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Isotretinoin: MedlinePlus Drug Information - Why is this medication prescribed? |
Isotretinoin (Oral Route) Proper Use - Mayo Clinic.
Isotretinoin must not be taken by patients who are pregnant or who may become pregnant. There is a high risk that isotretinoin will cause loss of the pregnancy, or will cause the baby to be born too early, to die shortly after birth, or to be born with birth defects physical problems that are present at birth.
A program called iPLEDGE has been set up to make sure that pregnant women do not take isotretinoin and that women do not become pregnant while taking isotretinoin. Do not buy isotretinoin over the internet. You will receive information about the risks of taking isotretinoin and must sign an informed consent sheet stating that you understand this information before you can receive the medication.
You will need to see your doctor every month during your treatment to talk about your condition and the side effects you are experiencing. At each visit, your doctor may give you a prescription for up to a day supply of medication with no refills.
If you are a woman who can become pregnant, you will also need to have a pregnancy test in an approved lab each month and have your prescription filled and picked up within 7 days of your pregnancy test. If you are a man or if you are a woman who cannot become pregnant, you must have this prescription filled and picked up within 30 days of your doctor visit.
Your pharmacist cannot dispense your medication if you come to pick it up after the allowed time period has passed. Tell your doctor if you do not understand everything you were told about isotretinoin and the iPLEDGE program or if you do not think you will be able to keep appointments or fill your prescription on schedule every month. Your doctor will give you an identification number and card when you start your treatment.
Keep the card in a safe place where it will not get lost. If you do lose your card, you can ask for a replacement through the website or phone line. Do not share isotretinoin with anyone else, even someone who has the same symptoms that you have.
Your doctor or pharmacist will give you the manufacturer's patient information sheet Medication Guide when you begin treatment with isotretinoin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. If you can become pregnant, you will need to meet certain requirements during your treatment with isotretinoin.
You need to meet these requirements even if you have not started menstruating having monthly periods or have had a tubal ligation 'tubes tied'; surgery to prevent pregnancy. If none of these are true for you, then you must meet the requirements below. You must use two acceptable forms of birth control for 1 month before you begin to take isotretinoin, during your treatment and for 1 month after your treatment.
Your doctor will tell you which forms of birth control are acceptable and will give you written information about birth control. You can also have a free visit with a doctor or family planning expert to talk about birth control that is right for you.
You must use these two forms of birth control at all times unless you can promise that you will not have any sexual contact with a male for 1 month before your treatment, during your treatment, and for 1 month after your treatment. If you choose to take isotretinoin, it is your responsibility to avoid pregnancy for 1 month before, during, and for 1 month after your treatment. You must understand that any form of birth control can fail.
Therefore, it is very important to decrease the risk of accidental pregnancy by using two forms of birth control at all times. Tell your doctor if you do not understand everything you were told about birth control or you do not think that you will be able to use two forms of birth control at all times. If you plan to use oral contraceptives birth control pills while taking isotretinoin, tell your doctor the name of the pill you will use. Isotretinoin interferes with the action of micro-dosed progestin 'minipill' oral contraceptives Ovrette, Micronor, Nor-QD.
Do not use this type of birth control while taking isotretinoin. If you plan to use hormonal contraceptives birth control pills, patches, implants, injections, rings, or intrauterine devices , be sure to tell your doctor about all the medications, vitamins, and herbal supplements you are taking.
Many medications interfere with the action of hormonal contraceptives. Do not take St. John's wort if you are using any type of hormonal contraceptive. You must have two negative pregnancy tests before you can begin to take isotretinoin. Your doctor will tell you when and where to have these tests. You will also need to be tested for pregnancy in a laboratory each month during your treatment, when you take your last dose and 30 days after you take your last dose.
You will only be able to continue to get isotretinoin if you have done this, if you have visited your doctor to talk about how you are feeling and how you are using your birth control and if you have had a negative pregnancy test within the past 7 days. Stop taking isotretinoin and call your doctor right away if you think you are pregnant, you miss a menstrual period, or you have sex without using two forms of birth control.
