DIN (Drug Identification Number)
02396971 Epuris
10 mg Capsule
02396998 Epuris 20 mg Capsule
02397005 Epuris 30 mg Capsule
02397013 Epuris 40 mg Capsule
How does this medication 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.
What form(s) does this medication come in?
10 mg
Each dark-yellow, opaque capsule imprinted "G 240" in black ink on cap
and "10" on the body, contains isotretinoin 10 mg. Nonmedicinal
ingredients: stearoyl macrogolglycerides, soybean oil, sorbitan
monooleate, and propyl gallate. The gelatin capsules contain iron oxide
(yellow) and titanium dioxide.
20 mg
Each red opaque capsule imprinted "G 241" in black ink on cap and
"20" on the body, contains isotretinoin 20 mg. Nonmedicinal
ingredients: stearoyl macrogolglycerides, soybean oil, sorbitan
monooleate, and propyl gallate. The gelatin capsules contain: iron oxide (red)
and titanium dioxide.
30 mg
Each brown opaque capsule imprinted "G 242" in white ink on cap and
"30" on the body, contains isotretinoin 30 mg. Nonmedicinal
ingredients: stearoyl macrogolglycerides, soybean oil, sorbitan
monooleate, and propyl gallate. The gelatin capsules contain iron oxide
(yellow, red and black) and titanium dioxide.
40 mg
Each brown opaque cap and red opaque body imprinted "G 325" in white
ink on cap and "40" on the body, contains isotretinoin
40 mg. Nonmedicinal ingredients: stearoyl macrogolglycerides,
soybean oil, sorbitan monooleate, and propyl gallate. The gelatin capsules
contain the following: iron oxide (yellow, red, and black) and titanium
dioxide.
How should I use this medication?
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.
Who should NOT take this medication?
Do not take isotretinoin if you:
are
allergic to isotretinoin or any ingredients of the medicationare
breast-feedingare
pregnantare
taking tetracycline antibiotics (e.g., tetracycline, doxycycline,
minocycline)have
excessively high blood cholesterol levelshave
excessively high levels of vitamin Ahave 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 this medication?
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 skindry
mouth or noseheadache
(mild)hoarsenessincreased
sensitivity of skin to sunlightnosebleedspain or
tenderness of eyespeeling
of skin on palms of hands or soles of feetstomach
upsetthinning
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 check with your doctor
or seek medical attention.
Check with your doctor as soon as possible if any of the following
side effects occur:
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attempts at suicide or
thoughts of suicide (usually stops after medication is stopped)bleeding or inflammation of
gumsblurred vision or other
changes in visionbone or joint painburning, redness, itching, or
other signs of eye inflammationchanges in behaviourdecreased hearingdecreased vision after sunset
or before sunrise (sudden or may continue after medication is stopped)ringing in the earsscaling, redness, burning,
pain, or other signs of inflammation of lipssigns of depression (e.g.,
poor concentration, changes in weight, changes in sleep, decreased
interest in activities, thoughts of suicide)pain, tenderness, or stiffness in
muscles (long-term treatment)
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signs of heart problems
(e.g., fast, irregular heartbeat or pulse, chest pain, sudden weight
gain, difficulty breathing, leg swelling)signs of increased pressure
in the brain (e.g., bad headaches, blurred vision, dizziness, nausea,
vomiting, seizures)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 rashsymptoms of high blood sugar (e.g.,
frequent urination, increased thirst, excessive eating, unexplained
weight loss, poor wound healing, infections, fruity breath odour)
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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 this
medication?
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.
HEALTHCANADAADVISORY
SEPTEMBER
7, 2016
HealthCanadahas issued new restrictions concerning the use of isotretinoin. To read the
full Health Canada Advisory, visit HealthCanada's web site at www.hc-sc.gc.ca.
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.
If you are at risk for developing depression or have a history of
depression, 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.
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.
Inflammatory Bowel Disease: This medication 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 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: 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 experience sudden onset of vision problems, use
caution when driving or operating any vehicle at night. Report any vision
changes to your doctor.
Pancreatitis: Isotretinoin can cause the pancreas to become inflamed. If
you have a history of pancreatitis, 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.
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: 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, or laser procedures.
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 this
medication?
There may be an interaction between isotretinoin and any of the
following:
acitretinalcoholbirth
control pills (estrogen/progestin)carbamazepinecorticosteroids
(e.g., prednisone)multivitamins
with vitamin AporfimerSt. John'sworttetracycline
antibiotics (e.g., doxycycline, minocycline, tetracycline)tigecyclinetretinoinvitamin 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, orleave 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.
