Each tablet contains:
  Oxycodone Hydrochloride 5 mg

Each 5 mL Oral Solution contains:
  Oxycodone Hydrochloride 5 mg

Each mL Liquid Concentrate contains:
  Oxycodone Hydrochloride 20 mg

Inactive Ingredients:

The tablets contain microcrystalline cellulose and stearic acid.

The oral solution contains alcohol, FD&C Red No.40, flavoring, glycol, sorbitol, water, and other ingredients.

The liquid concentrate contains citric acid, sodium benzoate, and water.

Oxycodone is 14-hydroxydihydrocodeinone, a white odorless crystalline powder which is derived from the opium alkaloid, the-baine, and may be represented by the following structural formula:

For the relief of moderate to moderately severe pain.

The usual adult oral dose is 10 to 30 mg every 4 hours as needed for pain or as directed by physician. 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 dosage may be required.

For control of severe, chronic pain in patients with certain terminal diseases, this drug should be administered on a regularly scheduled basis, every 4 hours, at the lowest dosage level that will achieve adequate analgesia.

5 mg white scored tablets (Identified 54 582).

NDC 66479-580-25: Unit dose, 25 tablets per card, (reverse numbered), 4 cards per shipper.
NDC 66479-580-10: Bottles of 100 tablets.

5 mg per 5 mL Oral Solution

NDC 66479-583-05: Unit dose patient cup filled to deliver 5 mL (5 mg Oxycodone Hydrochloride), ten 5 mL patient cups per shelf pack, four shelf packs per shipper.
NDC 66479-583-50: Bottles of 500 mL.

20 mg per mL Liquid Concentrate

NDC 66479-584-03: Bottles of 30 mL with calibrated dropper [graduations of 0.25 mL (5 mg), 0.5 mL (10 mg), 0.75 mL (15mg), and 1 mL (20 mg) on the dropper].

Store at 25°C (77°F);excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]

DEA Order Form Required.
ROXICODONE is a registered trademark of Xanodyne Pharmaceuticals, Inc. Marketed by: Xanodyne® Pharmaceuticals, Inc. Newport, KY 41071. Rev.02-2006. FDA rev date: 8/31/2000

Serious adverse reactions that may be associated with ROXICODONE® therapy in clinical use are those observed with other opioid analgesics and include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypoten-sion, and/or shock (see OVERDOSE, WARNINGS).

The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include euphoria, dysphoria, constipation, skin rash and pruritus.

Oxycodone is metabolized in part to oxymor-phone via the cytochrome p450 isoenzyme CYP2D6. While this pathway may be blocked by a variety of drugs (e.g., certain cardiovascular drugs and antidepressants), such blockade has not yet been shown to be of clinical significance with this agent. However, clinicians should be aware of this possible interaction.

Neuromuscular Blocking Agents: Oxycodone, as well as other opioid analgesics, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

CNS Depressants: Patients receiving narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with ROXICODONE® may exhibit an additive CNS depression. Interactive effects resulting in respiratory depression, hypoten-sion, profound sedation, or coma may result if these drugs are taken in combination with the usual dosage of ROXICODONE®. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

Mixed Agonist/Antagonist Opioid Analgesics: Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic such as ROXICODONE®. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of ROXICODONE® and/or may precipitate withdrawal symptoms in these patients.

Monoamine Oxidase Inhibitors (MAOIs): MAOIs have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant depression of respiration or coma. The use of ROXICODONE® is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.

Respiratory Depression: Respiratory depression is the chief hazard from all opioid agonist preparations. Respiratory depression occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.

ROXICODONE® should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pul-monale, and in patients having substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of ROXICODONE® may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.

Hypotensive Effect: ROXICODONE®, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. ROXICODONE® may produce orthostatic hypotension in ambulatory patients. ROXICODONE®, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilatation produced by the drug may further reduce cardiac output and blood pressure.

Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

Drug Dependence: Oxycodone can produce drug dependence of the morphine type, and therefore, has the potential for being abused. Psychological dependence, physical dependence and tolerance may develop upon repeated administration of this drug, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic-containing medications. Like other narcotic-containing medications, this drug is subject to the Federal Controlled Substances Act.

General: ROXICODONE® is intended for use in patients who require oral pain therapy with an opioid agonist. As with any opi-oid analgesic, it is critical to adjust the dosing regimen individually for each patient (see DOSAGE AND ADMINISTRATION).

Use of ROXICODONE® is associated with increased potential risks and should be used only with caution in the following condi-tions: acute alcoholism;adrenocortical insufficiency (e. g., Addison's disease);convulsive disorders;CNS depression or coma;delirium tremens;debilitated patients;kyphoscoliosis associated with respiratory depression;myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture;severe impairment of hepatic, pulmonary or renal function;and toxic psychosis.

