IMIQUIMOD cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Imiquimod (UNII: P1QW714R7M) (Imiquimod - UNII:P1QW714R7M)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: - urethral, intravaginal, cervical, rectal, or intra-anal human papilloma viral disease. - actinic keratosis when treated with more than one 2-cycle treatment course in the same area. - patients with xeroderma pigmentosum. - superficial basal cell carcinoma. - immunosuppressed patients. None. The

Product summary:

Imiquimod Cream USP, 3.75%, is white to slightly yellow in color and supplied in single-use packets which contain 0.25 g of the cream available as: Imiquimod Cream USP, 3.75%, is also supplied as white plastic 30 mL pump bottle, equipped with a white cap. The 7.5 g pump delivers no fewer than 28 full actuations. Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Avoid freezing. Store imiquimod cream pumps upright.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IMIQUIMOD- IMIQUIMOD CREAM
TARO PHARMACEUTICALS U.S.A., 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, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
Cream: 3.75% packets or pump. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Intense local inflammatory reactions can occur (e.g., skin weeping,
erosion). Dosing interruption may be
required. (2, 5.1, 6)
Severe local inflammatory reactions of the female external genitalia
can lead to severe vulvar swelling.
Severe vulvar swelling can lead to urinary retention; dosing should be
interrupted or discontinued. (5.1)
Flu-like systemic signs and symptoms including fatigue, nausea, fever,
myalgias, arthralgias, and chills
can occur. Dosing interruption may be required. (2.1, 2.2, 5.2, 6)
Avoid concomitant use of imiquimod cream, 3.75% and any other
imiquimod cream because of
increased risk for adverse reactions. (5.4)
ADVERSE REACTIONS