Isotretinoin

ایزوترتینوئین (راکوتان)

⚠ Unverified

🧴 DermatologicalsOral retinoid

Market / country: 🇺🇸 USA

Accutane (US) · Roaccutane (GB)

🧮 Dose calculator

Severe recalcitrant nodular acne · Regimen source: FDA Zenatane · 2.1

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🛡️ Safety & information

Contraindications

Warnings

Formulations

👥 Special populations

  • 🤰 PregnancyContraindicated

    Label: contraindicated in pregnancy. FDA Zenatane · 4

    “Zenatane is contraindicated in: Pregnancy [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )].”
  • 🤱 BreastfeedingDangerous / avoid

    Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Zenatane · 8.2

    “Because of the potential for serious adverse reactions in nursing infants from isotretinoin, advise patients that breastfeeding is not recommended during treatment with Zenatane, and for at least 8 days after the last dose of Zenatane.”
  • 👶 ChildrenUse with caution

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

    “The safety and effectiveness of Zenatane for the treatment of severe recalcitrant nodular acne have been established in non-pregnant pediatric patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater who are unresponsive to conventional treatment, including systemic …”
  • 👴 Older adultsUse with caution

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

    “Clinical studies of Zenatane did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.”
  • ⚥ Females & males of reproductive potentialUse with caution

    Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Zenatane · 8.3

    “… of Zenatane treatment, AND (2) after the patient has used their chosen pregnancy prevention methods (i.e., two forms of contraception or committed to abstinence) for at least 30 days.”

📚 Reference status for this drug

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