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Accutane

Accutane is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly.

Accutane is used to treat severe nodular acne. It is usually given after other acne medicines or antibiotics have been tried without successful treatment of symptoms.

Accutane may also be used for other purposes not listed in this medication guide.

Accutane is a powerful drug used in the treatment of acne. Four to five months of Accutane treatment usually leads to clearing of acne. It is a potent medication that is very effective for nearly all types of breakouts. Accutane is needed for moderate to severe acne that has failed other treatments. It should be used for a severe, scarring acne. Is also used for acne present for many years that has not respond completely to antibiotic pills and creams. While it has many side effects, in some ways it is safer than long-term antibiotic usage.

Most other acne-controlling medicines are antibacterial agents, which are effective only if used daily. Over two million people have taken this drug, so a lot is known about its safety and effectiveness.

Accutane is a naturally occurring derivative of vitamin A and is detectable in the bloodstream of all people. Vitamin A in large doses has the same effects as Accutane, both good and bad, but quickly becomes harmful since it builds up in the tissue. (Important: Don’t take any vitamin A while on Accutane).

Accutane is formed naturally in the body from the Vitamin A present in the bloodstream. This is why large amounts of Vitamin A taken during pregnancy cause the same birth defects that Accutane does. Fortunately, because it is a naturally occurring product, the body is able to quickly remove Accutane from the bloodstream. It is gone from the blood within nine days and has no lasting effect on future pregnancies.

Accutane “cures” about half of those people who take it so that they never need to do anything else for acne. In the first few weeks of treatment, about one in five patients gets a little worse, and one in 500 patients gets much worse. The rest either get much better, or better for a while. There is nothing else in the world that comes close to being this effective for severe acne. The usual patient takes it for 4 to 6 months, but some need more and must be “retreated” for an additional 4 to 6 months.

Taking Accutane with food increases the absorption of the medicine. The more Accutane one takes, the greater the chance of cure. Unfortunately, side effects depend on the dose as well. At the lowest doses, there are almost no side effects at all. At the highest, everyone get rather nasty side effects, which are related on the drying effects on the oil glands. The dose needs to be adjusted to strike a balance between effectiveness and side effects.

Why is Accutane Prescribed?

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.

How should Accutane be used?

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.

Other uses for Accutane

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.

What special precautions should I follow?

Before taking isotretinoin,

  • tell your doctor and pharmacist if you are allergic to isotretinoin, vitamin A, any other medications, or any of the ingredients in isotretinoin capsules. Ask your pharmacist or check the Medication Guide for a list of the inactive ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, herbal products, and nutritional supplements you are taking or plan to take. Be sure to mention medications for seizures such as phenytoin (Dilantin); medications for mental illness; oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone; tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Monodox, Vibramycin, others), minocycline (Minocin, Vectrin), oxytetracycline (Terramycin), and tetracycline (Sumycin, Tetrex, others); and vitamin A supplements. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you or anyone in your family has thought about or attempted suicide and if you or anyone in your family has or has ever had depression, mental illness, diabetes, asthma, osteoporosis (a condition in which the bones are fragile and break easily), osteomalacia (weak bones due to a lack of vitamin D or difficulty absorbing this vitamin), or other conditions that cause weak bones, a high triglyceride (fats in the blood) level, a lipid metabolism disorder (any condition that makes it difficult for your body to process fats), anorexia nervosa (an eating disorder in which very little is eaten), or heart or liver disease. Also tell your doctor if you are overweight or if you drink or have ever drunk large amounts of alcohol.
  • do not breast-feed while you are taking isotretinoin and for 1 month after you stop taking isotretinoin.
  • plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Isotretinoin may make your skin sensitive to sunlight.
  • you should know that isotretinoin may cause changes in your thoughts, behavior, or mental health. Some patients who took isotretinoin have developed depression or psychosis (loss of contact with reality), have become violent, have thought about killing or hurting themselves, and have tried or succeeded in doing so. You or your family should call your doctor right away if you experience any of the following symptoms: anxiety,sadness, crying spells, loss of interest in activities you used to enjoy, poor performance at school or work, sleeping more than usual, difficulty falling asleep or staying asleep, irritability, anger, aggression, changes in appetite or weight, difficulty concentrating, withdrawing from friends or family, lack of energy, feelings of worthlessness or guilt, thinking about killing or hurting yourself, acting on dangerous thoughts, or hallucinations (seeing or hearing things that do not exist). Be sure that your family members know which symptoms are serious so that they can call the doctor if you are unable to seek treatment on your own.
  • you should know that isotretinoin may cause your eyes to feel dry and make wearing contact lenses uncomfortable during and after your treatment.
  • you should know that isotretinoin may limit your ability to see in the dark. This problem may begin suddenly at any time during your treatment and may continue after your treatment is stopped. Be very careful when you drive or operate machinery at night.
  • plan to avoid hair removal by waxing, laser skin treatments, and dermabrasion (surgical smoothing of the skin) while you are taking isotretinoin and for 6 months after your treatment. Isotretinoin increases the risk that you will develop scars from these treatments. Ask your doctor when you can safely undergo these treatments.
  • talk to your doctor before you participate in hard physical activity such as sports. Isotretinoin may cause the bones to weaken or thicken abnormally and may increase the risk of certain bone injuries in people who perform some types of physical activity. If you break a bone during your treatment, be sure to tell all your healthcare providers that you are taking isotretinoin.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Isotretinoin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • red, cracked, and sore lips
  • dry skin, eyes, mouth, or nose
  • nosebleeds
  • changes in skin color
  • peeling skin on the palms of the hands and soles of the feet
  • changes in the nails
  • slowed healing of cuts or sores
  • bleeding or swollen gums
  • hair loss or unwanted hair growth
  • sweating
  • flushing
  • voice changes
  • tiredness
  • cold symptoms

