|Labeler Name||STAT Rx USA LLC|
|Dosage & Substance||tablet, film coated, extended release oxycodone hydrochloride|
|Date First Marketed||August 08, 2010|
OxyContin is a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Limitations of Usage
OxyContin is not intended for use on an as-needed basis.
OxyContin is not indicated for the management of pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. OxyContin is indicated for postoperative use following the immediate post-operative period only if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines).
OxyContin is not indicated for pre-emptive analgesia (preoperative administration for the management of postoperative pain).
OxyContin is not indicated for rectal administration.
OxyContin is contraindicated in:
- patients who have significant respiratory depression
- patients who have or are suspected of having paralytic ileus
- patients who have acute or severe bronchial asthma
- patients who have known hypersensitivity to any of its components or the active ingredient, oxycodone.
The following adverse reactions described elsewhere in the labeling include:
- Respiratory depression
- CNS depression
- Hypotensive effects
- Drug abuse, addiction, and dependence
- Paralytic ileus
6.1 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 safety of OxyContin was evaluated in double-blind clinical trials involving 713 patients with moderate to severe pain of various etiologies. In open-label studies of cancer pain, 187 patients received OxyContin in total daily doses ranging from 20 mg to 640 mg per day. The average total daily dose was approximately 105 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 shockOverdosage (10)].
The most common adverse reactions (>5%) reported by patients in clinical trials comparing OxyContin with placebo are shown in Table 2 below:
In clinical trials, the following adverse reactions were reported in patients treated with OxyContin with an incidence between 1% and 5%:
Gastrointestinal disorders: abdominal pain, diarrhea, dyspepsia, gastritis, hiccups
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
The following adverse reactions occurred in less than 1% of patients involved in clinical trials:
Blood and lymphatic system disorders: lymphadenopathy
Ear and labyrinth disorders: tinnitus
Eye disorders: abnormal vision
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
Investigations: ST depression
Metabolism and nutrition disorders: dehydration
Nervous system disorders: syncope, migraine, abnormal gait, amnesia, hyperkinesia, hypesthesia, 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
6.2 Postmarketing Experience
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.
5.1 Information Essential for Safe Administration
OxyContin tablets must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Taking cut, broken, chewed, crushed or dissolved OxyContin tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone.
OxyContin 60 mg and 80 mg Tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in opioid-tolerant patients. Use of these doses in patients who are not opioid tolerant may cause fatal respiratory depression.
Instruct patients against use by individuals other than the patient for whom OxyContin was prescribed, as such inappropriate use may have severe medical consequences, including death.
Opioid analgesics have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant 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.
5.2 CNS Depression
OxyContin may cause somnolence, dizziness, alterations in judgment and alterations in levels of consciousness, including coma.
5.3 Interactions with Alcohol, CNS Depressants and Illicit Drugs
Hypotension, profound sedation, coma or respiratory depression may result if OxyContin is added to a regimen that includes other CNS depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids). Therefore, use caution when deciding to initiate therapy with OxyContin in patients who are taking other CNS depressants. Take into account the types of other medications being taken, the duration of therapy with them, and the patient’s response to those medicines, including the degree of tolerance that has developed to CNS depression. Consider the patient’s use, if any, of alcohol and/or illicit drugs that cause CNS depression. If the decision to begin OxyContin is made, start with a lower OxyContin dose than usual.
Consider using a lower initial dose of a CNS depressant when given to a patient currently taking OxyContin due to the potential of additive CNS depressant effects.
5.4 Respiratory Depression
Decreased respiratory drive resulting in respiratory depression is the chief hazard from the use or abuse of opioid agonists, including OxyContin. The risk of opioid-induced respiratory depression is increased, for example, in elderly or debilitated patients; following large initial doses in any patient who is not tolerant to the respiratory-depressant or sedating effects of opioids; or when opioids are given in conjunction with other agents that either depress respiratory drive or consciousness.
Use OxyContin with extreme caution in patients with any of the following:
- significant chronic obstructive pulmonary disease or cor pulmonale
- other risk of substantially decreased respiratory reserve
- pre-existing respiratory depression
Respiratory depression induced by opioids typically follows a pattern entailing first a shift in CO2 responsiveness of the CNS respiratory drive center, which results in a decrease in the urge to breathe, despite the presence of hypercapnia. The increase in brain CO2 can result in sedation that can accentuate the sedation from the opioid itself. Profound sedation, unresponsiveness, infrequent deep ("sighing") breaths or atypical snoring frequently accompany opioid-induced respiratory depression. Eventually, hypoxia ensues. In addition to further decreasing consciousness, hypoxia, along with hypercapnia, can predispose to life-threatening cardiac arrhythmias.