You will also talk with a doctor who specializes in problems during pregnancy who can help you make choices that are best for you and your baby. Information about your health and your baby's health will be used to help doctors learn more about the effects of isotretinoin on unborn babies. A very small amount of isotretinoin will probably be present in your semen when you take prescribed doses of this medication. It is not known if this small amount of isotretinoin may harm the fetus if your partner is or becomes pregnant.
Tell your doctor if your partner is pregnant, plans to become pregnant, or becomes pregnant during your treatment with isotretinoin.
Isotretinoin is used to treat severe recalcitrant nodular acne a certain type of severe acne that has not been helped by other treatments, such as antibiotics. Isotretinoin is in a class of medications called retinoids. It works by slowing the production of certain natural substances that can cause acne. Isotretinoin comes as a capsule to take by mouth.
Isotretinoin is usually taken twice a day with meals for 4 to 5 months at a time. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take isotretinoin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Swallow the capsules whole with a full glass of liquid.
Do not chew, crush, or suck on the capsules. Your doctor will probably start you on an average dose of isotretinoin and increase or decrease your dose depending on how well you respond to the medication and the side effects you experience.
Follow these directions carefully and ask your doctor or pharmacist if you are not sure how much isotretinoin you should take. It may take several weeks or longer for you to feel the full benefit of isotretinoin.
Your acne may get worse during the beginning of your treatment with isotretinoin. This is normal and does not mean that the medication is not working. Your acne may continue to improve even after you finish your treatment with isotretinoin. Isotretinoin has been used to treat certain other skin conditions and some types of cancer.
Talk to your doctor about the possible risks of using this medication for your condition. This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Isotretinoin may cause the bones to stop growing too soon in teenagers. Talk to your child's doctor about the risks of giving this medication to your child.
Isotretinoin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture not in the bathroom.
It is important to keep all medication out of sight and reach of children as many containers such as weekly pill minders and those for eye drops, creams, patches, and inhalers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. In case of overdose, call the poison control helpline at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at Anyone who has taken an overdose of isotretinoin should know about the risk of birth defects caused by isotretinoin and should not donate blood for 1 month after the overdose.
Pregnant woman should talk to their doctors about the risks of continuing the pregnancy after the overdose. Women who can become pregnant should use two forms of birth control for 1 month after the overdose.
Men whose partners are or may become pregnant should use condoms or avoid sexual contact with that partner for 1 month after the overdose because isotretinoin may be present in the semen. Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to isotretinoin.
It is important for you to keep a written list of all of the prescription and nonprescription over-the-counter medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Generic alternatives may be available. Isotretinoin pronounced as eye soe tret' i noyn. Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow?
What should I do if I forget a dose? What side effects can this medication cause? What should I know about storage and disposal of this medication?
Brand names.
❾-50%}- IMPORTANT WARNING:
Your acne may get worse when you first start taking Accutane. This should last only a short while. Talk with your doctor if this is a problem for you. Your doctor may do blood tests to check for serious side effects from Accutane. Patients who can get pregnant will get a pregnancy test each month. Patients who can get pregnant must agree to use two separate forms of effective birth control at the same time one month before, while taking, and for one month after taking Accutane.
You must access the iPLEDGE Program system to answer questions about the program requirements and to enter your two chosen forms of birth control. You must talk about effective birth control forms with your doctor or go for a free visit to talk about birth control with another doctor or family planning expert.
Your doctor can arrange this free visit, which will be paid for by the company that makes Accutane. If you have sex at any time without using two forms of effective birth control, get pregnant, or miss your expected period, stop using Accutane and call your doctor right away. 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.
What are the possible side effects of Accutane? Accutane can cause birth defects deformed babies , loss of a baby before birth miscarriage , death of the baby, and early premature births. 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 doctor 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 that your internal organs are being damaged. These organs include 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 taking Accutane and call your doctor 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 and muscle problems. Accutane may affect bones, muscles, and ligaments and cause pain in your joints or muscles.
