What is isotretinoin, and how does it work (mechanism of action)?
- Isotretinoin is an oral drug used for the
treatment and prevention of severe
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.
What brand names are available for isotretinoin?
Claravis, Amnesteem, Absorica, Myorisan, Zenatane, Sotret
Is isotretinoin available as a generic drug?
Do I need a prescription for isotretinoin?
What are the uses for isotretinoin?
- 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
- Because isotretinoin causes
birth defects, isotretinoin is sold only under a
special program approved by the Food and Drug Administration called
Isotretinoin can only be prescribed by healthcare providers and dispensed by
pharmacies registered in iPLEDGE.
What are the side effects of isotretinoin?
The most common side effects of isotretinoin are:
- Dry nose,
- Nosebleeds (epistaxis),
- Cracks in the corners of the mouth (chilitis),
- Inflammation of the whites of the eyes.
Other side effects include:
- Increased cholesterol
- Increased triglycerides
- Increased glucose
- Ringing in the ears
- Abnormal periods
Serious side effects include:
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.
What is the dosage for isotretinoin?
- The recommended dose of isotretinoin is 0.5 to 2 mg per kg of body
- The daily dose usually is administered in two divided doses for
- Isotretinoin should be taken with food in order to improve its
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Which drugs or supplements interact with isotretinoin?
- 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
(Achromycin) and isotretinoin should not be given at the same
time since the combination has been associated with brain swelling. (See side
Is isotretinoin safe to take if I’m pregnant or breastfeeding?
- 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
must be used during therapy, and pregnancy should be avoided one month before,
during, and at least one month after stopping isotretinoin.
- It is not known whether isotretinoin is secreted in
milk, but because of its potentially serious side effects, it should not be used
by nursing mothers.
What else should I know about isotretinoin?
What preparations of isotretinoin are available?
capsules: 10, 20, 30 and 40 mg
How should I keep isotretinoin stored?
Store at room temperature 15-30 C (59-86 F) and protect from