect at the site of
application is burning or a feeling of warmth. The burning feeling is usually
mild or moderate, occurring in the first 5 days of treatment, and the burning
usually clears up in a few days. See your doctor if an application site reaction
is severe or persists for more than 1 week. Other common side effects include
headache, and with long-term intermittent use, common cold/stuffy nose,
influenza, sore throat, fever, viral infection, and cough. Some people may get
herpes skin infections (like cold sores, chicken pox, or shingles), warts, or
swollen lymph nodes (glands).
Storage
Store at 25°C (77°F); excursions permitted to
15°C-30°C (59°F-86°F). Do not freeze.
Overdose
There has been no experience of overdose with
Elidel cream 1%. If oral ingestion occurs, medical advice should be sought.
More Information
Avoid sunlight and sun lamps, tanning beds, and
treatments with UVA or UVB light. If you need to be outdoors after applying
Elidel, wear loose clothing that protects the treated area from the sun. Also,
ask your doctor what other type of protection from the sun may be needed. Unless
otherwise instructed by your doctor, do not apply any other skin products on the
areas treated with Elidel.
See WARNINGS, boxed WARNING concerning long-term safety of
topical calcineurin inhibitors.
ELIDEL®
(pimecrolimus)
Cream 1% contains the compound pimecrolimus, the immunosuppressant
33-epi-chloro-derivative of the macrolactam ascomycin.
Chemically, pimecrolimus is:
(1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-
3-methoxycyclohexyl}
-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-
tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone.
The compound has the empirical formula C43H68CINO11 and
the molecular weight of 810.47.
Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in
methanol and ethanol and insoluble in water.
Each gram of ELIDEL Cream 1% contains 10 mg of pimecrolimus in a whitish cream
base of benzyl alcohol, cetyl alcohol, citric acid, mono- and di-glycerides,
oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide,
stearyl alcohol, triglycerides, and water.
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