Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
IMIQUIMOD (UNII: P1QW714R7M) (IMIQUIMOD - UNII:P1QW714R7M)
Physicians Total Care, Inc.
IMIQUIMOD
IMIQUIMOD 50 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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 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. 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 exposure ratios presented in t
Imiquimod cream, 5%, is supplied in single-use packets which contain 250 mg of the cream. Available as: box of 24 packets NDC 54868-6179-0 . Store at 4° - 25°C (39° - 77°F) Avoid freezing. Keep out of reach of children.
Abbreviated New Drug Application
IMIQUIMOD - IMIQUIMOD CREAM PHYSICIANS TOTAL CARE, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION FO UG E RA IMIQUIMOD CREAM 5% R ONLY [I MI WEH MOD] 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 ONLY INITIAL U.S. APPROVAL 1997 INDICATIONS AND USAGE Imiquimod Cream 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 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 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) 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) 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 and efficacy in immunosuppressed patients have not been established (1.5) ADVERSE REACTIONS Most common adverse reactions (incidence >28%) are application site reactions or local skin r Läs hela dokumentet