HYSINGLA® ER (hye-SING-luh)
(hydrocodone bitartrate) extended-release tablets, CII
|HYSINGLA 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
- 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.
about HYSINGLA ER:
Get emergency help right away if you take too much
HYSINGLA ER (overdose). When you first start taking HYSINGLA
ER, when your dose is changed, or if you take too much (overdose),
serious or life-threatening breathing problems that can lead to death
- Taking HYSINGLA 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 HYSINGLA ER. They could die
from taking it. Selling or giving away HYSINGLA ER is against the
- Store HYSINGLA ER securely, out of sight and reach of children,
and in a location not accessible by others, including visitors to
|Do not take HYSINGLA ER
if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
|Before taking HYSINGLA
ER, tell your healthcare provider if you have a history of:
Tell your healthcare provider if you are:
- head injury, seizures
- liver, kidney, thyroid problems
- problems urinating
- pancreas or gallbladder problems
- heart rhythm problems (long QT syndrome)
- abuse of street or prescription drugs, alcohol addiction,
or mental health problems
pregnant or planning to become pregnant. Prolonged
use of HYSINGLA ER during pregnancy can cause withdrawal symptoms
in your newborn baby that could be life-threatening if not recognized
breastfeeding. Not recommended during treatment
with HYSINGLA ER. It may harm your baby.
- taking prescription or over-the-counter medicines, vitamins,
or herbal supplements. Taking HYSINGLA ER with certain other medicines
can cause serious side effects and could lead to death.
|When taking HYSINGLA ER:
Call your healthcare provider if the dose you are taking
does not control your pain.
- Do not change your dose. Take HYSINGLA ER exactly as prescribed
by your healthcare provider. Use the lowest dose possible for the
shortest time needed.
- Take your prescribed dose every 24 hours, at the same time
every day. Do not take more than your prescribed dose in 24 hours.
If you miss a dose, take your next dose at your usual time the next
- Swallow HYSINGLA ER whole. Do not cut, break, chew, crush,
dissolve, snort, or inject HYSINGLA ER because this may cause you
to overdose and die.
- HYSINGLA ER should be taken 1 tablet at a time. Do not
pre-soak, lick, or wet the tablet before placing it in your mouth
to avoid choking on the tablet.
Do not stop taking HYSINGLA ER without talking to
your healthcare provider.
Dispose of expired, unwanted, or unused HYSINGLA ER,
by promptly flushing down the toilet, if a drug take-back option is
not readily available. Visit www.fda.gov/drugdisposal for additional
information on disposal of unused medicines.
|While taking HYSINGLA
ER, DO NOT:
The possible side effects of HYSINGLA ER are:
- Drive or operate heavy machinery until you know how HYSINGLA
ER affects you. HYSINGLA 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 HYSINGLA ER may cause you to overdose and die.
Get emergency medical help if you have:
- constipation, nausea, sleepiness, vomiting, tiredness, headache,
dizziness, abdominal pain. Call your healthcare provider if you have
any of these symptoms and they are severe.
- trouble breathing, shortness of breath, fast heartbeat,
chest pain, swelling of your face, tongue or throat, extreme drowsiness,
light-headedness when changing positions, feeling faint, agitation,
high body temperature, trouble walking, stiff muscles, or mental changes
such as confusion.
These are not all the possible side effects of
HYSINGLA 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