Oxycodone, as with other opioids, may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. Use OxyContin with caution in patients with a history of seizure disorders.
5.6 Difficulty Swallowing and Gastrointestinal Effects
5.7 Head Injury
The respiratory depressant effects of opioids include carbon dioxide retention, which can lead to an elevation of cerebrospinal fluid pressure. This effect may be exaggerated in the presence of head injury, intracranial lesions, or other sources of pre-existing increased intracranial pressure. Oxycodone may produce miosis that is independent of ambient light, and altered consciousness, either of which may obscure neurologic signs associated with increased intracranial pressure in persons with head injuries.
5.8 Hypotensive Effect
OxyContin may cause severe hypotension. There is an added risk to individuals 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. Oxycodone may produce orthostatic hypotension in ambulatory patients. Administer OxyContin with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.
5.9 Cytochrome P450 3A4 Inhibitors and Inducers
Since the CYP3A4 isoenzyme plays a major role in the metabolism of OxyContin, drugs that alter CYP3A4 activity may cause changes in clearance of oxycodone which could lead to changes in oxycodone plasma concentrations.
The expected clinical results with CYP3A4 inhibitors would be an increase in oxycodone plasma concentrations and possibly increased or prolonged opioid effects. The expected clinical results with CYP3A4 inducers would be 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 is necessary, caution is advised when initiating OxyContin treatment in patients currently taking, or discontinuing, CYP3A4 inhibitors or inducers. Evaluate these patients at frequent intervals and consider dose adjustments until stable drug effects are achieved.
5.10 Interactions with Mixed Agonist/Antagonist Opioid Analgesics
It is generally not advisable to administer mixed agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) to a patient receiving OxyContin. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect and may precipitate withdrawal symptoms in these patients.
5.11 Use in Pancreatic/Biliary Tract Disease
Oxycodone may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids may cause increases in the serum amylase.
Tolerance to opioids is demonstrated by the need for increasing doses to maintain adequate analgesic effect (in the absence of disease progression or other external factors). If tolerance develops, or if pain severity increases, a gradual increase in dose may be required. The first sign of tolerance is usually a reduced duration of effect. Tolerance to different effects of opioids may develop to varying degrees and at varying rates in a given individual. There is also inter-patient variability in the rate and extent of tolerance that develops to various opioid effects, whether the effect is desirable (e.g., analgesia) or undesirable (e.g., nausea).
5.13 Special Risk Groups
Use OxyContin with caution in the following conditions, due to increased risk of adverse reactions: alcoholism; delirium tremens; adrenocortical insufficiency; CNS depression; debilitation; kyphoscoliosis associated with respiratory compromise; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis.
5.14 Driving and Operating Machinery
OxyContin may impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Caution patients accordingly.
5.15 Use in Addiction Treatment
OxyContin has no approved use in the treatment of addiction. Its proper usage in individuals with drug or alcohol addiction (substance dependence), either active or in remission, is for the management of pain requiring opioid analgesia.
5.16 Laboratory Monitoring
Not every urine drug test for "opioids" or "opiates" detects oxycodone reliably, especially those designed for in-office use. Further, many laboratories will report urine drug concentrations below a specified "cut-off" value as "negative". 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 use caution in interpreting results.
OXYCONTIN® (ox-e-KON-tin) CII
(oxycodone hydrochloride controlled-release)
Read this Medication Guide before you start taking OxyContin and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about OxyContin?
- OxyContin can cause serious side effects, including addiction or death.
- Do not cut, break, chew, crush, or dissolve OxyContin before swallowing. If OxyContin is taken in this way, the medicine in the tablets will be released too fast. This is dangerous. It may cause you to stop breathing, and may lead to death.
- OxyContin is not for use to treat pain that you only have once in a while ("as needed").
- Do not take OxyContin 60 mg or 80 mg tablets unless you are "opioid tolerant." Opioid tolerant means that you regularly use OxyContin or another opioid medicine for your constant (around-the-clock) pain and your body is used to it.
