- 10 mg - Isotretinoin USP;
- 20 mg - Isotretinoin USP;
Without a Prescription
Severe Recalcitrant Nodular Acne
Isotretinoin is prescribed for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter
of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, means "many" as opposed to "few
or several" nodules. Because of significant adverse effects associated with its use, Isotretinoin should be reserved for patients
with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics . In addition, Isotretinoin is prescribed only for those female patients who are not pregnant, because Isotretinoin can cause severe birth defect.
Isotretinoin should be administered with a meal.
The recommended dosage range for Isotretinoin is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In
studies comparing 0.1, 0.5, and 1.0 mg/kg/day, it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages.
During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects - some of which
may be dose related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may
require dose adjustments up to 2.0 mg/kg/day, as tolerated. Failure to take Isotretinoin with food will significantly decrease absorption.
Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions.
The safety of once daily dosing with isotretinoin has not been established. Once daily dosing is not recommended.
If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of isotretinoin, even in low doses, has not been studied, and is not recommended. It is important that Isotretinoin be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of isotretinoin on bone loss is unknown.
Isotretinoin is contraindicated in patients who are hypersensitive to this medication or to any of its components. Isotretinoin should
not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule.
Pregnancy: Category X.
Blister Pack of 10 capsules.