Accutane - Consumer Medicine Information
|Class:||Miscellaneous antineoplastics, Miscellaneous uncategorized agents|
|Ingredients:||Isotretinoin, beeswax, black iron oxide, gelatin, glycerol, hydrogenatedhydrolysed starch, hydrogenated soybean oil, mannitol,partially hydrogenated soybean oil, propylene glycol, rediron oxide, shellac, sorbitol, soybean oil, titaniumdioxide|
About This Medication
What the Medication is Used For
ACCUTANE is a medicine used to treat severe acne (nodularand or inflammatory acne) that cannot be cleared up by otheracne treatments, including antibiotics.
What it Does
- The mechanism of action of ACCUTANE is not known. Itis believed to act on the sebaceous glands (oil/waxproducing glands) to reduce sebum excretion. This mayindirectly reduce bacterial activity associated with acneand improve the condition.
- ACCUTANE contains the active ingredient isotretinoin.This is a vitamin A derivative, belonging to the retinoidclass of medicines. Retinoids are normally used to treatskin problems.
- During the first few weeks of treatment, your acne mayseem to get worse. Redness and itching of the affectedskin are common initial effects. These should disappear asyou continue to take ACCUTANE. Most often, the firstsigns of healing occur after two to three weeks oftreatment. It may take one to two months before beneficialeffects are seen. Most patients with severe acne notice amarked improvement after one or two courses of treatmentwith ACCUTANE.
When it Should Not be Used
- Do not use if pregnant
- Do not get pregnant while taking ACCUTANE and stoptaking immediately if you do get pregnant (SeeSERIOUS WARNINGS AND PRECAUTIONS)
- Do not breast feed while taking ACCUTANE and for 1month after stopping ACCUTANE. ACCUTANE maypass through your milk and harm the baby.
- Do not take tetracyclines with ACCUTANE. For someantibiotics, you may have to stop taking ACCUTANE untilthe antibiotic treatment is finished. Use of tetracyclineswith ACCUTANE together can increase the chances ofgetting increased pressure in the brain. Certain antibioticsinterfere with the effectiveness of birth control pills.
- Do not take Vitamin A supplements. Vitamin A in highdoses has many of the same side effects as ACCUTANE.Taking both together may increase your chance of gettingside effects.
- Do not take ACCUTANE if you have liver or kidneydisease.
- Do not take ACCUTANE if you have high blood fat (lipid)levels.
- Do not take ACCUTANE if you are sensitive to retinoids,or hydrogenated soybean oil, parabens, partiallyhydrogenated soybean oil, soybean oil, or any other nonmedicinal ingredient listed under: What the non-medicinalingredients are:
What the Medicinal Ingredient Is
What the Non-medicinal Ingredients Are
ACCUTANE 10 mg capsules:beeswax, black iron oxide, gelatin, glycerol, hydrogenatedhydrolysed starch, hydrogenated soybean oil, mannitol,partially hydrogenated soybean oil, propylene glycol, rediron oxide, shellac, sorbitol, soybean oil, titaniumdioxide.
ACCUTANE 40 mg capsules:beeswax, black iron oxide, gelatin, glycerol, hydrogenatedsoybean oil, methylparaben, partially hydrogenatedsoybean oil, propylene glycol, propylparaben, quinolineyellow WS, shellac, soybean oil , sunset yellow FCF,titanium dioxide.
What Dosage Forms it Comes In
ACCUTANE capsules 10 mg and 40 mg are available in blisterpackages of 30 capsules.
Warnings and Precautions
ACCUTANE can cause serious side effects. Before startingACCUTANE, discuss with your doctor how bad your acne is, thepossible benefits of ACCUTANE, and its possible side effects, todecide if ACCUTANE is right for you. Your doctor will ask youto read and sign a form indicating you understand some of theserious risks of ACCUTANE.
Possible serious side effects of taking ACCUTANE includebirth defects and mental health problems.
Serious Warnings and Precautions
All patients must sign the informed consent form prior toinitiating therapy.
Birth defects: ACCUTANE can cause birth defects (deformedbabies).It can also cause miscarriage, premature birth, ordeath of the baby. Therefore, adequate birth controlmeasures are essential when taking ACCUTANE. See What are the important warnings for females takingACCUTANE?
Mental health problems and suicide: Some patients, while taking ACCUTANE or soon afterstopping ACCUTANE, have become depressed ordeveloped other serious mental health problems. Signs ofthese problems include feelings of sadness, irritability,unusual tiredness, trouble concentrating, and loss ofappetite. Some patients taking ACCUTANE have hadthoughts about putting an end to their own lives (suicidalthoughts), tried to end their own lives, and some peoplehave ended their own lives. There were reports that someof these people did not appear depressed. There havebeen reports of patients on ACCUTANE becomingaggressive or violent.No one knows if ACCUTANE caused these behaviours orif they would have happened even if the person did nottake.
For other possible serious side effects of ACCUTANE,see: Serious Side Effects and What to do AboutThem table.
