What is oxycontin 20 mg

The side effects of oxycodone and OxyContin are very similar. This is because they contain the same active ingredient. The most common side effects of these drugs include:. Learn more: Detailed drug information for oxycodone ». An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well. Do not drink alcohol while taking immediate-release oxycodone or OxyContin. This combination can be deadly. Immediate-release oxycodone and OxyContin can make these conditions worse.

If you are breastfeeding, do not take either of these drugs. Both of these drugs can pass through breast milk and harm your child.

Certain side effects of these drugs, such as changes in mood and behavior, breathing problems, constipation, and lightheadedness can be particularly bothersome while you are pregnant. Also, results from one study have shown a link between certain birth defects and the use of opioids by pregnant women.

These drugs are very powerful pain relievers. It is important to know everything you can about these drugs before you take them. They can be habit forming, even at low doses and when taken exactly as prescribed. Misuse of these drugs can lead to addiction, poisoning, overdose, or even death.

Tramadol, oxycodone, and controlled-release oxycodone are drugs used to treat moderate to severe pain. Learn how these drugs are similar and different. Opana and Roxicodone are medications that can relieve pain. They work in similar ways, but have important differences. Learn more. A new study looking into adverse effects from medication use found that anticoagulants and diabetes agents send a significant amount of adults ages 65….

We all experience pain. Fortunately, there are many ways to manage pain, whether that means treating the source of the pain or coping with the pain…. Federal officials have set up locations across the country on National Prescription Drug Take Back Day for people go properly dispose of their old…. If you were prescribed morphine, it's important to understand how long the effects of the drug will last in your body.

Health Conditions Discover Plan Connect. Oxycodone vs. Medically reviewed by Alan Carter, Pharm. OxyContin Side-by-side Effectiveness Cost and availability Side effects Interactions With other conditions Pregnancy and breastfeeding Takeaway Introduction There are many different types of pain that affect people in different ways.

Oxycodone and OxyContin. Side by side: Drug features. Immediate-release oxycodone OxyContin Why is it used? Treatment of moderate to severe pain, such as pain after surgery or from a severe injury Treatment of moderate to severe pain that usually is associated with the last stages of chronic diseases Is a generic version available? Yes No What are the brands? Oxaydo Roxicodone OxyContin What are forms? Immediate-release oral tablet Immediate-release oral capsule Immediate-release oral solution Extended-release tablet Can the capsule or tablet be opened, cut, or crushed?

Yes No What are the strengths? Immediate-release oral tablet: Generic: 5 mg, 10 mg, 15 mg, 20 mg, 30 mg Roxicodone brand : 5 mg, 15 mg, 30 mg Oxaydo brand : 5 mg, 7. Every four to six hours Every 12 hours Do I take it for long-term or short-term treatment? Short-term treatment, usually three days or fewer Long-term treatment How do I store it? Cost, insurance coverage, and availability. Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.

When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking OXYCONTIN, there are a variety of factors that should be considered, including the dose of OXYCONTIN the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic.

When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder. Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder. Complex patients with comorbid pain and substance use disorders may benefit from referral to a specialist.

There are no standard opioid tapering schedules that are suitable for all patients. Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually. Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper. It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper.

Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge. Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper.

In addition, monitor patients for any changes in mood, emergence of suicidal thoughts, or use of other substances. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see Warnings and Precautions 5. Because extended-release products such as OXYCONTIN deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of oxycodone present [see Drug Abuse and Dependence 9 ].

Addiction can occur at recommended doses and if the drug is misused or abused. Risks are increased in patients with a personal or family history of substance abuse including drug or alcohol abuse or addiction or mental illness e.

The potential for these risks should not, however, prevent the proper management of pain in any given patient. Consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration 2.

Abuse or misuse of OXYCONTIN by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of oxycodone and can result in overdose and death [see Overdosage 10 ]. Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counseling Information 17 ].

Contact local state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product. Healthcare providers are strongly encouraged to do all of the following:. The FDA Blueprint can be found at www. Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended.

Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Carbon dioxide CO 2 retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of OXYCONTIN, the risk is greatest during the initiation of therapy or following a dosage increase.

Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling or getting emergency medical help right away in the event of a known or suspected overdose [see Patient Counseling Information 17 ]. Opioids can cause sleep-related breathing disorders including central sleep apnea CSA and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper [see Dosage and Administration 2.

Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with OXYCONTIN.

Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling or getting emergency medical help, even if naloxone is administered [see Patient Counseling Information 17 ].

The presence of risk factors for overdose should not prevent the proper management of pain in any given patient. Also consider prescribing naloxone if the patient has household members including children or other close contacts at risk for accidental ingestion or overdose. If naloxone is prescribed, educate patients and caregivers on how to treat with naloxone.

Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Use in Specific Populations 8.

Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone.

Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see Drug Interactions 7 ].

If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use.

In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response.

Follow patients closely for signs and symptoms of respiratory depression and sedation. If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration 2. Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see Drug Interactions 7 , Patient Counseling Information 17 ].

Patients with Chronic Pulmonary Disease : OXYCONTIN-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of OXYCONTIN [see Warnings and Precautions 5.

Elderly, Cachectic, or Debilitated Patients : Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see Warnings and Precautions 5. Alternatively, consider the use of non-opioid analgesics in these patients. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids.

Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers.

Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.

There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs e. In patients who may be susceptible to the intracranial effects of CO 2 retention e. Opioids may also obscure the clinical course in a patient with a head injury. These reports included choking, gagging, regurgitation and tablets stuck in the throat.

Instruct patients not to pre-soak, lick, or otherwise wet OXYCONTIN tablets prior to placing in the mouth, and to take one tablet at a time with enough water to ensure complete swallowing immediately after placing in the mouth.

There have been rare post-marketing reports of cases of intestinal obstruction, and exacerbation of diverticulitis, some of which have required medical intervention to remove the tablet. Patients with underlying GI disorders such as esophageal cancer or colon cancer with a small gastrointestinal lumen are at greater risk of developing these complications.

Consider use of an alternative analgesic in patients who have difficulty swallowing and patients at risk for underlying GI disorders resulting in a small gastrointestinal lumen. Opioids may cause increases in the serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

The oxycodone in OXYCONTIN may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Rapid tapering of oxycodone in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain [see Dosage and Administration 2.

Therefore, if urine testing for oxycodone is considered in the clinical management of an individual patient, ensure that the sensitivity and specificity of the assay is appropriate, and consider the limitations of the testing used when interpreting results. The following serious adverse reactions are described elsewhere in the labeling:. Adult Clinical Trial Experience. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The average total daily dose was approximately mg per day. OXYCONTIN may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock [see Overdosage 10 ]. Gastrointestinal disorders: abdominal pain, diarrhea, dyspepsia, gastritis. General disorders and administration site conditions: chills, fever.

Metabolism and nutrition disorders: anorexia. Musculoskeletal and connective tissue disorders: twitching. Psychiatric disorders: abnormal dreams, anxiety, confusion, dysphoria, euphoria, insomnia, nervousness, thought abnormalities.

Respiratory, thoracic and mediastinal disorders: dyspnea, hiccups. Skin and subcutaneous tissue disorders: rash. Vascular disorders: postural hypotension. Blood and lymphatic system disorders: lymphadenopathy. Ear and labyrinth disorders: tinnitus. Gastrointestinal disorders: dysphagia, eructation, flatulence, gastrointestinal disorder, increased appetite, stomatitis.

General disorders and administration site conditions: withdrawal syndrome with and without seizures , edema, peripheral edema, thirst, malaise, chest pain, facial edema. Injury, poisoning and procedural complications: accidental injury. Metabolism and nutrition disorders: dehydration. Nervous system disorders: syncope, migraine, abnormal gait, amnesia, hyperkinesia, hypoesthesia, hypotonia, paresthesia, speech disorder, stupor, tremor, vertigo, taste perversion.

Psychiatric disorders: depression, agitation, depersonalization, emotional lability, hallucination. Renal and urinary disorders: dysuria, hematuria, polyuria, urinary retention. Reproductive system and breast disorders: impotence. Respiratory, thoracic and mediastinal disorders: cough increased, voice alteration. Skin and subcutaneous tissue disorders: dry skin, exfoliative dermatitis.

