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|Isotretinoin

Isotretinoin

Isotretinoin is used for:

Treating severe acne in patients who do not respond to other medicines. It may also be used for other conditions as determined by your doctor.

Isotretinoin is a retinoid. It works by reducing skin oil production, changing the characteristics of the skin oil, and preventing abnormal hardening of the skin.

Do NOT use Isotretinoin if:

• you are allergic to any ingredient in Isotretinoin
• you are pregnant, planning to become pregnant, or become pregnant while taking Isotretinoin
• you are breast-feeding
• you do not understand the possible risks of Isotretinoin or you are not able to follow all of the instructions in the medication guide
• you are taking tetracycline antibiotics or vitamin A-type medicines (eg, etretinate, vitamin A)

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

Before using Isotretinoin :

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

• 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 Isotretinoin . Tell your health care provider if you are taking any other medicines, especially any of the following:

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Isotretinoin 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.

How to use Isotretinoin :

Use Isotretinoin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Isotretinoin comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Isotretinoin refilled.
• Take Isotretinoin 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 Isotretinoin regularly. Taking your medicine at the same time each day will help you to remember.
• Isotretinoin can only be dispensed through a special program. You must sign a consent form stating that you will follow your doctor"s instructions before you can take Isotretinoin . This will be necessary each time you refill your prescription.
• You will get no more than a 30-day supply of Isotretinoin at a time to be sure you check in with your doctor each month to discuss side effects.
• If you miss a dose of Isotretinoin , 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 Isotretinoin .

Important safety information:

• Isotretinoin may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Isotretinoin . Using Isotretinoin alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• A sudden decrease in night vision may occur while you are taking Isotretinoin . 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 Isotretinoin and for 1 month after stopping taking Isotretinoin .
• Do not drink alcohol while taking Isotretinoin .
• 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 Isotretinoin and for at least 6 months after you stop. Isotretinoin can increase your chance of scarring from these procedures.
• Isotretinoin may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Isotretinoin . Use a sunscreen or wear protective clothing if you must be outside for a prolonged period.
• Some patients, while taking Isotretinoin or soon after stopping it, have become depressed or developed serious mental problems. Stop using Isotretinoin 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 Isotretinoin .
• 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 Isotretinoin .
• Certain birth control pills (progestin-only pills, "mini pills") that do not contain estrogen may not be as effective while you are taking Isotretinoin .
• You should not take the herbal supplement St. John"s wort because it makes birth control pills less effective.
• Diabetes patients - Isotretinoin may affect your blood sugar. Check blood sugar levels closely and ask your health care provider before adjusting 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 required to monitor your progress or to check for side effects. Be sure to keep all lab and doctor appointments.
• Isotretinoin is not recommended for CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not become pregnant. Isotretinoin 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 Isotretinoin and call your health care provider. Do not breast-feed while taking Isotretinoin and for 1 month after stopping Isotretinoin . Isotretinoin may pass through your milk and harm the baby.

Possible side effects of Isotretinoin :

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.

Severe allergic reactions (rash; hives; 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.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include dizziness; facial flushing; headache; loss of balance; stomach pain; vomiting.

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

General information:

• If you have any questions about Isotretinoin , please talk with your doctor, pharmacist, or other health care provider.
• Isotretinoin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about this medicine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.