There have been reports of serious skin reactions occurringwith the use of ACCUTANE, such as erythema multiforme(EM), Stevens-Johnson Syndrome (SJS) and toxic epidermalnecrolysis (TEN) which can result in hospitalization, disabilityand/or death.
Stop using ACCUTANE and call your doctor immediately ifyou develop a serious skin reaction with symptoms such asblisters, peeling skin, severe red/purple rash, multiple lesionsand sores, particularly in your mouth, nose, eyes and genitals,as well as facial and tongue swelling.
What are the Important Warnings for Females Taking Accutane
- Do not take ACCUTANE if you are pregnant
- If you become pregnant, stop taking ACCUTANE andcontact your doctor immediately
- ACCUTANE can cause deformed babies. There is anextremely high risk that your baby will be deformed ifyou are pregnant while taking ACCUTANE. This riskexists even if ACCUTANE is taken for a short time. Ifyou are a female of childbearing potential, yourphysician should have discussed this risk with you, and explained how to avoid becoming pregnant while takingACCUTANE.
- You must avoid becoming pregnant while you are takingACCUTANE and for at least one month after you stoptaking ACCUTANE.
- You must discuss effective birth control with your doctorbefore beginning ACCUTANE treatment, and you mustuse effective birth control:
- For at least one month before you startACCUTANE;
- While you are taking ACCUTANE; and
- For at least one month after you stop takingACCUTANE;
- It is recommended that you either abstain from sexualintercourse or use two reliable methods of birth controlat the same time, even if you have a history of infertilityor are not sexually active.
- Do not take ACCUTANE until you are sure that you arenot pregnant.
- You must have two negative pregnancy tests, one of themmust be done in a lab, before you start ACCUTANE andbe assessed on a monthly basis while on the drug and onemonth after the termination of ACCUTANE. If yourmenstrual period is abnormal in length and intensity,first contact your doctor. (see the ACCUTANEPREGNANCY PREVENTION PLAN)
- You must wait until the second or third day of your nextnormal menstrual period before you start ACCUTANE.
- Stop taking ACCUTANE and contact your doctorimmediately if you do become pregnant while takingACCUTANE or during the first month after treatmenthas stopped, if you miss your period, or if you havesexual intercourse without using effective birth control.You should discuss with your doctor the serious risk ofyour baby having severe birth deformities because youare taking or have taken ACCUTANE. You should alsodiscuss the desirability of continuing with yourpregnancy.
- Do not breast feed while taking ACCUTANE.
You should have been counseled using the manufacturersPREGNANCY PREVENTION PLAN which includes:
- Comprehensive information about the risks of this drug
- A line drawing of a deformed baby
- A checklist of criteria you had to meet before receiving thisdrug
- Detailed information on birth control options
- A chart: ACCUTANE PREGNANCY PREVENTIONPLAN
- A chart: ACCUTANE PREGNANCY PREVENTIONPLAN
Please note that the manufacturer of ACCUTANE providesconfidential contraception counseling (from a health care professional). For more information, please contact HoffmannLa Roche Limited.
If you were not counseled using the PREGNANCYPREVENTION PLAN, please contact your doctor for moreinformation.
All patients should read the rest of this ConsumerInformation.
Do not take ACCUTANE unless you completely understandits possible risks and are willing to follow all of theinstructions in this Consumer Information.
What Should You Tell Your Doctor Before Starting Accutane
- Tell your doctor if you or someone in your family has everhad any mental illness, including depression, suicidalbehaviour, or psychosis. Psychosis means a loss of contactwith reality, such as hearing voices or seeing things thatare not there. Also, you should tell your doctor if you aretaking medicines for any of these problems.
- Tell your doctor if you or any member of your family haveliver disease, kidney disease, heart disease or highcholesterol or, diabetes or asthma.
- Tell your doctor if you plan vigorous physical activityduring treatment with ACCUTANE.
- Tell your doctor if you have any food or drug allergies.
- Tell your doctor if you are taking any vitamin preparationsor health food supplements that contain Vitamin A.
- Tell your doctor the brand of contraceptives you are taking.There are certain types of contraceptives that should not betaken while on ACCUTANE.
- Tell your doctor if you are taking an antibiotic (particularlytetracyclines).
What Should You Avoid While Taking Accutane
- Do not give blood while you take ACCUTANE and for 1month after stopping ACCUTANE. If someone who ispregnant gets your donated blood, her baby may beexposed to ACCUTANE and may be born with birthdefects.
- Do not have cosmetic procedures to smooth your skin,such as waxing, dermabrasion, or laser procedures, while you are using ACCUTANE and for at least 6months after you stop.ACCUTANE can increase yourchance of scarring or inflammation of the skin from theseprocedures. Check with your doctor for advice about whenyou can have cosmetic procedures.
- Avoid the use of artificial ultraviolet lights such as theones used in tanning machines and protect yourself fromexcessive sunlight. ACCUTANE may make your skin moresensitive to ultraviolet light. When necessary, sunscreenwith a high protection factor of at least SPF 15 should beused
- Avoid the use of exfoliative anti-acne agents
- Do not share ACCUTANE with other people.It can causebirth defects and other serious health problems.
