Important Safety Information for Accutane® (Isotretinoin Capsules USP)
What is the most important data I should know most Accutane?
Accutane is used to treat a type of astringent acne (nodular acne) that has not been helped past other treatments, including antibiotics.
Accutane tin can harm your unborn babe, 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 Accutane.
Patients must not go meaning:
- for one calendar month before starting Accutane
- while taking Accutane
- for i month later on stopping Accutane
If y'all get pregnant while taking Accutane, end taking information technology right away and call your healthcare provider.
Accutane is only for patients who can understand and concur to follow all the instructions in the iPLEDGE® Program. Patients taking Accutane must register in the iPLEDGE® Pregnancy Registry at 1-866-495-0654 or www.ipledgeprogram.com. See your healthcare provider for further data.
Accutane can crusade serious mental health problems, including:
- depression
- psychosis (seeing or hearing things that are not real)
- suicide. Some patients taking Accutane have had thoughts about hurting themselves or suicide. Consult your healthcare provider if you have such thoughts.
End Accutane and call your doctor right away if you lot or a family unit member notices that y'all take any of the post-obit signs and symptoms of low or psychosis:
- offset to experience distressing or take crying spells
- lose involvement in activities yous once enjoyed
- sleep too much or have trouble sleeping
- go more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
- accept a change in your appetite or body weight
- have trouble concentrating
- withdraw from your friends or family
- feel like you accept no energy
- have feelings of worthlessness or guilt
- start having thoughts about pain yourself or taking your own life (suicidal thoughts)
- offset acting on dangerous impulses
- start seeing or hearing things that are not real
After stopping Accutane, you may also need follow-up mental health intendance if you had whatever of these symptoms.
Who should not have Accutane?
- Exercise not have Accutane if y'all are significant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes severe nascency defects. See What is the nearly important data I should know about Accutane?
- Do not take Accutane if you are allergic to annihilation in it. See the end of the Medication Guide for a complete list of ingredients in Accutane. Accutane contains parabens as the preservatives.
What should I tell my doctor before taking Accutane?
Tell your dr. if you or a family member has any of the post-obit health conditions:
- mental problems
- asthma
- liver illness
- diabetes
- heart affliction
- bone loss (osteoporosis) or weak bones
- an eating problem called anorexia nervosa (where people eat too little)
- food or medicine allergies
Tell your doctor if you lot are pregnant or breastfeeding. Accutane must not be used past women who are pregnant or breastfeeding.
Tell your physician about all of the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Accutane and certain other medicines can interact with each other, sometimes causing serious side effects. Particularly tell your md if you take:
- Vitamin A supplements. Vitamin A in loftier doses has many of the same side effects as Accutane. Taking both together may increment your adventure of getting side effects.
- Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane tin increase the chances of getting increased pressure in the brain.
- Progestin-simply birth command pills (mini-pills). They may not work while you take Accutane. Ask your doctor or pharmacist if you lot are not sure what type you are using.
- Dilantin (phenytoin). This medicine taken with Accutane may weaken your bones.
- Corticosteroid medicines. These medicines taken with Accutane may weaken your bones.
- St. Johns Wort. This herbal supplement may make nascency control pills work less effectively.
These medicines should not be used with Accutane unless your md tells y'all it is okay.
Know the medicines yous take. Go along a listing of them to show to your physician and pharmacist. Do not take any new medicine without talking with your doctor.
What should I avoid while taking Accutane?
- Do not become significant while taking Accutane and for one month after stopping Accutane. See What is the almost important information I should know about Accutane?
- Do not breastfeed while taking Accutane and for i month later stopping Accutane. We do not know if Accutane tin laissez passer through your milk and harm the baby.
- Exercise not requite blood while you accept Accutane and for one month after stopping Accutane. If someone who is significant gets your donated blood, their baby may be exposed to Accutane and may be born with nascence defects.
- Do not have other medicines or herbal products with Accutane unless you talk to your doctor. See What should I tell my doctor earlier taking Accutane?
- Do not bulldoze at night until you know if Accutane has affected your vision. Accutane may decrease your ability to run into in the nighttime.
