Azelaic acid 15% gel

🧮 Dose calculator

Rosacea · Regimen source: FDA Azelaic acid 15% · 2

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👥 Special populations

• 🤰 PregnancyNo specific problem stated

  Label: minimal systemic absorption; fetal exposure not expected. FDA Azelaic acid 15% · 8.1

  “Risk Summary Azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [ see Clinical Pharmacology (12.3) ].”

• 🤱 BreastfeedingNo specific problem stated

  Label: infant exposure not expected. FDA Azelaic acid 15% · 8.2

  “… elevant amounts to cause a change in azelaic acid concentration in milk or milk production; therefore, breastfeeding is not expected to result in exposure of the infant to Azelaic Acid Gel, 15%.”

• 👶 ChildrenUse with caution

  The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Azelaic acid 15% · 8.4

  “The safety and effectiveness of Azelaic Acid Gel, 15% have not been established in pediatric patients.”

• 👴 Older adultsUse with caution

  Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Azelaic acid 15% · 8.5

  “Clinical studies of Azelaic Acid Gel, 15% did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.”

• ⚥ Females & males of reproductive potentialNo data

  The source for this drug has no section for this group.