PROTOPIC- tacrolimus ointment

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Astellas Pharma US Inc.

DCI (Denominação Comum Internacional):

TACROLIMUS

Composição:

TACROLIMUS 0.3 mg in 1 g

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

PROTOPIC 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. PROTOPIC Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use). PROTOPIC (tacrolimus) Ointment is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the ointment.

Resumo do produto:

PROTOPIC® (tacrolimus) Ointment 0.03% NDC 0469-5201-30 Product Code 520130 30 gram laminate tube NDC 0469-5201-60 Product Code 520160 60 gram laminate tube NDC 0469-5201-11 Product Code 520111 100 gram laminate tube PROTOPIC® (tacrolimus) Ointment 0.1% NDC 0469-5202-30 Product Code 520230 30 gram laminate tube NDC 0469-5202-60 Product Code 520260 60 gram laminate tube NDC 0469-5202-11 Product Code 520211 100 gram laminate tube Store at room temperature 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Product of Japan Manufactured by: Astellas Pharma Tech Co., Ltd. Toyama Technology Center, 2-178 Kojin-machi, Toyama city, Toyama 930-0809, Japan Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062 Revised: May 2012 12D030-PRT-SPL

Status de autorização:

New Drug Application

Folheto informativo - Bula

PROTOPIC- TACROLIMUS OINTMENT
Astellas Pharma US Inc.
----------
MEDICATION GUIDE
PROTOPIC® [pro-TOP-ik]
(tacrolimus)
Ointment 0.03%
Ointment 0.1%
Read the Medication Guide every time you or a family member gets
PROTOPIC 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 PROTOPIC
Ointment, ask your doctor or
pharmacist.
What is the most important information I should know about PROTOPIC
Ointment?
The safety of using PROTOPIC Ointment for a long period of time is not
known. A very small number of
people who have used PROTOPIC Ointment have had cancer (for example,
skin or lymphoma).
However, a link with PROTOPIC Ointment has not been shown. Because of
this concern:
•
Do not use PROTOPIC Ointment continuously for a long time.
•
Use PROTOPIC Ointment only on areas of your skin that have eczema.
•
Do not use PROTOPIC Ointment on a child under 2 years old.
PROTOPIC Ointment comes in two strengths:
•
Only PROTOPIC Ointment 0.03% is for use on children aged 2 to 15
years.
•
Either PROTOPIC 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 PROTOPIC Ointment?
PROTOPIC Ointment is a prescription medicine used on the skin
(topical) to treat eczema (atopic
dermatitis). PROTOPIC 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. PROTOPIC
Ointment is used on the skin for short periods, and if needed,
treatment may be repeated with breaks in
between.
PROTOPIC 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 PROTOPIC Ointment?
PROTOPIC Ointment should not be used:
•
on children younger than 2 years of age.
•
if you are allergic to PROTOPIC Ointment or anythin

Características técnicas

PROTOPIC- TACROLIMUS OINTMENT
ASTELLAS PHARMA US INC.
----------
PROTOPIC (TACROLIMUS)
OINTMENT 0.03%
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
PROTOPIC (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 PROTOPIC 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
®
44
69
12
2
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