Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
Pimecrolimus (UNII: 7KYV510875) (Pimecrolimus - UNII:7KYV510875)
Bausch Health US, LLC
Pimecrolimus
Pimecrolimus 10 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
ELIDEL Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. There are no adequate and well-controlled studies with ELIDEL Cream, 1% in pregnant women. Therefore, ELIDEL Cream, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In dermal embryofetal developmental studies, no maternal or fetal toxicity was observed up to the highest practicable doses tested, 10 mg/kg/day (1% pimecrolimus cream) in rats (0.14X MRHD based on body surface area) and 10 mg/kg/day (1% pimecrolimus cream) in rabbits (0.65X MRHD based on AUC comparisons). The 1% pimecrolimus cream was administered topically for 6 hours/day during the period of organogenesis in rats and rabbits (gestational days 6-21 in rats and gestational days 6-20 in rabbits). A second dermal embryofetal development study was conducted in rats using pimecrolimus cream applied dermally to pregnant rats (1 g cream/kg body weight of 0
ELIDEL Cream, 1% is a whitish cream available in tubes of 30 grams, 60 grams, and 100 grams. 30 gram tube NDC 0187-5100-01 60 gram tube NDC 0187-5101-02 100 gram tube NDC 0187-5102-03 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze.
New Drug Application
Bausch Health US, LLC ---------- MEDICATION GUIDE ELIDEL® (EL-ee-del) (pimecrolimus) Cream, 1% Important: ELIDEL Cream, 1% is for use on the skin only (topical). Do not get ELIDEL Cream, 1% in your eyes, nose, mouth, vagina, or rectum. What is the most important information I should know about ELIDEL Cream, 1%? It is not known if ELIDEL Cream, 1% is safe to use for a long period of time. A very small number of people who have used ELIDEL Cream, 1% have developed cancer (for example, skin cancer or lymphoma). But a link that ELIDEL Cream, 1% use caused these cancers has not been shown. Because of this concern: • Do not use ELIDEL Cream, 1% continuously for a long time. • Use ELIDEL Cream, 1% only on areas of your skin that have eczema. • Do not use ELIDEL Cream, 1% on a child under 2 years of age. What is ELIDEL Cream, 1%? ELIDEL Cream, 1% is a prescription medicine used on the skin (topical) to treat mild to moderate eczema (atopic dermatitis). ELIDEL Cream, 1% is for adults and children age 2 years and older who do not have a weakened immune system. ELIDEL Cream, 1% is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. ELIDEL Cream, 1% 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. It is not known if ELIDEL Cream, 1% is safe and effective in people who have a weakened immune system. ELIDEL Cream, 1% is not for use in children under 2 years of age. Who should not use ELIDEL Cream, 1%? Do not use ELIDEL Cream, 1% if you are allergic to pimecrolimus or any of the ingredients in ELIDEL Cream, 1%. See the end of this Medication Guide for a complete list of ingredients in ELIDEL Cream, 1%. What should I tell my doctor before using ELIDEL Cream, 1%? Before using ELIDEL Cream, 1%, tell your doctor about all of your medical conditions, including if you: • have a skin disease called Netherton’s syndrome (a rare inherited condition). • have any infection on Прочетете целия документ
ELIDEL- PIMECROLIMUS CREAM BAUSCH HEALTH US, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ELIDEL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ELIDEL. ELIDEL (PIMECROLIMUS) CREAM, FOR TOPICAL USE INITIAL U.S. APPROVAL: 2001 WARNING: LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT BEEN ESTABLISHED _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ ALTHOUGH A CAUSAL RELATIONSHIP HAS NOT BEEN ESTABLISHED, RARE CASES OF MALIGNANCY (E.G., SKIN AND LYMPHOMA) HAVE BEEN REPORTED IN PATIENTS TREATED WITH TOPICAL CALCINEURIN INHIBITORS, INCLUDING ELIDEL CREAM, 1%. (5.1). T HE RE FO RE : • • INDICATIONS AND USAGE ELIDEL Cream, 1% is a calcineurin inhibitor immunosuppressant 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. (1) DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS Cream, 1%. (3) CONTRAINDICATIONS ELIDEL Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. (4, 6.2) WARNINGS AND PRECAUTIONS • • • ADVERSE REACTIONS The most commonly reported adverse reactions (≥1%) were application site burning, headache, nasopharyngitis, cough, influenza, pyrexia and viral infection. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAUSCH HEALTH US, LLC AT 1-800-321-4576 OR FDA AT 1- 800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE. REVISED: 9/2020 ® CONTINUOUS LONG-TERM USE OF TOPICAL CALCINEURIN INHIBITORS, INCLUDING ELIDEL CREAM, 1%, IN ANY AGE GROUP SHOULD BE AVOIDED AND APPLICATION LIMITED TO AREAS OF INVOLVEMENT WITH ATOPIC DERMATITIS. (2, 5.1) ELIDEL CREAM, 1% IS NOT INDICATED FOR Прочетете целия документ