Accutane

Accutane Medication Information:

Accutane medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.

Accutane 10 mg
Accutane 40 mg

About Accutane

What Accutane is used for

ACCUTANE is a medicine used to treat severe acne (nodular and or inflammatory acne) that cannot be cleared up by other acne treatments, including antibiotics.

What Accutane does

  • The mechanism of action of ACCUTANE is not known. It is believed to act on the sebaceous glands (sweat producing glands) to reduce sebum excretion. This may indirectly reduce bacterial activity associated with acne and improve the condition.

  • ACCUTANE contains the active ingredient isotretinoin. This is a vitamin A derivative, belonging to the retinoid class of medicines. Retinoids are normally used to treat skin problems.

  • During the first few weeks of treatment, your acne may seem to get worse. Redness and itching of the affected skin are common initial effects. These should disappear as you continue to take ACCUTANE. Most often, the first signs of healing occur after two to three weeks of treatment. It may take one to two months before beneficial effects are seen. Most patients with severe acne notice a marked improvement after one or two courses of treatment with ACCUTANE.

When Accutane should not be used

  • Do not use if pregnant.

  • Do not get pregnant while taking ACCUTANE and stop taking immediately if you do get pregnant (see Warnings and Precautions: Serious Warnings and Precautions).

  • Do not breast feed while taking ACCUTANE and for 1 month after stopping ACCUTANE. ACCUTANE may pass through your milk and harm the baby.

  • Do not take tetracyclines with ACCUTANE. For some antibiotics, you may have to stop taking ACCUTANE until the antibiotic treatment is finished. Use of tetracyclines with ACCUTANE together can increase the chances of getting increased pressure in the brain. Certain antibiotics interfere with the effectiveness of birth control pills.

  • Do not 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.

  • Do not take ACCUTANE if you have liver or kidney disease.

  • 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, partially hydrogenated soybean oil, peanut oil, soybean oil, or any other non-medicinal ingredient listed under: “What the important nonmedicinal ingredients are:”.

What the medicinal ingredient is

Isotretinoin.

What the important nonmedicinal ingredients for Accutane are

ACCUTANE 10 mg capsules

beeswax, black iron oxide, canthaxanthin (contains peanut oil), gelatin, glycerol, hydrogenated soybean oil, mannitol, partially hydrogenated soybean oil, shellac, sorbitol, soybean oil, titanium dioxide.

ACCUTANE 40 mg capsules

beeswax, black iron oxide, gelatin, glycerol, hydrogenated soybean oil, methylparaben, partially hydrogenated soybean oil, propylparaben, quinoline yellow WS, shellac, soybean oil, sunset yellow FCF, titanium dioxide.

What dosage forms Accutane comes in

ACCUTANE capsules 10 mg and 40 mg are available in blister packages of 30 capsules.


Warnings and Precautions

ACCUTANE can cause serious side effects. Before starting ACCUTANE, discuss with your doctor how bad your acne is, the possible benefits of ACCUTANE, and its possible side effects, to decide if ACCUTANE is right for you. Your doctor will ask you to read and sign a form indicating you understand some of the serious risks of ACCUTANE.

Possible serious side effects of taking ACCUTANE include birth defects and mental health problems.

Serious Warnings and Precautions

All Females: Birth defects:

ACCUTANE can cause birth defects (deformed babies). It can also cause miscarriage, premature birth, or death of the baby. Therefore, adequate birth control measures are essential when taking ACCUTANE. See What are the important warnings for females taking ACCUTANE?

All Patients: Mental health problems and suicide:

Some patients, while taking ACCUTANE or soon after stopping ACCUTANE, have become depressed or developed other serious mental health problems. Signs of these problems include feelings of sadness, irritability, unusual tiredness, trouble concentrating, and loss of appetite. Some patients taking ACCUTANE have had thoughts about putting an end to their own lives (suicidal thoughts), tried to end their own lives, and some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on ACCUTANE becoming aggressive or violent.

No one knows if ACCUTANE caused these behaviors or if they would have happened even if the person did not take ACCUTANE.

For other possible serious side effects of ACCUTANE, see: “Special symptoms you must immediately tell your doctor about:”.

What are the important warnings for females taking ACCUTANE?

  • Do not take ACCUTANE if you are pregnant.

  • If you become pregnant, stop taking ACCUTANE and contact your doctor immediately.

  • ACCUTANE can cause deformed babies. There is an extremely high risk that your baby will be deformed if you are pregnant while taking ACCUTANE. This risk exists even if ACCUTANE is taken for a short time. If you are a female of childbearing potential, your physician should have discussed this risk with you, and explained how to avoid becoming pregnant while taking ACCUTANE.

  • You must avoid becoming pregnant while you are taking ACCUTANE and for at least one month after you stop taking ACCUTANE.

