Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Monitor patients for signs of urinary retention or reduced gastric motility when Oxycodone Hydrochloride Capsules is used concomitantly with anticholinergic drugs. Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions 5.
Available data with Oxycodone Hydrochloride Capsules are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.
In several published studies, treatment of pregnant rats with oxycodone 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 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. Oxycodone Hydrochloride Capsules is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate.
Opioid analgesics, including Oxycodone Hydrochloride Capsules, can 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 dilation, which tends to shorten labor.
Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. These studies revealed no evidence of teratogenicity or embryo-fetal toxicity due to oxycodone. The highest doses tested in rats and rabbits were equivalent to approximately 2. 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 Oxycodone Hydrochloride Capsules, and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Oxycodone Hydrochloride Capsules and any potential adverse effects on the breastfed infant from Oxycodone Hydrochloride Capsules or from the underlying maternal condition.
Monitor infants exposed to Oxycodone Hydrochloride Capsules through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast feeding is stopped. 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 , Clinical Pharmacology The safety and effectiveness and the pharmacokinetics of Oxycodone Hydrochloride Capsules in pediatric patients below the age of 18 have not been established.
Elderly patients aged 65 years or older may have increased sensitivity to oxycodone. In general, use caution when selecting a dose for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.
Titrate the dosage of Oxycodone Hydrochloride Capsules slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see Warnings and Precautions 5.
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. Since oxycodone is extensively metabolized in the liver, its clearance may decrease in patients with hepatic impairment. Initiate therapy in these patients with a lower than usual dosage of Oxycodone Hydrochloride Capsules and titrate carefully.
Monitor closely for adverse events such as respiratory depression, sedation, and hypotension [see Clinical Pharmacology Information from oxycodone tablets indicate that patients with renal impairment had higher plasma concentrations of oxycodone than subjects with normal renal function. Initiate therapy with a lower than usual dosage of Oxycodone Hydrochloride Capsules and titrate carefully. Oxycodone hydrochloride capsules contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol.
Oxycodone Hydrochloride Capsules can be abused and is subject to misuse, addiction, and criminal diversion [see Warnings and Precautions 5. 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. Drug seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated "loss" of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating health care provider s.
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. Health care 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. Oxycodone Hydrochloride Capsules, like other opioids, can be diverted for non-medical use into illicit channels of distribution.
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 re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Oxycodone Hydrochloride Capsules are for oral use only. Abuse of oxycodone poses a risk of overdose and death. The risk is increased with concurrent abuse of alcohol and other central nervous system depressants.
Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. 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 results 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.
Oxycodone hydrochloride capsules should not be abruptly discontinued in a physically dependent patient [see Dosage and Administration 2. If Oxycodone Hydrochloride Capsules are abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur.
Some or all of the following can characterize this syndrome: 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. 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.
Acute overdose with Oxycodone hydrochloride capsules 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 [see Clinical Pharmacology 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 and vasopressors in the management of circulatory shock and pulmonary edema as indicated.
Cardiac arrest or arrhythmias will require advanced life-support techniques. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to oxycodone overdose, administer an opioid antagonist.
Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose. Because the duration of opioid reversal is expected to be less than the duration of action of oxycodone in Oxycodone Hydrochloride Capsules, carefully monitor the patient until spontaneous respiration is reliably re-established.
If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product's prescribing information. 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. Oxycodone hydrochloride capsule is an agonist, available as a hard gelatin capsule 5 mg for oral administration. The molecular weight is Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine.
It is soluble in water and slightly soluble in alcohol. The imprinting on the hard gelatin capsule is black ink. Oxycodone is a full opioid agonist and is relatively selective for the mu-opioid 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 for analgesia with 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.
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 carbon dioxide 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 due to hypoxia in overdose situations.
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.
Oxycodone produces peripheral vasodilation which may result in orthostatic hypotension or syncope. They also stimulate prolactin, growth hormone OH secretion, and pancreatic secretion of insulin and glucagon. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see Adverse Reactions 6 ]. Opioids have been shown to have a variety of effects on components of the immune system in in-vitro and animal models.
