Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
TACROLIMUS (UNII: WM0HAQ4WNM) (TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J)
Glenmark Pharmaceuticals Inc., USA
TOPICAL
PRESCRIPTION DRUG
Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use). Tacrolimus ointment is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the ointment.
Tacrolimus Ointment 0.03% 30 gram laminate tube NDC 68462-881-35 60 gram laminate tube NDC 68462-881-65 100 gram laminate tube NDC 68462-881-94 Tacrolimus Ointment 0.1% 30 gram laminate tube NDC 68462-534-35 60 gram laminate tube NDC 68462-534-65 100 gram laminate tube NDC 68462-534-94 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Medication Guide available at www.glenmarkpharma-us.com/medguides Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com July 2023
Abbreviated New Drug Application
TACROLIMUS- TACROLIMUS OINTMENT Glenmark Pharmaceuticals Inc., USA ---------- MEDICATION GUIDE Tacrolimus (ta-KROE-li-mus) Ointment 0.03% Ointment 0.1% Read the Medication Guide every time you or a family member gets tacrolimus ointment. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. If you have questions about tacrolimus ointment, ask your doctor or pharmacist. What is the most important information I should know about tacrolimus ointment? The safety of using tacrolimus ointment for a long period of time is not known. A very small number of people who have used tacrolimus ointment have had cancer (for example, skin or lymphoma). However, a link with tacrolimus ointment has not been shown. Because of this concern: • Do not use tacrolimus ointment continuously for a long time. • Use tacrolimus ointment only on areas of your skin that have eczema. • Do not use tacrolimus ointment on a child under 2 years old. Tacrolimus ointment comes in two strengths: • Tacrolimus ointment 0.03% is for use on children aged 2 to 15 years. • Either tacrolimus ointment 0.03% or 0.1% can be used by adults and children 16 years and older. Talk to your doctor for more information. What is tacrolimus ointment? Tacrolimus ointment is a prescription medicine used on the skin (topical) to treat eczema (atopic dermatitis). Tacrolimus ointment is in a class of medicines called topical calcineurin inhibitors. It is for adults and children 2 years of age and older who do not have a weakened immune system. Tacrolimus ointment is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. Tacrolimus ointment 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 tacrolimus ointment? Tacrolimus ointment should not be used: • on children younger than 2 years of age. • if you are all Lesen Sie das vollständige Dokument
TACROLIMUS- TACROLIMUS OINTMENT GLENMARK PHARMACEUTICALS INC., USA ---------- TACROLIMUS OINTMENT 0.03% TACROLIMUS OINTMENT 0.1% FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE RX ONLY PRESCRIBING INFORMATION SEE BOXED WARNING CONCERNING LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS DESCRIPTION Tacrolimus Ointment contains tacrolimus, USP a macrolide immunosuppressant produced by _Streptomyces tsukubaensis_. It is for topical dermatologic use only. Chemically, tacrolimus, USP is designated as (-)- (3_S_,4_R_,5_S_,8_R_,9_E_,12_S_,14_S_,15_R_,16_S_,18_R_,19_R_,26a_S_)-8-Allyl- 5,6,8,11,12,13,14,15,16,17,18,19,24,25, 26,26a-hexadecahydro-5,19-dihydroxy-3-[(_E_)- 2-[(1_R_,3_R_,4_R_)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy- 4,10,12,18-tetramethyl-15,19-epoxy-3_H_-pyrido[2,1-c][1,4] oxaazacyclotricosine- 1,7,20,21(4_H_,23_H_)-tetrone,monohydrate. It has the following structural formula: Tacrolimus, USP has a molecular formula of C H NO •H O and a formula weight of 822.03. Each gram of tacrolimus ointment contains either 0.03% or 0.1% w/w of tacrolimus, USP in a base of mineral oil, paraffin, propylene carbonate, white petrolatum and white wax. CLINICAL PHARMACOLOGY MECHANISM OF ACTION 44 69 12 2 The mechanism of action of tacrolimus 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 tacrolimus inhibits T-lymphocyte activation by first binding to an intracellular protein, FKBP-12. A complex of tacrolimus- FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This effect has been shown to prevent the dephosphorylation and translocation of nuclear factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of lymphokines (such as interleukin-2, gamma interferon). Tacrolimus also inhibits the transcription for genes which encode IL-3, IL-4, I Lesen Sie das vollständige Dokument