TACROLIMUS ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Accord Healthcare Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Tacrolimus ointment 0.03% NDC 16729-421-10 30 gram laminate tube NDC 16729-421-12 60 gram laminate tube 16729-421-01 100 gram laminate tube Tacrolimus ointment 0.1% NDC 16729-422-10 30 gram laminate tube NDC 16729-422-12 60 gram laminate tube NDC 16729-422-01 100 gram laminate tube Store at 25°C (77°F): excursions permitted to 15°-30°C (59°-86°F)[See USP Controlled Room Temperature.] Manufactured for: Accord Healthcare, Inc., 1009, Slater Road, Suite 210-B, Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Plot No.: 457, 458, Village - Matoda, Bavla Road, Ta. - Sanand, Dist. - Ahmedabad – 382 210, INDIA. 10 2400 0 677812 Issued 06/2018

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TACROLIMUS- TACROLIMUS OINTMENT
Accord Healthcare Inc.
----------
MEDICATION GUIDE
Tacrolimus (ta kroe' li mus) Ointment, 0.03% and 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 t

Summary of Product characteristics

TACROLIMUS- TACROLIMUS OINTMENT
ACCORD HEALTHCARE INC.
----------
TACROLIMUS OINTMENT, 0.03% AND 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, 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 an empirical 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
following have been observed, the clinical significance of these
observations in atopic
44
69
12
2
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, IL-5, GM