Isotretinoin (Accutane): Acne Prescription Side Effects & Dosage

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.
  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?

Yes

Do I need a prescription for isotretinoin?

Yes

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
  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.

What are the side effects of isotretinoin?

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,

• 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.

Other side effects include:

• Joint
  aches
• Increased cholesterol
• Increased triglycerides
• Increased glucose
• Headache
• Ringing in the ears
• Insomnia
• Abnormal periods
• Edema

Serious side effects include:

• Skin infections
• Peeling
• Sun-sensitivity to drugs

• Hearing impairment

• 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.

What is the dosage for isotretinoin?

• 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.

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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
  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.)

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
  birth control
  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
  breast
  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
light