-What is Roxicodone?
ROXICODONE® (oxycodone hydrochloride tablets, USP) are available as follows:
5 mg white scored tablets (Identified 54 582)
[Embossed 54 582 on one side]
NDC 66479-580-25: Unit dose, 25 tablets per card, (reverse numbered), 4 card per shipper
NDC 66479-580-10: Bottles of 100 tablets
15 mg green tablets scored (Identified 54 710)
[Embossed 54 710 on one side]
NDC 66479-581-10: Bottles of 100 tablets
30 mg blue tablets scored (Identified 54 199)
[Embossed 54 199 on one side]
NDC 66479-582-10: Bottles of 100 tablets
Roxicodone 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.
ROXICODONE (oxycodone hydrochloride) ® is intended for the management of moderate to severe pain in patients who require treatment with an oral opioid analgesic. The dose should be individually adjusted according to severity of pain, patient response and patient size. If the pain increases in severity, if analgesia is not adequate, or if tolerance occurs, a gradual increase in dosage may be required.
Patients who have not been receiving opioid analgesics should be started on ROXICODONE (oxycodone hydrochloride) ® in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose should be titrated based upon the individual patient’s response to their initial dose of ROXICODONE (oxycodone hydrochloride) ®. Patients with chronic pain should have their dosage given on an aroundthe-clock basis to prevent the reoccurrence of pain rather than treating the pain after it has occurred. This dose can then be adjusted to an acceptable level of analgesia taking into account side effects experienced by the patient.
For control of severe chronic pain, ROXICODONE (oxycodone hydrochloride) ® should be administered on a regularly scheduled basis, every 4-6 hours, at the lowest dosage level that will achieve adequate analgesia.
As with any potent opioid, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. Although it is not possible to list every condition that is important to the selection of the initial dose of ROXICODONE (oxycodone hydrochloride) ®, attention should be given to: 1) the daily dose, potency, and characteristics of a pure agonist or mixed agonist/antagonist the patient has been taking previously, 2) the reliability of the relative potency estimate to calculate the dose of oxycodone needed, 3) the degree of opioid tolerance, 4) the general condition and medical status of the patient, and 5) the balance between pain control and adverse experiences.
Conversion from Fixed-Ratio Opioid/Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal Combination Drugs
When converting patients from fixed ratio opioid/non-opioid drug regimens a decision should be made whether or not to continue the non-opioid analgesic. If a decision is made to discontinue the use of non-opioid analgesic, it may be necessary to titrate the dose of ROXICODONE (oxycodone hydrochloride) ® in response to the level of analgesia and adverse effects afforded by the dosing regimen. If the non-opioid regimen is continued as a separate single entity agent, the starting dose ROXICODONE (oxycodone hydrochloride) ® should be based upon the most recent dose of opioid as a baseline for further titration of oxycodone. Incremental increases should be gauged according to side effects to an acceptable level of analgesia.
Patients Currently on Opioid Therapy
If a patient has been receiving opioid-containing medications prior to taking ROXICODONE (oxycodone hydrochloride) ®, the potency of the prior opioid relative to oxycodone should be factored into the selection of the total daily dose (TDD) of oxycodone.
In converting patients from other opioids to ROXICODONE (oxycodone hydrochloride) ® close observation and adjustment of dosage based upon the patient’s response to ROXICODONE (oxycodone hydrochloride) ® is imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of ROXICODONE (oxycodone hydrochloride) ® may be necessary, especially in patients who have disease states that are changing rapidly.
Maintenance of Therapy
Continual re-evaluation of the patient receiving ROXICODONE (oxycodone hydrochloride) ® is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain.
During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), the continued need for the use of opioid analgesics should be re-assessed as appropriate.
Cessation of Therapy
When a patient no longer requires therapy with ROXICODONE (oxycodone hydrochloride) ® or other opioid analgesics for the treatment of their pain, it is important that therapy be gradually discontinued over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal (see Drug Abuse and Dependence section for description of the signs and symptoms of withdrawal). If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. It is not known at what dose of ROXICODONE (oxycodone hydrochloride) ® that treatment may be discontinued without risk of the opioid abstinence syndrome.
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.
Before taking this medicine
You should not use Roxicodone 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 Roxicodone 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:
- 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.
How should I use Roxicodone?
Follow the directions on your prescription label and read all medication guides. Never use Roxicodone in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of Roxicodone.
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 Roxicodone.
Take Roxicodone 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 Roxicodone 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 Roxicodone 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. Roxicodone 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.
What happens if I miss a dose?
Since Roxicodone 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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An Roxicodone 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.
What should I avoid while using Roxicodone?
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or operating machinery until you know how Roxicodone 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.
Roxicodone side effects
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;
- 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.
Signs and Symptoms
Acute overdose with ROXICODONE (oxycodone hydrochloride) ® can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, bradycardia, hypotension, and death.
To treat ROXICODONE (oxycodone hydrochloride) ® overdose, primary attention should be given to the reestablishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.
The narcotic antagonists, naloxone or nalmefene, are specific antidotes for opioid overdose. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to ROXICODONE (oxycodone hydrochloride) ® overdose. If needed the appropriate dose opioids should be administered simultaneously with efforts at respiratory resuscitation (see package insert for each drug for the details). Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. Gastric emptying may be useful in removing unabsorbed drug.
Opioid antagonists should be administered cautiously to persons who are suspected to be physically dependent on any opioid agonist, including oxycodone. (see Opioid-Tolerant Individuals)
Opioid-Tolerant Individuals: In an individual physically dependent on opioids, administration of a usual dose of antagonist will precipitate an acute withdrawal. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Use of an opioid antagonist should be reserved for cases where such treatment is clearly needed. If it is necessary to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses.