Medication
Guide
TARGINIQ™ ER (tar-gih-NEEK E-R)
(oxycodone
hydrochloride and naloxone hydrochloride extended-release tablets),
CII |
TARGINIQ ER
is:
- A strong prescription pain medicine that contains an opioid
(narcotic) that is used to manage pain severe enough to require daily,
around-the-clock, long-term treatment with an opioid, when other pain
treatments such as non-opioid pain medicines or immediate-release
opioid medicines do not treat your pain well enough or you cannot
tolerate them.
- A long-acting (extended-release) opioid pain medicine that
can put you at risk for overdose and death. Even if you take your
dose correctly as prescribed you are at risk for opioid addiction,
abuse, and misuse that can lead to death.
- Not for use to treat pain that is not around-the-clock.
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Important
information about TARGINIQ ER:
-
Get emergency help right away if you take too much
TARGINIQ ER (overdose). When you first start taking TARGINIQ
ER, when your dose is changed, or if you take too much (overdose),
serious or life-threatening breathing problems that can lead to death
may occur.
- Taking TARGINIQ ER with other opioid medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe drowsiness, decreased awareness, breathing
problems, coma, and death.
- Never give anyone else your TARGINIQ ER. They could die
from taking it. Store TARGINIQ ER away from children and in a safe
place to prevent stealing or abuse. Selling or giving away TARGINIQ
ER is against the law.
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Do not take
TARGINIQ ER if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
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| Before taking TARGINIQ
ER, tell your healthcare provider if you have a history of: |
- head injury, seizures
- liver, kidney, thyroid or heart problems
- abuse of street or prescription drugs, alcohol addiction,
or mental health problems
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- problems urinating
- pancreas or gallbladder problems
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Tell your healthcare
provider if you are:
-
pregnant or planning to become pregnant. Prolonged
use of TARGINIQ ER during pregnancy can cause withdrawal symptoms
in your newborn baby that could be life-threatening if not recognized
and treated.
-
breastfeeding. Not recommended during treatment
with TARGINIQ ER. It may harm your baby.
- taking prescription or over-the-counter medicines, vitamins,
or herbal supplements. Taking TARGINIQ ER with certain other medicines
can cause serious side effects that could lead to death.
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When taking
TARGINIQ ER:
- Do not change your dose. Take TARGINIQ ER exactly as prescribed
by your healthcare provider. Use the lowest dose possible for the
shortest time needed.
- Take your prescribed dose every 12 hours at the same time
every day. Do not take more than your prescribed dose in 12 hours.
If you miss a dose, take your next dose at your usual time.
- Swallow TARGINIQ ER whole. Do not cut, break, chew, crush,
dissolve, snort, or inject TARGINIQ ER because this may cause you
to overdose and die.
-
Call your healthcare provider if the dose you are
taking does not control your pain.
-
Do not stop taking TARGINIQ ER without talking to
your healthcare provider.
- After you stop taking TARGINIQ ER, flush any unused tablets
down the toilet.
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While taking
TARGINIQ ER DO NOT:
- Drive or operate heavy machinery, until you know how TARGINIQ
ER affects you. TARGINIQ ER can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines
that contain alcohol. Using products containing alcohol during treatment
with TARGINIQ ER may cause you to overdose and die.
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The possible
side effects of TARGINIQ ER are:
- constipation, nausea, sleepiness, vomiting, tiredness, headache,
dizziness, abdominal pain, anxiety, and sweating. Call your healthcare
provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat,
chest pain, swelling of your face, tongue, or throat, extreme drowsiness,
lightheadedness when changing positions, feeling faint, agitation,
high body temperature, trouble walking, stiff muscles, or mental changes
such as confusion.
Call your healthcare provider if you get symptoms that may
be related to opioid withdrawal including tremors, chills, diarrhea,
irritability, and yawning.
These are not all
the possible side effects of TARGINIQ ER. Call your doctor for medical
advice about side effects. You may report side effects to FDA at
1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.
Manufactured by: Purdue Pharma L.P., Stamford,
CT 06901-3431, www.purduepharma.com or call 1-888-726-7535 |