The median duration of treatment was approximately three weeks. The most frequently reported adverse events were vomiting, nausea, headache, pyrexia, and constipation. Blood and lymphatic system disorders: febrile neutropenia, neutropenia. Gastrointestinal disorders: abdominal pain, gastroesophageal reflux disease.

General disorders and administration site conditions: fatigue, pain, chills, asthenia. Injury, poisoning, and procedural complications: procedural pain, seroma.

Investigations: oxygen saturation decreased, alanine aminotransferase increased, hemoglobin decreased, platelet count decreased, neutrophil count decreased, red blood cell count decreased, weight decreased. Metabolic and nutrition disorders: hypochloremia, hyponatremia. Musculoskeletal and connective tissue disorders: pain in extremity, musculoskeletal pain. Nervous system disorders: somnolence, hypoesthesia, lethargy, paresthesia.

Psychiatric disorders: insomnia, anxiety, depression, agitation. Renal and urinary disorders: dysuria, urinary retention. Respiratory, thoracic, and mediastinal disorders: oropharyngeal pain. Skin and subcutaneous tissue disorders: hyperhidrosis, rash.

The following adverse reactions have been identified during post-approval use of extended-release oxycodone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Abuse, addiction, aggression, amenorrhea, cholestasis, completed suicide, death, dental caries, increased hepatic enzymes, hyperalgesia, hypogonadism, hyponatremia, ileus, intentional overdose, mood altered, muscular hypertonia, overdose, palpitations in the context of withdrawal , seizures, suicidal attempt, suicidal ideation, syndrome of inappropriate antidiuretic hormone secretion, and urticaria.

In addition to the events listed above, the following have also been reported, potentially due to the swelling and hydrogelling property of the tablet: choking, gagging, regurgitation, tablets stuck in the throat and difficulty swallowing the tablet.

Serotonin syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Adrenal insufficiency : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Androgen deficiency : Cases of androgen deficiency have occurred with chronic use of opioids [see Clinical Pharmacology Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions 5. In animal reproduction studies, there was no embryo-fetal toxicity when oxycodone hydrochloride was orally administered to rats and rabbits, during the period of organogenesis, at doses 1. In several published studies, treatment of pregnant rats with oxycodone hydrochloride at clinically relevant doses and below resulted in neurobehavioral effects in offspring [see Data ].

Based on animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U. Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn.

Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions 5. Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. OXYCONTIN is not recommended for use in women immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate.

However, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Pregnant rats were treated with 0. Oxycodone did not cause adverse effects to the fetus at exposures up to 1.

The high dose produced maternal toxicity characterized by excessive gnawing on forelimbs and decreased body weight gain. However, body weight of these pups recovered. Oxycodone is present in breast milk. Published lactation studies report variable concentrations of oxycodone in breast milk with administration of immediate-release oxycodone to nursing mothers in the early postpartum period.

The lactation studies did not assess breastfed infants for potential adverse reactions. Lactation studies have not been conducted with extended—release oxycodone, including OXYCONTIN, and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production.

Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with OXYCONTIN. Withdrawal symptoms can occur in breast-fed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped.

Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential.

It is not known whether these effects on fertility are reversible [see Adverse Reactions 6. However, there were insufficient numbers of patients less than 11 years of age enrolled in this study to establish the safety of the product in this age group.

Patients were started on a total daily dose ranging between 20 mg and mg depending on prior opioid dose. The most frequent adverse events observed in pediatric patients were vomiting, nausea, headache, pyrexia, and constipation [see Dosage and Administration 2. In controlled pharmacokinetic studies in elderly subjects greater than 65 years the clearance of oxycodone was slightly reduced. Of the total number of subjects in clinical studies of oxycodone hydrochloride controlled-release tablets, In clinical trials with appropriate initiation of therapy and dose titration, no untoward or unexpected adverse reactions were seen in the elderly patients who received oxycodone hydrochloride controlled-release tablets.

Thus, the usual doses and dosing intervals may be appropriate for elderly patients. However, a dosage reduction in debilitated, non-opioid-tolerant patients is recommended [see Dosage and Administration 2. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who are not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.

