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.

INN (International Name):

Imiquimod

Composition:

Imiquimod 50 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Imiquimod Cream USP, 5% is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults. Imiquimod Cream USP, 5% is indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years or older. Imiquimod Cream USP, 5% 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 USP, 5% 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 an

Product summary:

Imiquimod Cream USP, 5%, is supplied in single-use packets which contain 250 mg of the cream: Box of 24 single-use packets – NDC 51672-4145-6 Discard unused packet. Store at 4° to 25°C (39° to 77°F) Avoid freezing. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IMIQUIMOD- IMIQUIMOD CREAM
TARO PHARMACEUTICALS U.S.A., INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IMIQUIMOD CREAM, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IMIQUIMOD CREAM,
USP.
IMIQUIMOD CREAM
FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Imiquimod Cream USP, 5% is indicated for the topical treatment of:
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)
Limitations of Use: Efficacy was not demonstrated for molluscum
contagiosum in children aged 2-12 (1.4, 8.4)
DOSAGE AND ADMINISTRATION
Imiquimod Cream USP, 5% is not for oral, ophthalmic, or intravaginal
use. (2)
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)
DOSAGE FORMS AND STRENGTHS
Imiquimod Cream USP, 5%, is supplied in single-use packets (24 per
box), each of which contains 250 mg of the cream,
equivalent to 12.5 mg of imiquimod. (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.
Flu-like systemic signs and symptoms including malaise, fever, nausea,
myalgias and rigors may occur. Dosing
interruption may be required (2, 5.2, 6).
Avoid exposure to sunlight and sunlamps. Wear sunscreen daily (5.3).
Safety and efficacy have not been established for repeat courses of
treatment to the same area for AK (5.4).
Treatment of urethral, intra-vaginal, cervical, rectal or intra-anal
viral disease is not recommended (5.6).
Safety