isotretinoin.

INDICATIONS

Accutane is given to patients for treating severe acne that do not respond to other medicines. Accutane is a retinoid. It works by reducing skin oil production, changing the characteristics of the skin oil, and preventing abnormal hardening of the skin.

INSTRUCTIONS

Use Accutane as directed by your doctor.

• Take Accutane by mouth with food.
• Swallow the capsule with a full glass of water or other liquid. Do not break, crush, chew, or suck on the capsule before swallowing. This will help prevent the medication inside the capsule from irritating your throat.
• For best results, take Accutane regularly. Taking Accutane at the same time each day will help you remember to take it.
• If you miss a dose of Accutane, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Accutane.

STORAGE

Store Accutane at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Accutane out of the reach of children and away from pets.

Do NOT use Accutane if:

• you are allergic to any ingredient in Accutane
• you are pregnant, planning to become pregnant, or become pregnant while taking Accutane
• you are breast-feeding
• you are taking tetracycline antibiotics or vitamin A-type medicines (eg, etretinate, vitamin A).

Contact your doctor or health care provider if any of these apply to you.

Some medical conditions may interact with Accutane. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are woman and unable to use 2 effective forms of birth control or avoid sexual intercourse
• if you have diabetes, a family history of diabetes, high blood cholesterol or triglyceride levels, psychiatric disorders, suicidal thoughts, liver disease, pancreatitis, a bone loss condition (eg, osteoporosis), decreased bone density, an eating disorder, severe diarrhea, rectal bleeding, hearing problems, ringing in the ears, or stomach pain.

Some medicines may interact with Accutane. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Tetracyclines because of the risk of increasing pressure in the brain
• St. John’s wort because of risk of failure of hormonal contraceptives (eg, birth control pills)
• Vitamin A-type medicines (eg, etretinate, vitamin A) because they may increase the risk of Accutane’s side effects
• Corticosteroids (eg, prednisone) or phenytoin because the risk of their side effects may be increased by Accutane
• Progestin-only birth control (eg, “mini-pill”) because its effectiveness may be decreased by Accutane.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Accutane may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

• Accutane may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Accutane with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• A sudden decrease in night vision may occur while you are taking Accutane. Use caution when driving at night and avoid driving at night if you experience decreased night vision.
• If you wear contact lenses, you may have difficulty wearing them during and after therapy.
• Do not give blood while taking Accutane and for 1 month after stopping taking Accutane.
• Do not drink alcohol while taking Accutane.
• Worsening of acne may occur during the first part of therapy. This does not suggest failure or a need to stop the medicine.
• To prevent cracking of lips, use a lip moisturizer or balm.
• Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are taking Accutane and for at least 6 months after you stop. Accutane can increase your chance of scarring from these procedures.
• Accutane may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Accutane. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Some patients, while taking Accutane or soon after stopping it, have become depressed or developed serious mental problems. Stop using Accutane and tell your health care provider right away if you have any of these symptoms: feeling sad or having crying spells; feeling anxious; becoming more irritable, angry, or aggressive than usual; losing pleasure or interest in social or sports activities; sleeping too much or too little; changes in weight or appetite; feeling like you have no energy; having trouble concentrating; having thoughts about taking your own life or hurting yourself (suicidal thoughts).
• Tell your health care provider if you plan vigorous physical activity (sports) during treatment with Accutane.
• Sexually active women of childbearing age must use 2 effective forms of birth control at least 1 month before starting therapy, during therapy, and for 1 month after stopping the medicine. Your health care provider should conduct pregnancy tests on a monthly basis while you are taking Accutane.
• Certain birth control pills (progestin-only pills, “mini pills”) that do not contain estrogen may not be as effective while you are taking Accutane.
• You should not take the herbal supplement St. John’s wort because it makes birth control pills less effective.
• Diabetes patients – Accutane may affect your blood sugar. Check blood sugar levels carefully. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including pregnancy tests, cholesterol and lipid levels, liver function, blood sugar levels, and white blood cell counts, may be performed while you use Accutane. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Accutane should not be used in children younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• Pregnancy and breast-feeding: Do not become pregnant. Accutane can cause serious birth defects, miscarriage, early birth, or death of the fetus. If you have sex at any time without using 2 forms of effective birth control, become pregnant, think you may be pregnant, or miss your menstrual period, stop using Accutane and call your health care provider. Do not breast-feed while taking Accutane and for 1 month after stopping Accutane. Accutane may pass through your milk and harm the baby.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Abnormal hair growth; abnormal skin sensations; bleeding and redness or swelling of the gums;changes in menstrual flow; chapped lips; decreased tolerance to contact lenses; dizziness; dry eyes and mouth; dry nose that may lead to nosebleeds; dry or peeling skin; fatigue; flushing; general body discomfort; hair thinning; headache; itching; lack of energy; nervousness; respiratory tract infection; sleeplessness; sweating; temporary worsening of acne; voice changes.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre, aggressive, or violent behavior; bowel pain; chest pain or pounding in the chest; dark urine; depression; difficult or painful swallowing; difficulty moving; excessive thirst or urination; fainting; fast heartbeat; fever; fractured or weak bones; hearing problems or ringing in the ears; increased pressure in the brain (pressure in the eye; nausea; vision changes; vomiting); joint or back pain; leg swelling; muscle weakness with or without pain; nausea; new or worsening heartburn; rectal bleeding; red patches or bruises on the legs; shortness of breath; seizures; severe birth defects; severe diarrhea; severe headache; skin infection; slurred speech; stomach pain or tenderness; stroke; stunted growth in children; sun sensitivity; swelling of the pancreas (fever; increased heartbeat; nausea; stomach tenderness; vomiting); swollen glands; thoughts of suicide; tightness in the lungs; vision changes; vomiting; weakness; yellowing of the skin or eyes.

Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling under the skin, swelling of the lips, and loss of balance or coordination.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

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