STAQUIS Ointment Ref.[28063] Active ingredients: Crisaborole

Posology

Adults

A layer of ointment is to be applied twice daily to affected areas.

The ointment should only be applied to affected skin areas up to a maximum of 40% BSA.

The ointment can be used on all skin areas except on the scalp. Use on the scalp has not been studied.

The ointment can be used twice daily for up to 4 weeks per treatment course. If any signs and/or symptoms persist, or new areas affected with atopic dermatitis appear, further treatment course(s) can be used as long as the application does not exceed 40% BSA (see section 5.1).

Use of the ointment should be discontinued if signs and/or symptoms on treated areas persist after 3 consecutive treatment courses of 4 weeks each or if the signs and/or symptoms worsen during treatment.

Paediatric population

For children and adolescents (2-17 years) the posology is the same as for adults. The safety and efficacy of Staquis in children less than 2 years of age has not been established. No data are available.

Special populations

Hepatic impairment

Clinical studies in subjects with hepatic impairment have not been conducted. However, dosage adjustment is not expected to be necessary in subjects with mild to moderate hepatic impairment.

Renal impairment

Clinical studies in subjects with renal impairment have not been conducted. However, dosage adjustment is not expected to be necessary in this patient population.

Elderly

Atopic dermatitis is uncommonly observed in patients aged 65 years and over. Clinical studies of Staquis did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects (see section 5.1). However, dosage adjustment is not expected to be necessary in this patient population.

Method of administration

The ointment is for cutaneous use only.

The ointment is not for ophthalmic, oral, or intravaginal use (see section 4.4).

Staquis has not been specifically studied under occlusion. However, clinical experience available for use of the ointment under occlusion (i.e., nappies or clothing) has not shown the necessity for any dosage adjustment.

Patients should be instructed to wash their hands after applying the ointment, unless it is their hands that are being treated. If someone else applies the ointment to the patient, they too should wash their hands after application.

Overdose following cutaneous administration is unlikely. If too much of the ointment has been applied, the excess can be wiped off.

In cases of accidental ophthalmic, oral mucosa, or intravaginal exposure, the ointment should be thoroughly wiped off and/or rinsed with water (see sections 4.2 and 4.4).

3 years.

After first opening the container: 1 year.

Do not store above 25ºC. Do not freeze.

Keep the tube tightly closed.

Multi-layered laminate tube with a high density polyethylene tube head with a peel seal, and a white polypropylene cap closure. The exterior layer of the tube consists of seven layers (low-density polyethylene, white high-density polyethylene, high-density polyethylene, low-density polyethylene, ethylene-acrylic acid, foil, and ethylene-acrylic acid). The inner lining consists of linear low-density polyethylene.

Tubes of 2.5 g, 30 g, 60 g, and 100 g. Six tubes per carton for the 2.5 g tubes. One tube per carton for the 30 g, 60 g, and 100 g tubes.

Not all tube sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.