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What is the dosage for isotretinoin?
- The recommended dose of isotretinoin is 0.5 to 2 mg per kg of body weight daily.
- The daily dose usually is administered in two divided doses for 15-20 weeks.
- Isotretinoin should be taken with food in order to improve its absorption.
Indications and Usage for Accutane
Severe Recalcitrant Nodular Acne
Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition,2 means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Accutane is indicated only for those female patients who are not pregnant, because Accutane can cause severe birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS).
A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, and Premature Epiphyseal Closure).
MEDICATION GUIDE Accutane (ACK-u-tane) (isotretinoin capsules)
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.
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.
- Because Accutane can cause birth defects, Accutane is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE program.
- Accutane may cause serious mental health problems.
- for 1 month before starting Accutane
- while taking Accutane
- for 1 month after stopping Accutane.
- FDA MedWatch at 1-800-FDA-1088, and
- the iPLEDGE pregnancy registry at 1-866-495-0654
- 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.
- 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?
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 cause serious side effects (see "What is the most important information I should know about Accutane?"). Accutane can only be:
- prescribed by doctors that are registered in the iPLEDGE program
- dispensed by a pharmacy that is registered with the iPLEDGE program
- given to patients who are registered in the iPLEDGE program and agree to do everything required in the program
What is severe nodular acne?
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.
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 "What is the most important information I should know about Accutane?"
- Do not take Accutane if you are allergic to anything in it. Accutane contains parabens as the preservative. See the end of this Medication Guide for a complete list of ingredients in Accutane.
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
- liver disease
- 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. Accutane must not be used by women who are pregnant or breastfeeding.
Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Accutane and certain other medicines can interact with each other, sometimes causing serious side effects. 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.
- St. John's Wort. This herbal supplement may make birth control pills work less effectively.
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.
How should I take Accutane?
- You must take Accutane exactly as prescribed. You must also follow all the instructions of the iPLEDGE program. Before prescribing Accutane, your doctor will:
- explain the iPLEDGE program to you
- have you sign the Patient Information/Informed Consent (for all patients). Female patients who can get pregnant must also sign another consent form.
You will not be prescribed Accutane if you cannot agree to or follow all the instructions of the iPLEDGE program.
- You will get no more than a 30-day supply of Accutane at a time. This is to make sure you are following the Accutane iPLEDGE program. 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 Accutane 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 2 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.
- You must return to your doctor as directed to make sure you don't have signs of serious side effects. Your doctor may do blood tests to check for serious side effects from Accutane. Female patients who can get pregnant will get a pregnancy test each month.
- Female patients who can get pregnant must agree to use 2 separate forms of effective birth control at the same time 1 month before, while taking, and for 1 month after taking Accutane. You must access the iPLEDGE system to answer questions about the program requirements and to enter your 2 chosen forms of birth control. To access the iPLEDGE system, go to www.ipledgeprogram.com or call 1-866-495-0654.
You must talk about effective birth control methods 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 2 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 1 month after stopping Accutane. See "What is the most important information I should know about Accutane?"
- Do not breast feed while taking Accutane and for 1 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 1 month after stopping Accutane. If someone who is pregnant gets your donated blood, her 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. See "What should I tell my doctor before taking Accutane?"
- Do not drive at night until you know if Accutane has affected your vision. 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. See "What is the most important information I should know about Accutane?"
- Accutane may cause serious mental health problems. See "What is the most important information I should know about Accutane?"
- 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 doctor right away if you get any of these signs of increased brain pressure:
- bad headache
- blurred vision
- nausea or vomiting
- seizures (convulsions)
- skin problems. Skin rash can occur in patients taking Accutane. In some patients a rash can be serious. Stop using Accutane and call your doctor right away if you develop conjunctivitis (red or inflamed eyes, like "pink eye"), a rash with a fever, blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes, or if your skin begins to peel.
- stomach area (abdomen) problems. 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
- 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 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.
