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Roxycodone, also spelled “Roxicodone” is a painkiller that is often prescribed for moderate to severe pain.

Description

Roxycodone Uses

This medication is used to help relieve moderate to severe pain. Oxycodone belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain.

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How to use Roxicodone

Read the Medication Guide provided by your pharmacist before you start taking oxycodone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor. You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).

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Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Ask your doctor or pharmacist if you are not sure how to check or measure the dose.

The dosage is based on your medical condition and response to treatment. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

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Pain medications work best if they are used when the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

If you have ongoing pain (such as due to cancer), your doctor may direct you to also take long-acting opioid medications. In that case, this medication might be used for sudden (breakthrough) pain only as needed. Other pain relievers (such as acetaminophenibuprofen) may also be prescribed with this medication. Ask your doctor or pharmacist about using oxycodone safely with other drugs.

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Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxietytrouble sleeping, thoughts of suicide), watering eyesrunny nose, nausea, diarrheasweating, muscle aches, or sudden changes in behavior.

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When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

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Roxycodone Side Effects

Nauseavomitingconstipationlightheadednessdizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

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Tell your doctor right away if you have any serious side effects, including: interrupted breathing during sleep (sleep apnea), mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).

Get medical help right away if you have any very serious side effects, including: faintingseizure, slow/shallow breathing, severe drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rashitching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Roxycodone Precautions

Before taking oxycodone, tell your doctor or pharmacist if you are allergic to it; or to other opioid pain relievers (such as oxymorphone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthmasleep apneachronic obstructive pulmonary diseaseCOPD), kidney diseaseliver disease, mental/mood disorders (such as confusion, depression), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stomach/intestinal problems (such as blockage, constipationdiarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate), gallbladder disease, disease of the pancreas (pancreatitis).

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This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Liquid products may contain sugar, aspartame, and/or alcohol. Caution is advised if you have diabetesalcohol dependenceliver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

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Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.)

This drug passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: certain pain medications (mixed opioid agonist/antagonists such as pentazocine, nalbuphine, butorphanol), naltrexone.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolamlorazepam, zolpidem), muscle relaxants (such as carisoprodolcyclobenzaprine), or antihistamines (such as cetirizinediphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Other medications can affect the removal of oxycodone from your body, which may affect how oxycodone works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), mifepristoneHIV medications (such as ritonavir), rifamycins (such as rifabutinrifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, slow heartbeat, coma.

Notes

Do not share this medication with others. Sharing it is against the law.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

Missed Dose

If you are taking this medication on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. See also Warning section.

What Is Roxycodone?

Roxycodone, also spelled “Roxicodone” is a painkiller that is often prescribed for moderate to severe pain. Because it has emotionally “soothing” properties, it is sometimes also administered prior to certain types of surgery both to negate pain, and to reduce feelings of fear or anxiety.

Roxycodone is an opioid analgesic, meaning that it has been designed and synthesized in labs primarily to relieve pain symptoms. Under normal circumstances, the drug is administered in pill form, and, unlike other painkillers such as oxycodone, can take effect quite quickly, which is one of the reasons that it has grown in popularity, and justified a need for Roxy rehab in Florida.

It’s classified in the United States as a “Schedule II Drug,” which means that, under the United States Controlled Substances Act, this drug is confirmed as having legitimate medical uses, and subsequently can be prescribed to individuals at the discretion of a medical professional. However, the drug is also recognized as having a potential for abuse and addiction and is known to cause physical and/or psychological addiction. Because of this, treatment is a growing need in America thanks to the widespread use—and unintended addiction—of the drug.

How Roxycodone Addiction Occurs

Once a person becomes addicted, it’s critical that the people around them have a clear understanding of the nature of the problem and the signs of addiction. And so we’ve listed several signs of addiction below:

Roxycodone falls under the opioid class of drugs, meaning that it is a lab-created substance designed to mimic the effects of naturally occurring “opiates,” which are drugs derived from opium, which has well documented pain-killing properties. They can become highly addictive because of their effectiveness in reducing pain. Their ability to create an emotional sense of “euphoria” or well-being, and their ability to “trick” the nervous system into becoming dependent on the presence of the drug in the system, creates a real physical “craving” or appetite for the drug similar to food or water, which then requires treatment.

Unfortunately, as with many prescription drugs, addiction often occurs in the most innocent of ways. A doctor will prescribe the drug for legitimate medical reasons, usually to ease physical pain. If the drug is taken for too long, addiction can occur because of a number of causes.

A “plateau effect” can also occur where, as the user develops a tolerance to the drug in the body, it becomes less effective at killing the pain. This may encourage users to increase the dosage in order to maintain effectiveness, which also increases chances of addiction. Physical addiction can also occur if the user takes the drug for too long a period of time, encouraging the body to rely on the presence of the drug in the system.

What is Roxicodone (Roxycodone)?

Roxicodone (Roxycodone) is a narcotic pain reliever. It works by dulling the pain perception center in the brain. It may also affect other body systems (eg, respiratory and circulatory systems) at higher doses.

Roxicodone (Roxycodone) is used to treat moderate to severe pain. It may be used before surgery to sedate the patient and reduce fear. Roxicodone (Roxycodone) is not for treating pain just after a surgery unless you were already taking Roxicodone (Roxycodone) before the surgery. It may also be used for other conditions as determined by your doctor.

The usual adult dose of Roxicodone (Roxycodone) is 10 to 30 mg every 4 hours as needed for pain. The dose must be individually adjusted according to severity of pain, patient response and patient size. More severe pain may require 30 mg or more every 4 hours. If the pain increases in severity, analgesia is not adequate or tolerance occurs, a gradual increase in Roxicodone (Roxycodone) dosage may be required.

ROXICODONE® (oxycodone hydrochloride tablets USP) is an opioid analgesic.

Each tablet for oral administration contains 5 mg, 15 mg or 30 mg of oxycodone hydrochloride USP.

Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7).

Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula:

 

ROXICODONE<sup>®</sup>® (Oxycodone Hydrochloride) Structural Formula Illustration

C18H21NO4•HCl
MW 351.82

 

The 5 mg ROXICODONE® tablet contains inactive ingredients: microcrystalline cellulose and stearic acid. The 15 mg and 30 mg tablets contain the following inactive ingredients: microcrystalline cellulose; sodium starch glycolate; corn starch; lactose; stearic acid; D&C Yellow No. 10 (15 mg tablet); and FD&C Blue No. 2 (15 mg and 30 mg tablets).

The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base.

INDICATIONS

ROXICODONE® tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.

DOSAGE AND ADMINISTRATION

ROXICODONE® 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® 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® . Patients with chronic pain should have their dosage given on an around-the-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® should be administered on a regularly scheduled basis, every 4 to 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® , 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 nonopioid analgesic, it may be necessary to titrate the dose of ROXICODONE® 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® 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® , 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® close observation and adjustment of dosage based upon the patient’s response to ROXICODONE® is imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of ROXICODONE® 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® 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® 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® that treatment may be discontinued without risk of the opioid abstinence syndrome.

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