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ACCUTANE
ISOTRETINOIN - ORAL

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ISOTRETINOIN - ORAL

(eye-so-tret-ih-NO-in)

COMMON BRAND NAME(S): Accutane, Amnesteem, Claravis, Sotret

WARNING: Women who are pregnant must not use isotretinoin. Women must avoid becoming pregnant while taking this medication. Birth defects (sometimes fatal), spontaneous miscarriages, and premature births have occurred while using this drug during pregnancy. Females - Two effective forms of birth control (or complete avoidance of sexual intercourse) must be used together for 1 month before starting this drug, during the use of this drug, and for 1 month after stopping isotretinoin use. You must also have monthly pregnancy avoidance counseling from your doctor. Do not use "minipills" for birth control (non-estrogen-containing pills), since they may not work as well with isotretinoin. If you are late in having your period, or if you have sexual intercourse at any time without using two forms of effective birth control, contact your doctor immediately (also see the Precautions section). Only carefully selected patients may use this medication. Consult your doctor or pharmacist for more information about the risks and benefits of using this medication.

Uses

This medication is used to treat severe cystic acne.

How To Use

Read and complete the material in the Pregnancy Prevention Program (PPP) booklet provided by your doctor, which includes the Informed Consent document and the "Be Smart Be Safe Be Sure" educational materials. Watch the video provided. Also be sure to get a Medication Guide from your pharmacist, and then read it carefully. Your prescription must have a yellow "Qualification Sticker" attached to it in order for the pharmacy to dispense a 30 day supply without refills. This sticker indicates you have been properly educated about isotretinoin. The preceding requirements apply in the United States. If you live in Canada or other countries, consult your doctor and pharmacist for your specific regulations. 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. Isotretinoin is generally taken twice daily with food, or as directed for 15-20 weeks. Food helps increase absorption of this medication into your bloodstream. Take this with a full glass of water, and do not lie down for 30 minutes after taking it. It may take a month or two before the full benefits of this medication are noticed, and acne may worsen during the first few days of therapy. A second course of treatment may be started after two months off the drug if severe acne reoccurs. The manufacturer does not recommend long-term use of isotretinoin. Do not exceed the recommended dose.

Side Effects

May cause dry lips and mouth, minor swelling of the eyelids or lips, crusty skin, nosebleeds, indigestion, 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, aggressive or violent behavior, and in rare cases, thoughts of suicide), tingling sensation of the skin, sun sensitivity ("sunburn" effect), back, joint, or muscle pain, fever or other signs of infection. Isotretinoin may infrequently cause pancreatic disease (pancreatitis), which rarely can be fatal. Stop taking this medication and tell your doctor immediately if you develop: severe stomach pain, severe or persistent nausea/vomiting. Stop taking this medication and tell your doctor immediately if you develop these unlikely but serious side effects: severe headache, vision changes, ringing in the ears or hearing loss, dark urine or yellowing eyes and skin, severe diarrhea, rectal bleeding. 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.

Precautions

Before using this drug, tell your doctor or pharmacist your medical history, including: diabetes, family or personal history of high blood fats (triglycerides), family or personal history of psychiatric disorders, liver disease, pancreatitis, bone loss conditions (e.g., osteoporosis/osteomalacia, decreased bone density), 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 this medication. Do not have cosmetic procedures to smooth your skin (e.g., waxing, laser, or dermabrasion) during and for six months after isotretinoin therapy. Skin scarring may occur. Avoid the use of alcohol while taking this medication, as it may worsen drug side effects (e.g., pancreatitis risk). Limited information suggests isotretinoin may cause some bone loss effects. Therefore, playing impact sports (e.g., football) may result in bone problems, including an increased risk of fractures. Limited information also suggests isotretinoin may stop normal growth in some children (epiphyseal plate closure).Consult your doctor for more details. You must have two negative pregnancy tests before starting this medication. You must have a monthly pregnancy test during treatment with isotretinoin. If the test is positive, you must stop taking this medication and consult your doctor immediately. This drug must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This drug should not be used by those who may become pregnant during treatment. Consult your doctor (see also Warning section). It is not known if this drug passes into breast milk. Due to the potential risks to an infant, do not breast-feed while using this medication. Use two reliable forms of birth control together, starting one month before treatment, during and at least one month after stopping the drug.

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), tetracyclines (e.g., minocycline), drugs which cause bone loss (e.g., phenytoin, corticosteroids such as prednisone). Avoid use of St John's wort or any other product which may decrease the effectiveness of birth control pills. Consult your doctor or pharmacist for details (see also Warning section). Do not start or stop any medicine without doctor or pharmacist approval.

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.

Notes

Do not allow anyone else to take this medication. It can cause birth defects and other serious health problems. Laboratory and/or medical tests should be performed (e.g., pregnancy, lipid/cholesterol, liver function, white blood count) to monitor for side effects.

Missed 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.

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.