The administration of ROXICODONE® like all opioid analgesics, may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Tolerance and Physical Dependence: Physical dependence and tolerance are not unusual during chronic opioid therapy. Significant tolerance should not occur in most patients treated with the lowest doses of oxycodone. It should be expected, however, that a fraction of patients will develop some degree of tolerance and require progressively higher dosages of ROXICODONE® to maintain pain control during chronic treat-ment. The dosage should be selected according to the patient's individual analgesic response and ability to tolerate side effects. Tolerance to the analgesic effects of opioids is usually paralleled by tolerance to side effects except for constipation.

Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug or may be precipitated through the administration of drugs with opioid antagonist activity. If ROXICODONE® is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur. If signs and symptoms of withdrawal occur, patients should be treated by reinstitution of opioid therapy followed by gradual tapered dose reduction of ROXICODONE® combined with symptomatic support.

Use In Pancreatic/Biliary Tract Disease: ROXICODONE® may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pan-creatitis. Opioids like ROXICODONE® may cause increases in the serum amylase level.

Carcinogenesis, Mutagenesis,Impairment of Fertility: Long-term studies have not been performed in animals to evaluate the carcinogenic potential of ROXICODONE® or oxycodone. The possible effects on male or female fertility have not been studied in animals.

Pregnancy:Category B: There are no adequate and well controlled studies of oxycodone in pregnant women. ROXICODONE® should be used during pregnancy only if potential benefit justifies the potential risk to the fetus. Neonates whose mothers have taken oxycodone chronically may exhibit respiratory depression and/or withdrawal symptoms, either at birth and/or in the nursery.

Labor and Delivery: ROXICODONE® is not recommended for use in women during or immediately prior to labor. Occasionally, opioid analgesics may prolong labor through actions which temporarily reduce the strength, duration and frequency of uterine contractions. Neonates, whose mothers received opioid analgesics during labor, should be observed closely for signs of respiratory depression. A specific narcotic antagonist, naloxone, should be available for reversal of narcotic-induced respiratory depression in the neonate.

Nursing Mothers: Oxycodone has been detected in breast milk. Withdrawal symptoms can occur in breast-feeding infants when maternal administration of an opioid analgesic is stopped. Ordinarily, nursing should not be undertaken while a patient is receiving ROXICODONE® since oxycodone may be excreted in milk.

Pediatric Use: The safety and efficacy of oxycodone in pediatric patients have not been evaluated.

Geriatric Use: Of the total number of subjects in clinical studies of ROXICODONE®, 20.8% (112/538) were 65 and over, while 7.2% (39/538) were 75 and over.No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment: Since oxycodone is extensively metabolized, its clearance may decrease in hepatic failure patients. Dose initiation in patients with hepatic impairment should follow a conservative approach. Dosages should be adjusted according to the clinical situation.

Renal Impairment: Published data reported that elimination of oxycodone was impaired in end-stage renal failure. Mean elimination half-life was prolonged in uremic patients due to increased volume of distribution and reduced clearance. Dose initiation should follow a conservative approach. Dosages should be adjusted according to the clinical situation.

Ambulatory Patients: ROXICODONE® may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.

MANAGEMENT OF OVERDOSAGE

Signs and Symptoms: Serious overdose of oxycodone hydrochloride is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

Treatment: Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventila-tion. The narcotic antagonist naloxone is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including oxycodone.

Therefore, an appropriate dose of naloxone (usual initial adult dose: 0.4 mg) should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscita-tion. 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. An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

ROXICODONE® is contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. ROXICODONE® is contraindicated in any patient who has or is suspected of having paralytic ileus.

Actions

The analgesic ingredient, oxycodone, is a semi-synthetic narcotic with multiple actions qualitatively similar to those of morphine; the most prominent of these involve the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value of oxycodone are analgesia and sedation. Oxycodone is similar to codeine and methadone in that it retains at least one half of its analgesic activity when administered orally.

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

OXYCODONE - ORAL

(ox-ee-KOH-doan)

COMMON BRAND NAME(S): OxyIr, Percolone, Roxicodone

USES: This medication is used to treat moderate to severe pain. It acts on certain centers in the brain to give you pain relief. Oxycodone is a narcotic pain reliever (opiate-type).

HOW TO USE: Take this medication by mouth, usually every 4 to 6 hours, or as directed by your doctor. Follow your doctor's instructions exactly as prescribed. Your doctor may instruct you to take this medication only "as needed" for acute pain (e.g., pain after surgery) or on a regular schedule for chronic pain (e.g., cancer pain).

If you are taking this medication only as needed for pain, remember to take it as the first signs of pain occur. If you wait until the pain has significantly worsened, the medication may not work as well.

