TACROLIMUS ointment

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

TACROLIMUS (UNII: WM0HAQ4WNM) (TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J)

Disponibil de la:

Glenmark Pharmaceuticals Inc., USA

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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.

Rezumat produs:

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 [phone] www.glenmarkpharma-us.com July 2023

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

TACROLIMUS- TACROLIMUS OINTMENT
Glenmark Pharmaceuticals Inc., USA
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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

Caracteristicilor produsului

TACROLIMUS- TACROLIMUS OINTMENT
GLENMARK PHARMACEUTICALS INC., USA
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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
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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