Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
Imiquimod (UNII: P1QW714R7M) (Imiquimod - UNII:P1QW714R7M)
Taro Pharmaceuticals U.S.A., Inc.
Imiquimod
Imiquimod 50 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Belgenin tamamını okuyun