MEDICATION
GUIDE
PRISTIQ® (pris-TEEK) Extended-Release Tablets
(desvenlafaxine)
Antidepressant Medicines, Depression and Other Serious Mental
Illnesses, and Suicidal Thoughts or Actions
Read the Medication Guide
that comes with your or your family member's antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts and actions with
antidepressant medicines.
Talk to
your, or your family member's, healthcare provider about:
- all risks and benefits of treatment with antidepressant medicines
- all treatment choices for depression or other serious mental illness
What is the most important
information I should know about antidepressant medicines, depression and other
serious mental illnesses, and suicidal thoughts or actions?
-
Antidepressant medicines may increase suicidal thoughts or
actions in some children, teenagers, and young adults within the first few
months of treatment.
-
Depression and other serious mental illnesses are the most
important causes of suicidal thoughts and actions. Some people may have a
particularly high risk of having suicidal thoughts or actions. These
include people who have (or have a family history of) bipolar illness (also
called manic-depressive illness) or suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts
and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings. This is very important when an antidepressant
medicine is started or when the dose is changed.
- Call the healthcare provider right away to report new or sudden changes in
mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with the healthcare provider as scheduled. Call
the healthcare provider between visits as needed, especially if you have
concerns about symptoms.
Call a
healthcare provider right away if you or your family member has any of the
following symptoms, especially if they are new, worse, or worry you:
• thoughts about suicide or dying | • trouble sleeping (insomnia) |
• attempts to commit suicide | • new or worse irritability |
• new or worse depression | • acting aggressive, being angry, or violent |
• new or worse anxiety | • acting on dangerous impulses |
• feeling very agitated or restless | • an extreme increase in activity and talking (mania)
|
• panic attacks | • other unusual changes in behavior or mood
|
What else do I need to know about
antidepressant medicines?
- Never stop an antidepressant medicine without first talking to a healthcare
provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
-
Antidepressants are medicines used to treat depression and
other illnesses. It is important to discuss all the risks of treating
depression and also the risks of not treating it. Patients and their families or
other caregivers should discuss all treatment choices with the healthcare
provider, not just the use of antidepressants.
-
Antidepressant medicines have other side effects.
Talk to the healthcare provider about the side effects of the medicine
prescribed for you or your family member.
-
Antidepressant medicines can interact with other
medicines. Know all of the medicines that you or your family member
takes. Keep a list of all medicines to show the healthcare provider. Do not
start new medicines without first checking with your healthcare provider.
-
Not all antidepressant medicines prescribed for children
are FDA approved for use in children. Talk to your child's healthcare
provider for more information.
This Medication Guide has
been approved by the U.S. Food and Drug Administration for all antidepressants.
Important Information about
PRISTIQ® Extended-Release
Tablets
Read the patient
information that comes with PRISTIQ before you take PRISTIQ and each time you
refill your prescription. There may be new information. If you have questions,
ask your healthcare provider. This information does not take the place of
talking with your healthcare provider about your medical condition or treatment.
What is PRISTIQ?
- PRISTIQ is a prescription medicine used to treat depression. PRISTIQ belongs
to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake
inhibitors).
- PRISTIQ has not been studied or approved for use in children and
adolescents.
Who should not take PRISTIQ?Do not take PRISTIQ if
you:
- are allergic to desvenlafaxine, venlafaxine or any of the ingredients in
PRISTIQ. See the end of this Medication Guide for a complete list of ingredients
in PRISTIQ.
- currently take or have taken within the last 14 days, any medicine known as
an MAOI. Taking an MAOI with certain other medicines, including PRISTIQ, can
cause serious or even life-threatening side effects. Also, you must wait at
least 7 days after you stop taking PRISTIQ before you take any MAOI.
What should I tell my healthcare
provider before taking PRISTIQ?
