Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
imiquimod (UNII: P1QW714R7M) (imiquimod - UNII:P1QW714R7M)
Teva Pharmaceuticals USA, Inc.
TOPICAL
PRESCRIPTION DRUG
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: None. Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Imiquimod Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The animal multiples of human exposure calculations were based on daily dose co
Imiquimod Cream, 3.75% is white to faintly yellow in color and supplied as white plastic 30 mL pump bottles, equipped with a white cap. The 7.5 g pump delivers no fewer than 28 full actuations. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid freezing. Store Imiquimod Cream pumps upright.
New Drug Application Authorized Generic
IMIQUIMOD- IMIQUIMOD CREAM TEVA PHARMACEUTICALS USA, INC. ---------- 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 • • • DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS Most common adverse reactions (>4%) are local skin reactions (erythema, edema, erosion/ulceration, exudate, scabbing/crusting), headache, application site pain, application site irritation, application site pruritus, fatigue, influenza-like illness, and nausea. (6.1, 6.2) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAUSCH HEALTH US, LLC AT 1-800-321- 4576 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 9/2020 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) 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) Cream: 3.75% pump. (3) None. (4) Intense local inflammatory reactions can occur (e.g., skin weeping, erosion). Dosing interruption may be Lees het volledige document