Isotretinoin

DRUG INFORMATION

  ADULT
    - ( 2.2 , 5.3 ) Recommended dosage for (2.2 ): o ABSORICA is 0.5 to 1 mg/kg/day
      given in two divided doses without regard to meals for 15 to 20 weeks ( 2.1 ) o
      ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses without regard to
      meals for 15 to 20 weeks ( 2.1 ) Adult patients with very severe disease
      (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of ABSORICA (1.6
      mg/kg/day of ABSORICA LD) in divided doses.
      Source: US FDA label for isotretinoin (Absorica LD), section 'dosage and
      administration', retrieved 2026-08-29
    - The recommended dosage of: ABSORICA is 0.5 to 1 mg/kg/day given in two divided
      doses with or without meals for 15 to 20 weeks (see Table 1).
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for isotretinoin (Absorica
      LD), section 'dosage and administration', retrieved 2026-08-29
    - ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses with or without
      meals for 15 to 20 weeks (see Table 2).
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for isotretinoin (Absorica
      LD), section 'dosage and administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of ABSORICA/ABSORICA LD 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 therapy, including systemic
      antibiotics .
      Source: US FDA label for isotretinoin (Absorica LD), section 'pediatric use',
      retrieved 2026-08-29
    - Evaluations Prior To Prescribing and Use of ABSORICA/ABSORICA LD: In patients who
      can get pregnant, only prescribe ABSORICA/ABSORICA LD after verification and
      documentation that they are not pregnant. See the Full Prescribing Information for
      the detailed requirements prior to prescribing ABSORICA/ABSORICA LD ( 2.1 , 8.3 )
      Complete the following laboratory tests in all patients: fasting lipid profile and
      liver function tests.
      Source: US FDA label for isotretinoin (Absorica LD), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.2 , 5.3 ) Recommended dosage for (2.2 ): o ABSORICA is 0.5 to 1 mg/kg/day
      given in two divided doses without regard to meals for 15 to 20 weeks ( 2.1 ) o
      ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses without regard to
      meals for 15 to 20 weeks ( 2.1 ) Adult patients with very severe disease
      (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of ABSORICA (1.6
      mg/kg/day of ABSORICA LD) in divided doses.
      Source: US FDA label for isotretinoin (Absorica LD), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for isotretinoin (Absorica LD),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for isotretinoin (Absorica LD),
      retrieved 2026-08-29

  PREGNANCY   [ AVOID ]
    The label says not to use it. Read the quote below before deciding.
    - Pregnancy Exposure Registry There is a pregnancy exposure registry that documents
      pregnancies in patients exposed to isotretinoin during pregnancy.
      Source: US FDA label for isotretinoin (Absorica LD), section 'pregnancy',
      retrieved 2026-08-29
    - Report any suspected fetal exposure during or 1 month after ABSORICA/ABSORICA LD
      treatment immediately to the FDA via the MedWatch telephone number 1-800-FDA-1088
      and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the internet (
      www.ipledgeprogram.com) .
      Source: US FDA label for isotretinoin (Absorica LD), section 'pregnancy',
      retrieved 2026-08-29
    - Risk Summary ABSORICA/ABSORICA LD are contraindicated during pregnancy because
      isotretinoin can cause fetal harm when administered to a pregnant patient.
      Source: US FDA label for isotretinoin (Absorica LD), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - All patients who can become pregnant must comply with the iPLEDGE program
      requirements [see Warnings and Precautions (5.2) ].
      Source: US FDA label for isotretinoin (Absorica LD), section 'nursing mothers',
      retrieved 2026-08-29
    - Pregnancy Testing All patients who can get pregnant must comply with the iPLEDGE
      REMS requirements [see Warnings and Precautions ( 5.2 )] .
      Source: US FDA label for isotretinoin (Absorica LD), section 'nursing mothers',
      retrieved 2026-08-29
    - Pregnancy Testing In patients who can get pregnant, pregnancy testing is required
      prior to, during, and after ABSORICA/ABSORICA LD treatment.
      Source: US FDA label for isotretinoin (Absorica LD), section 'nursing mothers',
      retrieved 2026-08-29