MEDICATION GUIDE
PROLATE
Oxycodone Hydrochloride and Acetaminophen Oral Solution, CII
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Prolate is:
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain, severe enough to require
an opioid analgesic and for which alternative treatments are inadequate and when other pain treatments such as non-opioid
pain medicines do not treat your pain well enough or you cannot tolerate them.
- An 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.
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Important information about Prolate:
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Get emergency help or call 911 right away if you take too much Prolate (overdose). When you first start taking Prolate,
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. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to
reverse an opioid overdose.
- Taking Prolate with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other
central nervous system depressants (including street drugs)
can cause severe drowsiness, decreased awareness, breathingproblems, coma, and death.
Never give anyone else your Prolate. They could die from taking it. Selling or giving away Prolate is against the law.
- Store Prolate securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
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Do not take Prolate if you have:
- Severe asthma, trouble breathing, or other lung problems.
- A bowel blockage or have narrowing of the stomach or intestines
- Known hypersensitivity to oxycodone, acetaminophen, or any ingredient in Prolate
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Before taking Prolate, tell your healthcare provider if you have a history of:
- Head injury, seizures
- Liver, kidney, thyroid problems
- Problems urinating
- Pancreas or gallbladder problems
- Abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems
Tell your healthcare provider if you are:
- noticing your pain getting worse. If your pain gets worse after you take Prolate, do not take more of Prolate without first talking
to your healthcare provider. Talk to your healthcare provider if the pain you have increases, if you feel more sensitive to pain, or
if you have new pain after taking Prolate.
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pregnant or planning to become pregnant. Use of Prolate for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
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breastfeeding. Prolate passes into breast milk and may harm your baby. Carefully observe infants for increased sleepiness
(more than usual), breathing difficulties, or limpness. Seekimmediate medical care if you notice these signs.
- living in a household where there are small children or someone who has abused street or prescription drugs.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Prolate with certain other medicines
can cause serious side effects that could lead to death.
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When taking Prolate:
- Do not change your dose. Take Prolate exactly as prescribed by your healthcare provider. Use the lowest dose possible for the
shortest time needed.
- For acute (short-term) pain, you may only need to take Prolate for a few days. You may have some Prolate left over that you did
not use. See disposal information at the bottom of this sectionfor directions on how to safely throw away (dispose of) your
unused Prolate.
- Ask your healthcare provider if you have any questions on how to correctly measure your dose. Always use a calibrated
measuring device for Prolate to correctly measure your dose. A household teaspoon or tablespoon is not an adequate measuring
device. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon,
which could lead to overdosage, it is strongly recommended that caregivers obtain and use a calibrated measuring device.
- Take your prescribed dose every 6 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose,
take your next dose at your usual time.
- Call your healthcare provider if the dose you are taking does not control your pain.
- If you have been taking Prolate regularly, do not stop taking Prolate without talking to your healthcare provider.
- Dispose of expired, unwanted, or unused Prolate 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.
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While taking Prolate DO NOT:
- Drive or operate heavy machinery, until you know how Prolate affects you. Prolate 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 Prolate may cause you to overdose and die.
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The possible side effects of Prolate:
- Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you
have any of these symptoms and they are severe.
Get emergency medical help or call 911 right away if you have:
- 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 Prolate. Call your healthcare provider 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.
Distributed by: Forte Bio-Pharma LLC, Las Vegas, NV 89113
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