TACROLIMUS ointment

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Mayne Pharma Inc.

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

Tacrolimus ointment 0.1% NDC 68308-703-60 60 gram laminate tube Store at room temperature 25°C (77°F); excursions permitted to 15°to 30°C (59°to 86°F).

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

Mayne Pharma Inc.
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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:
•
Only 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 allergic to tacrolimus ointment or anything in

Αρχείο Π.Χ.Π.

TACROLIMUS- TACROLIMUS OINTMENT
MAYNE PHARMA INC.
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TACROLIMUS OINTMENT 0.03%
TACROLIMUS OINTMENT 0.1%
Distributed by: Mayne Pharma
RX ONLY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
PRESCRIBING INFORMATION
SEE BOXED WARNINGS CONCERNING LONG-TERM SAFETY OF TOPICAL CALCINEURIN
INHIBITORS
DESCRIPTION
Tacrolimus ointment contains tacrolimus, a macrolide immunosuppressant
produced by
_Streptomyces tsukubaensis_.
It is for topical dermatologic use only. Chemically, tacrolimus is
designated as
[3_S-_[3_R_ [_E_(1_S_ ,3_S_ ,4_S_ )],4_S_ ,5_R_ ,8_S_ ,9_E_,12_R_
,14_R_ ,15_S_ ,16_R_ ,18_S_ ,19_S_ ,26a_R_ ]]-
5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-
(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-
tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-_c_][1,4]oxaazacyclotricosine-
1,7,20,21(4H,23H)-tetrone, monohydrate.
It has the following structural formula:
Tacrolimus has a molecular formula of C
H
NO
•H O and a formula weight of
822.03.
Each gram of tacrolimus ointment contains (w/w) either 0.03% or 0.1%
of tacrolimus in
a base of mineral oil, paraffin, propylene carbonate, white petrolatum
and white wax.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The mechanism of action of tacrolimus in atopic dermatitis is not
known. While the
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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
transcrip