Isotretinoin
ایزوترتینوئین (راکوتان)
🧴 DermatologicalsOral retinoid
Market / country: 🇺🇸 USA
Accutane (US) · Roaccutane (GB)
🧮 Dose calculator
Severe recalcitrant nodular acne · Regimen source: FDA Zenatane · 2.1
- • Adults with very severe disease up to 2 mg/kg/day. Only within the iPLEDGE programme (US). FDA Zenatane · 2.1FDA Zenatane · 5.2
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Pregnancy — severe birth defects. Two forms of contraception and pregnancy tests required. FDA Zenatane · 4FDA Zenatane · Boxed Warning
- ⛔ Hypersensitivity to isotretinoin or vitamin A. FDA Zenatane · 4
Warnings
- • Boxed warning: embryo-fetal toxicity; contraindicated in pregnancy. FDA Zenatane · Boxed Warning
Formulations
- 10 mg capsule — capsule 🇺🇸 USA FDA Zenatane · 3
- 20 mg capsule — capsule 🇺🇸 USA FDA Zenatane · 3
- 40 mg capsule — capsule 🇺🇸 USA FDA Zenatane · 3
👥 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 links
- FDA (approval record)ANDA202099
- DailyMed (FDA label)FDA Zenatane
- MedlinePlus (NIH)Isotretinoin
- WHO ATC/DDDD10BA01
- Darooyab (Iran)Isotretinoin
🇮🇷 Registered in Iran Darooyab · G-2284/Isotretinoin
Dosage forms with Iranian generic codes, per Darooyab.
- 06184 · ISOTRETINOIN 0.05% GEL · ژل ایزوترتینوئین ۰٫۰۵ درصد
- 12056 · ISOTRETINOIN 10MG CAP · کپسول ایزوترتینوئین ۱۰ میلیگرم
- 20711 · ISOTRETINOIN 16MG CAP · کپسول ایزوترتینوئین ۱۶ میلیگرم
- 00720 · ISOTRETINOIN 20MG CAP · کپسول ایزوترتینوئین ۲۰ میلیگرم
- 53031 · ISOTRETINOIN CAPSULE, LIQUID FILLED ORAL 10 mg · کپسول ایزوترتینوئین پرشده ۱۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Zenatane · 3FDA Zenatane · 2.1FDA Zenatane · 5.2FDA Zenatane · 4FDA Zenatane · Boxed WarningFDA Zenatane · 8.2FDA Zenatane · 8.4FDA Zenatane · 8.5FDA Zenatane · 8.3FDA Zenatane · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-2284/Isotretinoin
- Clinical review⚠ Unverified