MEDICATION GUIDE ADHANSIA (ad han' see ah) XR®
(methylphenidate hydrochloride) extended-release capsules, CII |
What is the
most important information I should know about ADHANSIA XR? ADHANSIA XR can cause serious side effects, including:
-
Abuse and dependence. ADHANSIA XR, other methylphenidate
containing medicines, and amphetamines have a high chance for abuse
and can cause physical and psychological dependence. Your healthcare
provider should check you or your child for signs of abuse and dependence
before and during treatment with ADHANSIA XR.
- Tell your healthcare provider if you or your child have
ever abused or been dependent on alcohol, prescription medicines,
or street drugs.
- Your healthcare provider can tell you more about the differences
between physical and psychological dependence and drug addiction.
-
Heart-related problems, including:
- sudden death, stroke, and heart attack in adults
- sudden death in children who have heart problems or heart
defects
- increased blood pressure and heart rate
Your healthcare provider should check you or your child carefully
for heart problems before starting treatment with ADHANSIA XR. Tell
your healthcare provider if you or your child have any heart problems,
heart defects, high blood pressure, or have a family history of these
problems. Your healthcare provider should check your or
your child’s blood pressure and heart rate regularly during treatment
with ADHANSIA XR.
Call your healthcare provider or
go to the nearest hospital emergency room right away if you or your
child have any signs of heart problems such as chest pain, shortness
of breath, or fainting during treatment with ADHANSIA XR.
-
Mental (psychiatric) problems, including:
- new or worse behavior and thought problems
- new or worse bipolar illness
- new psychotic symptoms (such as hearing voices, or seeing
or believing things that are not real) or new manic symptoms
Tell your healthcare provider about any mental problems you
or your child have, or about a family history of suicide, bipolar
illness, or depression.
Call your healthcare provider
right away if you or your child have any new or worsening mental symptoms
or problems during treatment with ADHANSIA XR, especially hearing
voices, seeing or believing things that are not real, or new manic
symptoms.
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What is ADHANSIA
XR?
ADHANSIA XR is a central nervous system (CNS)
stimulant prescription medicine used for the treatment of Attention
Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and
older. ADHANSIA XR may help increase attention and decrease impulsiveness
and hyperactivity in people with ADHD. It is not known
if ADHANSIA XR is safe and effective in children under 6 years of
age.
ADHANSIA XR is a federally controlled substance
(CII) because it contains methylphenidate that can be a target for
people who abuse prescription medicines or street drugs. Keep
ADHANSIA XR in a safe place to protect it from theft. Never give your
ADHANSIA XR to anyone else, because it may cause death or harm them.
Selling or giving away ADHANSIA XR may harm others and is against
the law. |
Do not take
ADHANSIA XR if you or your child are:
- allergic to methylphenidate hydrochloride or any of the
ingredients in ADHANSIA XR. See the end of this Medication Guide for
a complete list of ingredients in ADHANSIA XR.
- taking, or have stopped taking within the past 14 days,
a medicine used to treat depression called a monoamine oxidase inhibitor
(MAOI).
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Before taking
ADHANSIA XR tell your healthcare provider about all medical conditions,
including if you or your child:
- have heart problems, heart defects, or high blood pressure
- have mental problems including psychosis, mania, bipolar
illness, or depression, or have a family history of suicide, bipolar
illness, or depression
- have circulation problems in fingers and toes
- are pregnant or plan to become pregnant. It is not known
if ADHANSIA XR will harm the unborn baby.
- There is a pregnancy registry for females who are exposed
to ADHANSIA XR during pregnancy. The purpose of the registry is to
collect information about the health of females exposed to ADHANSIA
XR and their baby. If you or your child becomes pregnant during treatment
with ADHANSIA XR, talk to your healthcare provider about registering
with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.
- are breastfeeding or plan to breastfeed. ADHANSIA XR passes
into breast milk. Talk to your healthcare provider about the best
way to feed the baby during treatment with ADHANSIA XR.
Tell your healthcare provider about all the medicines
that you or your child take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. ADHANSIA XR
and some medicines may interact with each other and cause serious
side effects. Sometimes the doses of other medicines will need to
be changed during treatment with ADHANSIA XR. Your healthcare provider
will decide whether ADHANSIA XR can be taken with other medicines.
Especially tell your healthcare provider if you or your child
take a medicine used to treat depression called a monoamine
oxidase inhibitor (MAOI). Know the medicines that you or
your child take. Keep a list of the medicines with you to show your
healthcare provider and pharmacist. Do not start any new medicine
during treatment with ADHANSIA XR without talking to your healthcare
provider first. |
How should
ADHANSIA XR be taken?