- hearing problems. 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.
- vision problems. 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.
- 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 doctor 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 doctor if you are very thirsty or urinate a lot.
- decreased red and white blood cells. Call your doctor if you have trouble breathing, faint, or feel weak.
- The common, less serious side effects of Accutane are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Call your doctor if you get any side effect that bothers you or that does not go away.
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. You may report side effects to FDA at 1-800-FDA-1088 or Roche at 1-800-526-6367.
How should I store Accutane?
- Store Accutane at room temperature, between 59° and 86°F. Protect from light.
- Keep Accutane and all medicines out of the reach of children.
General Information about Accutane
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 health care professionals. You can also call iPLEDGE program at 1-866-495-0654 or visit www.ipledgeprogram.com.
What are the ingredients in Accutane?
Active Ingredient: Isotretinoin
Inactive Ingredients: beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg iron oxide (red) and titanium dioxide; 20 mg FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 40 mg FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Dilantin is a registered trademark of Warner-Lambert Company LLC.
Roche Laboratories Inc.
340 Kingsland Street
Nutley, New Jersey 07110-1199
PI Revised: January 2010
Copyright © 2000-2010 by Roche Laboratories Inc. All rights reserved.
Representative sample of labeling (see the HOW SUPPLIED section for complete listing):
Accutane Drug Class
Accutane is part of the drug class:
Retinoids for topical use in acne
If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.
If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
What should i discuss with my healthcare provider before taking isotretinoin (amnesteem, claravis, sotret)?
Isotretinoin is available only under a special program called iPLEDGE. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program. Ask your doctor or call the drug maker if you have questions about the program or the written requirements.
It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States. The sale and distribution of isotretinoin outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.
Do not use this medication if you are allergic to isotretinoin or to parabens, or if you are pregnant or may become pregnant.
To make sure you can safely take isotretinoin, tell your doctor if you have any of these other conditions:
- a personal or family history of depression or mental illness;
- heart disease, high cholesterol or triglycerides;
- osteoporosis or other bone disorders;
- an intestinal disorder such as inflammatory bowel disease, ulcerative colitis, or Crohn's disease;
- an eating disorder (anorexia nervosa); or
- liver disease.
Isotretinoin can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use isotretinoin if you are pregnant.
For Women: Unless you have had your uterus and ovaries removed (total hysterectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential.
Even women who have had their tubes tied are required to use birth control while taking isotretinoin.
You must have a negative pregnancy test 30 days before you start taking isotretinoin. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of isotretinoin, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.
You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking isotretinoin and ending 30 days after you stop taking it. Both a primary and a secondary form of birth control must be used together.
Primary forms of birth control include:
- tubal ligation (tubes tied);
- vasectomy of the male sexual partner;
- an IUD (intrauterine device);
- estrogen-containing birth control pills (not mini-pills); and
- hormonal birth control patches, implants, injections, or vaginal ring.
Secondary forms of birth control include:
- a male latex condom plus spermicidal foam or gel;
- a diaphragm plus spermicidal foam or gel;
- a cervical cap plus spermicidal foam or gel; and
- a vaginal sponge containing spermicide.
Stop using isotretinoin and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant. If you get pregnant while taking isotretinoin, call the iPLEDGE pregnancy registry at 1-866-495-0654.
It is not known whether isotretinoin passes into breast milk. Do not take isotretinoin without first talking to your doctor if you are breast-feeding a baby.
What should i avoid while taking isotretinoin (amnesteem, claravis, sotret)?
Do not take vitamin supplements containing vitamin A while you are taking isotretinoin.
Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it. Donated blood that is later given to pregnant woman could lead to birth defects in her baby if the blood contains any level of isotretinoin.
Do not use wax hair removers or have dermabrasion or laser skin treatments while you are taking isotretinoin and for at least 6 months after you stop taking it. Scarring may result.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Isotretinoin can make your skin more sensitive to sunlight and sunburn may result.
