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Questions and Answers on the iPLEDGE REMS | FDA - Publication types

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  The iPLEDGE® Program is a computer-based risk management program designed to reduce risk of birth defects and inform you of the risks that Accutane® can. Some patients treated with ACCUTANE™ (isotretinoin) have become depressed and this checklist) is a self-assessment questionnaire to be completed by the. Before the pharmacy will dispense your prescription, you must answer your monthly online questionnaire where you will enter your two forms of contraception.  




  Type of Contraception: Signed Consent: Y N. Previous Accutane Use: Y N. No. of Courses: Last Use:______. History: LMP: Liver Disease: Y N. Isotretinoin is used to treat severe and recalcitrant acne. Possible side effects include depression, suicide, and suicidal ideation; however, other studies. Some patients treated with ACCUTANE™ (isotretinoin) have become depressed and this checklist) is a self-assessment questionnaire to be completed by the.     ❾-50%}

 

- Accutane questionnaire



    This herbal supplement may make birth control pills work less effectively.

Answer: Isotretinoin is a prescription medicine approved for use 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, including birth defects. Answer: A REMS is a risk management program that uses risk minimization strategies beyond approved labeling to manage serious risks associated with a drug.

A REMS can include a Medication Guide or patient package insert, communication plan, one or more elements to ensure safe use, an implementation system, and a timetable for submission of the REMS assessments. A REMS may also include certain packaging and safe disposal technologies for drugs that pose a serious risk of abuse or overdose. Accutane can cause serious mental health problems, including:. Stop Accutane and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis:.

After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms. What should I tell my doctor before taking Accutane? Tell your doctor if you or a family member has any of the following health conditions:. Tell your doctor if you are pregnant or breastfeeding. Accutane must not be used by women who are pregnant or breastfeeding. Accutane and certain other medicines can interact with each other, sometimes causing serious side effects.

Especially tell your doctor if you take:. These medicines should not be used with Accutane unless your doctor tells you it is okay. Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor. What are the possible side effects of Accutane? The common, less serious side effects of Accutane include:. These are not all of the possible side effects of Accutane. Call your healthcare professional for medical advice about side effects.

No female patient starts isotretinoin therapy if pregnant. No female patient on isotretinoin therapy becomes pregnant. Patient must not get pregnant: for 1 month before starting Accutane while taking Accutane for 1 month after stopping Accutane If you get pregnant while taking Accutane, stop taking it right away and call your healthcare provider. Accutane can cause serious mental health problems, including: depression.

Some patients taking Accutane have had thoughts about hurting themselves or suicide. Consult your healthcare provider if you have such thoughts. Stop Accutane and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis: start to feel sad or have crying spells lose interest in activities you once enjoyed sleep too much or have trouble sleeping become more irritable, angry, or aggressive than usual for example, temper outbursts, thoughts of violence have a change in your appetite or body weight have trouble concentrating withdraw from your friends or family feel like you have no energy have feelings of worthlessness or guilt start having thoughts about hurting yourself or taking your own life suicidal thoughts start acting on dangerous impulses start seeing or hearing things that are not real After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms.

Who should not take Accutane? Do not take Accutane if you are pregnant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes severe birth defects. See the end of the Medication Guide for a complete list of ingredients in Accutane. Accutane contains parabens as the preservatives. Tell your doctor if you or a family member has any of the following health conditions: mental problems asthma liver disease diabetes heart disease 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 are pregnant or breastfeeding.

Especially tell your doctor if you take: Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Accutane. Taking both together may increase your chance of getting side effects. Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane can increase the chances of getting increased pressure in the brain.

Progestin-only birth control pills mini-pills. They may not work while you take Accutane. Ask your doctor or pharmacist if you 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.

This herbal supplement may make birth control pills work less effectively. What should I avoid while taking Accutane? Do not get pregnant while taking Accutane and for one month after stopping Accutane. We do not know if Accutane can pass through your milk and harm the baby. Do not give blood while you take Accutane and for one month after stopping Accutane.

If someone who is pregnant gets your donated blood, their baby may be exposed to Accutane and may be born with birth defects. Do not take other medicines or herbal products with Accutane unless you talk to your doctor. Accutane may decrease your ability to see in the dark. Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Accutane and for at least 6 months after you stop. Accutane can increase your chance of scarring from these procedures.

Answer: Isotretinoin is a prescription medicine approved for use 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, including birth defects. Answer: A REMS is a risk management program that uses risk minimization strategies beyond approved labeling to manage serious risks associated with a drug.

A REMS can include a Medication Guide or patient package insert, communication plan, one or more elements to ensure safe use, an implementation system, and a timetable for submission of the REMS assessments.

A REMS may also include certain packaging and safe disposal technologies for drugs that pose a serious risk of abuse or overdose.

There were previously three risk categories: females of reproductive potential, females not of reproductive potential, and males. Patients who can get pregnant must follow the REMS requirements to prevent pregnancy before, during, and 30 days after isotretinoin treatment. Patients who cannot get pregnant must also receive monthly counseling from their prescriber during isotretinoin therapy. Patients who can get pregnant must follow the REMS guidelines to prevent pregnancy during isotretinoin treatment.

Index to Drug-Specific Information. What is isotretinoin?