Tell your healthcare
provider about all your medical conditions, including if you:
- have high blood pressure
- have heart problems
- have high cholesterol or high triglycerides
- have a history of a stroke
- have glaucoma
- have kidney problems
- have liver problems
- have or had bleeding problems
- have or had seizures or convulsions
- have mania or bipolar disorder
- have low sodium levels in your blood
- are pregnant or plan to become pregnant. It is not known if PRISTIQ will
harm your unborn baby.
- are breastfeeding. PRISTIQ can pass into your breast milk and may harm your
baby. Talk with your healthcare provider about the best way to feed your baby if
you take PRISTIQ.
Serotonin syndrome or neuroleptic
malignant syndrome (NMS)-like reactions
Rare, but potentially
life-threatening, conditions called serotonin syndrome or Neuroleptic Malignant
Syndrome (NMS)-like reactions can happen when medicines such as PRISTIQ are
taken with certain other medicines. Serotonin syndrome or NMS-like reactions can
cause serious changes in how your brain, muscles, heart and blood vessels, and
digestive system work. Especially tell your healthcare provider
if you take the following:
- medicines to treat migraine headaches known as triptans
- medicines used to treat mood, anxiety, psychotic, or thought disorders,
including tricyclics, lithium, selective serotonin reuptake inhibitors (SSRIs),
serotonin norepinephrine reuptake inhibitors (SNRIs), antipsychotic drugs, or
other dopamine antagonists, such as metoclopramide
- silbutramine
- tramadol
- St. John's Wort
- MAOIs (including linezolid, an antibiotic)
- tryptophan supplements
Ask your healthcare
provider if you are not sure if you are taking any of these medicines.
Before you take PRISTIQ
with any of these medicines, talk to your healthcare provider about serotonin
syndrome. See “What are the
possible side effects of PRISTIQ?”
PRISTIQ
contains the medicine desvenlafaxine. Do not take PRISTIQ with other medicines
containing venlafaxine or desvenlafaxine.
How should I take PRISTIQ?
- Take PRISTIQ exactly as your healthcare provider has told you.
- Take PRISTIQ at about the same time each day.
- PRISTIQ may be taken either with or without food.
- Swallow PRISTIQ tablets whole, with fluid. Do not crush, cut, chew, or
dissolve PRISTIQ tablets because the tablets are time-released.
- When you take PRISTIQ, you may see something in your stool that looks like a
tablet. This is the empty shell from the tablet after the medicine has been
absorbed by your body.
- It is common for antidepressant medicines such as PRISTIQ to take several
weeks before you start to feel better. Do not stop taking PRISTIQ if you do not
feel results right away.
- Do not stop taking or change the dose of PRISTIQ without talking with your
healthcare provider, even if you feel better.
- Talk with your healthcare provider about how long you should use PRISTIQ.
Take PRISTIQ for as long as your healthcare provider tells you to.
- If you miss a dose of PRISTIQ, take it as soon as you remember. If it is
almost time for your next dose, skip the missed dose. Do not try to “make up”
for the missed dose by taking two doses at the same time.
- Do not take more PRISTIQ than prescribed by your healthcare provider. If you
take more PRISTIQ than the amount prescribed, contact your healthcare provider
right away.
- In case of an overdose of PRISTIQ, call your healthcare provider or poison
control center, or go to the emergency room right away.
Switching from other
antidepressants
Side effects from
discontinuing antidepressant medication have occurred when patients switched
from other antidepressants, including venlafaxine, to PRISTIQ. Your doctor may
gradually reduce the dose of your initial antidepressant medication to help to
reduce these side effects.
What should I avoid while taking
PRISTIQ?
- Do not drive a car or operate machinery until you know how PRISTIQ affects
you.
- Avoid drinking alcohol while taking PRISTIQ.
What are the possible side effects
of PRISTIQ?PRISTIQ can cause serious side
effects, including:
• restlessness | • increase in blood pressure |
• hallucinations (seeing and hearing things that are not real) | • diarrhea |
• loss of coordination | • coma |
• fast heart beat | • nausea |
• increased body temperature | • vomiting |
• muscle stiffness | • confusion |
PRISTIQ may also cause other serious
side effects, including:
-
New or worsened high blood pressure (hypertension).