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, stop taking isotretinoin and call your doctor or get emergency medical treatment immediately:

  • headache
  • blurred vision
  • dizziness
  • nausea
  • vomiting
  • seizures
  • slow or difficult speech
  • weakness or numbness of one part or side of the body
  • stomach pain
  • chest pain
  • difficulty swallowing or pain when swallowing
  • new or worsening heartburn
  • diarrhea
  • rectal bleeding
  • yellowing of the skin or eyes
  • dark colored urine
  • back, bone, joint or muscle pain
  • muscle weakness
  • difficulty hearing
  • ringing in the ears
  • vision problems
  • painful or constant dryness of the eyes
  • unusual thirst
  • frequent urination
  • trouble breathing
  • fainting
  • fast or pounding heartbeat
  • red, swollen, itchy, or teary eyes
  • fever
  • rash
  • peeling or blistering skin, especially on the legs, arms, or face
  • sores in the mouth, throat, nose, or eyes
  • red patches or bruises on the legs
  • swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
  • difficulty swallowing or pain when swallowing

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.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of 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. http://www.upandaway.org

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. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

  • vomiting
  • flushing
  • severe chapped lips
  • stomach pain
  • headache
  • dizziness
  • loss of coordination

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.

What other information should I know?

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.

Accutane ACCUTANE 10 ROCHE

Accutane ACCUTANE 40 ROCHE

Brand names

  • Absorica®
  • Accutane®
  • Amnesteem®
  • Claravis®
  • Myorisan®
  • Sotret®
  • Zenatane®

This branded product is no longer on the market. Generic alternatives may be available.

Last Revised – 08/15/2018

Effects of Isotretinoin (Accutane) on the Body

Isotretinoin is a drug used to treat severe acne that hasn’t responded to other treatments. It may be prescribed for other uses, including other skin problems and certain kinds of cancer.

This drug is a vitamin A derivative (retinoid), so your body reacts to it in a similar way that it does to vitamin A. Because vitamin A can build up in your tissues, it can quickly become a problem. You shouldn’t take vitamin A supplements while taking isotretinoin.

It can do a good job of clearing up your skin, but there are some potential side effects. Most of these fade within a few weeks after you stop taking it.

The dose is tailored to each person, and treatment usually lasts four to five months. It’s important that you never take more than prescribed.

Isotretinoin is available in a variety of brand names, including Absorica, Amnesteem, Claravis, Myorisan, and Sotret. The original brand, Accutane, is no longer on the market.