If you are using the oral liquid, use a specially marked medicine spoon or medicine cup to measure the correct amount of medication. Consult your pharmacist if you have any questions.

If you have nausea, you may take this drug with food. If nausea persists or worsens, consult your doctor or pharmacist about alternatives for decreasing nausea (e.g., antihistamines, lying down for 1 to 2 hours with minimal head movement).

The dosage is based on your medical condition, use of other pain medications, and response to therapy. Do not increase your dose without consulting your doctor or pharmacist.

If so directed by your doctor, you may also take long-acting narcotic medications or use narcotic patches for chronic pain, in which case this medication might be used for "breakthrough" pain only as needed. Also follow your doctor's or pharmacist's instruction for the safe use of non-narcotic pain relievers (e.g., acetaminophen, ibuprofen). Ask your doctor or pharmacist about any questions regarding your treatment.

This medication may cause dependence, especially if it has been used regularly for an extended period of time (more than a few weeks), or if it has been used in high doses. If you suddenly stop this drug, withdrawal reactions (e.g., anxiety, irritability, sweating, trouble sleeping, diarrhea) may occur. Report to your doctor immediately any such reactions. When stopping extended, regular use of this medication, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details.

Though it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit-forming). Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed. You should properly stop this medication when directed by your doctor. This will lessen the chances of becoming addicted.

If you use this medication for an extended period of time, it may not be as effective and you will need a different dose. Talk with your doctor if you think this medication has stopped working well.

Inform your doctor if your pain persists or worsens.

SIDE EFFECTS: Nausea, vomiting, constipation, mild itching, drowsiness, dry mouth, lightheadedness, loss of appetite, or weakness may occur. Some of these side effects may decrease after continued use of the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in the use of a laxative (e.g., stimulant-type and stool softener).

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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/irregular/shallow breathing, dizziness upon standing, slow/fast/irregular heartbeats, mental/mood changes, uncontrolled muscle movements (tremors), vision changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

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

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain relievers (e.g., codeine, hydrocodone); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: serious breathing problems (e.g., severe asthma, respiratory depression, hypercarbia), certain bowel diseases (e.g., paralytic ileus), intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (e.g., seizures, head injury, increased intracranial pressure), adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., enlarged prostate, urethral stricture), personal or family history of regular use/abuse of drugs/alcohol/other substances, kidney or liver disease, heart problems (e.g., low blood pressure, irregular heartbeats), lung diseases (e.g., chronic obstructive pulmonary disease, hypoxia, hypercapnia), metabolic disorders (e.g., low sodium, dehydration), disease of the pancreas (e.g., pancreatitis), psychiatric problems (e.g., major depression, toxic psychosis), spinal problem (kyphoscoliosis), stomach/intestinal problems (e.g., gallbladder disease, severe diarrhea or constipation), underactive thyroid (hypothyroidism).

This drug may make you dizzy or drowsy; do not drive or operate machinery until you know how this medication affects you. Avoid alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Tell your doctor or dentist you are taking this medication prior to having surgery.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects (e.g., slow/shallow breathing and drowsiness).

This medication should be used only when clearly needed during pregnancy. It is not recommended for use near or at the time of delivery because of possible side effects in the newborn (e.g., slow/shallow breathing). Discuss the risks and benefits with your doctor. If you have been taking this medication regularly for an extended period of time or in high doses, do not suddenly stop taking it. Consult your doctor for further instructions. Infants born to mothers who have been using this medication, especially for an extended time, may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because very serious interactions may occur: naltrexone.

If you are currently using this medication listed above, tell your doctor or pharmacist before starting oxycodone.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other medications for pain (e.g., butorphanol, codeine, pentazocine, tramadol), anti-seizure drugs (e.g., carbamazepine, phenobarbital), anticholinergic medications (e.g., atropine, scopolamine), drugs affecting removal of oxycodone from your body (e.g., cimetidine, SSRI antidepressants such as fluoxetine), drugs that lower blood pressure (e.g., diuretics such as hydrochlorothiazide, furosemide), MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, phenelzine, procarbazine, selegiline, tranylcypromine), muscle relaxants (e.g., carisoprodol, methocarbamol), pyridostigmine, sodium oxybate.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: antihistamines that cause drowsiness (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), medicine for sleep (e.g., zolpidem), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclic antidepressants such as amitriptyline), tranquilizers.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This medication can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: slowed breathing, slowed heartbeats, persistent dizziness/fainting, cold/clammy skin, limp/weak muscles, excessive drowsiness, or loss of consciousness.

NOTES: Do not share this medication with others. 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 those cases.

MISSED DOSE: If you take this medication regularly and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.