IMIQUIMOD cream

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

imiquimod (UNII: P1QW714R7M) (imiquimod - UNII:P1QW714R7M)

Dostupné s:

Oceanside Pharmacueticals

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Imiquimod Cream, 3.75% is indicated for the topical treatment of clinically typical visible or palpable, actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults. Imiquimod Cream, 3.75% is indicated for the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older. Imiquimod cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see Use in Specific Populations (8.4)] . Treatment with Imiquimod Cream has not been studied for prevention or transmission of human papillomavirus (HPV). The safety and efficacy of Imiquimod Cream have not been established in the treatment of: None. Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Imiquimod Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The animal multiples of human exposure calculations were based on daily dose co

Přehled produktů:

Imiquimod Cream, 3.75% is white to faintly yellow in color and supplied as white plastic 30 mL pump bottles, equipped with a white cap. The 7.5 g pump delivers no fewer than 28 full actuations. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid freezing. Store Imiquimod Cream pumps upright.

Stav Autorizace:

New Drug Application

Charakteristika produktu

IMIQUIMOD- IMIQUIMOD CREAM
OCEANSIDE PHARMACUETICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IMIQUIMOD CREAM SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IMIQUIMOD CREAM.
IMIQUIMOD CREAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (>4%) are local skin reactions
(erythema, edema, erosion/ulceration,
exudate, scabbing/crusting), headache, application site pain,
application site irritation, application site
pruritus, fatigue, influenza-like illness, and nausea. (6.1, 6.2)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT OCEANSIDE
PHARMACEUTICALS AT 1-800-
321-4576 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 6/2020
Imiquimod Cream, 3.75% is indicated for the topical treatment of
clinically typical, visible or palpable
actinic keratoses (AK) of the full face or balding scalp in
immunocompetent adults. (1.1)
Imiquimod Cream, 3.75% is also indicated for the topical treatment of
external genital and perianal
warts/condyloma acuminata (EGW) in patients 12 years or older. (1.2)
Limitations of Use: Efficacy of imiquimod cream was not demonstrated
for molluscum contagiosum in
children 2 to 12 years of age. (1.3, 8.4)
For topical use only; not for oral, ophthalmic, intra-anal, or
intravaginal use. (2)
Actinic Keratosis: Once daily to the skin of the affected area (either
the entire face or balding scalp)
for two 2-week treatment cycles separated by a 2-week no-treatment
period. (2.1)
External Genital Warts: Once daily to the external genital/perianal
warts until total clearance or up to 8
weeks. (2.2)
Cream: 3.75% pump. (3)
None. (4)
Intense local inflammatory reactions can occur (e.g., skin weeping,
erosion). Dosing interruption may
be