Your healthcare provider should monitor your blood pressure before and while you
are taking PRISTIQ. If you have high blood pressure, it should be controlled
before you start taking PRISTIQ.
-
Abnormal bleeding or bruising. PRISTIQ and other
SNRIs/SSRIs may cause you to have an increased chance of bleeding. Taking
aspirin, NSAIDs (non-steroidal anti-inflammatory drugs), or blood thinners may
add to this risk. Tell your healthcare provider right away about any unusual
bleeding or bruising.
-
Glaucoma (increased eye pressure)
-
Increased cholesterol and triglyceride levels in your
blood
-
Symptoms when stopping PRISTIQ (discontinuation
symptoms). Side effects may occur when stopping PRISTIQ (discontinuation
symptoms), especially when therapy is stopped suddenly. Your healthcare provider
may want to decrease your dose slowly to help avoid side effects. Some of these
side effects may include:
• dizziness | • anxiety |
• nausea | • abnormal dreams |
• headache | • tiredness |
• irritability | • sweating |
• sleeping problems (insomnia) | • diarrhea |
-
Seizures (convulsions)
-
Low sodium levels in your blood. Symptoms of this
may include: headache, difficulty concentrating, memory changes, confusion,
weakness and unsteadiness on your feet. In severe or more sudden cases, symptoms
can include: hallucinations (seeing or hearing things that are not real),
fainting, seizures and coma. If not treated, severe low sodium levels could be
fatal.
-
Allergic reactions. Some reactions can be severe
such as swelling beneath the skin (e.g., throat, face, hands).
Contact your healthcare
provider if you think you have any of these side effects.
Common side effects with
PRISTIQ include:
• nausea | • tiredness |
• headache | • diarrhea |
• dry mouth | • vomiting |
• sweating | • anxiety |
• dizziness | • tremor |
• insomnia | • dilated pupils |
• constipation | • decreased sex drive |
• loss of appetite | • delayed orgasm and ejaculation |
• sleepiness | |
These are not all the
possible side effects of PRISTIQ. Tell your healthcare provider about any side
effect that bothers you or does not go away. Call your doctor for medical advice
about side effects. You may report side effects to FDA at 1-800-FDA-1088. For
more information on these and other side effects associated with PRISTIQ, talk
to your healthcare provider, visit our web site at www.pristiq.com or call our
toll-free number at 1‑888‑PRISTIQ (774‑7847).
How should I store PRISTIQ?
- Store PRISTIQ at 68° to 77°F (20° to 25°C).
- Do not use PRISTIQ after the expiration date (EXP), which is on the
container. The expiration date refers to the last day of that month.
- Keep PRISTIQ and all medicines out of the reach of children.
General Information about the safe
and effective use of PRISTIQ
Medicines are sometimes
used for conditions that are not mentioned in Medication Guides. Do not use
PRISTIQ for a condition for which it was not prescribed. Do not give PRISTIQ to
other people, even if they have the same symptoms that you have. It may harm
them.
This Medication Guide
summarizes the most important information about PRISTIQ. If you would like more
information, talk with your healthcare provider. You can ask your pharmacist or
healthcare provider for information about PRISTIQ that is written for healthcare
professionals. For more information, go to www.pristiq.com or call
1‑888‑PRISTIQ (774‑7847).
What are the ingredients in
PRISTIQ?
Active
ingredient: desvenlafaxine
Inactive
ingredients: For the 50 mg tablet, hypromellose, microcrystalline
cellulose, talc, magnesium stearate and film coating, which consists of
polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron
oxides.
For the 100 mg tablet,
hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film
coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium
dioxide, iron oxide and FDandC yellow #6.
This Medication Guide has
been approved by the U.S. Food and Drug Administration.
Issued November 2010.
Contact Information
Please visit our web site
at www.pristiq.com, or call our toll-free number 1-888-PRISTIQ (774-7847) to
receive more information