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ELIDEL is a brand name for Pimecrolimus, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ELIDEL (pimecrolimus) Cream 1% is indicated for: second-line therapy for short term and intermittent long-term therapy of mild to moderate atopic dermatitis in non-immunocompromised patients 3 months of age and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential…
Verbatim from this product's HC label. Tap a section to expand.
1 Recommended Dose and Dosage Adjustment Apply a thin layer of ELIDEL (pimecrolimus) Cream, 1% to sufficiently cover the affected skin area twice daily. ELIDEL may be used on all skin surfaces, including the head, neck, and intertriginous areas.
ELIDEL Cream should be used for short or long intermittent periods of treatment. g. pruritus, inflammation and erythema). Treatment should be discontinued if resolution of disease occurs. If no improvement occurs after 3 weeks of treatment, or in case of disease exacerbation, ELIDEL therapy should be discontinued, and patients should consult their physicians.
The use of ELIDEL under occlusion has not been studied, therefore occlusive dressings are not recommended.
1 Adverse Reaction Overview In human dermal safety studies, ELIDEL (pimecrolimus) Cream, 1% did not induce contact ELIDEL® Product Monograph Page 8 of 28 sensitization, phototoxicity, or photoallergy, nor did it show any cumulative irritation.
ELIDEL did not elicit skin atrophy compared to topical corticosteroid use. 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 1%. In these clinical trials, 48 (4%) of the 1171 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.
In a five-year multicenter, open-label, parallel group, randomized study in pediatric patients age 3 months to less than 12 months, 1205 patients were randomized to ELIDEL cream and 1213 patients were randomized to topical corticosteroids (TCS).
4%) were under 12 months old. 9%). 2% each). 9%). 4%) during the treatment period. 1%, respectively). 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
3) 09-2019 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................ 2 TABLE OF CONTENTS ..................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 4 1 INDICATIONS ...................................................................................................... 1 Pediatrics .....................................................................................................
2 Geriatrics ..................................................................................................... 4 2 CONTRAINDICATIONS ....................................................................................... 4 3 DOSAGE AND ADMINISTRATION .....................................................................
1 Recommended Dose and Dosage Adjustment ............................................ 4 4 OVERDOSAGE .................................................................................................... 5 5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............
5 6 WARNINGS AND PRECAUTIONS ...................................................................... 1 Special Populations ..................................................................................... 1 Pregnant Women .....................................................................................
2 Breast-feeding .......................................................................................... 3 Pediatrics ( 3 months of age).................................................................. 4 Geriatrics (> 65 years of age) ...................................................................
7 7 ADVERSE REACTIONS ...................................................................................... 1 Adverse Reaction Overview ........................................................................ 2 Clinical Trial Adverse Reactions ..................................................................
ELIDEL (pimecrolimus) Cream, 1% is contraindicated in individuals who have known or suspected hypersensitivity to pimecrolimus or any of the components of the cream. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION and PACKAGING.
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Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The table below 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 control study is also included in this table. Adverse events are listed regardless of relationship to study drug. 6%) 0 0 Upper […]
3 Less Common Clinical Trial Adverse Reactions ........................................ 4 Clinical Trial Adverse Reactions (Pediatrics) ............................................. 5 Post-Market Adverse Reactions ................................................................
14 8 DRUG INTERACTIONS ..................................................................................... 1 Overview.................................................................................................... 2 Drug-Food Interactions ..............................................................................
3 Drug-Herb Interactions .............................................................................. 4 Drug-Laboratory Test Interactions ............................................................. 15 9 ACTION AND CLINICAL PHARMACOLOGY ...................................................
1 Mechanism of Action ................................................................................. 2 Pharmacodynamics ................................................................................... 3 Pharmacokinetics ......................................................................................
16 10 STORAGE, STABILITY AND DISPOSAL ......................................................... 17 11 SPECIAL HANDLING INSTRUCTIONS ............................................................ 17 12 PHARMACEUTICAL INFORMATION ...............................................................
18 13 CLINICAL TRIALS ............................................................................................. 19 14 DETAILED PHARMACOLOGY – CLINICAL STUDIES .................................... 21 15 MICROBIOLOGY ...............................................................................................
22 16 NON-CLINICAL TOXICOLOGY ......................................................................... 22 PATIENT MEDICATION INFORMATION ..................................................................... 25 ELIDEL® Product Monograph Page 4 of 28 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ELIDEL (pimecrolimus) Cream 1% is indicated for: second-line therapy for short term and intermittent long-term therapy of mild to moderate atopic dermatitis in non-immunocompromised patients 3 months of age and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies.
For additional safety information, please refer to WARNINGS AND PRECAUTIONS section. 1 Pediatrics Pediatrics ( 3 months of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ELIDEL cream in pediatric patients have been established; therefore, Health Canada has authorized an indication for pediatric use.
2 Geriatrics Geriatrics (> 65 years of age): Clinical studies of ELIDEL did not include sufficient numbers of subjects aged 65 and older to establish efficacy and safety of the drug in geriatric patients. 2 CONTRAINDICATIONS ELIDEL (pimecrolimus) Cream, 1% is contraindicated in individuals who have known or suspected hypersensitivity to pimecrolimus or any of the components of the cream.
For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION and PACKAGING. 1 Recommended Dose and Dosage Adjustment Apply a thin layer of ELIDEL (pimecrolimus) Cream, 1% to sufficiently cover the affected skin area twice daily.
ELIDEL may be used on all skin surfaces, including the head, neck, and intertriginous areas. ELIDEL Cream should be used for short or long intermittent […]