Isotretinoin

What it is and how it works

Mechanism of Action The exact mechanism of action of isotretinoin capsules in 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 who are unresponsive to conventional therapy, including systemic antibiotics is unknown. isotretinoin, a retinoid, inhibits sebaceous gland function and keratinization. Clinical improvement in nodular acne patients occurs in association with a reduction in sebum secretion. The decrease in sebum secretion is temporary and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation.

Indications

Isotretinoin capsules 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, isotretinoin capsules 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 isotretinoin capsules 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-week to 20-week course of treatment . Isotretinoin capsules 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.

Dosage and administration (summary)

Evaluations Prior to Prescribing and Use of Isotretinoin Capsules: In patients who can get pregnant, only prescribe isotretinoin capsules after verification and documentation that they are not pregnant. See the Full Prescribing Information for the detailed requirements prior to prescribing isotretinoin capsules ( 2.1 , 8.3 ) Complete the following laboratory tests in all patients: fasting lipid profile and liver function tests. Recommended dosage is 0.5 mg/kg/day to 1 mg/kg/day given in two divided doses with food for 15 weeks to 20 weeks Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day in two divided doses with food.

Contraindications

Isotretinoin capsules is contraindicated in: Pregnancy . Patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have occurred) . Isotretinoin capsules are contraindicated in: Pregnancy ( 4 , 8.1 ) Patients with hypersensitivity to isotretinoin (or Vitamin A) or any of its components ( 4 , 5.13 )

Warnings and precautions

Psychiatric Disorders (depression, psychosis, suicidal thoughts and behavior, and aggressive and/or violent behaviors): Prior to and during treatment assess for these conditions; stop if these conditions occur on treatment Intracranial Hypertension (Pseudotumor Cerebri) : Avoid concomitant use with tetracyclines ( 5.4 , 7.2 ) Serious Skin Reactions : Monitor for Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious skin reactions and discontinue treatment if they occur Acute Pancreatitis : If pancreatitis symptoms occur, discontinue treatment Lipid Abnormalities (…

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that documents pregnancies in patients exposed to isotretinoin during pregnancy. Report any suspected fetal exposure during or 1 month after isotretinoin capsules treatment immediately to the FDA via the MedWatch telephone number 1-800-FDA-1088 and also to the iPLEDGE preg…

Storage and supply

Isotretinoin Capsules USP, 10 mg are reddish brown-colored, oval-shaped, soft gelatin capsules imprinted '1022' with black ink containing orange oily dispersion and are supplied as follows: NDC 70710-1022-8 in cartons of 30 (3 x 10) unit-dose capsules (Unit-dose blisters are child-resistant) NDC 70710-1022-4 in cartons of 100 (10 x 10) unit-dose ca…

Source: Isotretinoin (Isotretinoin) — US FDA prescribing information, 2026-07-08, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.