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By Consumer Reports. Last updated: December 30, Sharing is Nice Yes, send me a copy of this email. Send We respect your privacy. Oops, we messed up. Certain people should never take oxycodone: These include people who already have slow or shallow breathing, or who have too much carbon dioxide in their blood due to poor breathing.
They also include people with acute or severe asthma. For all of these people, taking this drug could harm their breathing too much and cause death. For people with gastrointestinal GI problems: Oxycodone can worsen certain stomach or bowel problems. This is because this drug makes it harder for food to move through your digestive tract.
It can also make it harder for doctors to diagnose or find the cause of these problems. If you have a condition called a paralytic ileus, you should not take oxycodone. Or if you have any type of GI obstruction, you should not take extended-release oxycodone. The immediate-release version may be used cautiously.
For people with head injury: Oxycodone may cause increased pressure in your brain. It may also cause breathing problems. Both of these issues raise your risk of complications, and can cause death. For people with liver problems: Your body may process drugs more slowly.
Your doctor may start you on a lower dosage. For people with kidney problems: If you have kidney problems or a history of kidney disease, you may not be able to clear this drug from your body well.
This may increase the levels of oxycodone in your body and cause more side effects. This medication may also decrease your kidney function, making your kidney disease worse.
For people with seizure problems: Oxycodone may cause or worsen seizures. If you have epilepsy , talk with your doctor about whether this drug is safe for you. Oxycodone may make your condition worse.
Your doctor may prescribe a lower dosage of this drug. For people with hypothyroidism low thyroid levels : Talk with your doctor about whether this drug is safe for you. Oxycodone could make your condition better or worse. For people with urination problems: If you have trouble urinating due to certain problems, talk with your doctor about whether this drug is safe for you.
These problems include an enlarged prostate, a bladder obstruction, or kidney problems. Oxycodone can make it even harder for you to urinate, or make you unable to urinate. For people with pancreas and gallbladder problems: Oxycodone raises your risk of pancreatitis. If you have acute or chronic pancreatitis , this drug may worsen your condition.
Talk with your doctor about whether this drug is safe for you. For pregnant women: Using oxycodone long term during pregnancy may cause withdrawal symptoms in your newborn child. Symptoms include irritability, overactive behaviors, or an abnormal sleep pattern.
They also include high-pitched crying, tremors, vomiting, diarrhea, or failure to gain weight. This drug should only be used in pregnancy if clearly needed. For women who are breastfeeding: Oxycodone is present in breast milk and may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication. For seniors: The kidneys of older adults may not work as well as they used to.
For people at risk of misuse, addiction, or overdose: Using oxycodone can lead to addiction and misuse, which can result in overdose or death. Your doctor may prescribe naloxone, which is a drug used to treat an oxycodone overdose. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions. Oxycodone extended-release capsules or tablets should only be used by patients who have already been taking narcotic pain medicines, also called opioids.
These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine. Measure the oral liquid concentrate with the calibrated dropper that comes with the package. Your doctor may have you mix the concentrate with a small amount of liquid or food. Carefully follow the instructions and take the medicine mixture right away.
Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Do not break, crush, cut, chew, or dissolve it. Do not pre-soak, lick, or wet the tablet before placing it in the mouth.
Take one tablet at a time. Also, do not give this medicine through nasogastric or feeding tubes. Oxycodone extended-release capsules or tablets work differently from the regular oxycodone oral solution or tablets, even at the same dose. Respiratory, thoracic and mediastinal disorders: cough increased, voice alteration. Skin and subcutaneous tissue disorders: dry skin, exfoliative dermatitis.
The following adverse reactions have been identified during post-approval use of controlled-release oxycodone. Because these events 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, overdose, death, amenorrhea, symptoms associated with an anaphylactic or anaphylactoid reaction, cholestasis, dental caries, increased hepatic enzymes, muscular hypertonia, hyponatremia, ileus, palpitations in the context of withdrawal , seizures, 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. A published study showed that the co-administration of the antifungal drug, voriconazole, increased oxycodone AUC and C max by 3. Although clinical studies have not been conducted with other CYP3A4 inhibitors, the expected clinical results would be increased or prolonged opioid effects.
If co-administration with OxyContin is necessary, caution is advised when initiating therapy with, currently taking, or discontinuing CYP inhibitors.
