November 22, 2014
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Accutane Roche

(isotretinoin)

DIN (Drug Identification Number)

00582344 ACCUTANE 10MG CAPSULE
00582352 ACCUTANE 40MG CAPSULE

How does Accutane Roche work? What will it do for me?

Isotretinoin is a vitamin A derivative that belongs to the class of medications called retinoids. Retinoids are usually used to treat skin problems. Isotretinoin is used to treat severe types of acne, such as nodular or inflammatory acne, where other medications with less potential for severe side effects have failed to help. It may also be used to treat acne conglobata and recalcitrant acne.

Isotretinoin helps to reduce sebum production, which is often associated with bacteria that contributes to acne. In many cases, it can produce remission of the acne condition.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use Accutane Roche?

The usual starting daily dose is 0.5 mg per kilogram of body weight taken daily for a period of 2 to 4 weeks. Based on body weight, severity of acne, and your response to the medication, your doctor will then adjust your dose. Isotretinoin should be taken as a single dose or in 2 divided doses during the day.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Your acne may get worse temporarily, before it gets better. Your doctor will adjust your daily dose after the initial treatment to between 0.1 mg and 1 mg per kilogram of body weight depending on your response to the medication.

Food increases the amount of medication available to the body. It also helps to reduce upset stomach. For these reasons, isotretinoin medication should be taken with food

The first signs of healing usually occur after 2 to 3 weeks of treatment, however, it may take 1 or 2 months before you see beneficial effects. The complete course of treatment usually lasts 12 to 16 weeks. Most people with severe acne notice a marked improvement after 1 or 2 courses of treatment. You may continue to see even more improvement in your acne condition for several months after you have stopped taking the medication.

If any of your side effects do not clear up in a few weeks after you stop taking your medication, speak to your doctor. Be sure to read the patient information that comes with each package of medication.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, in the original package, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.





What form(s) does Accutane Roche come in?

10 mg
Each brown-red, opaque, oval-shaped, soft gelatin capsule, imprinted "ROA 10" contains isotretinoin 10 mg. Nonmedicinal ingredients: beeswax, black iron oxide, hydrogenated hydrolyzed starch, gelatin, glycerol, hydrogenated soybean oil, propylene glycol, red iron oxide, mannitol, partially hydrogenated soybean oil, shellac, sorbitol, soybean oil, and titanium dioxide.

40 mg
Each yellow, opaque, oval-shaped, soft gelatin capsule, imprinted "ROA 40" contains isotretinoin 40 mg. Nonmedicinal ingredients: beeswax, black iron oxide, gelatin, glycerol, hydrogenated soybean oil, methylparaben, partially hydrogenated soybean oil, propylene glycol, propylparaben, quinoline yellow WS, shellac, soybean oil, sunset yellow FCF, and titanium dioxide.

Who should NOT take Accutane Roche?

Do not take isotretinoin if you:

  • are allergic to isotretinoin or any ingredients of the medication
  • are breast-feeding
  • are pregnant
  • are taking tetracycline antibiotics (e.g., tetracycline, doxycycline, minocycline)
  • have excessively high blood cholesterol levels
  • have excessively high levels of vitamin A
  • have reduced kidney or liver function

Isotretinoin should not be taken by women who may become pregnant unless all of the following conditions apply:

  1. You have severe disfiguring nodular or inflammatory acne, acne conglobata, or recalcitrant acne that has not responded to standard therapy, including systemic antibiotics.
  2. You are reliable in understanding and carrying out instructions.
  3. You are able to comply with the mandatory birth control measures for at least one month before, during, and at least one month after treatment.
  4. You have received, and acknowledged understanding of, a careful oral and printed explanation of the hazards of fetal exposure to isotretinoin, and the risk of possible birth control failure.
  5. You have been informed and understand the need to quickly consult your doctor if there is a risk that you may be pregnant.
  6. You understand the need for monthly follow-up.
  7. You use effective birth control without any interruption for one month before, during, and for one month after stopping isotretinoin. You are aware that 2 reliable forms of birth control should be used at the same time.
  8. You have had a blood or urine pregnancy test with a negative result, performed in a licensed laboratory, within 2 weeks prior to initiating therapy. You have had 2 or 3 days of your next normal menstrual period before isotretinoin therapy is initiated.
  9. If you require additional treatment with isotretinoin in the future, you must also follow the same requirement for birth control before, during and after taking isotretinoin.

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