  • You must discuss effective birth control with your doctor before beginning ACCUTANE treatment, and you must use effective birth control:

    • For at least one month before you start ACCUTANE;

    • While you are taking ACCUTANE; and

    • For at least one month after you stop taking ACCUTANE.

    Bearing in mind that any method of birth control can fail.

  • It is recommended that you either abstain from sexual intercourse or use two reliable methods of birth control at the same time, even if you have a history of infertility or are not sexually active.

  • Do not take ACCUTANE until you are sure that you are not pregnant.

  • You must have two negative pregnancy tests before you start ACCUTANE, be assessed on a monthly basis while on the drug and one month after the termination of ACCUTANE. If your menstrual period is abnormal in length and intensity, first contact your doctor (see the ACCUTANE Pregnancy Prevention Plan, Figure 1).

  • You must wait until the second or third day of your next normal menstrual period before you start ACCUTANE.

  • Stop taking ACCUTANE and contact your doctor immediately if you do become pregnant while taking ACCUTANE or during the first month after treatment has stopped, if you miss your period, or if you have sexual intercourse without using effective birth control. You should discuss with your doctor the serious risk of your baby having severe birth deformities because you are taking or have taken ACCUTANE. You should also discuss the desirability of continuing with your pregnancy.

  • Do not breast feed while taking ACCUTANE.

You should have been counseled using the manufacturer's Pregnancy Prevention Program 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 this drug

  • Detailed information on birth control options

  • A chart: “ACCUTANE Pregnancy Prevention Plan (Figure 1)”

  • An informed consent for you to review and sign

Please note that the manufacturer of ACCUTANE provides confidential contraception counseling (from a health care professional). For more information, please contact Hoffmann-La Roche Limited.

If you were not counseled using the Pregnancy Prevention Program (Figure 1), please contact your doctor for more information.


Figure 1-Accutane RocheACCUTANE Pregnancy Prevention Plan

All patients should read the rest of this Consumer Information.

Do not take ACCUTANE unless you completely understand its possible risks and are willing to follow all of the instructions in this Consumer Information.

What should you tell your doctor before starting ACCUTANE?

  • Tell your doctor if you or someone in your family has ever had any mental illness, including depression, suicidal behavior, or psychosis. Psychosis means a loss of contact with reality, such as hearing voices or seeing things that are not there. Also, you should tell your doctor if you are taking medicines for any of these problems.

  • Tell your doctor if you or any member of your family have liver disease, kidney disease, heart disease or high cholesterol or, diabetes or asthma.

  • Tell your doctor if you plan vigorous physical activity during treatment with ACCUTANE.

  • Tell your doctor if you have any food or drug allergies.

  • Tell your doctor if you are taking any vitamin preparations or 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 be taken while on ACCUTANE.

  • Tell your doctor if you are taking an antibiotic (particularly tetracyclines).

What should you avoid while taking ACCUTANE?

  • 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 have cosmetic procedures to smooth your skin, such as 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 or inflammation of the skin from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.

  • Avoid the use of artificial ultraviolet lights such as the ones used in tanning machines and protect yourself from excessive sunlight. ACCUTANE may make your skin more sensitive to ultraviolet light. When necessary, sunscreen with a high protection factor of at least SPF 15 should be used.

  • Avoid the use of exfoliative anti-acne agents.

  • Do not share ACCUTANE with other people. It can cause birth defects and other serious health problems.

  • Do not take Vitamin A.

  • Do not take antibiotics unless you have discussed with your doctor. See “When it should not be used:”.


Interactions with Accutane

  • Do not use low dose birth control pills. They may not work while you take ACCUTANE.

  • The following medications may interact with ACCUTANE or ACCUTANE may interfere with the actions of: low-dose contraceptives, antibiotics, corticosteroids, phenytoin, and natural health products such as herbs (i.e., St. John's Wort)


Proper Use of Accutane

Usual dose

  • Read your prescription label carefully and be sure to take the exact amount of medicine prescribed by your doctor. Your doctor may change your prescribed dose from time to time, therefore, it is important that you check the label each time you fill your ACCUTANE prescription. If you have any questions, call your doctor.

  • Take ACCUTANE with food or just after a meal.

  • Be sure to return to your doctor as scheduled. It is important for your doctor to see you regularly, every month, when you are taking ACCUTANE. Blood tests and other tests allow your doctor to check your response to ACCUTANE. Discuss your progress and any concerns with your doctor.

Overdose

In cases of overdose or suspected overdose, contact the poison control centre or your doctor immediately.

Missed dose

If you forget to take a dose of ACCUTANE it may be taken later the same day, but, do not take more ACCUTANE in one day than your doctor has prescribed.

Do not double dose.


Side Effects for Accutane and What to Do About Them

 

Technical Information