Evaluate these patients at frequent intervals and consider dose adjustments until stable drug effects are achieved. Inducers of CYP3A4: CYP inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of oxycodone and, therefore, may cause increased clearance of the drug which could lead to a decrease in oxycodone plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome in a patient who had developed physical dependence to oxycodone.
If co-administration with OxyContin is necessary, caution is advised when initiating therapy with, currently taking, or discontinuing CYP3A4 inducers.
While this pathway may be blocked by a variety of drugs e. No specific interaction between oxycodone and monoamine oxidase inhibitors has been observed, but caution in the use of any opioid in patients taking this class of drugs is appropriate.
There are no adequate and well-controlled studies of oxycodone use during pregnancy. Based on limited human data in the literature, oxycodone does not appear to increase the risk of congenital malformations. In animal reproduction and developmental toxicology studies, no evidence of fetal harm was observed. Because animal reproduction studies are not always predictive of human response, oxycodone should be used during pregnancy only if clearly needed.
The effect of oxycodone in human reproduction has not been adequately studied. In a pre- and postnatal toxicity study, female rats received oxycodone during gestation and lactation. There were no long-term developmental or reproductive effects in the pups. Oxycodone hydrochloride was administered orally to female rats during gestation and lactation in a pre- and postnatal toxicity study.
There were no drug-related effects on reproductive performance in these females or any long-term developmental or reproductive effects in pups born to these rats. However, body weight of these pups recovered. Opioids cross the placenta and may produce respiratory depression and psychophysiologic effects in neonates. OxyContin is not recommended for use in women immediately prior to and during labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate.
Occasionally, opioid analgesics may prolong labor through actions which temporarily reduce the strength, duration and frequency of uterine contractions. However this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. Closely observe neonates whose mothers received opioid analgesics during labor for signs of respiratory depression. Have a specific opioid antagonist, such as naloxone or nalmefene, available for reversal of opioid-induced respiratory depression in the neonate.
This is not, however, synonymous with addiction [see Drug Abuse and Dependence 9. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening and should be treated according to protocols developed by neonatology experts. Oxycodone has been detected in breast milk. Instruct patients not to undertake nursing while receiving OxyContin. Do not initiate OxyContin therapy while nursing because of the possibility of sedation or respiratory depression in the infant.
Withdrawal symptoms can occur in breast-fed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. Safety and effectiveness of OxyContin in pediatric patients below the age of 18 years have not been established.
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. Respiratory depression is the chief risk in elderly or debilitated patients, usually the result of large initial doses in patients who are not tolerant to opioids, or when opioids are given in conjunction with other agents that depress respiration.
Titrate the dose of OxyContin cautiously in these patients. 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. Follow a conservative approach to dose initiation and adjust according to the clinical situation [see Clinical Pharmacology OxyContin contains oxycodone, which is a Schedule II controlled substance with an abuse liability similar to morphine.
OxyContin, like morphine and other opioids used for analgesia, can be abused and is subject to criminal diversion. Abuse of OxyContin poses a hazard of overdose and death. This risk is increased with compromising the tablet and with concurrent abuse of alcohol or other substances.
With parenteral abuse, the tablet excipients can result in death, local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases, such as hepatitis and HIV. Opioid drugs are sought by people with substance use disorders abuse or addiction, the latter of which is also called "substance dependence" and criminals who supply them by diverting medicines out of legitimate distribution channels.
OxyContin is a target for theft and diversion. Drug-seeking tactics include, but are not limited to, emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, altering or forging of prescriptions and reluctance to provide prior medical records or contact information for other treating physician s.
The risks of misuse and abuse should be considered when prescribing or dispensing OxyContin. Concerns about abuse and addiction, should not prevent the proper management of pain, however. Treatment of pain should be individualized, balancing the potential benefits and risks for each patient.
Compromising an extended or controlled-release delivery system will result in the uncontrolled delivery of oxycodone and pose a significant risk to the abuser that could result in overdose and death [see Warnings and Precautions 5. The risk of fatal overdose is further increased when oxycodone is abused concurrently with alcohol or other CNS depressants, including other opioids [see Warnings and Precautions 5. Abuse may occur by taking intact tablets without legitimate purpose, by crushing and chewing or snorting the crushed formulation, or by injecting a solution made from the crushed formulation.
