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pimecrolimus
Overview
What is Elidel?
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 HCINO 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.
What does Elidel look like?
What are the available doses of Elidel?
Sorry No records found.
What should I talk to my health care provider before I take Elidel?
Sorry No records found
How should I use Elidel?
ELIDEL (pimecrolimus) Cream 1% is indicated as for the short-term and non-continuous chronic treatment ofmild 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).
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.
What interacts with Elidel?
Sorry No Records found
What are the warnings of Elidel?
Sorry No Records found
What are the precautions of Elidel?
Sorry No Records found
What are the side effects of Elidel?
Sorry No records found
What should I look out for while using Elidel?
ELIDEL (pimecrolimus) Cream 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.
What might happen if I take too much Elidel?
There has been no experience of overdose with ELIDEL (pimecrolimus) Cream 1%. If oral ingestion occurs, medical advice should be sought.
How should I store and handle Elidel?
GEODON for Injection should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature] in dry form. Protect from light. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15°–30°C (59°–86°F) or up to 7 days refrigerated, 2°–8°C (36°–46°F).ELIDEL (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.30 gram tube.................................................................................................NDC 54868-4878-060 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 GmbHWehr, GermanyDistributed by:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936Relabeling of "Additional Barcode Label" by: Tulsa, OK 74146 ELIDEL (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.30 gram tube.................................................................................................NDC 54868-4878-060 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 GmbHWehr, GermanyDistributed by:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936Relabeling of "Additional Barcode Label" by: Tulsa, OK 74146 ELIDEL (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.30 gram tube.................................................................................................NDC 54868-4878-060 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 GmbHWehr, GermanyDistributed by:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936Relabeling of "Additional Barcode Label" by: Tulsa, OK 74146 ELIDEL (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.30 gram tube.................................................................................................NDC 54868-4878-060 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 GmbHWehr, GermanyDistributed by:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936Relabeling of "Additional Barcode Label" by: Tulsa, OK 74146 ELIDEL (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.30 gram tube.................................................................................................NDC 54868-4878-060 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 GmbHWehr, GermanyDistributed by:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936Relabeling of "Additional Barcode Label" by: Tulsa, OK 74146 ELIDEL (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.30 gram tube.................................................................................................NDC 54868-4878-060 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 GmbHWehr, GermanyDistributed by:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936Relabeling of "Additional Barcode Label" by: Tulsa, OK 74146 ELIDEL (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.30 gram tube.................................................................................................NDC 54868-4878-060 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 GmbHWehr, GermanyDistributed by:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936Relabeling of "Additional Barcode Label" by: Tulsa, OK 74146 ELIDEL (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.30 gram tube.................................................................................................NDC 54868-4878-060 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 GmbHWehr, GermanyDistributed by:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936Relabeling of "Additional Barcode Label" by: Tulsa, OK 74146 ELIDEL (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.30 gram tube.................................................................................................NDC 54868-4878-060 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 GmbHWehr, GermanyDistributed by:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936Relabeling of "Additional Barcode Label" by: Tulsa, OK 74146 ELIDEL (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.30 gram tube.................................................................................................NDC 54868-4878-060 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 GmbHWehr, GermanyDistributed by:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936Relabeling of "Additional Barcode Label" by: Tulsa, OK 74146 ELIDEL (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.30 gram tube.................................................................................................NDC 54868-4878-060 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 GmbHWehr, GermanyDistributed by:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936Relabeling of "Additional Barcode Label" by: Tulsa, OK 74146 ELIDEL (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.30 gram tube.................................................................................................NDC 54868-4878-060 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 GmbHWehr, GermanyDistributed by:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936Relabeling of "Additional Barcode Label" by: Tulsa, OK 74146 ELIDEL (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.30 gram tube.................................................................................................NDC 54868-4878-060 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 GmbHWehr, GermanyDistributed by:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936Relabeling of "Additional Barcode Label" by: Tulsa, OK 74146
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 from mast cells in vitro after stimulation by antigen/IgE.
Non-Clinical Toxicology
ELIDEL (pimecrolimus) Cream 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.Potential interactions between ELIDEL and other drugs, including immunizations, have not been systematically evaluated. Due to low blood levels of pimecrolimus detected in some patients after topical application, systemic drug interactions are not expected, but cannot be ruled out. The concomitant administration of known CYP3A family of inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.
The use of ELIDEL Cream should be avoided on malignant or pre-malignant skin conditions. Malignant or pre-malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), can present as dermatitis.
ELIDEL Cream should not be used in patients with Netherton’s Syndrome or other skin diseases where there is the potential for increased systemic absorption of pimecrolimus The safety of ELIDEL Cream has not been established in patients with generalized erythroderma.
The use of ELIDEL Cream may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. Localized symptoms are most common during the first few days of ELIDEL Cream application and typically improve as the lesions of atopic dermatitis resolve (see ).
Bacterial and Viral Skin Infections:
While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment with ELIDEL Cream may be independently associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum.
In clinical studies, 15/1,544 (1%) cases of skin papilloma (warts) were observed in patients using ELIDEL Cream. The youngest patient was age 2 and the oldest was age 12. In cases where there is worsening of skin papillomas or they do not respond to conventional therapy, discontinuation of ELIDEL Cream should be considered until complete resolution of the warts is achieved.
Patients with Lymphadenopathy
Sun Exposure
Immunocompromised Patients
No phototoxicity and no photoallergenicity were detected in clinical studies with 24 and 33 normal volunteers, respectively. In human dermal safety studies, ELIDEL (pimecrolimus) Cream 1% did not induce contact sensitization or cumulative irritation.
In a one-year safety study in pediatric patients age 2-17 years old involving sequential use of ELIDEL Cream and a topical corticosteroid, 43% of ELIDEL patients and 68% of vehicle patients used corticosteroids during the study. Corticosteroids were used for more than 7 days by 34% of ELIDEL patients and 54% of vehicle patients. An increased incidence of impetigo, skin infection, superinfection (infected atopic dermatitis), rhinitis, and urticaria were found in the patients that had used ELIDEL Cream and topical corticosteroid sequentially as compared to ELIDEL Cream alone.
In 3 randomized, double-blind vehicle-controlled pediatric studies and one active-controlled adult study, 843 and 328 patients respectively, were treated with ELIDEL Cream. In these clinical trials, 48 (4%) of the 1,171 ELIDEL patients and 13 (3%) of 408 vehicle-treated patients discontinued therapy due to adverse events. Discontinuations for AEs were primarily due to application site reactions, and cutaneous infections. The most common application site reaction was application site burning, which occurred in 8%-26% of patients treated with ELIDEL Cream.
The following table depicts the incidence of adverse events pooled across the 2 identically designed 6-week studies with their open label extensions and the 1-year safety study for pediatric patients ages 2-17. Data from the adult active-controlled study is also included in this table. Adverse events are listed regardless of relationship to study drug.
*Ages 2-17 years
Two cases of septic arthritis have been reported in infants less than one year of age in clinical trials conducted with ELIDEL Cream (n = 2,443). Causality has not been established.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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