IMIQUIMOD cream

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (Међународно име):

imiquimod

Састав:

imiquimod 50 mg in 1 g

Пут администрације:

TOPICAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Imiquimod Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults. Imiquimod Cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years old 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) ]. The safety and efficacy of Imiquimod Cream in immunosuppressed patients have not been established. Imiquimod Cream should be used with caution in patients with pre-existing autoimmune conditions. The efficacy and safety of Imiquimod Cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum. None. Pregnancy Category C: Note: The Maximum Recommended Human Dose (MRHD) was set at 2 packets per treatment of Imiquimod Cream (25 mg imiquimod) for the animal multiple of human ex

Резиме производа:

Imiquimod Cream 5%, is supplied in single-use packets which contain 250 mg of the cream. Available as: box of 24 packets NDC 0168-0432-24. Store at 4° to 25°C (39° to 77°F). Avoid freezing. Keep out of reach of children.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

IMIQUIMOD- IMIQUIMOD CREAM
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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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 5%
FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Imiquimod Cream is indicated for the topical treatment of:
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Limitations of Use: Efficacy was not demonstrated for molluscum
contagiosum in children aged 2 to 12 (1.4, 8.4)
DOSAGE AND ADMINISTRATION
Imiquimod Cream is not for oral, ophthalmic, or intravaginal use. (2)
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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 (incidence >28%) are application site
reactions or local skin reactions: itching, burning,
erythema, flaking/scaling/dryness, scabbing/crusting, edema,
induration, excoriation, erosion, ulceration. Other reported
reactions (≥1 %) include fatigue, fever, and headache (6.1, 6.3)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FOUGERA PHARMACEUTICALS
INC. AT 1-800-645-9833 OR
FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 7/2015
Clinically typical, nonhyperkeratotic, nonhypertrophic actinic
keratoses (AK) on the face or scalp in
immunocompetent adults (1.1)
External genital and perianal warts/condyloma acuminata in patients 12
years old or older (1.3)
Actinic keratosis: 2 times per week for a full 16 weeks (2.1)
External genital warts (EGW): 3 times per week until total clearance
or a maximum of 16 weeks (2.3)
Imiquimod Cream 5% is supplied in a box containing 24 single-use
packets, each of which contains 250 mg of the
cream, equivalent to 12.5 mg of imiquimod. (3)
None (4)
Intense local inflammatory reactions can occur (e.g., skin weeping,
erosion). Dosing interruption may be required (2,
5.1, 6)
Severe local inflammator