MEDICATION GUIDE
Isotretinoin ( eye'' soe tret' i noyn) capsules, USP for oral use
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Read the Medication Guide that comes with isotretinoin capsules before you start taking it and each time you get a prescription. There may be new information. This information does not take the place of talking with your health care provider about your medical condition or your treatment.
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What is the most important information I should know about isotretinoin capsules?
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Isotretinoin capsules can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Patients who are pregnant or who plan to become pregnant must not take isotretinoin capsules.
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Because of the risk of birth defects, isotretinoin capsules are only available through a special program called the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS).
- Your healthcare provider must be enrolled in the iPLEDGE REMS for you to be prescribed isotretinoin capsules.
- Before you start treatment with isotretinoin capsules, you must enroll in the iPLEDGE REMS.
- You must understand and agree to do everything required in the iPLEDGE REMS.
Patients must not get pregnant:
- for 1 month before starting isotretinoin capsules
- during treatment with isotretinoin capsules
- for 1 month after stopping isotretinoin capsules
If you get pregnant during treatment with isotretinoin capsules, stop taking it right away and tell your health care provider. Health care providers and patients should report all cases of pregnancy that happen during treatment or 1 month after stopping treatment to:
o FDA MedWatch at 1-800-FDA-1088, and
o the iPLEDGE Pregnancy Registry at 1-866-495-0654 or www.ipledgeprogram.com
If you have any questions about the iPLEDGE REMS, ask your healthcare provider, or go to www.ipledgeprogram.com or call 1-866-495-0654.
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Serious mental health problems , including:
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depression
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psychosis (seeing or hearing things that are not real)
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suicide. Some patients taking isotretinoin capsules have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. Some people have ended their own lives.
Stop taking isotretinoin capsules and tell your health care provider right away if you or a family member notices that you get any of the following signs and symptoms of depression or psychosis:
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o start to feel sad or have crying spells
| o have trouble concentrating
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o lose interest in activities you once enjoyed
| o withdraw from your friends or family
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o sleep too much or have trouble sleeping
| o feel like you have no energy
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o become more irritable, angry, or aggressive than o have feelings of worthlessness or guilt
o usual (for example, temper outbursts, thoughts of o start having thoughts about hurting yourself or
o violence)
| o have feelings of worthlessness or guilt
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o have a change in your appetite or body weight
| o start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
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o suicide attempts
| o start acting on dangerous impulses
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| o start seeing or hearing things that are not real
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Your health care provider may tell you to see a mental health care professional if you have any of these symptoms.
See " What are the possible side effects of isotretinoin capsules?" for more information about side effects.
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What are isotretinoin capsules?
Isotretinoin capsules is a prescription medicine used in patients 12 years of age and older, who are not pregnant, for the treatment of severe acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. Isotretinoin capsules can cause serious side effects (see "What is the most important information I should know about isotretinoin capsules?" ).
Isotretinoin capsules can only be:
- prescribed by health care providers that are enrolled in the iPLEDGE REMS
- dispensed by a pharmacy that is enrolled in the iPLEDGE REMS
- given to patients who are enrolled in the iPLEDGE REMS and agree to do everything required in the program.
It is not known if isotretinoin capsules is safe and effective in children less than 12 years of age.
Do not take isotretinoin capsules if you:
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are pregnant, plan to become pregnant, or become pregnant during isotretinoin capsules treatment. Isotretinoin Capsules can cause life-threatening birth defects. See "What is the most important information I should know about isotretinoin capsules?"
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are allergic to isotretinoin, vitamin A, or any of the ingredients in isotretinoin capsules. See the end of this Medication Guide for a complete list of ingredients in isotretinoin capsules.
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Before taking isotretinoin capsules, tell your health care provider if you or a family member has any of the following health conditions:
- mental health problems
- asthma
- liver problems
- diabetes
- heart disease
- increase blood fat levels (cholesterol and triglycerides)
- bone loss (osteoporosis), weak bones or any other bone problems
- an eating problem called anorexia nervosa (where people eat too little)
- bowel or digestion problems
Tell your health care provider if you are pregnant or breastfeeding. Do not breastfeed during treatment or for at least 8 days after the last dose of isotretinoin capsules.
Tell your health care provider about all of the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. Isotretinoin capsules and certain other medicines can affect each other, sometimes causing serious side effects.
Do not take the following medicines during treatment with isotretinoin capsules:
- vitamin A supplements
- tetracycline antibiotics
Know the medicines you take. Keep a list of them to show to your health care provider and pharmacist. Do not take any new medicine without talking with your healthcare provider.