Drug addiction is characterized by compulsive abuse, repeated use for non-medical purposes, loss of control over intake, craving of psychic effects and continued abuse despite harm or risk of harm in medical, social, legal or occupational domains. There is a potential for drug addiction to develop following exposure to opioids, including oxycodone. Drug addiction is a treatable disease, but relapse is common.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of addiction and is characterized by intentional misuse for non-medical purposes, often in combination with other psychoactive substances.
OxyContin has been diverted for non-medical use. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, proper dispensing and correct storage and handling are appropriate measures that help to limit misuse and abuse of opioid drugs. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.
Physical dependence to an opioid is manifested by characteristic withdrawal signs and symptoms after abrupt discontinuation of a drug, significant dose reduction or upon administration of an antagonist.
Physical dependence and tolerance are not unusual during chronic opioid therapy. The opioid abstinence or withdrawal syndrome in adults is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, piloerection, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
In general, opioids should not be abruptly discontinued [see Dosage and Administration 2. Acute overdosage with OxyContin can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring and death. It is important to take the pharmacokinetic profile of OxyContin into account when treating overdose.
Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects as opioid continues to be absorbed from ingested tablets. Deaths due to overdose have been reported with abuse and misuse of whole OxyContin tablets, and with abuse and misuse by ingesting, inhaling, or injecting crushed tablets. Review of case reports has indicated that the risk of fatal overdose is further increased when OxyContin is abused concurrently with alcohol or other CNS depressants, including other opioids.
In the treatment of OxyContin overdosage, primary attention should be given to the maintenance of a patent airway, and of effective ventilation clearance of CO 2 and oxygenation, whether by spontaneous, assisted or controlled respiration. 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 pure opioid antagonists such as naloxone or nalmefene are specific antidotes against respiratory depression from opioid overdose.
Since the duration of action of OxyContin may exceed that of the antagonist, especially when the overdose involves intact tablets, keep the patient under continued surveillance and administer repeated doses of the antagonist according to the antagonist labeling as needed to maintain adequate respiration.
Do not administer opioid antagonists in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose. In patients who are physically dependent on any opioid agonist including OxyContin, an abrupt partial or complete reversal of opioid effects may precipitate an acute abstinence or withdrawal syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered.
See the prescribing information for the specific opioid antagonist for details of its proper use. OxyContin oxycodone hydrochloride controlled-release is an opioid analgesic supplied in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg tablets for oral administration.
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 30 mg tablets also contain: polysorbate 80, red iron oxide, yellow iron oxide, and black iron oxide. Oxycodone is a pure mu receptor opioid agonist whose principal therapeutic action is analgesia. Other members of the class known as opioid agonists include substances such as morphine, hydromorphone, fentanyl, codeine, hydrocodone and oxymorphone.
Pharmacological effects of opioid agonists include anxiolysis, euphoria, feelings of relaxation, respiratory depression, constipation, miosis, and cough suppression, as well as analgesia. Increasing doses of pure mu receptor agonists are associated with increasing analgesia.
There is no defined maximum dose; the ceiling to analgesic effectiveness is imposed only by adverse reactions, the more serious of which may include somnolence and respiratory depression. Central Nervous System. 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.
A single-dose, double-blind, placebo- and dose-controlled study was conducted using OxyContin 10, 20, and 30 mg in an analgesic pain model involving patients with moderate to severe pain. OxyContin doses of 20 mg and 30 mg produced statistically significant pain reduction compared to placebo. Oxycodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves both a reduction in the responsiveness of the brain stem respiratory centers to increases in CO 2 tension and to electrical stimulation.
Oxycodone depresses the cough reflex by direct effect on the cough center in the medulla. Antitussive effects may occur with doses lower than those usually required for analgesia. 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 the setting of oxycodone overdose [See Overdosage 10 ]. Gastrointestinal Tract and Other Smooth Muscle. 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 gastric, biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase. Oxycodone may produce release of histamine with or without associated peripheral vasodilation. Opioids may influence the hypothalamic-pituitary-adrenal or -gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone.
Clinical signs and symptoms may be manifest from these hormonal changes. In vitro and animal studies indicate that opioids have a variety of effects on immune functions, depending on the context in which they are used.
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