The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive. The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids.
There is a relationship between increasing oxycodone plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions [see Dosage and Administration 2.
The activity of oxycodone hydrochloride is primarily due to the parent drug oxycodone. Food causes a delay in Tmax l. Similar effects of food are expected with the oral solution.
Following intravenous administration, the volume of distribution Vss for oxycodone was 2. Oxycodone has been found in breast milk. Oxycodone hydrochloride is extensively metabolized by multiple metabolic pathways to noroxycodone, oxymorphone, and noroxymorphone, which are subsequently glucuronidated.
CYP3A4 mediated N-demethylation to noroxycodone is the primary metabolic pathway of oxycodone with a less contribution from CYP2D6 mediated 0-demethylation to oxymorphone. Therefore, the formation of these and related metabolites can, in theory, be affected by other drugs. The major circulating metabolite is noroxycodone with an AUC ratio of 0.
Noroxycodone is reported to be a considerably weaker analgesic than oxycodone. Oxymorphone, although possessing analgesic activity, is present in the plasma only in low concentrations. The correlation between oxymorphone concentrations and opioid effects was much less than that seen with oxycodone plasma concentrations.
The analgesic activity profile of other metabolites is not known. Oxycodone and its metabolites are excreted primarily via the kidney.
The total plasma clearance was 0. Apparent elimination half-life of oxycodone following the administration of oxycodone is approximately 4 hours. Information obtained from oxycodone tablets indicate that the plasma concentrations of oxycodone did not appear to be increased in patients over of the age of Because oxycodone is extensively metabolized in the liver, its clearance may decrease in hepaticimpaired patients.
A dose adjustment is recommended in these patients [see Use in Specific Populations 8. Because this drug 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, a dose reduction is recommended for renal impaired patients [see Use in Specific Populations 8.
CYP3A4 is the major enzyme involved in noroxycodone formation. While this pathway may be blocked by a variety of drugs e. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Oxycodone Hydrochloride is not recommended for use in women during and immediately prior to labor and delivery because oral opioids may cause respiratory depression in the newborn. Low concentrations of oxycodone have 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 Oxycodone Hydrochloride Capsules, since oxycodone may be excreted in the milk.
The most frequently observed reactions include light-headedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.
Many of these adverse events will cease or decrease in intensity as oxycodone therapy is continued and some degree of tolerance is developed.
Oxycodone products are common targets for both drug abusers and drug addicts. Drug addiction drug dependence, psychological dependence is characterized by a preoccupation with the procurement, hoarding, and abuse of drugs for non-medicinal purposes. Drug dependence is treatable, utilizing a multi-disciplinary approach, but relapse is common.
Tolerance and physical dependence in pain patients are not signs of psychological dependence. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Most chronic pain patients limit their intake of opioids to achieve a balance between the benefits of the drug and dose-limiting side effects.
Physicians should be aware that psychological dependence 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 psychological dependence and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. Primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation.
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. 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.
Dosage should be adjusted to the severity of the pain and the response of the patient. It may be occasionally necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effects of narcotics. This drug is given orally. The usual adult dosage is 5 mg every 6 hours as needed for pain. Keep this and all medication out of the reach of children. In case of accidental overdose, seek professional assistance or call a poison control center immediately.
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View Package Photos. Drug Label Info. Central Nervous System: Oxycodone is a pure agonist opioid whose principal therapeutic action is analgesia. 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.
Cardiovascular System: Oxycodone may produce release of histamine with or without associated peripheral vasodilation. Concentration—Efficacy Relationships Pharmacodynamics : Studies in normal volunteers and patients reveal predictable relationships between oxycodone dosage and plasma oxycodone concentrations, as well as between concentrations and certain expected opioid effects.
