Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
PIMECROLIMUS (UNII: 7KYV510875) (PIMECROLIMUS - UNII:7KYV510875)
Physicians Total Care, Inc.
PIMECROLIMUS
PIMECROLIMUS 10 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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.
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
New Drug Application
ELIDEL - PIMECROLIMUS CREAM Physicians Total Care, Inc. ---------- 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 Прочитать полный документ
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 Прочитать полный документ