Staquis Ointment 2% w/w

4.1. Therapeutic indications

STAQUIS is indicated for topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.2. Posology and method of administration

Posology

Adults

STAQUIS is to be applied as a thin layer twice daily to affected areas.

STAQUIS can be used on all skin areas, including the face, neck, and intertriginous areas. The use of STAQUIS on the scalp has not been studied.

STAQUIS ointment can be used continuously for up to 28 days per treatment course. The efficacy for continuous use beyond 28 days has not been studied in a controlled trial. Multiple treatment course over 48 weeks have been studied in an open-label extension trial.

Pediatric population

For children and adolescents (3 months to 17 years of age) the posology is the same as for adults. The safety and effectiveness of STAQUIS in pediatric patients below the age of 3 months have not been established.

Special populations

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

Clinical studies of STAQUIS did not include sufficient numbers of subjects 65 years of age and over to determine whether they respond differently from younger subjects. However, dosage adjustment is not expected to be necessary in this patient population.

Method of administration

STAQUIS is for topical use only and not for oral, ophthalmic, or intravaginal use.

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

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