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You will not be prescribed isotretinoin capsules if you cannot agree to or follow all the instructions of the iPLEDGE REMS.
- You will get no more than a 30-day supply of isotretinoin capsules at a time. This is to make sure you are following the isotretinoin capsules iPLEDGE REMS.
How should I take isotretinoin capsules?
You must take isotretinoin capsules exactly as prescribed. You must also follow all the instructions of the iPLEDGE REMS.
Before prescribing isotretinoin capsules, your health care provider will:
o explain the iPLEDGE REMS to you
o have you sign the Patient Informed Consent form (for all patients). Patients who can get pregnant must also sign another consent form.
o get pregnancy tests to make sure you are not pregnant before you start isotretinoin capsules. You will take 2 pregnancy tests at least 30 days apart before starting treatment.
o The amount of isotretinoin capsules you take has been specially chosen for you. It is based on your body weight and may change during treatment.
o Take isotretinoin capsules two times a day with food. Swallow isotretinoin capsules whole with a full glass of liquid. Do not split, crush, chew, or suck on the capsules. Isotretinoin capsules can hurt the tube that connects your mouth to your stomach (esophagus) if not swallowed whole.
- Your health care provider will tell you how long you will receive treatment with isotretinoin capsules.
- If you miss a dose, just skip that dose. Do not take two doses at the same time.
- If you take too much isotretinoin capsules, call your health care provider or Poison Help line at 1-800-222-1222 right away.
- Your acne may get worse when you first start taking isotretinoin capsules. This should last only a short while. Talk with your health care provider if this is a concern for you. Your acne may continue to improve after treatment.
- You must return to your health care provider as directed to make sure you don't have signs of serious side effects. Your health care provider may do blood tests to check for serious side effects from isotretinoin capsules and may stop treatment if you get certain side effects.
- Patients who can get pregnant will get a pregnancy test before each prescription is given during treatment with isotretinoin capsules, when you stop treatment, and 1 month after you stop treatment.
- You must get your prescription within seven days of receiving your pregnancy test.
- Patients who can get pregnant must:
o Talk about birth control options with your health care provider or go for a free visit to talk about birth control with another health care provider or family planning expert. Your health care provider can arrange this free visit, which will be paid for by the company that makes isotretinoin capsules.
o Use your chosen pregnancy prevention methods. You must choose two separate forms of birth control at the same time or commit to not having sexual contact with a partner that could result in pregnancy for at least 1 month before treatment, during treatment, and for 1 month after treatment with isotretinoin capsules.
o Access the iPLEDGE REMS system to answer questions about the REMS requirements and enter your two chosen pregnancy prevention methods (two separate forms of birth control or commitment to not having sexual contact with a partner that could result in pregnancy). To access the iPLEDGE REMS system, go to www.ipledgeprogram.com or call 1-866-495-0654.
If you have sex at any time without using two forms of birth control 1 month before, during, or 1 month after treatment, get pregnant, or miss your expected period, stop taking isotretinoin capsules and call your health care provider right away.
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What should I avoid while taking isotretinoin capsules?
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Do not give blood during treatment with Isotretinoin capsules and for 1 month after stopping isotretinoin capsules. If someone who is pregnant gets your donated blood, isotretinoin capsules may cause miscarriage, premature birth, birth defects, or death of the baby.
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Do not take other medicines or herbal products during treatment with isotretinoin capsules unless you talk to your health care provider. See "Before taking isotretinoin capsules"
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Do not drive at night until you know if isotretinoin capsules have affected your vision. Isotretinoin capsules may decrease your ability to see in the dark.
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Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, during treatment with isotretinoin capsules and for at least 6 months after you stop. Isotretinoin capsules can increase your chance of scarring from these procedures. Check with your health care provider for advice about when you can have cosmetic procedures.
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Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Isotretinoin capsules may make your skin more sensitive to light.
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Do not share isotretinoin capsules with other people. Isotretinoin capsules can cause life-threatening birth defects and other serious health problems.
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What are the possible side effects of isotretinoin capsules?
Isotretinoin capsules can cause serious side effects, including:
- See "What is the most important information I should know about isotretinoin capsules"?
