PIMECROLIMUS cream

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

PIMECROLIMUS (UNII: 7KYV510875) (PIMECROLIMUS - UNII:7KYV510875)

Prieinama:

REMEDYREPACK INC.

Vartojimo būdas:

TOPICAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus c ream, 1% is not indicated for use in children less than 2 years of age [see   Warnings and Precautions (5.1) ,   Use in Specific Populations (8.4) ]. Pimecrolimus cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. Pregnancy Category C There are no adequate and well-controlled studies with pimecrolimus cream, 1% in pregnant women. Therefore, pimecrolimus cream, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In dermal embryofetal developmental studies, no maternal or fetal toxicity was obs

Produkto santrauka:

Pimecrolimus cream, 1% is a whitish cream available in tubes of 30 grams, 60 grams, and 100 grams. NDC: 70518-2292-00 PACKAGING: 30g in 1 TUBE Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

PIMECROLIMUS- PIMECROLIMUS CREAM
REMEDYREPACK INC.
----------
MEDICATION GUIDE
Pimecrolimus (pimʺ e kroeʹ li mus) Cream, 1%
Important: Pimecrolimus cream, 1% is for use on the skin only
(topical). Do not get pimecrolimus cream, 1%
in your eyes, nose, mouth, vagina, or rectum.
What is the most important information I should know about
pimecrolimus cream, 1%?
It is not known if pimecrolimus cream, 1% is safe to use for a long
period of time. A very small number of
people who have used pimecrolimus cream, 1% have developed cancer (for
example, skin cancer or
lymphoma). But a link that pimecrolimus cream, 1% use caused these
cancers has not been shown. Because
of this concern:
•
Do not use pimecrolimus cream, 1% continuously for a long time.
•
Use pimecrolimus cream, 1% only on areas of your skin that have
eczema.
•
Do not use pimecrolimus cream, 1% on a child under 2 years of age.
What is pimecrolimus cream, 1%?
Pimecrolimus cream, 1% is a prescription medicine used on the skin
(topical) to treat mild to moderate
eczema (atopic dermatitis). Pimecrolimus cream, 1% is for adults and
children age 2 years and older who do
not have a weakened immune system. Pimecrolimus cream, 1% is used on
the skin for short periods, and if
needed, treatment may be repeated with breaks in between. Pimecrolimus
cream, 1% 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.
It is not known if pimecrolimus cream, 1% is safe and effective in
people who have a weakened immune
system.
Pimecrolimus cream, 1% is not for use in children under 2 years of
age.
Who should not use pimecrolimus cream, 1%?
Do not use pimecrolimus cream, 1% if you are allergic to pimecrolimus
or any of the ingredients in
pimecrolimus cream, 1%. See the end of this Medication Guide for a
complete list of ingredients in
pimecrolimus cream, 1%.
What should I tell my doctor before using pimecrolimus cream, 1%?
Before using pimecrolimus cream, 1%, tell your doctor abo

Prekės savybės

PIMECROLIMUS- PIMECROLIMUS CREAM
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PIMECROLIMUS CREAM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PIMECROLIMUS CREAM.
PIMECROLIMUSCREAM, 1% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT
BEEN
ESTABLISHED
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ALTHOUGH A CAUSAL RELATIONSHIP HAS NOT BEEN ESTABLISHED, RARE CASES OF
MALIGNANCY
(E.G., SKIN AND LYMPHOMA) HAVE BEEN REPORTED IN PATIENTS TREATED WITH
TOPICAL
CALCINEURIN INHIBITORS, INCLUDING PIMECROLIMUS CREAM, 1%. (5.1)
THEREFORE:
CONTINUOUS LONG-TERM USE OF TOPICAL CALCINEURIN INHIBITORS, INCLUDING
PIMECROLIMUS
CREAM, 1%, IN ANY AGE GROUP SHOULD BE AVOIDED, AND APPLICATION LIMITED
TO AREAS OF
INVOLVEMENT WITH ATOPIC DERMATITIS. (2, 5.1)
PIMECROLIMUS CREAM, 1% IS NOT INDICATED FOR USE IN CHILDREN LESS THAN
2 YEARS OF AGE.
(1, 5.1, 8.4)
INDICATIONS AND USAGE
Pimecrolimus cream, 1% is a calcineurin inhibitor immunosuppressant
indicated as _second-_
_line therapy _for the short-term and non-continuous chronic treatment
of mild to
moderate atopic dermatitis in non-immunocompromised adults and
children 2 years of age and older, who
have failed to respond adequately to other topical prescription
treatments, or when those treatments
are not advisable. ( 1)
DOSAGE AND ADMINISTRATION
Apply a thin layer of pimecrolimus cream, 1% to the affected skin
twice daily. ( 2)
If signs and symptoms persist beyond 6 weeks, patients should be
re-examined. ( 2)
Continuous long-term use of pimecrolimus cream, 1% should be avoided.
( 2)
Avoid use with occlusive dressings. ( 2)
DOSAGE FORMS AND STRENGTHS
Cream, 1%. ( 3)
CONTRAINDICATIONS
Pimecrolimus cream 1% is contraindicated in individuals with a history
of hypersensitivity to pimecrolimus
or any of the components of the cream. ( 4, 6.2)
WARNINGS AND PRECAUTIONS
Should not be used in immunocompromised adults an