- Do not take more than 40 mg of OxyContin in one dose or more than 80 mg of OxyContin in one day unless you are "opioid tolerant." This may cause you to stop breathing and may lead to death.
- Do not drink alcohol while using OxyContin. Using alcohol with OxyContin may increase your risk of dangerous side effects, including death.
- Certain medicines can interact with OxyContin and cause you to have high levels of oxycodone in your blood. This may cause you to stop breathing and lead to death. Before taking OxyContin, tell your healthcare provider if you take an antibiotic, an antifungal medicine, or an anti-HIV medicine.
What is OxyContin?
- OxyContin is a prescription medicine used when an opioid medicine is needed to manage moderate to severe pain that continues around-the-clock and is expected to last for a long period of time.
- It is not known if OxyContin is safe and effective in children younger than 18 years.
- OxyContin is not for use:
- to manage pain "as needed"
- before surgery to manage any pain from your surgery
- to manage pain after surgery if the pain is mild and is not expected to last for a long period of time
- If you already take OxyContin, it may be used to manage your pain after surgery if:
- it has been at least 12 to 24 hours after your surgery, and
- your pain from surgery is expected to be moderate to severe, and last for a long period of time.
Who should not take OxyContin?
Do not take OxyContin if you:
- are allergic to any of its ingredients. See the end of this Medication Guide for a list of the ingredients in OxyContin.
- have had a severe allergic reaction to a medicine that contains oxycodone. Ask your healthcare provider if you are not sure.
- are having an asthma attack or have severe asthma, trouble breathing, or lung problems
- have a bowel blockage called paralytic ileus
What should I tell my healthcare provider before taking OxyContin?
OxyContin may not be right for you. Before taking OxyContin, tell your doctor if you:
- have trouble breathing or lung problems
- have had a head injury
- have liver or kidney problems
- have adrenal gland problems, such as Addison’s disease
- have severe scoliosis that affects your breathing
- have thyroid problems
- have enlargement of your prostate or a urethral stricture
- have or had convulsions or seizures
- have a past or present drinking problem or alcoholism
- have hallucinations or other severe mental problems
- have past or present substance abuse or drug addiction
- have any other medical conditions
- are pregnant or plan to become pregnant. If you take OxyContin regularly before your baby is born, your newborn baby may have signs of withdrawal because their body has become used to the medicine. Signs of withdrawal in a newborn baby can include:
- crying more than usual
- shaking (tremors)
- breathing faster than normal
- diarrhea or more stools than normal
If you take OxyContin right before your baby is born, your baby could have breathing problems at birth.
- are breast-feeding. You should not take OxyContin if you are nursing. Some oxycodone from OxyContin passes into breast milk. A nursing baby could become very drowsy or have difficulty breathing or feeding well.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Sometimes the doses of medicines that you take with OxyContin may need to be changed if used together.
- See "What is the most important information I should know about OxyContin?"
- Be especially careful about taking other medicines that make you sleepy such as:
- pain medicines
- sleeping pills
- anxiety medicines
- anti-nausea medicine
Do not take other medicines without talking to your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines while you take OxyContin.
Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist.
How should I take OxyContin?
- See "What is the most important information I should know about OxyContin?"
- Take OxyContin exactly as prescribed. Do not change your dose unless your healthcare provider tells you to.
- Swallow OxyContin tablets whole. Do not cut, break, chew, crush, or dissolve the tablets.
- In order to reduce the possibility of choking on the tablets or having difficulty swallowing the tablets:.
- OxyContin tablets should be taken one tablet at a time.
- Do not pre-soak, lick or otherwise wet the tablet prior to placing in your mouth.
- Take each tablet with enough water to ensure complete swallowing immediately after placing in your mouth.
- Take OxyContin every 12 hours.
- You can take OxyContin with or without food.
- If you miss a dose, take it as soon as possible. Take your next dose 12 hours later. Do not take more than your prescribed dose of OxyContin. Call your healthcare provider if you are not sure about your dose of OxyContin or when to take it.
- If you take more OxyContin than prescribed, or overdose, call your local emergency number (such as 911) or your local Poison Control Center right away, or get emergency help.
- Talk with your healthcare provider regularly about your pain to see if you still need to take OxyContin.
What should I avoid while taking OxyContin?
- Do not drink alcohol while using OxyContin. See "What is the most important information I should know about OxyContin?" Do not drive, operate heavy machinery, or do other dangerous activities, especially when you start taking OxyContin and when your dose is changed, until you know how you react to this medicine. OxyContin can make you sleepy, and also cause you to feel dizzy. Ask your healthcare provider to tell you when it is okay to do these activities.
