20mg, 100 tablets per bottle
Manufactured By: Genomex Pharma

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?

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.

There may be temporary worsening of acne 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 to take this medication 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.

Who should NOT take Accutane?

Do not take this medication 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:

You have severe disfiguring nodular or inflammatory acne, acne conglobata, or recalcitrant acne that has not responded to standard therapy, including systemic antibiotics.
You are reliable in understanding and carrying out instructions.
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.
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.
You have been informed and understand the need to quickly consult your doctor if there is a risk that you may be pregnant.
You understand the need for monthly follow-up.
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.
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.
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.

What side effects are possible with Accutane?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

difficulty in wearing contact lenses (may continue after treatment is stopped)
dry eyes (may continue after treatment is stopped)
dry or itchy skin
dry mouth or nose
headache (mild)
increased sensitivity of skin to sunlight
pain or tenderness of eyes
peeling of skin on palms of hands or soles of feet
stomach upset
thinning of hair (may continue after treatment is stopped)
unusual tiredness
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

attempts at suicide or thoughts of suicide (usually stops after medication is stopped)
back pain
bleeding or inflammation of gums
blurred vision or other changes in vision
bone or joint pain
burning, redness, itching, or other signs of eye inflammation
changes in behaviour
decreased hearing
decreased vision after sunset or before sunrise (sudden or may continue after medication is stopped)
difficulty in moving
headache (severe or continuing)
nausea and vomiting
pain, tenderness, or stiffness in muscles (long-term treatment)
ringing in the ears
scaling, redness, burning, pain, or other signs of inflammation of lips
signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
signs of inflammatory bowel disease (e.g., severe abdominal or stomach pain, severe diarrhea, rectal bleeding)
signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
skin infection or rash
Stop taking the medication and seek immediate medical attention if any of the following occur:

signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.



Are there any other precautions or warnings for Accutane?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Behaviour changes and suicidal thoughts: Some people taking this medication have experienced depression, including thoughts of suicide. If you experience any behaviour change or symptoms such as sad mood, hopelessness, feelings of guilt, loss of pleasure or interest in activities, changes in sleep pattern, irritability, or restlessness while taking this medication, contact your doctor immediately.

Family members or caregivers of people who are taking this medication should contact the person’s doctor immediately if they notice unusual behaviour changes.

Blood donation: You should not give blood during treatment with isotretinoin and for one month after stopping treatment in case the blood is given to a pregnant woman.

Bones and joints: Isotretinoin may cause some minor bone changes. Talk to your doctor if you notice aches or pains in the bones or joints, or have difficulty moving. Your doctor may monitor you for bone changes while you are taking this medication.

Cholesterol: Isotretinoin can cause increases in cholesterol and other lipids in the blood. If you are already at an increased risk of developing high cholesterol, for example if you have a family history of high cholesterol, diabetes, are overweight, or have an increased alcohol intake, you are more likely to experience this.

If you are at any increased risk of developing increased blood lipids, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Diabetes: Isotretinoin may cause a loss of control of blood sugar levels for people with diabetes. If you have diabetes, or anyone in your family has diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You may need to check your blood glucose levels more often.

Liver disease: Several cases of hepatitis (inflammation of the liver) have been reported that are considered to be possibly or probably related to isotretinoin therapy.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Medical conditions: Isotretinoin may rarely cause other conditions. Report to your doctor any headaches, nausea, vomiting, blurred vision, changes in mood, severe stomach pain, diarrhea, or rectal bleeding. You should not use isotretinoin if you have reduced kidney or liver function.

Neurologic: Isotretinoin has been linked to causing intracranial hypertension, also known as pseudotumor cerebri. Early symptoms of this condition include headache, nausea, vomiting, and visual disturbances. If you have these symptoms call your doctor immediately.

Night vision: Decreased night vision has been reported during isotretinoin therapy. Because some patients experienced sudden onset, use caution when driving or operating any vehicle at night. Report any vision changes to your doctor.

Psychiatric: Some patients treated with isotretinoin have become depressed and attempted or committed suicide. Talk to you doctor if you think you are at risk for developing depression.

Skin care: Isotretinoin causes irritated, dry skin and lips. Ask your doctor or pharmacist for appropriate moisturizers and lip balms to use to prevent severe dryness. While you are taking isotretinoin, avoid exfoliators, waxing and dermabrasion.

Sun sensitivity: Isotretinoin may make you more likely to burn in the sun. Use appropriate measures to prevent excessive exposure to the sun. These include wearing a hat and sunglasses when out in the sun, using a sunscreen that provides an SPF of 15 or more, and avoiding going out in the sun between 10 am and 2 pm when the sun is at its strongest.

Vitamin supplements: You should not take vitamin supplements containing vitamin A if you also take isotretinoin as this may increase the side effects of vitamin A. Talk to your doctor or pharmacist if you are not sure which of your supplements might contain vitamin A.

Pregnancy: Isotretinoin causes severe birth defects in an extremely high percentage of infants born to women who take this medication even for a short period of time during pregnancy.

Isotretinoin must not be used during pregnancy. Women must not become pregnant while taking isotretinoin or for at least one month after stopping the medication. Your doctor may routinely perform pregnancy tests while you are taking isotretinoin to confirm the safety of continuing to take this medication.

Women who may become pregnant must not be given isotretinoin until pregnancy is excluded. A pregnancy test must be performed within 11 days of starting treatment. Isotretinoin treatment should start on the second or third day of the next normal menstrual period following this negative pregnancy test. Effective birth control must be used for at least one month before starting isotretinoin treatment, during the treatment, and for at least one month following the discontinuation of treatment.

Two reliable forms of birth control should be used at the same time during treatment unless abstinence is the chosen method.

Breast-feeding: It is not known if isotretinoin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding. Because of the potential for side effects, women should consider not breast-feeding if they take isotretinoin.

Children: The long-term safety of using this medication have not been established for children under 12 years of age.

Seniors: The use of isotretinoin by seniors has not been well studied. It is likely that seniors would be at an increased risk for side effects from this medication.

What other drugs could interact with Accutane?

There may be an interaction between isotretinoin and any of the following:

corticosteroids (e.g., prednisone)
St. John’s wort
tetracycline antibiotics (e.g., doxycycline, minocycline, tetracycline)
vitamin A
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

stop taking one of the medications,
change one of the medications to another,
change how you are taking one or both of the medications, or
leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.