- Take ADHANSIA XR exactly as prescribed by your healthcare
provider.
- Your healthcare provider may change the dose if needed.
- Take ADHANSIA XR by mouth 1 time each day in the morning.
- ADHANSIA XR can be taken with or without food, but take
it the same way each time.
- Swallow ADHANSIA XR capsules whole. If ADHANSIA XR capsules
cannot be swallowed whole, the capsules may be opened and sprinkled
onto a tablespoonful of applesauce or yogurt. Make sure to sprinkle
all the medicine onto the applesauce or yogurt. The ADHANSIA XR dose
should not be divided.
- swallow all the applesauce or yogurt and medicine mixture
without chewing right away or within 10 minutes
-
do not chew the applesauce or yogurt
-
do not store applesauce or yogurt and medicine
mixture
- Your healthcare provider may sometimes stop ADHANSIA XR
treatment for a while to check ADHD symptoms.
- If a dose of ADHANSIA XR is missed do not take the dose
later in the day or take an extra dose to make up for the missed dose,
wait until the next morning to take the next scheduled dose.
In case of poisoning call your poison control center
at 1-800-222-1222 or go to the nearest hospital emergency room right
away. |
What should
be avoided during treatment with ADHANSIA XR?
Avoid
drinking alcohol during treatment with ADHANSIA XR. This may cause
a faster release of the ADHANSIA XR medicine. |
What are possible
side effects of ADHANSIA XR?
ADHANSIA XR can
cause serious side effects, including:
- See “What is the most important information I should
know about ADHANSIA XR?”
-
Painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. If you or your child develop priapism, get medical help right away.
-
Circulation problems in fingers and toes (peripheral
vasculopathy, including Raynaud’s phenomenon). Signs and symptoms
may include:
- fingers or toes may feel numb, cool, painful
- fingers or toes may change color from pale, to blue, to
red
Tell your healthcare provider if you or your child have numbness,
pain, skin color change, or sensitivity to temperature in the fingers
or toes. Call your healthcare provider right away if your
child have any signs of unexplained wounds appearing on fingers or
toes during treatment with ADHANSIA XR.
-
Slowing of growth (height and weight) in children. Children should have their height and weight checked often while
taking ADHANSIA XR. ADHANSIA XR treatment may be stopped if your
child is not growing or gaining weight.
-
FD&C Yellow No. 5. ADHANSIA XR 45 mg capsules
contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type
reactions (including bronchial asthma) in certain people, especially
people who also have an allergy to aspirin.
The most common side effects in adults include trouble sleeping, dry mouth, nausea, and decreased appetite.
The most common side effects of ADHANSIA XR in children include decreased appetite, trouble sleeping, and decreased weight. Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088. |
How should
I store ADHANSIA XR?
- Store ADHANSIA XR at room temperature between 68°F to 77°F
(20°C to 25°C).
- Store ADHANSIA XR in a safe place, like a locked cabinet.
Protect from light and moisture.
- Dispose of remaining, unused, or expired ADHANSIA XR by
a medication take-back program at authorized collection sites such
as retail pharmacies, hospital or clinic pharmacies, and law enforcement
locations. If no take-back program or authorized collector is available,
mix ADHANSIA XR with an undesirable, nontoxic substance such as dirt,
cat litter, or used coffee grounds to make it less appealing to children
and pets. Place the mixture in a container such as a sealed plastic
bag and throw away ADHANSIA XR in the household trash.
Keep ADHANSIA XR and all medicines out of the reach of
children. |
General information
about the safe and effective use of ADHANSIA XR.
Medicines are sometimes prescribed for purposes other than those
listed in a Medication Guide. Do not use ADHANSIA XR for a condition
for which it was not prescribed. Do not give ADHANSIA XR to other
people, even if they have the same symptoms. It may harm them and
it is against the law. You can ask your healthcare provider or pharmacist
for information about ADHANSIA XR that was written for healthcare
professionals. |
What are the
ingredients in ADHANSIA XR?
Active Ingredient: methylphenidate hydrochloride
Inactive Ingredients: ammonio methacrylate copolymer dispersion (type B), anionic copolymer
(consisting of methyl acrylate, methyl methacrylate and methacrylic
acid), glyceryl monostearate, hypromellose, polyethylene glycol, polysorbate,
silicon dioxide, sodium hydroxide, sodium lauryl sulfate, sorbic acid,
sugar spheres, triethyl citrate
Manufactured by: Purdue Pharmaceuticals L.P., Wilson, NC 27893 To report
SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535
or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. |