Tell your doctor if you plan hard physical activity during treatment with Accutane. Tell your doctor if you get: back pain joint pain broken bone. Tell all healthcare providers that you take Accutane if you break a bone. Stop using Accutane and call your doctor if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent. Accutane may affect your ability to see in the dark. This condition usually clears up after you stop taking Accutane, but it may be permanent.
Other serious eye effects can occur. Stop taking Accutane and call your doctor right away if you have any 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 while taking Accutane and after treatment. Accutane can raise the level of fats and cholesterol in your blood.
This can be a serious problem. You will not get another prescription unless you follow the instructions for the program. Swallow the capsule whole with a full glass 8 ounces of water or other liquid. Do not crush, break, chew, or suck the capsule. It is very important that you take isotretinoin only as directed by your doctor.
Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. It is very important that you not share this medicine with anyone else because of the risk of birth defects and other serious side effects.
Different brands may not work the same way. If you refill your medicine and it looks different, check with your pharmacist. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine.
If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. If you miss a dose of this medicine, take it as soon as possible. Your doctor will probably start you on an average dose of isotretinoin and increase or decrease your dose depending on how well you respond to the medication and the side effects you experience.
Follow these directions carefully and ask your doctor or pharmacist if you are not sure how much isotretinoin you should take. It may take several weeks or longer for you to feel the full benefit of isotretinoin. Your acne may get worse during the beginning of your treatment with isotretinoin. This is normal and does not mean that the medication is not working. Your acne may continue to improve even after you finish your treatment with isotretinoin. Isotretinoin has been used to treat certain other skin conditions and some types of cancer.
Talk to your doctor about the possible risks of using this medication for your condition. This medication may be prescribed for other uses.
Ask your doctor or pharmacist for more information. Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Isotretinoin may cause the bones to stop growing too soon in teenagers. Talk to your child's doctor about the risks of giving this medication to your child.
Isotretinoin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. Keep this medication in the container it came in, tightly closed, and out of reach of children.
Store it at room temperature and away from excess heat and moisture not in the bathroom. It is important to keep all medication out of sight and reach of children as many containers such as weekly pill minders and those for eye drops, creams, patches, and inhalers are not child-resistant and young children can open them easily.
To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program.
In case of overdose, call the poison control helpline at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at Anyone who has taken an overdose of isotretinoin should know about the risk of birth defects caused by isotretinoin and should not donate blood for 1 month after the overdose. Pregnant woman should talk to their doctors about the risks of continuing the pregnancy after the overdose.
Women who can become pregnant should use two forms of birth control for 1 month after the overdose. Men whose partners are or may become pregnant should use condoms or avoid sexual contact with that partner for 1 month after the overdose because isotretinoin may be present in the semen. Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to isotretinoin.
It is important for you to keep a written list of all of the prescription and nonprescription over-the-counter medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital.
It is also important information to carry with you in case of emergencies. Generic alternatives may be available. Isotretinoin pronounced as eye soe tret' i noyn. Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose?
What side effects can this medication cause?
Read the Medication Guide that comes with Accutane 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 doctor about your medical condition or your treatment. Birth defects deformed babiesloss of a baby before birth miscarriagedeath of the baby, and early premature births.
Patients who are pregnant or who plan to become pregnant must not take Accutane. Patients must not get pregnant:. If you get pregnant while taking Accutane, stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy to:. 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. Accutane is a medicine taken by mouth to treat the most severe form of acne nodular acne that cannot be cleared up by any other acne treatments, including antibiotics. Accutane can only be:. Severe nodular acne is when many red, swollen, tender lumps form in the skin.
These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars. 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. Stop Accutane and call your doctor right away 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.
These are not all of the possible side effects with Accutane. Your doctor or pharmacist can give you more detailed information. Call your doctor for medical advice about side effects. Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides.
Do not use Accutane for a condition for which it was not prescribed. Do not give Accutane to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about Accutane.
If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Accutane that is written for healthcare professionals. Inactive Ingredients: butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil Type-I and Type-IImedium chain triglyceride, refined soybean oil and white wax.