- Do not take Vitamin A
- Do not take antibiotics unless you have discussed withyour doctor. See When it should not be used
Interactions with This Medication
- Do not use low dose birth control pills. They may not workwhile you take ACCUTANE.
- The following medications may interact with ACCUTANEor ACCUTANE may interfere with the actions of: low-dosecontraceptives, antibiotics, corticosteroids, phenytoin, andnatural health products such as herbs (i.e., St. Johns Wort)
Proper Use of this Medication
If you are of child bearing age, your doctor will limit yourACCUTANE prescription to 30 days, so that continuedtreatment will require a new prescription.
- Read your prescription label carefully and be sure to take theexact amount of medicine prescribed by your doctor. Yourdoctor may change your prescribed dose from time to time,therefore, it is important that you check the label each timeyou fill your ACCUTANE prescription. If you have anyquestions, call your doctor.
- Take ACCUTANE with food or just after a meal.
- Be sure to return to your doctor as scheduled. It is importantfor your doctor to see you regularly, every month, when youare taking ACCUTANE. Blood tests and other tests allowyour doctor to check your response to ACCUTANE. Discussyour progress and any concerns with your doctor.
|In case of an overdose or suspected overdose, contactyour doctor, hospital emergency department or theregional poison control centre, even if there are nosymptoms.|
If you forget to take a dose of ACCUTANE it may be takenlater the same day, but, do not take more ACCUTANE in oneday than your doctor has prescribed.
Do not double dose.
Side Effects and What to Do About Them
Serious side effects you must immediately tell your doctorabout:
ACCUTANE may cause serious side effects. Stop takingACCUTANE and call your doctor right away if you or a familymember notices that you have any of the following signs andsymptoms, listed in the table below:
Serious Side Effects and What to Do About Them
your doctor or
|Signs of mental health problems such as depression or psychosis (a severe mental disturbance)||
|Signs ofinflammationof the liver,pancreas orintestine(bowel)||
|Signs of Boneand MuscleChanges||
|Signs ofincreasedpressure inthe brain||
|Signs ofhearing andvisiondifferences||
|Signs ofproblemswith bloodsugar levels||
ACCUTANE may affect blood fat, cholesterol, or sugar levels. Therefore it is important for you to see your doctor at regularly scheduled visits.
What are the Other Possible Side Effects of Accutane
It is important to watch for the symptoms listed in the tableabove as these may be signs of serious side effects.
The side effects listed below are generally temporary anddisappear when ACCUTANE treatment is stopped; however,you must tell your doctor if any of your side effects do not clearup in a few weeks after you stop taking ACCUTANE.Youmust also check with your doctor, if these effects becomebothersome, to see if any change in your medication isneeded.
- Some of the most common side effects aredryness ofthe skin, lips, mouth, and lining of the nose. It isrecommended that you use a skin-moisturizing ointment orcream and a lip balm from the start of treatment ofACCUTANE.
- Some other side effects that may occur include: facial orbody rash, flaking of the skin, itching, peeling of the palmsand soles, increased sensitivity to the sun, sunburn,inflammation of the lips, mild nose bleed, bleeding andinflammation of the gums, easily injured skin andincreased fatigue. You may experience some redness,dryness, or irritation of the eyes.
- If you wear contact lenses, you may find themuncomfortable during treatment because ACCUTANE may cause dry eyes. This may continue after treatment hasstopped. Dry eyes can be helped by applying a lubricatingeye ointment or tear replacement therapy.
- In some patients variable amounts of hair loss haveoccurred. In rare cases, this hair loss persisted after treatmentwas completed.
These are not all of the possible side effects associated withACCUTANE. Your doctor or pharmacist can give you moredetailed information that is written for health care professionals.
How to Store It
- Keep out of reach from children.
- ACCUTANE should be stored at 15-30°C. Store in theoriginal package. Protect from exposure to moisture, heatand light.
- ACCUTANE does not need to be refrigerated.
Special Handling Instructions
It is recommended that ACCUTANE not be disposed of inhousehold waste or waste water. Please return any unusedACCUTANE to the pharmacist or use an established "collectionsystem" if available in your location.
Reporting Suspected Side Effects
You can report any suspected adverse reactionsassociated with the use of health products to the CanadaVigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance ProgramHealth CanadaPostal Locator 0701DOttawa, OntarioK1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your healthprofessional. The Canada Vigilance Program does notprovide medical advice.
This Consumer Information is only a summary of someimportant information about ACCUTANE. Medicines aresometimes prescribed for purposes other than those listed in aConsumer Information. If you have any concerns or questionsabout ACCUTANE, ask your doctor. Do not use ACCUTANEfor a condition for which it was not prescribed
This document plus the full product monograph, prepared forhealth professionals can be found at: www.rochecanada.com, or by contacting Hoffmann-LaRoche Limited at: 1-888-762-4388