Isotretinoindrug info
isotretinoin 20 MG Oral Capsule [Amnesteem]
What it is used for
Amnesteem is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Amnesteem is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.
Limitations of Use: If a second course of Amnesteem treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment. Amnesteem is a retinoid indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Amnesteem is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.
Limitations of Use: If a second course of Amnesteem treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 15, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Chemically, isotretinoin is 13- cis -retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. Isotretinoin has high lipophilicity.
The structural formula is: Amnesteem contains 10 mg, 20 mg, 30 mg or 40 mg of isotretinoin (a retinoid) for oral administration. In addition to the active ingredient, isotretinoin, each 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsule contains the following inactive ingredients: butylhydroxyanisole, gelatin, glycerol, hydrogenated partially vegetable oil, medium chain triglycerides, sodium edetate, soy lecithin, soybean oil and yellow beeswax. The 10 mg, 20 mg, and 40 mg capsules also contain red iron oxide in glycerin, and the 20 mg, 30 mg and 40 mg capsules also contain titanium dioxide in glycerin and yellow iron oxide in glycerin. The black imprinting ink contains ammonium hydroxide, black iron oxide, polyethylene glycol, propylene glycol and polyvinyl acetate phthalate. Meets USP Dissolution Test 4. Isotretinoin Structural Formula
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 15, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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