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    Active Ingredient
    Crisaborole 2% W/W

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ointment

    2.5, 30, 60, 100 g

    not in the basket chart

    Dosage

    Should be applied twice daily to affected areas.
    The Drug is for topical use only and not for ophthalmic, oral, or intravaginal use.


    Indications

    Topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.


    Contra-Indications

    Known hypersensitivity to crisaborole or any component of the formulation.


    Special Precautions

    Hypersensitivity reactions, including contact urticaria, have occurred in patients treated with Crisaborole. Hypersensitivity should be suspected in the event of severe pruritus, swelling and erythema at the application site or at a distant site. If signs and symptoms of hypersensitivity occur, discontinue Crisaborole immediately and initiate appropriate therapy.
    The product contains butylated hydroxytoluene that may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
    The product contains Propylene glycol that may cause skin irritation.
    See prescribing information for full details.


    Side Effects

    Adverse Reaction Occurring in ≥1% of Subjects in Atopic Dermatitis Trials was
    Application site pain.
    Less common (<1%) adverse reactions in subjects treated with STAQUIS included contact urticaria.
    See prescribing information for full details.


    Drug interactions

    In vitro studies using human liver microsomes indicated that under the conditions of clinical use, crisaborole and metabolite 1 are not expected to inhibit cytochrome P450 (CYP) 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4.
    In vitro human liver microsomes studies for metabolite 2 showed that it did not
    inhibit activities of CYP2C19, 2D6, and 3A4; was a weak inhibitor of CYP1A2
    and 2B6; and a moderate inhibitor of CYP2C8 and 2C9. The most sensitive enzyme, CYP2C9, was further investigated in a clinical trial using warfarin as a
    CYP2C9 substrate. The results of this study showed no drug interaction potential.
    In vitro studies in human hepatocytes showed that under the conditions of clinical use, crisaborole and metabolites 1 and 2 are not expected to induce CYP enzymes.


    Pregnancy and Lactation

    Pregnancy: There is no available data with Crisaborole in pregnant women to inform the drug-associated risk for major birth defects and miscarriage.
    LactationThere is no information available on the presence of Crisaborole in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production after topical application of Crisaborole to women who are breastfeeding.
    See prescribing information for full details.


    Manufacturer
    DPT LABORATORIES LTD, USA
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