IMPEKLO- clobetasol propionate lotion

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

Tilgjengelig fra:

Mylan Specialty L.P.

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

IMPEKLO lotion is a super-high potent topical corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older. IMPEKLO lotion should not be used in the treatment of rosacea or perioral dermatitis. Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]. None. There are no available data for the use of IMPEKLO during pregnancy to inform any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published data report an increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use IMPEKLO on the smallest area of skin and for the shortest duration possible (see Data ). In animal reproduction studies,

Produkt oppsummering:

IMPEKLO™ lotion, 0.05% is a white to off white, opaque to translucent, homogenous and lump free lotion without any phase separation provided in a white bottle with a metered-dose pump having an integral pump locking feature. Each pump actuation delivers 0.15 mg of clobetasol propionate, USP in 0.30 g of lotion. The metered-dose pump is capable of dispensing not less than 138 actuations to deliver not less than 41.4 g of lotion. It is available as follows: NDC 49502-537-35 one metered dose pump contains 68 g lotion Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

Autorisasjon status:

New Drug Application

Preparatomtale

IMPEKLO- CLOBETASOL PROPIONATE LOTION
MYLAN SPECIALTY L.P.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IMPEKLO, SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR IMPEKLO.
IMPEKLO™ (CLOBETASOL PROPIONATE) LOTION, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
IMPEKLO lotion is a corticosteroid indicated for the relief of the
inflammatory and pruritic manifestations of corticosteroid-
responsive dermatoses, in patients 18 years of age or older (1).
Limitations of Use:
Do not in the treatment of rosacea or perioral dermatitis.
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Lotion, 0.05% w/w (3)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (incidence > 1%) are skin atrophy,
telangiectasia, discomfort skin and skin dry (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 5/2020
Not for oral, ophthalmic, or intravaginal use. (2)
IMPEKLO lotion should be applied directly onto the affected skin areas
twice daily (not to exceed 10
actuations/application or 20 actuations/day) and rubbed in gently. (2)
Limit treatment to 2 weeks. For moderate to severe plaque psoriasis,
treatment may be extended for additional 2
weeks for localized lesions that have not sufficiently improved. (2)
Total dosage should not exceed 50 g per week (i.e., 20 actuations/day
for 7 days). (2)
Avoid use on the face, axillae or groin. (2)
Avoid use if atrophy is present at the treatment site. (2)
Avoid use with occlusive dressings unless directed by a physician. (2)
Discontinue when control is achieved. (2)
Clobetasol propionate is a highly potent topical corticosteroid that
has been shown to suppress the hypothalamic-
pituitary- adrenal (HPA) axis at the lowest doses tested. (5.1)
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