Uses of ISOtretinoin:

• It is used to treat pimples (acne).
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take ISOtretinoin?

• If you are allergic to ISOtretinoin (systemic); any part of ISOtretinoin (systemic); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are able to get pregnant and are not using 2 kinds of birth control.
• If you are planning to get pregnant within 1 month before treatment, during treatment, or within 1 month after your last dose.
• If you are breast-feeding. Do not breast-feed for some time after getting ISOtretinoin (systemic). Talk with your doctor to see how long to avoid breast-feeding after getting ISOtretinoin (systemic).
• If you are taking any of these drugs: Demeclocycline, doxycycline, minocycline, tetracycline, a product that has vitamin A in it, a product that is like vitamin A, or St. John's wort.

This is not a list of all drugs or health problems that interact with ISOtretinoin (systemic).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ISOtretinoin (systemic) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take ISOtretinoin?

• Tell all of your health care providers that you take ISOtretinoin (systemic). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how ISOtretinoin (systemic) affects you.
• Lowered night eyesight may happen. This may be sudden. This may clear up after you stop the drug but sometimes it may not go away.
• Use care when driving at night or doing other tasks in lowered lighting.
• Do not donate blood while using ISOtretinoin (systemic) and for 1 month after stopping.
• Treatment with ISOtretinoin (systemic) may lead to higher cholesterol and triglycerides. The effect of these changes on heart health is not known. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• High blood sugar has happened with ISOtretinoin (systemic). This includes diabetes that is new or worse.
• Check your blood sugar as you have been told by your doctor.
• Talk with your doctor before you drink alcohol.
• Avoid cosmetic skin treatments like waxing, dermabrasion, or laser treatments during treatment and for at least 6 months after the last dose. The chance of scarring may be increased.
• This medicine may cause weak bones and tendon problems in some people. The chance of bone problems like broken bones may be raised in people who play certain sports. Talk with the doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Low white blood cell counts have happened with ISOtretinoin (systemic). This may lead to a higher chance of getting an infection. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
• Raised pressure in the brain has happened with ISOtretinoin (systemic). This can cause long lasting loss of eyesight and sometimes death. Call your doctor right away if you have a bad headache, dizziness, upset stomach or throwing up, or seizures. Call your doctor right away if you have weakness on 1 side of the body, trouble speaking or thinking, change in balance, or change in eyesight.
• Severe bowel problems may happen with ISOtretinoin (systemic) (inflammatory bowel disease). Tell your doctor right away if you have signs like severe diarrhea, stomach pain, bleeding from the rectum, or rectal pain. This may clear up after you stop the drug but sometimes it may not go away.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Do not use progestin-only birth control pills (minipills). They may not work well. Talk with your doctor.
• If you have sex without using 2 kinds of birth control that you can trust, if you think you may be pregnant, or if you miss your period, call your doctor right away.

How is this medicine (ISOtretinoin) best taken?

Use ISOtretinoin (systemic) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take ISOtretinoin (systemic).
• Swallow whole. Do not chew, break, or crush.
• Take with a full glass of water.
• Keep taking ISOtretinoin (systemic) as you have been told by your doctor or other health care provider, even if you feel well.
• You will get a month's supply of ISOtretinoin (systemic) at a time.
• Skin may look worse before it looks better.
• If your weight changes, talk with your doctor. The dose of ISOtretinoin (systemic) may need to be changed.
• If you are allergic to tartrazine, talk with your doctor. Some products have tartrazine.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs or symptoms of depression, suicidal thoughts, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of esophagus problems like chest pain, trouble swallowing, or new or worse heartburn.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Behavior problems.
• Eye pain.
• Back, bone, joint, or muscle pain.
• Muscle weakness.
• Any unexplained bruising or bleeding.
• Feeling very tired or weak.
• Not able to pass urine or change in how much urine is passed.
• Swelling.
• Swollen gland.
• Fast or abnormal heartbeat.
• Hearing problems like change in hearing or ringing in the ears may happen. This may go away after stopping the drug but sometimes it may not.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Very bad and sometimes deadly pancreas problems (pancreatitis) have happened with ISOtretinoin (systemic). Call your doctor right away if you have very bad stomach pain, very bad back pain, or very upset stomach or throwing up.

What are some other side effects of ISOtretinoin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dry mouth, skin, or eyes.
• Dry lips.
• Nose irritation.
• Change in how contact lenses feel in the eyes.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out ISOtretinoin?

• Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time ISOtretinoin (systemic) is refilled. If you have any questions about ISOtretinoin (systemic), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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