Oxycodone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. A study of OXYCONTIN in patients with hepatic impairment demonstrated greater plasma concentrations than those seen at equivalent doses in persons with normal hepatic function [see Clinical Pharmacology Therefore, a dosage reduction is recommended for these patients [see Dosage and Administration 2.

Monitor closely for signs of respiratory depression, sedation, and hypotension. Follow a conservative approach to dose initiation and adjust according to the clinical situation.

OXYCONTIN contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. The high drug content in extended-release formulations adds to the risk of adverse outcomes from abuse and misuse. All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.

Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. With parenteral abuse, the inactive ingredients in OXYCONTIN can be expected to result in local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, valvular heart injury, embolism, and death. Cases of thrombotic microangiopathy a condition characterized clinically by thrombocytopenia and microangiopathic hemolytic anemia associated with parenteral abuse have been reported.

Parenteral drug abuse is commonly associated with transmission of infectious diseases, such as hepatitis and HIV. In Vitro Testing In vitro physical and chemical tablet manipulation studies were performed to evaluate the success of different extraction methods in defeating the extended-release formulation. Clinical Studies In a randomized, double-blind, placebo-controlled 5-period crossover pharmacodynamic study, 30 recreational opioid users with a history of intranasal drug abuse received intranasally administered active and placebo drug treatments.

Drug liking was measured on a bipolar drug liking scale of 0 to where 50 represents a neutral response of neither liking nor disliking, 0 represents maximum disliking and represents maximum liking. Twenty-seven of the subjects completed the study.

The intranasal administration of finely crushed OXYCONTIN was associated with a numerically lower mean and median drug liking score and a lower mean and median score for take drug again, compared to finely crushed original OxyContin or powdered oxycodone HCl as summarized in Table 5.

The data from the clinical study, along with support from the in vitro data, also indicate that OXYCONTIN has physicochemical properties that are expected to reduce abuse via the intranasal route. Additional data, including epidemiological data, when available, may provide further information on the impact of the current formulation of OXYCONTIN on the abuse liability of the drug. Accordingly, this section may be updated in the future as appropriate.

OXYCONTIN contains oxycodone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit, including fentanyl, hydromorphone, methadone, morphine, and oxymorphone.

Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia in the absence of disease progression or other external factors. Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug.

Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity e. Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient.

In patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support if needed , is in place prior to initiating an opioid analgesic taper [see Dosage and Administration 2. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Use in Specific Populations 8. Clinical Presentation. Acute overdose with OXYCONTIN can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death.

Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations. In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures including oxygen, vasopressors in the management of circulatory shock and pulmonary edema as indicated.

Cardiac arrest or arrhythmias will require advanced life support techniques. Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose.

For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid antagonist.

Because the duration of reversal is expected to be less than the duration of action of oxycodone in OXYCONTIN, carefully monitor the patient until spontaneous respiration is reliably reestablished. OXYCONTIN will continue to release oxycodone and add to the oxycodone load for 24 to 48 hours or longer following ingestion, necessitating prolonged monitoring.

In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered.

If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.

The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows:. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water 1 g in 6 to 7 mL. It is slightly soluble in alcohol octanol water partition coefficient 0.

The 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg tablets contain the following inactive ingredients: butylated hydroxytoluene BHT , hypromellose, polyethylene glycol , polyethylene oxide, magnesium stearate, titanium dioxide. The 15 mg tablets also contain black iron oxide, yellow iron oxide, and red iron oxide. The 20 mg tablets also contain polysorbate 80 and red iron oxide.

The 30 mg tablets also contain polysorbate 80, red iron oxide, yellow iron oxide, and black iron oxide. The 40 mg tablets also contain polysorbate 80 and yellow iron oxide. The 60 mg tablets also contain polysorbate 80, red iron oxide and black iron oxide. Oxycodone is a full opioid agonist and is relatively selective for the mu receptor, although it can bind to other opioid receptors at higher doses.

The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect to analgesia for oxycodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

Effects on the Central Nervous System. Oxycodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in CO 2 tension and electrical stimulation.

Oxycodone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic e. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Overdosage 10 ]. Oxycodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased.

Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase. Effects on the Cardiovascular System. Oxycodone produces peripheral vasodilation which may result in orthostatic hypotension or syncope.

Effects on the Endocrine System.