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by Pfizer Ltd
Crisaborole 20MG Cream
₹1,781.25
20MG · 1 TUBE(s) OF 20GM
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Crisaborole is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. Crisaborole is a phosphodiesterase 4 inhibitor indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.
Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.
Hypersensitivity reactions: If signs and symptoms of hypersensitivity occur, discontinue Crisaborole immediately and initiate appropriate therapy. Hypersensitivity Reactions 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.
Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.
The most common adverse reaction occurring in ≥1% in subjects is application site pain. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two double-blind, vehicle-controlled clinical trials (Trial 1 and Trial 2), 1012 subjects 2 to 79 years of age with mild to moderate atopic dermatitis were treated with Crisaborole twice daily for 4 weeks. The adverse reaction reported by ≥1% of Crisaborole-treated subjects is listed in Table 1. Table 1: Adverse Reaction Occurring in ≥1% of Subjects in Atopic Dermatitis Trials through Week 4 Adverse Reaction Crisaborole Twice Daily N=1012 n (%) Vehicle Twice Daily N=499 n (%) Application site pain Refers to skin sensations such as burning or stinging. 45 6 Less common (<1%) adverse reactions in subjects treated with Crisaborole included contact urticaria. In one double-blind, vehicle-controlled trial including an initial open-label period (Trial 3), 497 subjects 3 months of age and older with mild to moderate atopic dermatitis received Crisaborole twice daily for up to 8 weeks. This was followed by a double-blind period, during which 135 subjects out of 270 randomized subjects received Crisaborole and 135 subjects received vehicle once daily for 52 weeks or until they developed a flare. The adverse reactions observed in the open-label period were similar to the known safety profile of twice daily treatment with Crisaborole. The adverse reactions observed with once daily treatment were similar to vehicle. Postmarketing Experience The following adverse reactions have been identified during postapproval use of Crisaborole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Skin and Subcutaneous: allergic contact dermatitis
Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.
