Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
IMIQUIMOD (UNII: P1QW714R7M) (IMIQUIMOD - UNII:P1QW714R7M)
Strides Shasun Limited
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 old 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 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 animal multiple of human expos
Imiquimod cream, 5%, is supplied as: Store at 4 - 25°C (39 - 77°F). Do not freeze. Keep out of reach of children.
Abbreviated New Drug Application
IMIQUIMOD- IMIQUIMOD CREAM STRIDES SHASUN LIMITED ---------- FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 ACTINIC KERATOSIS Imiquimod cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults. 1.2 EXTERNAL GENITAL WARTS Imiquimod cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years old or older. 1.3 LIMITATIONS OF USE 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)]. 1.4 UNEVALUATED POPULATIONS 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. 2 DOSAGE AND ADMINISTRATION The application frequency for Imiquimod Cream is different for each indication. Imiquimod is not for oral, ophthalmic, or intravaginal use. 2.1 ACTINIC KERATOSIS Imiquimod cream should be applied 2 times per week for a full 16 weeks to a defined treatment area on the face or scalp (but not both concurrently). The treatment area is defined as one contiguous area of approximately 25 cm (e.g., 5 cm x 5 cm) on the face (e.g. forehead or one cheek) or on the scalp. Examples of 2 times per week application schedules are Monday and Thursday, or Tuesday and Friday. Imiquimod cream should be applied to the entire treatment area and rubbed in until the cream is no longer visible. No more than one packet of imiquimod cream should be applied to the contiguous treatment area at each application. Imiquimod cream should be applied prior to normal sleeping hours and left on the skin for approximately 8 hours, after which time the cream should be removed by washing the Lees het volledige document