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. Accutane (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, Accutane (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 Accutane (Isotretinoin) 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 Accutane (Isotretinoin) 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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause dryness and peeling of the skin; it may cause joint pain; it may cause your lips to swell; it may cause nasal dryness; it may make your skin more sensitive to UV rays (e.g., sunlight, tanning lamps) - avoid exposure to UV rays as much as possible and protect yourself when out in the sun; it may irritate your eyes. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

10 mg
Each brown-red, opaque, oval-shaped, soft gelatin capsule, imprinted "ROA 10" contains 10 mg of Accutane (Isotretinoin). 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 40 mg of Accutane (Isotretinoin). 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.

Do not take Accutane (Isotretinoin) if you:

• are allergic to Accutane (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

Accutane (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 Accutane (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 Accutane (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 Accutane (Isotretinoin) therapy is initiated.
• If you require additional treatment with Accutane (Isotretinoin) in the future, you must also follow the same requirement for birth control before, during and after taking Accutane (Isotretinoin).

There may be an interaction between Accutane (Isotretinoin) and any of the following:

• acitretin
• alcohol
• birth control pills (estrogen/progestin)
• Carbamazepine
• corticosteroids (e.g., Prednisone)
• multivitamins with vitamin A
• Phenytoin
• Porfimer
• St. John's wort
• tetracycline antibiotics (e.g., doxycycline, minocycline, tetracycline)
• tigecycline
• tretinoin
• 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 Accutane (Isotretinoin). 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.

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 Accutane (Isotretinoin).

HEALTH CANADA ADVISORY

September 7, 2016

Health Canada has issued new restrictions concerning the use of Accutane (Isotretinoin). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Behaviour changes and suicidal thoughts: Some people taking Accutane (Isotretinoin) 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 Accutane (Isotretinoin), contact your doctor immediately.

If you are at risk for developing depression or have a history of depression, discuss with your doctor how Accutane (Isotretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Accutane (Isotretinoin), and whether any special monitoring is needed.

Family members or caregivers of people who are taking Accutane (Isotretinoin) should contact the person's doctor immediately if they notice unusual behaviour changes.

Birth Control: Accutane (Isotretinoin) causes birth defects in a large percentage of babies born to women who take Accutane (Isotretinoin) during pregnancy. Accutane (Isotretinoin) interacts with hormonal birth control (i.e., birth control pills), making it very important that women of childbearing age use an additional type of birth control.

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

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

Bones and joints: Accutane (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 Accutane (Isotretinoin).

Cholesterol: Accutane (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 Accutane (Isotretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Accutane (Isotretinoin), and whether any special monitoring is needed.

Diabetes: Accutane (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 Accutane (Isotretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Accutane (Isotretinoin), and whether any special monitoring is needed. You may need to check your blood glucose levels more often.

Inflammatory Bowel Disease: Accutane (Isotretinoin) may cause irritation in the digestive system. If you experience stomach pain, rectal bleeding or diarrhea, contact your doctor immediately.

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

Neurologic: Accutane (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 Accutane (Isotretinoin) therapy. Because some patients experience sudden onset of vision problems, use caution when driving or operating any vehicle at night. Report any vision changes to your doctor.

Pancreatitis: Accutane (Isotretinoin) can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how Accutane (Isotretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Accutane (Isotretinoin), and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

If you have a history of pancreatitis, gallstones, Alcoholism, or high triglycerides, you may be more at risk of experiencing this.

Skin care: Accutane (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 Accutane (Isotretinoin), avoid exfoliators, waxing and dermabrasion, or laser procedures.

Skin rash: Accutane (Isotretinoin) may cause skin rash or itchiness. Rarely, people taking Accutane (Isotretinoin) experience a severe skin reaction that can be life threatening. If you experience a rash that gets worse, or develops into blisters, sores on the lips or eyes, or covers a large area of the body, contact your doctor immediately.

Sun sensitivity: Accutane (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 Accutane (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: Accutane (Isotretinoin) causes severe birth defects in an extremely high percentage of infants born to women who take Accutane (Isotretinoin) even for a short period of time during pregnancy.

Accutane (Isotretinoin) must not be used during pregnancy. Women must not become pregnant while taking Accutane (Isotretinoin) or for at least one month after stopping the medication. Your doctor will perform monthly pregnancy tests while you are taking Accutane (Isotretinoin) to confirm the safety of continuing to take Accutane (Isotretinoin).

Women who may become pregnant must not be given Accutane (Isotretinoin) until pregnancy is excluded. A pregnancy test should be performed when you first see your doctor. A second pregnancy test must be performed within 11 days of starting treatment. Accutane (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 Accutane (Isotretinoin) treatment, during the treatment, and for at least one month following the discontinuation of treatment.

Breast-feeding: It is not known if Accutane (Isotretinoin) passes into breast milk. If you are a breast-feeding mother and are taking Accutane (Isotretinoin), 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 Accutane (Isotretinoin).

Children: The long-term safety of using Accutane (Isotretinoin) have not been established for children less than 12 years of age.

Seniors: The use of Accutane (Isotretinoin) by seniors has not been well studied. It is likely that seniors would be at an increased risk for side effects from Accutane (Isotretinoin).

This medication is typically used once or twice a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects. It is not advisable to chew, crush or open the capsule of this medication since it may irritate your mouth and gastrointestinal tract. Avoid taking vitamin A supplements while using this medication. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication is more effective if taken with food. Always take it with a meal or a snack.