- Do not have corrective procedures to smooth your peel, including waxing, dermabrasion, or laser procedures, while you are using Accutane and for at to the lowest degree vi months after you end. Accutane tin can increase your chance of scarring from these procedures. Cheque with your physician for advice about when you tin can have cosmetic procedures.
- Avoid sunlight and ultraviolet lights equally much as possible. Tanning machines apply ultraviolet lights. Accutane may make your skin more sensitive to calorie-free.
- Exercise not share Accutane with other people. It tin cause nascence defects and other serious health problems.
What are the possible side effects of Accutane?
- Accutane can harm your unborn baby, including nativity defects (deformed babies), loss of a babe before birth (miscarriage), death of the babe, and early (premature) births.
- Accutane can cause serious mental wellness problems.
- Serious brain bug. Accutane can increment the pressure in your brain. This can pb to permanent loss of eyesight and, in rare cases, expiry. Stop taking Accutane and telephone call your healthcare provider right away if you lot become whatever of these signs of increased brain pressure:
- bad headache
- blurred vision
- dizziness
- nausea or vomiting
- seizures (convulsions)
- stroke
- Skin problems. Skin rash can occur in patients taking Accutane. In some patients a rash can be serious. Stop using Accutane and call your healthcare provider immediately if you develop:
- conjunctivitis (red or inflamed optics, like pink middle)
- rash with a fever
- blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes
- skin begins to peel
- Stomach expanse (abdomen) problems. Certain symptoms may mean your internal organs are existence damaged, such every bit the liver, pancreas, bowel (intestines), and esophagus (connection between rima oris and stomach). If your organs are damaged, they may not get better fifty-fifty afterwards y'all end taking Accutane. Stop Accutane and call your healthcare provider if you lot get:
- severe stomach, breast or bowel pain
- trouble swallowing or painful swallowing
- new or worsening heartburn
- diarrhea
- rectal bleeding
- yellowing of your skin or eyes
- dark urine
- Bone or muscle problems. Accutane may bear upon your bones, muscles, and ligaments and crusade pain in your joints and muscles. Tell your healthcare provider if you plan difficult physical action during handling or get back or joint hurting or cleaved bones. Terminate Accutane and call your healthcare provider immediately if you have muscle weakness. Muscle weakness with or without hurting tin can exist a sign of serious musculus damage. Accutane may stop long os growth in teenagers who are still growing.
- Hearing problems. Cease using Accutane and call your healthcare provider if your hearing gets worse or if y'all take ringing in your ears. Your hearing loss may be permanent.
- Vision problems. Accutane may touch your ability to run into in the dark. Finish taking Accutane and call your healthcare provider correct away if y'all have problems with your vision or dryness of the eyes that is painful or constant. If you lot wear contact lenses, you may have trouble wearing them during and afterward yous stop treatment with Accutane.
- Lipid (fats and cholesterol in claret) problems. Accutane can heighten the level of fats and cholesterol in your blood. This tin can be a serious problem. Return to your doctor for blood tests to check your lipids and to get any needed handling. These problems usually go away when Accutane handling is finished.
- Serious allergic reactions. Terminate taking Accutane and get emergency intendance right away if you lot develop hives, a swollen confront or mouth, or have problem animate. Stop taking Accutane and call your healthcare provider if you lot become a fever, rash, or red patches or bruises on your legs.
- Blood carbohydrate bug. Accutane may cause blood sugar problems including diabetes. Tell your healthcare professional if you are very thirsty or urinate a lot.
- Decreased red or white blood cells. Call your healthcare professional if y'all have trouble breathing, faint, or experience weak.
- The mutual, less serious side furnishings of Accutane include:
- Dry peel
- Chapped lips
- Dry out eyes
- Dry olfactory organ that may lead to nosebleeds
These are not all of the possible side effects of Accutane. Call your healthcare professional for medical advice about side furnishings. Yous may study side effects to FDA at 1-800-FDA-1088 or JG Pharma, Inc. at ane-844-325-3350.
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