ACCUTANE (Isotretinoin) | Drug Digest

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ACCUTANE (isotretinoin) is indicated for the treatment of:

  • Severe Nodular and/or Inflammatory Acne
  • Acne Conglobata
  • Recalcitrant Acne

Because of significant side effects associated with its use, ACCUTANE should be reserved for patients where the conditions listed above are unresponsive to conventional first line therapies.

ACCUTANE should only be prescribed by physicians knowledgeable in the use of retinoids systemically, who understand the risk of teratogenicity in females of child bearing age and who are experienced in counselling young adults for whom ACCUTANE is generally indicated.

A careful assessment of the patient’s mental state should be made, including whether or not they have a history of previous psychiatric illness.

It is strongly recommended that each ACCUTANE prescription be limited to a one-month supply in order to encourage patients to return for follow-up to monitor side-effects.


The pharmacist must ensure that:

Prescriptions of ACCUTANE for women of child-bearing potential should be limited to 30 days of treatment and continuation of treatment requires a new prescription. Ideally, pregnancy testing, issuing a prescription and dispensing of ACCUTANE should occur on the same day.

Dispensing of ACCUTANE should occur within a maximum of 7 days of the prescription.


ACCUTANE is contraindicated in the following conditions:

  1. Pregnant and breastfeeding women
  2. Hepatic and renal insufficiency
  3. Hypervitaminosis A
  4. Patients with excessively elevated blood lipid values
  5. Patients taking tetracyclines
  6. Patients who are sensitive to isotretinoin, or to any of the excipients. ACCUTANE capsules contain hydrogenated soybean oil, parabens, partially hydrogenated soybean oil, and soybean oil

Many of the side effects and adverse reactions seen or expected in patients receiving ACCUTANE are similar to those described in patients taking high doses of vitamin A.

Adverse reactions were generally reversible when therapy was discontinued; however, some have persisted after cessation of therapy.

ACCUTANE therapy induces changes in serum lipids in a significant number of treated subjects. Abnormalities of serum triglycerides, HDL and cholesterol were reversible upon cessation of therapy.

A rise in serum levels of liver enzymes may occur, especially with higher dosages. Although the changes have usually been within the normal range, and may return to baseline levels despite continued treatment

An elevated erythrocyte sedimentation rate may also occur (40% of patients).

Other less commonly reported laboratory abnormalities were: Elevated fasting blood sugar, elevated CPK, and hyperuricemia. Decreases in red blood cell parameters, decreases in white blood cell counts, elevated sedimentation rates, elevated platelet counts, thrombocytopenia and anemia. White blood cells in the urine, proteinuria, and red blood cells in the urine.


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Resource Person: Lobna Adi

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