Read on to learn about the effects of isotretinoin on the body.

Skin and Hair

Since isotretinoin is designed to treat severe acne, it has a visible effect on the skin. The medication can be very effective in treating severe acne because it targets:

  • clogged pores
  • bacteria
  • inflammation
  • oil production

Unfortunately, when you first start using it, your acne may get worse before it gets better.

Some of the more common side effects include dry skin and chapped lips. You may also have dry nasal passages, which can make your nose bleed.

While taking isotretinoin, your skin will be more sensitive to the sun, so be sure to use sun protection. Don’t use any type of indoor tanning device.

Some people develop fragile skin, rash, or peeling skin on the palms and soles. You may notice a faint yellowing of your skin. Thinning hair is a possibility.

Because your skin can become so fragile, hair removal techniques like waxing, dermabrasion, or laser treatments can lead to scarring. Wait until you’ve been off isotretinoin for six months before having any of these procedures.

Your skin may keep improving for a time after you’ve finished the medication.

Reproductive System

Isotretinoin is dangerous for unborn babies.

Women of childbearing years should take a pregnancy test before starting this medication. You should also use an effective form of birth control, plus a backup method.

You shouldn’t get pregnant for four weeks after you stop taking it. If you do get pregnant, stop taking the medication and tell your doctor right away.

Taking isotretinoin during pregnancy can cause miscarriage, death of the fetus, or premature birth. It can also lead to severe birth defects such as:

  • small or missing ears
  • hearing loss
  • small eyes, which is called microphthalmia
  • missing eyes
  • a small or missing thymus gland, which is responsible for making white blood cells
  • a cleft palate
  • congenital heart defects

It can also cause a buildup of fluid and pressure on the brain called hydrocephalus. This can lead to intellectual disabilities.

Babies may be born with an underdeveloped brain and small head, which is called microcephaly. This can lead to intellectual and developmental disabilities.

Men who take isotretinoin may have some of the drug in their semen. It’s not clear if that can cause birth defects. It’s also unclear whether the drug passes to your baby through breast milk. You shouldn’t breastfeed while taking it.

Anyone who plans on taking isotretinoin must register with iPLEDGE. The FDA-approved restricted distribution program is designed to inform people about the risks of birth defects and to prevent pregnancy while taking the drug.

Central Nervous System

Isotretinoin can affect your central nervous system. Some potential side effects include headaches and tiredness.

You may have dry eyes or have trouble seeing in the dark. Some people have ringing in the ears or hearing loss. In some cases, hearing loss can become permanent.

Isotretinoin can cause increased pressure in your brain, which is a life-threatening condition. Symptoms of increasing brain pressure include:

  • severe headache
  • blurred vision
  • dizziness
  • nausea
  • vomiting
  • seizures
  • stroke

Some people go through mood changes, such as irritability or sadness.

There’s a potential for serious mental health problems, including depression, psychosis, and suicidal thoughts. Warning signs include emotional outbursts, withdrawal, and seeing or hearing things that aren’t real. Get medical help immediately if you have any of these symptoms.

Any medication can cause an allergic reaction. Symptoms include hives, swelling of the mouth or face, or breathing problems. You should see your doctors if you think you’re having an allergic reaction to your medication.

Digestive and Excretory Systems

Isotretinoin can cause problems all along the digestive tract. Some side effects include:

  • bleeding gums
  • a lack of appetite
  • heartburn
  • stomach pain
  • bowel pain
  • dark urine
  • nausea
  • vomiting
  • diarrhea
  • rectal bleeding

These symptoms could indicate damage to your:

  • esophagus
  • pancreas
  • liver
  • intestines

Your doctor may need to monitor your liver and cholesterol levels while you’re taking this medication.

Blood, Bones, and Muscles

While taking isotretinoin, your red and white blood cell counts may decrease. Symptoms include feeling faint and having difficulty breathing.

Isotretinoin can build up in your bloodstream. You may develop problems with blood sugar and lipid levels.

Because of the danger to pregnant women, you shouldn’t donate blood while taking this medication or for a full month after you stop taking it.

The side effects of isotretinoin can also include pain in the:

  • bones
  • joints
  • muscles
  • ligaments

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