Dermatology Book

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IsotretinoinAka: Accutane

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  1. Indications
    1. Acne Vulgaris (Refractory)
  2. Dosing
    1. Course: 15-20 weeks
    2. Facial Acne
      1. Lower dosing: 1 mg/kg divided bid)
    3. Truncal Acne
      1. Higher dosing: 2 mg/kg divided bid
      2. Consider repeat 4 month course after 2 month rest
        1. Indicated for severe, refractory truncal acne
  3. Adverse Effects
    1. Very Teratogenic (even 1 pill)
      1. Needs two forms Contraception while taking
      2. Counsel extensively before use
    2. Cheilitis (90%)
    3. Dry or chapped skin (90%)
    4. Dry nose and eyes (80%)
    5. Elevated serum Triglycerides (25%)
    6. Arthralgias and Myalgias (15%)
    7. Elevated liver transaminases (15%)
    8. Hair shedding (10%)
    9. Peeling of palms and soles (5%)
    10. Intracranial Hypertension
    11. Night blindness
  4. Monitoring
    1. Serum testing baseline and every 2-4 weeks
      1. Liver transaminases
      2. Triglycerides
    2. System Manage Accutane Related Teratogenicity (SMART)
      1. Only SMART registered members may prescribe Accutane
      2. Pregnancy prevention program per Roche and FDA
      3. Presciption limited to 30 days
      4. Mandates 2 forms of Birth Control
        1. Both forms started >1 month before Accutane
        2. Continue Contraception for 1 month after stopping
        3. One form must be primary Contraception
          1. Tubal Ligation or partner's Vasectomy
          2. Intrauterine Device
          3. Oral Contraceptive
          4. Depo Provera, Norplant or similar
      5. Mandates urine pregnancy timing
        1. Initial urine Pregnancy Test
        2. Urine Pregnancy Test immediately before Accutane
          1. First five days of Menstrual Cycle
          2. 11 days after last intercourse if Amenorrhea
        3. Urine Pregnancy Test monthly at time of refill
      6. Prescriptions must carry qualification sticker
        1. Yellow Accutane Qualification Sticker
        2. Requires provider completing best practices booklet
        3. Stickers available via: 1-800-93-ROCHE
  5. Other recommendations
    1. No supplemental Vitamin A intake while on Accutane
    2. Use Moisturizers, Lip balms, Artificial tears
  6. Resources: Patient Education
    1. Information from your Family Doctor
      1. http://www.familydoctor.org/handouts/631.html

Isotretinoin (C0022265)

Definition (MSH)A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.
Definition (CSP)a topical dermatologic agent that is used in the treatment of acne vulgaris and several other skin diseases.
Definition (NCI)A drug that belongs to the family of drugs called retinoids. It is used in the treatment of acne and psoriasis and is being studied in cancer prevention. Also called isotretinoin.
Definition (NCI)A naturally-occurring retinoic acid with potential antineoplastic activity and teratogenic properties. Isotretinoin binds to and activates nuclear retinoic acid receptors (RAR), thereby regulating cell proliferation and differentiation. This agent also exhibits immunomodulatory and anti-inflammatory responses and inhibits ornithine decarboxylase, thereby decreasing polyamine synthesis and keratinization. (NCI04)
Definition (PDQ)A naturally-occurring retinoic acid with potential antineoplastic activity and teratogenic properties. 13-cis retinoic acid binds to and activates nuclear retinoic acid receptors (RAR), thereby regulating cell proliferation and differentiation. This agent also exhibits immunomodulatory and anti-inflammatory responses and inhibits ornithine decarboxylase, thereby decreasing polyamine synthesis and keratinization. Check for "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=42657&idtype=1" active clinical trials or "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=42657&idtype=1&closed=1" closed clinical trials using this agent. ("http://nciterms.nci.nih.gov:80/NCIBrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C603" NCI Thesaurus)
ConceptsOrganic Chemical (T109) , Pharmacologic Substance (T121)
English13 cis retinoate, 13 cis retinoic acid, Isotretinoin, ISOTRETINOIN PREPARATION, Isotretinoinum, Neovitamin A Acid, RETINOIC ACID A CIS 013
Spanishisotretinoína, isotretinoina
CreditsDerived from the NIH UMLS (Unified Medical Language System)


Accutane (C0699581)

ConceptsOrganic Chemical (T109) , Pharmacologic Substance (T121)
EnglishAccutane
CreditsDerived from the NIH UMLS (Unified Medical Language System)



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