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increased pressure in the brain (intracranial hypertension). Isotretinoin capsules can increase the pressure in your brain. This can lead to permanent loss of eyesight, and in rare cases, death. Stop taking isotretinoin capsules and tell your health care provider right away if you get any of these signs of increased brain pressure:
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o bad headache
| o nausea or vomiting
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o blurred vision or other visual problems
| o seizures (convulsions)
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o dizziness
| o stroke
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serious skin problems. Skin rash can happen in patients taking isotretinoin capsules. Sometimes rash can be severe and may be life-threatening and lead to hospitalization or death. Stop taking isotretinoin capsules and tell your health care provider right away if you get:
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o conjunctivitis (red or inflamed eyes, like "pink eye")
| o sores in your mouth, throat, nose or eyes
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o rash with a fever
| o peeling of your skin
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o blisters on legs, arms or face
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inflammation of your pancreas (pancreatitis) can happen in patients who take isotretinoin capsules and can lead to death. Stop taking isotretinoin capsules and tell your health care provider right away if you get any of the following symptoms of pancreatitis:
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o severe upper stomach (abdomen) pain
| o nausea and vomiting
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o swelling of your stomach
| o fever
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increased blood fat (lipid) levels. Isotretinoin capsules can raise blood fat levels (cholesterol and triglycerides). Your health care provider will do blood tests to check your lipids before and during treatment. These problems usually go away when isotretinoin capsules treatment is finished.
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hearing problems. Stop taking isotretinoin capsules and tell your health care provider if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
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liver problems, including hepatitis. Your health care provider will do tests to check your liver before and during treatment with isotretinoin capsules. Tell your health care provider right away if you get:
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o yellowing of your skin or the whites of your eyes
| o dark urine
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o pain on the right side of your stomach area (abdomen)
| o bleeding or bruising more easily than normal
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inflammation of your digestive tract (inflammatory bowel disease). Stop taking isotretinoin capsules right away and teall your health care provider right away if you get:
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o severe stomach, chest or bowel pain
| o new or worsening heartburn
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o nausea or vomiting
| o diarrhea
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o trouble swallowing or painful swallowing
| o rectal bleeding
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bone and muscle problems including bone pain, softening or thinning of bones (which may lead to fractures). Isotretinoin capsules may stop long bone growth in teenagers who are still growing. Teenagers who participate in sports with hard physical activity and repeated actions during treatment with isotretinoin capsules may have a higher risk of bone fractures or injuries. Tell your health care provider if you get:
o bone pain
o back pain
o broken bone (fracture).
o muscle problems. Stop taking isotretinoin capsules and tell your health care provider right away if you have muscle or joint pain or weakness. Muscle weakness with or without pain can be a sign of serious muscle damage.
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vision problems. Stop taking isotretinoin capsules and tell your health care provider right away if you have any vision changes. Isotretinoin capsules may affect your ability to see in the dark. This usually goes away after you stop taking isotretinoin capsules, but it may be permanent. Some patients get dry eyes during treatment. If you wear contact lenses, you may have trouble wearing them during and after you stop treatment with isotretinoin capsules.
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serious allergic reactions. Stop taking isotretinoin capsules and get emergency medical help right away if you get hives, a swollen face or mouth, or have trouble breathing. Stop taking isotretinoin capsules and tell your health care provider if you get a fever, rash, or red patches or bruises on your legs.
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blood sugar problems, including diabetes. Tell your health care provider if you are very thirsty or urinate more than usual.
The most common side effects of isotretinoin capsules include:
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- upper respiratory tract infection (common cold)
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- chapped lips or swelling of the lips
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- eye problems, including decreased vision
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These are not all of the possible side effects of isotretinoin capsules.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Zydus Pharmaceuticals (USA) Inc., at 1-877-993-8779.
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How should I store isotretinoin capsules?
- Store isotretinoin capsules at 20°C to 25°C (68°F to 77°F). Protect from light.
- Isotretinoin capsules come in child-resistant package.
Keep isotretinoin capsules and all medicines out of the reach of children.
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General information about the safe and effective use of isotretinoin capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use isotretinoin capsules for a condition for which it was not prescribed. Do not give isotretinoin capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or health care provider for information about isotretinoin capsules that is written for health professionals.
You can also call iPLEDGE REMS at 1-866-495-0654 or visit www.ipledgeprogram.com.
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What are the ingredients in isotretinoin capsules?
Active ingredient: isotretinoin, USP
Inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax.
Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol.
All trademarks are the property of their respective owners.
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Manufactured by:
Zydus Lifesciences Ltd.
Ahmedabad, India.
Distributed by:
Zydus Pharmaceuticals (USA) Inc.
Pennington, NJ 08534
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This Medication Guide has been approved by the U.S. Food and Drug Administration.
| Rev.:07/26
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