ACCUTANE

Drug Name: ACCUTANE

ACCUTANE DESCRIPTION:
ISOTRETINOIN - ORAL (eye-so-tret-ih-NO-in)

COMMON ACCUTANE BRAND NAME(S):
Accutane

ACCUTANE SIDE EFFECTS:
May cause dry lips and mouth, minor swelling of the eyelids or lips, crusty skin, nosebleeds, indigestion, headache, or thinning of hair. If these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if you have any of these unlikely but serious side effects: mental/mood changes (e.g., depression, and in rare cases, thoughts of suicide); changes in vision; stomach pain; rectal bleeding; severe diarrhea; tingling sensation of the skin; sun sensitivity ("sunburn" effect). Acne may worsen during the first few days of therapy. In the unlikely event you have an allergic reaction to this drug, seek medical attention immediately. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

HOW TO USE ACCUTANE:
ACCUTANE: Read and complete the Informed Consent form with your doctor. Also be sure to get a Medication Guide from your pharmacist, and then read it carefully. If you have any questions regarding isotretinoin, consult your doctor or pharmacist before taking the medication. Swallow capsules whole. Do not crush or chew them. It may take a month or two before the full benefits of this medication are noticed.

ACCUTANE WARNING:
Women who are pregnant must not use isotretinoin. Women must avoid becoming pregnant while taking ACCUTANE. Birth defects, spontaneous abortion and premature births have occurred while using ACCUTANE during pregnancy. Two effective forms of birth control must be used for 1 month before starting ACCUTANE, during the use of ACCUTANE, and for 1 month after stopping isotretinoin use. If you are late in having your period, contact your doctor immediately. Only carefully selected patients may use ACCUTANE. Consult your doctor or pharmacist for more information about the risks and benefits of using ACCUTANE.

ACCUTANE USES:
ACCUTANE is used to treat severe cystic acne.

ACCUTANE PRECAUTIONS:
Before using ACCUTANE, tell your doctor your medical history, including: diabetes, family history of high blood fats (triglycerides), psychiatric disorders, any allergies. Do not donate blood while you take isotretinoin and for at least one month after you stop taking it. Avoid exposure to the sun and sunlamps. Use a sunscreen and wear protective clothing when you are exposed to direct sunlight. Isotretinoin can affect your night vision. Be cautious when driving or operating any machinery after dark. If you wear contact lenses, you may not tolerate them as well as usual while using ACCUTANE. Avoid the use of alcohol while taking ACCUTANE. ACCUTANE should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. ACCUTANE should not be used by those who may become pregnant during treatment. Consult your doctor. It is not known if ACCUTANE is excreted into breast milk. Breast-feeding is not recommended while using ACCUTANE. Use two reliable forms of birth control together, starting one month before treatment, during and at least one month after stopping the drug. Semen may pose a risk to a pregnant woman if the male is using ACCUTANE. Consult your doctor. This statement is based on information for a similar drug, acitretin.

ACCUTANE DRUG INTERACTIONS:
Tell your doctor of all prescription and nonprescription drugs you may use, especially of: vitamin A-type drugs (including etretinate and vitamin A itself), minocycline, tetracycline. Do not start or stop any medicine without doctor or pharmacist approval.

ACCUTANE OVERDOSE:
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include vomiting, stomach pain, facial flushing, headache, dizziness, and loss of balance.

ACCUTANE NOTES:
Do not allow anyone else to take ACCUTANE.

MISSED ACCUTANE DOSE:
If you miss a dose, take as soon as remembered; do not take if it is almost time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

ACCUTANE STORAGE:
Store at room temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight. Do not store in the bathroom.