• Do not take this medicine if you are pregnant. Your healthcare provider will talk about the risk before starting you on this medicine. Use two effective forms of birth control 1 month before starting this medicine and for 1 month after treatment ends. Pregnancy tests will be done to show that you are NOT pregnant before starting and while taking this medicine. If you become pregnant while taking this medicine, call healthcare provider right away. If you understand all the information and can follow the directions you must sign a patient information/consent form. Do not sign the form and do not take the medicine if you do not understand everything on the form.
• This medicine is only for patients enrolled in the iPLEDGE program.
• This medicine does not mix well with many medicines. Serious reactions may occur. Check all medicines with healthcare provider.
• Please read the medication guide.
• If you have an allergy to isotretinoin, vitamin A, or any other part of this medicine.
• Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.
• If you are of childbearing age, but are not using two forms of birth control or if you are planning to become pregnant during your treatment or within 6 months after treatment has ended.
• If you are pregnant or may be pregnant.
• If you are breast-feeding.
• Isotretinoin decreases gland size in the skin.
• It injures cancer cells causing their death.
• You will get a month's supply of this medicine at a time.
• Take this medicine with food.
• Swallow capsule whole. Do not chew, break, or crush.
• Take this medicine with a full glass of water.
• Follow diet plan and exercise program as recommended by healthcare provider.
• Take a missed dose as soon as possible.
• If it is almost time for the next dose, skip the missed dose and return to your regular schedule.
• Do not take a double dose or extra doses.
• Do not change dose or stop medicine. Talk with healthcare provider.
• Store at room temperature.
• Protect from light.
• Protect from moisture. Do not store in a bathroom or kitchen.
Created: 2006-10-13 13:23:24.0
Modified: 2010-03-17 13:57:12.0
Lexi-PALS TM © (1977)-(2007) Lexi-Comp, Inc. All rights reserved.
• Change in condition being treated. Is it better, worse, or about the same?
• Check blood work regularly. Talk with healthcare provider.
• If you are a female of childbearing age, take two pregnancy tests before starting this medicine and monthly while using this medicine.
• Bone density test.
• Dry mouth may cause an increase in cavities. Take good care of your teeth. See a dentist regularly.
• Follow up with healthcare provider.
• If you have a life-threatening allergy, wear allergy identification at all times.
• Do not share your medicine with others and do not take anyone else's medicine.
• Keep all medicine out of the reach of children and pets.
• Most medicines can be thrown away in household trash after mixing with coffee grounds or kitty litter and sealing in a plastic bag.
• Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).
• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or in Canada to Health Canada's Canada Vigilance Program at 1-866-234-2345.
• Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.
• Read the package insert for more details.
• This medicine is used to treat acne.
• This medicine is used to treat some cancers in children.
• Do not donate blood while using this medicine and for 1 month after stopping.
• If you have diabetes, talk with healthcare provider.
• If you have an eating disorder, talk with healthcare provider.
• If you have mental illness, talk with healthcare provider.
• If you have osteoporosis, talk with healthcare provider.
• Check medicines with healthcare provider. This medicine may not mix well with other medicines.
• Avoid other sources of vitamin A.
• Limit alcohol intake (includes wine, beer, and liquor).
• You can get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen; wear protective clothing and eyewear.
• Avoid cosmetic skin procedures for at least 6 months after stopping medicine.
• If you are a female of childbearing age, talk with healthcare provider about pregnancy risks when taking this medicine. You will also get a written paper talking about the risks.
• You must have two pregnancy tests that confirm you are not pregnant. You need a pregnancy test every month in order to get more medicine.
• Use two forms of birth control that you can trust 1 month before treatment begins, during treatment, and for at least 1 month after treatment ends.
• Do not use birth control pills that have a low dose of progesterone. They may not work well.
• Do not breast-feed for 1 month after treatment ends.
• Serious mental problems such as depression.
• Belly pain.
• Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help.
• Dry mouth. Frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help.
• Mouth irritation. Frequent mouth care with a soft toothbrush or cotton swabs and rinsing mouth may help.
• Nasal irritation.
• Skin irritation.
• Eye irritation.
• Decreased night vision. Use caution when driving or doing other tasks that require clear vision. Keep work area well lit.
• Sunburn.
• Weakened bones.
• If you suspect an overdose, call your local poison control center or emergency department immediately.
• Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat.
• Signs or symptoms of depression, suicidal thoughts, nervousness, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life.
• Violent actions or thoughts of violence.
• Severe dizziness or passing out.
• Severe headache.
• Severe nausea or vomiting.
• Severe belly pain or bloody diarrhea.
• Severe skin irritation.
• Difficulty swallowing.
• Seizures.
• Change in hearing.
• Increased trips to the bathroom, increased thirst, or weight loss.
• Not able to eat.
• Severe muscle pain or weakness.
• Sudden change in vision, eye pain, or irritation.
• Dark urine or yellow skin or eyes.
• Any rash.
• For females, if you are pregnant or may be pregnant.
• No improvement in condition or feeling worse.