What is the most important information I should know about Accutane? Accutane is used to treat a type of severe acne nodular acne that has not been helped by other treatments, including antibiotics.
Accutane may cause serious mental health problems. Patients 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 doctor. Serious mental health problems. Accutane may cause: depression psychosis seeing or hearing things that are not real suicide. Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their own lives suicidal thoughts.
Some people tried to end their own lives. And some people have ended their own lives. 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.
What is Accutane? 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 this 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 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. How should I take Accutane? You must take Accutane exactly as prescribed. Patients who can get pregnant must also sign another consent form. You will get no more than a 30 day supply of Accutane at a time. You should talk with your doctor each month about side effects.
The amount of Accutane you take has been specially chosen for you. It is based on your body weight, and may change during treatment. Take Accutane 2 times a day with a meal, unless your doctor tells you otherwise. Swallow your Accu tane capsules whole with a full glass of liquid.
Do not chew or suck on the capsule. Accutane can hurt the tube that connects your mouth to your stomach esophagus if it is not swallowed whole. If you miss a dose, just skip that dose. Do not take two doses at the same time. If you take too much Accutane or overdose, call your doctor or poison control center right away.
Your acne may get worse when you first start taking Accutane. This should last only a short while. Talk with your doctor if this is a problem for you.
Your doctor may do blood tests to check for serious side effects from Accutane. Patients who can get pregnant will get a pregnancy test each month. Patients who can get pregnant must agree to use two separate forms of effective birth control at the same time one month before, while taking, and for one month after taking Accutane.
You must access the iPLEDGE Program system to answer questions about the program requirements and to enter your two chosen forms of birth control.
You must talk about effective birth control forms with your doctor or go for a free visit to talk about birth control with another doctor or family planning expert. Your doctor can arrange this free visit, which will be paid for by the company that makes Accutane.
If you have sex at any time without using two forms of effective birth control, get pregnant, or miss your expected period, stop using Accutane and call your doctor right away. 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.
An Accutane Medication Guide must be given to the patient each time Accutane is dispensed, as required by law. This Accutane Medication Guide is an important. Medication Guide for a complete list of ingredients in Accutane. Accutane contains parabens as the preservatives. What should I tell my doctor before taking. Brand: Accutane (Aku-u-tane). Read the Medication Guide that comes with Isotretinoin before you start taking it and each time you get a prescription. patient information sheet (Medication Guide) when you begin treatment with isotretinoin and each time you refill your prescription. An Accutane Medication Guide must be given to the patient each time Accutane is dispensed, as required by law. This Accutane Medication Guide is an important. Swallow your Accu tane capsules whole with a full glass of liquid. If you miss a dose of this medicine, take it as soon as possible. Keep all appointments with your doctor and the laboratory. Doctors and patients should report all cases of pregnancy to:. Do not double doses. Patients who are pregnant or who plan to become pregnant must not take Accutane.Drug information provided by: IBM Micromedex. Isotretinoin comes with a patient information form and Medication Guide. It is very important that you read and understand this information. Be sure to carefully follow these instructions and ask your doctor if you have any questions.
Be sure to ask your doctor if you have any questions about this program. It is very important that you understand and follow all of the requirements. You will not get another prescription unless you follow the instructions for the program.
Swallow the capsule whole with a full glass 8 ounces of water or other liquid. Do not crush, break, chew, or suck the capsule. It is very important that you take isotretinoin only as directed by your doctor.
Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. It is very important that you not share this medicine with anyone else because of the risk of birth defects and other serious side effects. Different brands may not work the same way. If you refill your medicine and it looks different, check with your pharmacist.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine.
Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Do not take extra medicine to make up for a missed dose.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. There is a problem with information submitted for this request. Sign up for free, and stay up to date on research advancements, health tips and current health topics, like COVID, plus expertise on managing health. To provide you with the most relevant and helpful information, and understand which information is beneficial, we may combine your email and website usage information with other information we have about you.
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