ELIDEL- pimecrolimus cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PIMECROLIMUS (UNII: 7KYV510875) (PIMECROLIMUS - UNII:7KYV510875)

Available from:

Physicians Total Care, Inc.

INN (International Name):

PIMECROLIMUS

Composition:

PIMECROLIMUS 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ELIDEL ® (pimecrolimus) Cream 1% is indicated as second-line  therapy  for the short-term and non-continuous chronic treatment of  mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. ELIDEL Cream is not indicated for use in children less than 2 years of age (see WARNINGS, boxed WARNING, and PRECAUTIONS, Pediatric Use).  ELIDEL ® (pimecrolimus) Cream 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.

Product summary:

ELIDEL ® (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams. 30 gram tube.................................................................................................NDC 54868-4878-0 60 gram tube……………………………………………………………….NDC 54868-4878-2 100 gram tube……………………………………………………………...NDC 54868-4878-1 Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). Do not freeze. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany Distributed by: Novartis Pharmaceuticals Corp. East Hanover, NJ 07936 Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

New Drug Application

Patient Information leaflet

ELIDEL - PIMECROLIMUS CREAM
Physicians Total Care, Inc.
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MEDICATION GUIDE
ELIDEL® [EĹ-ee-del] (pimecrolimus) Cream 1%
You must read and follow all instructions before using ELIDEL Cream.
Read the Medication Guide you get every time you or a family member
gets ELIDEL Cream. There may
be new information. This Medication Guide does not take the place of
talking with your doctor about
your medical condition or treatment. If you have any questions about
ELIDEL Cream, ask your doctor or
pharmacist.
What is the most important information I should know about ELIDEL
Cream?
The safety of using ELIDEL Cream for a long period of time is not
known. A very small number of
people who have used ELIDEL Cream have had cancer (for example, skin
or lymphoma). However, a
link with ELIDEL Cream use has not been shown. Because of this
concern:
•
Do not use ELIDEL Cream continuously for a long time.
•
Use ELIDEL Cream only on areas of your skin that have eczema.
•
Do not use ELIDEL Cream on a child under 2 years old.
What is ELIDEL Cream?
ELIDEL Cream is a prescription medicine used on the skin (topical) to
treat eczema (atopic dermatitis).
ELIDEL Cream is in a class of medicines called topical calcineurin
inhibitors. ELIDEL Cream is for
adults and children age 2 years and older who do not have a weakened
immune system. ELIDEL Cream
is used on the skin for short periods, and if needed, treatment may be
repeated with breaks in between.
ELIDEL Cream is for use after other prescription medicines have not
worked for you or if your doctor
recommends that other prescription medicines should not be used.
Who should not use ELIDEL Cream?
Do not use ELIDEL Cream:
•
on children under 2 years of age
•
if you are allergic to ELIDEL Cream or anything in it. See the end of
this Medication Guide for a
complete list of ingredients.
What should I tell my doctor before starting ELIDEL Cream?
Before you start using ELIDEL Cream, tell your doctor about all of
your medical conditions, including if
you:
•
have a skin disease called N

Summary of Product characteristics

ELIDEL - PIMECROLIMUS CREAM
PHYSICIANS TOTAL CARE, INC.
----------
ELIDEL
ELIDEL
(PIMECROLIMUS) CREAM 1%
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
PRESCRIBING INFORMATION
SEE WARNINGS, BOXED WARNING CONCERNING LONG-TERM SAFETY OF TOPICAL
CALCINEURIN INHIBITORS.
DESCRIPTION
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[22.3.1.0
]octacos-18-ene-2,3,10,16-
tetraone.
The compound has the empirical formula C
H CINO and the molecular weight of 810.47. The
structural formula is
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.
CLINICAL PHARMACOLOGY
®
®
4,9
43
68
11
MECHANISM OF ACTION/PHARMACODYNAMICS
The mechanism of action of pimecrolimus in atopic dermatitis is not
known. While the following have
been observed, the clinical significance of these observations in
atopic dermatitis is not known. It has
been demonstrated that pimecrolimus binds with high affinity to
macrophilin-12 (FKBP-12) and inhibits
the calcium-dependent phosphatase, calcineurin. As a consequence, it
inhibits T cell activation by
blocking the transcription of early cytokines. In particular,
pimecrolimus inhibits at nanomolar
concentrations Interleukin-2 and interferon gamma (Th1-type) and
Interleukin-4 and Interleukin-10 (Th2-
type) cytokine synthesis in human T cells. In addition, pimecrolimus
prevents the release of
inflammatory cytokines and mediators fro