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    DEA Class; Rx

    Common Brand Names; Amnesteem, Claravis, Myorisan, Absorica, Zenatane, Absorica LD

    • Acne Agents, Systemic; 
    • Retinoid-like Agents

    Oral retinoid; synthetic 13-cis isomer of naturally occurring tretinoin
    Used primarily for severe, recalcitrant nodular acne
    Due to teratogenicity potential, only available through isotretinoin iPLEDGE REMs program

    Indicated for the treatment of severe recalcitrant cystic acne vulgaris (nodular acne) in patients with multiple inflammatory nodules with a diameter of at least 5 mm.

    For the treatment of keratinization disorders including keratosis follicularis, lamellar ichthyosis, and pityriasis rubra pilaris.
    For the treatment of juvenile chronic myelogenous leukemia (CML).
    For the treatment of newly diagnosed, high-risk neuroblastoma following autologous bone marrow transplantation.

    Indicated for severe nodular acne in nonpregnant patients who are unresponsive to conventional therapy, including systemic antibiotics


    Hypersensitivity to isotretinoin or vitamin A

    • Cheilitis (90%)
    • Xerosis
    • Xerostomia
    • Dry nose
    • Epistaxis
    • Pruritus
    • Conjunctivitis (including blepharoconjunctivitis) (40%)
    • Irritation (40%)
    • Increased erythrocyte sedimentation rates (40%)
    • Thinning of hair (which has persisted in rare instances)
    • Palmoplantar desquamation
    • Skin fragility
    • Skin infections (eg, paronychial infections)
    • Rash (including erythema, seborrhea, eczema), photosensitivity
    • Hypertriglyceridemia (25%)
    • Bone or joint pain
    • Generalized muscle aches
    • Arthralgia
    • Decreased HDLs (15%)
    • Increased LFTs (15%)
    • Increased CPK (12-24%)
    • Decreased hemoglobin concentration and hematocrit
    • Decreased erythrocyte and leukocyte counts
    • Increased platelet count

    Significant adverse effects are associated with isotretinoin use

    Neutropenia and agranulocytosis (rare) reported; discontinue if white cell counts decrease significantly

    Embryofetal toxicity; major congenital malformations, spontaneous abortions, and premature births documented (see Black Box Warnings)

    Do not donate blood during therapy and for 1 month after discontinuing treatment, because of embryofetal toxicity risk

    Restricted distribution program (iPLEDGE), a risk management program to minimize pregnancy exposure, has been implemented (see Black Box Warnings)

    Microdosed, progesterone-only preparations (‘minipills’) are an inadequate method of contraception during treatment

    Pseudotumor cerebri reported; some reports involved concomitant tetracycline use; concomitant treatment with tetracyclines should be avoided; early signs and symptoms of intracranial hypertension include papilledema, headache, nausea and vomiting, and visual disturbances; screen patients with these symptoms for papilledema and, if present, discontinue therapy immediately and refer patient to a neurologist for further diagnosis and care

    Serious skin reactions reported (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis); discontinue therapy if skin reaction occurs

    Acute pancreatitis reported with either elevated or normal serum triglyceride levels, including rare instances of fatal hemorrhagic pancreatitis; discontinue if unable to control hypertriglyceridemia; discontinue therapy if pancreatitis occurs

    Increased triglycerides and total cholesterol levels reported; whereas, decreased HDL-cholesterol reported

    Hearing impairment reported and may persist after discontinuing therapy; patients who experience tinnitus or hearing impairment should discontinue treatment and be referred for specialized care for further evaluation

    Hepatitis may occur; mild to moderate liver enzymes elevations also reported; some normalized with dosage reduction or continued administration of drug’ if normalization does not readily occur or if hepatitis is suspected during treatment, therapy should be discontinued

    Associated with inflammatory bowel disease (including regional ileitis); discontinue immediately if abdominal pain, rectal bleeding, or severe diarrhea occurs

    Negative effect on bone mineral density reported; caution with childhood osteoporosis, osteomalacia, chronic corticosteroid use, or anorexia nervosa

    Musculoskeletal symptoms, including arthralgia and rhabdomyolysis may occur; consider discontinuing therapy if any significant abnormality found

    Skeletal hyperostosis observed in clinical trial for keratinization disorders

    Avoid prolonged exposure to uv rays or sunlight

    Premature epiphyseal closure reported spontaneously with normal doses

    Therapy is contraindicated during pregnancy; it can cause fetal harm when administered to a pregnant patient

    There are no data on either animal or human milk, effects on breastfed infant, or on milk production


    2 mg/kg/day PO (all formulations EXCEPT Absorica LD) for cystic acne; 1.6 mg/kg/day PO (Absorica LD) for cystic acne.


    2 mg/kg/day PO (all formulations EXCEPT Absorica LD) for cystic acne; 1.6 mg/kg/day PO (Absorica LD) for cystic acne.


    1 mg/kg/day PO (all formulations EXCEPT Absorica LD) for cystic acne; 0.8 mg/kg/day PO (Absorica LD) for cystic acne.


    12 years: 1 mg/kg/day PO (all formulations EXCEPT Absorica LD) for cystic acne; 0.8 mg/kg/day PO (Absorica LD) for cystic acne.
    younger than 12 years: Safety and efficacy have not been established.


    Safety and efficacy have not been established.


    Safety and efficacy have not been established.



    • 10mg (Absorica, Amnesteem, Claravis, Myorisan, Zenatane)
    • 20mg (Absorica, Amnesteem, Claravis, Myorisan, Zenatane)
    • 25mg (Absorica)
    • 30mg (Absorica, Claravis, Zenatane)
    • 35mg (Absorica)
    • 40mg (Absorica, Amnesteem, Claravis, Myorisan, Zenatane)

    capsule, micronized (Absorica LD)

    • 8mg
    • 16mg
    • 20mg
    • 24mg
    • 28mg
    • 32mg