Concentration—Adverse Experience Relationships: Oxycodone Hydrochloride Capsules are associated with typical opioid-related adverse experiences similar to those seen with all opioids. For the relief of moderate to moderately severe pain. Respiratory Depression: Respiratory depression is the chief hazard from all opioid agonist preparations. Hypotensive Effect: Oxycodone Hydrochloride Capsules, 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.
Drug Dependence: Oxycodone can produce drug dependence of the morphine type, and therefore, has the potential for being abused. Interaction With Other Central Nervous System Depressants: Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants including alcohol concomitantly with oxycodone hydrochloride may exhibit an additive CNS depression.
Usage In Pregnancy: Safe use in pregnancy has not been established relative to possible adverse effects on fetal development.
Usage In Children: This drug should not be administered to children. General Opioid analgesics given on a fixed-dosage schedule have a narrow therapeutic index in certain patient populations, especially when combined with other drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. The flip side has the number 20 written boldly. RP 5 follows a similar design to the other tablets made by Rhodes Pharmaceuticals L.
It has a large 5 imprinted on one of its sides and R and P on the other. This is an oxycodone 5mg pill. Some addicts search for higher doses when they develop tolerance. The A 51 pill is another 30 mg oxycodone pill. It is round and blue. The manufacturer is Amneal Pharmaceuticals. It has A and 51 on one of its surfaces. Higher doses of opioids are more likely to cause side effects. This pill is round and green, with A written over the number The opposite surface of the tablet is blank, with no text.
A is made by Actavis, similar to the A In this case, the drug contains double the dosage, at 30mg. This is a blue, round tab, with one blank side and another that has A imprinted above Patients should take caution with higher doses of opioids.
The V pill is a product of Qualitest Pharmaceuticals, and it is a round tablet colored a light blue. It contains 30mg of oxycodone. It has a stylized V on one of its surfaces and the numbers 48 and 12 separated by a vertical groove. This tablet is also made by Qualitest Pharmaceuticals, with a stylized V on one of its surfaces and 48 and 10 on the other. It is white and round. This is an oxycodone 5mg tablet, which makes the risk of adverse health effects relatively low. Alvogen, Inc.
This round tablet is a distinct green tone and contains 15mg of the opioid as its sole active ingredient. One side is blank, though it has a horizontal groove. The other side has the letters ALG written directly on top of ALG is a blue, round tablet with those letters imprinted right above the numbers on one of its sides. The other side is clean, but for a horizontal line that provides a seam to break the tablet along. This is a 30mg tab. The other side is entirely blank. This is an oxycodone 5mg tab , and Mylan Pharmaceuticals Inc manufactures it.
The tablet is white and round. The risk of Oxycodone side effects with 5mg tabs is lower than doses like 15mg or 30mg. It is produced by Mylan Pharmaceuticals Inc. It has the number written on the upper half of one of its sides. This is a 30mg tablet with the number written in the upper half of one side. It has a horizontal groove on one side and the number , taking up most of the other surface.
This tablet contains 15mg of oxycodone. Similar to , is a round pill produced by Sun Pharmaceutical Industries Inc. It is white and contains 5mg , the lowest dosage available in tablet or capsule form. It has the number written boldly on a side. It is light blue and round, with a distinct written on one side. The other side has a horizontal groove for splitting the tablet.
Sun Pharmaceutical Industries Inc. It can easily be identified by its bright pink coloration and round shape. Additionally, the number can be seen on one of its sides. Opioids should not be used for longer than specified by their doctor for treatment.
ETH is made by Ethex Corporation. One of its sides has the number written, and the other has ETH, with a groove somewhat joining the stem of the letter T. It is yellow and round and contains 15mg of oxycodone. It is white and round and double the strength of ETH , with 30mg in each tab. The inscriptions on each side are and ETH. It is a round pill, make very distinct by its unique orange coloration.
It has a partial vertical groove on both sides, with the characters ETH and in the center of either face. Oxycodone capsules are relatively uncommon, with the LV being one of those.
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