isotretinoin, Sotret, Claravis, Amnesteem, (Accutane is no longer available)

Pharmacy Author:
Medical and Pharmacy Editor:

GENERIC NAME: isotretinoin

BRAND NAME: Sotret, Claravis, Amnesteem (Note: Accutane is no longer available)

DRUG CLASS AND MECHANISM: Isotretinoin is an oral drug used for the treatment and prevention of severe acne. Acne is caused by inflammation of the skin. It primarily affects teenagers, but it also affects adults. Severe acne causes permanent scarring of the skin. The inflammation is caused in part by an increased secretion of sebum (oily substance) from glands in the skin (sebaceous glands). The sebum provokes inflammation, and the inflammation resolves (heals) with the formation of a scar (keratinization). The exact mechanism of action of isotretinoin is not known; however, it may reduce acne by reducing the secretion of sebum. If less sebum is secreted it is likely that there will be less inflammation and keratinization. The Food and Drug Administration approved isotretinoin in May 1982.

PRESCRIPTION: yes

GENERIC AVAILABLE: yes

PREPARATIONS: capsules: 10, 20, 30 & 40 mg

STORAGE: Store at room temperature 15-30 C (59-86 F) and protect from light

PRESCRIBED FOR: Isotretinoin is used to treat severe acne that is resistant to more conservative treatments such as creams, drying agents, and topical or oral antibiotics. Complete remission or prolonged improvement is seen in many patients after one course of 15 to 20 weeks of isotretinoin. Because of its serious side effects, isotretinoin should be used only for severe resistant acne.

Because isotretinoin causes birth defects, isotretinoin is sold only under a special program approved by the Food and Drug Administration called iPLEDGE. Isotretinoin can only be prescribed by healthcare providers and dispensed by pharmacies registered in iPLEDGE.

DOSING: The recommended dose of isotretinoin is 0.5 to 2 mg per kg of body weight daily. The daily dose usually is administered in two divided doses for 15-20 weeks. Isotretinoin should be taken with food in order to improve its absorption.

DRUG INTERACTIONS: Isotretinoin is closely related to vitamin A. Therefore, the use of both vitamin A and isotretinoin at the same time may lead to vitamin A side effects.

Treatment with tetracycline (Achromycin) and isotretinoin should not be given at the same time since the combination has been associated with brain swelling. (See side effects below.)

PREGNANCY: Isotretinoin is harmful to the fetus and therefore should not be used during pregnancy. Women of childbearing age must have two negative pregnancy test results before therapy is started, and a pregnancy test must be conducted during each month of therapy. Two effective forms of birth control must be used during therapy, and pregnancy should be avoided one month before, during, and at least one month after stopping isotretinoin.

NURSING MOTHERS: It is not known whether isotretinoin is secreted in breast milk, but because of its potentially serious side effects, it should not be used by nursing mothers.

SIDE EFFECTS: The most common side effects of isotretinoin are dry skin, itching, dry nose, nosebleeds (epistaxis), cracks in the corners of the mouth (chilitis), dry mouth, and inflammation of the whites of the eyes. Joint aches also are common. Patients may develop an increase in blood cholesterol and triglycerides. Psychiatric problems such as depression, hallucinations and suicidal behavior have been reported. Rare side effects include skin infections, peeling, sun sensitivity, hearing impairment and hepatitis. Rarely, isotretinoin can cause brain swelling (pseudotumor cerebri or intracranial hypertension), which produces nausea, vomiting, headache, and changes in vision.

Erythema multiforme and severe skin reactions (for example, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been associated with isotretinoin use. These events may be serious and result in life-threatening events or death, hospitalization, or disability. Patients should be monitored closely for severe skin reactions, and isotretinoin discontinued if necessary.

Reference: FDA Prescribing Information


Last Editorial Review: 7/13/2010




Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Pill Finder Tool

Need help identifying pills and medications?
Use the pill identifier tool on RxList.


Back to Medications Index

STAY INFORMED

Get the Latest health and medical information delivered direct to your inbox!