Isotretinoin may impair your vision, especially at night. Be careful if you drive or do anything that requires you to see clearly.
Where can i get more information?
Your pharmacist can provide more information about isotretinoin.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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What happens if I miss a dose?
Skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling under the skin, swelling of the lips, and loss of balance or coordination.
For the Consumer
Applies to isotretinoin: oral capsule, oral capsule liquid filled
Along with its needed effects, isotretinoin (the active ingredient contained in Accutane) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking isotretinoin:More common
- Bone or joint pain
- burning, redness, itching, or other signs of eye inflammation
- difficulty with moving
- scaling, redness, burning, pain, or other signs of inflammation of the lips
- skin infection or rash
- Abdominal or stomach pain (severe)
- attempts at suicide or thoughts of suicide (usually stops after medicine is stopped)
- back pain
- bleeding or inflammation of the gums
- blurred vision or other changes in vision
- changes in behavior
- decreased vision after sunset or before sunrise (sudden or may continue after medicine is stopped)
- diarrhea (severe)
- headache (severe or continuing)
- mental depression
- nausea and vomiting
- pain or tenderness of the eyes
- pain, tenderness, or stiffness in the muscles (long-term treatment)
- rectal bleeding
- yellow eyes or skin
- Black, tarry stools
- bloody cough
- bloody or cloudy urine
- bone pain, tenderness, or aching
- burning or stinging of the skin
- chest pain
- cough or hoarseness
- dark-colored urine
- decrease in height
- difficulty breathing
- difficulty speaking
- difficulty swallowing
- discharge from the eyes
- double vision
- ear pain
- excessive tearing
- fast, irregular, pounding, or racing heartbeat or pulse
- fever with or without chills
- fractures and/or delayed healing
- high blood pressure
- hives or skin rash
- inability to move the arms, legs, or facial muscles
- inability to speak
- inflamed tissue from infection
- irregular yellow patch or lump on the skin
- joint pain, redness, stiffness, or swelling
- lack or slowing of normal growth in children
- loosening of the fingernails
- loss of appetite
- loss of bladder control
- loss or change in hearing
- muscle cramps, spasms, or weakness
- pain in the ribs, arms, or legs
- pain or burning in the throat
- pain or tenderness around the eyes and cheekbones
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- painful or difficult urination
- pains in the chest, groin, or legs, especially calves of the legs
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- pinpoint red spots on the skin
- redness or soreness around the fingernails
- redness, soreness, or itching skin
- sensitivity of the eyes to sunlight
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- stuffy or runny nose
- sudden loss of consciousness
- sudden loss of coordination
- sudden onset of severe acne on the chest and trunk
- sudden onset of slurred speech
- swelling of the eyelids, face, lips, hands, lower legs, or feet
- swollen, painful or tender lymph glands in the neck, armpit, or groin
- tightness in the chest
- unusual bleeding or bruising
- unusual weight gain or loss
- use of extreme physical or emotional force
- watery or bloody diarrhea
Some side effects of isotretinoin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Crusting of the skin
- difficulty in wearing contact lenses (may continue after medicine is stopped)
- dryness of the eyes (may continue after treatment is stopped)
- dryness of the mouth or nose
- dryness or itching of the skin
- headache (mild)
- increased sensitivity of the skin to sunlight
- peeling of the skin on palms of the hands or soles of the feet
- stomach upset
- thinning of the hair (may continue after treatment is stopped)
- Abnormal menstruation
- burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling
- changes in fingernails or toenails
- continuing ringing or buzzing, or other unexplained noise in the ears
- darkening of the skin
- hair abnormalities
- hair loss
- increased hair growth, especially on the face
- lightening of normal skin color
- lightening of treated areas of dark skin
- oily skin
- redness of the face
- severe sunburn
- skin rash, encrusted, scaly and oozing
- stomach burning
- trouble sleeping
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- unusually warm skin of the face
- voice changes