The iPLEDGE® Program is a computer-based risk management program designed to reduce risk of birth defects and inform you of the risks that Accutane® can. Isotretinoin is used to treat severe and recalcitrant acne. Possible side effects include depression, suicide, and suicidal ideation; however, other studies. (isotretinoin capsules). Rx only. CAUSES BIRTH. DEFECTS. DO NOT GET. PREGNANT. CONTRAINDICATIONS AND WARNINGS. Accutane must not be used by female patients. Before the pharmacy will dispense your prescription, you must answer your monthly online questionnaire where you will enter your two forms of contraception. Time on acne medication previous to Accutane? months Prior to Accutane, did you fill out the iPledge packet given to you by your doctor? Accutane can raise the level of fats and cholesterol in your blood. This medicine taken with Accutane may weaken your bones. If your organs are damaged, they may not get better even after you stop taking Accutane. These medicines taken with Accutane may weaken your bones.

The goals of this program are to ensure that:. We know it may be a lot to take in, and you probably have more questions. Accutane is used to treat a type of severe acne nodular acne that has not been helped by other treatments, including antibiotics.

Accutane 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 Accutane. If you get pregnant while taking Accutane, stop taking it right away and call your healthcare provider. See your healthcare provider for further information. Accutane can cause serious mental health problems, including:.

Stop Accutane and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis:. After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms. What should I tell my doctor before taking Accutane? Tell your doctor if you or a family member has any of the following health conditions:.

Tell your doctor if you are pregnant or breastfeeding. Accutane must not be used by women who are pregnant or breastfeeding. Accutane and certain other medicines can interact with each other, sometimes causing serious side effects.

Especially tell your doctor if you take:. These medicines should not be used with Accutane unless your doctor tells you it is okay. Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.

What are the possible side effects of Accutane? The common, less serious side effects of Accutane include:. These are not all of the possible side effects of Accutane. Call your healthcare professional for medical advice about side effects.

No female patient starts isotretinoin therapy if pregnant. No female patient on isotretinoin therapy becomes pregnant. Patient must not get pregnant: for 1 month before starting Accutane while taking Accutane for 1 month after stopping Accutane If you get pregnant while taking Accutane, stop taking it right away and call your healthcare provider. Accutane can cause serious mental health problems, including: depression. Some patients taking Accutane have had thoughts about hurting themselves or suicide.

Consult your healthcare provider if you have such thoughts. Stop Accutane and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis: start to feel sad or have crying spells lose interest in activities you once enjoyed sleep too much or have trouble sleeping become more irritable, angry, or aggressive than usual for example, temper outbursts, thoughts of violence have a change in your appetite or body weight have trouble concentrating withdraw from your friends or family feel like you have no energy have feelings of worthlessness or guilt start having thoughts about hurting yourself or taking your own life suicidal thoughts start acting on dangerous impulses start seeing or hearing things that are not real After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms.

Who should not take Accutane? Do not take Accutane if you are pregnant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes severe birth defects. See the end of the Medication Guide for a complete list of ingredients in Accutane.

Accutane contains parabens as the preservatives. Tell your doctor if you or a family member has any of the following health conditions: mental problems asthma liver disease diabetes heart disease 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 are pregnant or breastfeeding.

Especially tell your doctor if you take: Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Accutane. Taking both together may increase your chance of getting side effects. Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane can increase the chances of getting increased pressure in the brain. Progestin-only birth control pills mini-pills. They may not work while you take Accutane.

Ask your doctor or pharmacist if you 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. This herbal supplement may make birth control pills work less effectively.

What should I avoid while taking Accutane? Do not get pregnant while taking Accutane and for one month after stopping Accutane. We do not know if Accutane can pass through your milk and harm the baby. Do not give blood while you take Accutane and for one month after stopping Accutane. If someone who is pregnant gets your donated blood, their baby may be exposed to Accutane and may be born with birth defects. Do not take other medicines or herbal products with Accutane unless you talk to your doctor.

Accutane may decrease your ability to see in the dark. Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Accutane and for at least 6 months after you stop.

Accutane can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures. Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Accutane may make your skin more sensitive to light. Do not share Accutane with other people.

It can cause birth defects and other serious health problems. Accutane can cause serious mental health problems. Serious brain problems. Accutane can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking Accutane and call your healthcare provider right away if you get any 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. Certain symptoms may mean your internal organs are being damaged, such as the liver, pancreas, bowel intestines , and esophagus connection between mouth and stomach. If your organs are damaged, they may not get better even after you stop taking Accutane.

Stop Accutane and call your healthcare provider if you get: severe stomach, chest 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 affect your bones, muscles, and ligaments and cause pain in your joints and muscles. Tell your healthcare provider if you plan hard physical activity during treatment or get back or joint pain or broken bones.

Stop Accutane and call your healthcare provider immediately if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage. Accutane may stop long bone growth in teenagers who are still growing. Hearing problems. Stop using Accutane and call your healthcare provider if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.

Vision problems. Accutane may affect your ability to see in the dark. Stop taking Accutane and call your healthcare provider right away if you have problems with your vision or dryness of the eyes that is painful or constant.

If you wear contact lenses, you may have trouble wearing them during and after you stop treatment with Accutane. Lipid fats and cholesterol in blood problems. Accutane can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return to your doctor for blood tests to check your lipids and to get any needed treatment. These problems usually go away when Accutane treatment is finished.

Serious allergic reactions. Stop taking Accutane and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Accutane and call your healthcare provider if you get a fever, rash, or red patches or bruises on your legs.

Blood sugar problems. 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.



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