IMIQUIMOD- imiquimod cream

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

IMIQUIMOD (UNII: P1QW714R7M) (IMIQUIMOD - UNII:P1QW714R7M)

Disponible des:

Strides Shasun Limited

Designació comuna internacional (DCI):

IMIQUIMOD

Composición:

IMIQUIMOD 50 mg in 1 g

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Imiquimod cream, 5%, is supplied as: Store at 4 - 25°C (39 - 77°F). Do not freeze. Keep out of reach of children.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

IMIQUIMOD- IMIQUIMOD CREAM
STRIDES SHASUN LIMITED
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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