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Xtampza ER is an opioid pain medication used to treat moderate to severe pain.
The extended-release form of oxycodone is for around-the-clock treatment of pain and should not be used on an as-needed basis for pain.
Xtampza ER may also be used for purposes not listed in this medication guide.
MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.
Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
You should not use Xtampza ER if you are allergic to it, or if you have:
severe asthma or breathing problems; or
a blockage in your stomach or intestines.
You should not use Xtampza ER unless you are already using a similar opioid medicine and are tolerant to it.
Most brands of oxycodone are not approved for use in people under 18. OxyContin should not be given to a child younger than 11 years old.
Tell your doctor if you have ever had:
breathing problems, sleep apnea;
a head injury, or seizures;
drug or alcohol addiction, or mental illness;
liver or kidney disease;
urination problems; or
problems with your gallbladder, pancreas, or thyroid.
If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.
Do not breast-feed. Oxycodone can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby.
Follow the directions on your prescription label and read all medication guides. Never use Xtampza ER in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of Xtampza ER.
Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.
Stop taking all other around-the-clock narcotic pain medicines when you start taking extended-release Xtampza ER.
Take Xtampza ER with food.
Swallow the capsule or tablet whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, open, or dissolve.
Never crush or break an Xtampza ER pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This can cause in death.
Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
You should not stop using Xtampza ER suddenly. Follow your doctor's instructions about tapering your dose.
Store at room temperature, away from heat, moisture, and light. Keep track of your medicine. Xtampza ER is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.
Since Xtampza ER is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An Xtampza ER overdose can be fatal, especially in a child or other person using the medicine without a prescription.
Overdose can cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or operating machinery until you know how Xtampza ER will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Avoid medication errors. Always check the brand and strength of oxycodone you get from the pharmacy.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
a slow heart rate or weak pulse;
a light-headed feeling, like you might pass out;
confusion, unusual thoughts or behavior;
seizure (convulsions); or
low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, confusion, fever, sweating, fast heart rate, chest pain, feeling short of breath, muscle stiffness, trouble walking, or feeling faint.
Serious side effects may be more likely in older adults and those who are malnourished or debilitated.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
Common side effects may include:
drowsiness, headache, dizziness, tiredness; or
constipation, stomach pain, nausea, vomiting.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.
Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
other narcotic medications--opioid pain medicine or prescription cough medicine;
a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.
This list is not complete and many other drugs may affect Xtampza ER. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Xtampza Er (www.drugs.com/mtm/xtampza-er.html).
Note: This document contains side effect information about oxycodone. Some of the dosage forms listed on this page may not apply to the brand name Xtampza ER.
In SummaryCommon side effects of Xtampza ER include: constipation, drowsiness, nausea, pruritus, and vomiting. Other side effects include: asthenia, diaphoresis, and xerostomia. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to oxycodone: oral capsule, oral capsule extended release, oral solution, oral tablet, oral tablet extended release
Oral route (Capsule, Extended Release)
Addiction, Abuse, and MisuseOxycodone extended-release (ER) exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing oxycodone ER, and monitor all patients regularly for the development of these behaviors or conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of oxycodone ER. Monitor for respiratory depression, especially during initiation of oxycodone ER or following a dose increase.Accidental IngestionAccidental ingestion of even one dose of oxycodone ER, especially by children, can result in a fatal overdose of oxycodone ER.Neonatal Opioid Withdrawal SyndromeProlonged use of oxycodone ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Cytochrome P450 3A4 InteractionThe concomitant use of oxycodone ER with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving oxycodone ER and any CYP3A4 inhibitor or inducer.Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsReserve concomitant prescribing of oxycodone ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Oral route (Tablet; Tablet, Extended Release)
Addiction, abuse, and misuse, leading to overdose and death has been reported. Before prescribing, assess the patient's risk and watch for signs of the development of these behaviors. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Serious and fatal respiratory depression may occur. Monitor for respiratory depression, especially when beginning treatment or increasing dose. Advise patients to swallow tablets whole to avoid overdose. Accidental ingestion can result in a fatal overdose, especially in children. Prolonged use in pregnancy may lead to life-threatening neonatal withdrawal syndrome. If oxycodone hydrochloride must be used during pregnancy, advise the patient of the risk and ensure that treatment will be available to the infant. Initiation of CYP3A4 inhibitors or discontinuation of CYP3A4 inducers can cause a fatal oxycodone hydrochloride overdose. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.
Oral route (Solution)
Use caution when prescribing and administering oxycodone oral solution as dosing errors due to mg and mL could result in accidental overdose and death. Ensure the proper dose is indicated and dispensed. Oxycodone oral solution should be kept out of the reach of children. Seek emergency help immediately if accidental ingestion occurs.
Along with its needed effects, oxycodone (the active ingredient contained in Xtampza ER) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking oxycodone:
Less common
Rare
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking oxycodone:
Symptoms of overdose
Some side effects of oxycodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Rare
For Healthcare Professionals
Applies to oxycodone: compounding powder, oral capsule, oral capsule extended release, oral concentrate, oral solution, oral tablet, oral tablet extended release
GeneralThe most commonly reported adverse reactions in adults included constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating. In pediatric patients, the most frequently observed adverse reactions included vomiting, nausea, headache, pyrexia, and constipation.
Nervous systemVery common (10% or more): Headache (14%, pediatrics)
Common (1% to 10%): Dizziness (pediatrics)
Frequency not reported: Confusion, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, migraine
Postmarketing reports: Serotonin syndrome
RespiratorySevere adverse effects such as respiratory depression can be treated with the opioid antagonist naloxone.
Frequency not reported: Apnea, respiratory arrest, bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, sinusitis
GastrointestinalVery common (10% or more): Nausea (23% to 27%), constipation (23% to 26%), vomiting (12% to 14%)
Frequency not reported: Abdominal pain, anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis
In pediatric studies with the oral extended release product, gastrointestinal adverse events were reported in 40% of patients 11 to 16 years of age (56 of 140); vomiting, nausea, constipation, and diarrhea were experienced by 21%, 15%, 9%, and 6%, respectively. Abdominal pain and gastroesophageal reflux disease were reported in 1% to less than 5% of patients.
PsychiatricFrequency not reported: Paranoia, psychosis, hallucinations, agitation, anxiety
DermatologicCommon (1% to 10%): Pruritus, hyperhidrosis, rash
Frequency not reported: Herpes simplex, rash, sweating, urticaria
HepaticFrequency not reported: Increased hepatic enzymes
CardiovascularFrequency not reported: QTc prolongation at higher doses, deep thrombophlebitis, heart failure, hemorrhage, hypotension, palpitation, tachycardia, edema, peripheral edema, vasodilation, circulatory collapse
GenitourinaryCommon (1% to 10%): Dysuria, urinary retention
Frequency not reported: Urinary tract infection
HypersensitivityFrequency not reported: Allergic reaction
Postmarketing reports: Anaphylaxis
ImmunologicFrequency not reported: Flu syndrome, infection, sepsis
MetabolicCommon (1% to 10%): Decreased appetite (pediatrics)
Frequency not reported: Gout, hyperglycemia, iron deficiency anemia
MusculoskeletalFrequency not reported: Back pain, neck pain, arthralgia, arthritis, bone pain, myalgia, pathological fracture
OcularFrequency not reported: Photosensitivity reaction, amblyopia
OtherVery common (10% or more): Pyrexia (11%, pediatrics)
Frequency not reported: Chills and fever, accidental injury
EndocrineOpioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Xtampza Er (www.drugs.com/mtm/xtampza-er.html).
September 24, 2020
September 24, 2020
September 24, 2020
September 24, 2020
September 24, 2020
September 17, 2020