What are the possible side effects of OxyContin?
OxyContin can cause serious side effects, including:
- See "What is the most important information I should know about OxyContin?"
- OxyContin can cause serious breathing problems that can become life-threatening, especially if OxyContin is used the wrong way. Call your healthcare provider or get medical help right away if:
- your breathing slows down
- you have shallow breathing (little chest movement with breathing)
- you feel faint, dizzy, confused, or
- you have any other unusual symptoms
These can be signs or symptoms that you have taken too much OxyContin (overdose) or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away.
- Central nervous system effects, including sleepiness, dizziness, passing out, becoming unconscious, or coma.
- OxyContin may cause a worsening of seizures in people who already have seizures.
- OxyContin can cause your blood pressure to drop. This can make you feel dizzy and faint if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you take other medicines that can also lower your blood pressure. Severe low blood pressure can happen if you lost blood or take certain other medicines.
- OxyContin can cause physical dependence. Do not stop taking OxyContin or any other opioid without talking to your healthcare provider about how to slowly stop your medicine. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependence is not the same as drug addiction. Tell your healthcare provider if you have any of these signs or symptoms of withdrawal while slowly stopping OxyContin:
- feel restless
- tearing eyes
- runny nose
- chills or hair on your arms "standing up"
- muscle aches, backache
- dilated pupils of your eyes
- feel irritable or anxious
- nausea, loss of appetite, vomiting, diarrhea
- increase in your blood pressure, breathing faster, or your heart beats faster
- There is a chance of abuse or addiction with OxyContin. The chance is higher if you are or have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental problems.
The most common side effects of OxyContin include:
- dry mouth
Some of these side effects may decrease with continued use. Talk with your healthcare provider if you continue to have these side effects. These are not all the possible side effects of OxyContin. For a complete list, ask your healthcare provider or pharmacist.
Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including OxyContin, and is unlikely to go away without treatment. Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking OxyContin.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.
How should I store OxyContin?
- Keep OxyContin out of the reach of children. Accidental overdose by a child is dangerous and can lead to death.
- Store OxyContin at 59° F to 86°F (15° C to 30° C)
- Keep OxyContin in the container it comes in.
- Keep the container tightly closed and away from light.
- After you stop taking OxyContin, flush the unused tablets down the toilet.
General information about OxyContin
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OxyContin for a condition for which it was not prescribed. Never give your OxyContin to other people even if they have the same symptoms you have.
Selling or giving away OxyContin may harm others, even causing death, and is against the law.
This Medication Guide summarizes the most important information about OxyContin. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about OxyContin that is written for health professionals. For more information about OxyContin, go to www.purduepharma.com or call 1-888-726-7535.
What are the ingredients of OxyContin?
Active ingredient: oxycodone hydrochloride
Inactive ingredients in all strengths: butylated hydroxytoluene (BHT), hypromellose, polyethylene glycol 400, polyethylene oxide, magnesium stearate, titanium dioxide
- The 10 mg tablets also contain: hydroxypropyl cellulose.
- 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.
- The 80 mg tablets also contain: hydroxypropyl cellulose, yellow iron oxide and FD&C Blue #2/Indigo Carmine Aluminum Lake.
Always check to make sure that the medicine you are taking is the correct one. The dosage strength and appearance of each OxyContin tablet are as follows:
- 10 mg: white-colored with "OP" on one side and "10" on the other
- 15 mg: gray-colored with "OP" on one side and "15" on the other
- 20 mg: pink-colored with "OP" on one side and "20" on the other
- 30 mg: brown-colored with "OP" on one side and "30" on the other
- 40 mg: yellow-colored with "OP" on one side and "40" on the other
- 60 mg: red-colored with "OP" on one side and "60" on the other
- 80 mg: green-colored with "OP" on one side and "80" on the other
This Medication Guide has been approved by the U.S. Food and Drug Administration.
DEA Order Form Required.
©2010, Purdue Pharma L.P.
Purdue Pharma L.P.
Stamford, CT 06901-3431
U.S. Patent Numbers 5,508,042; 6,488,963; 7,129,248; 7,674,799; 7,674,800 and 7,683,072
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 CO2) 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:
C18 H21 NO4 • HCl MW 351.83
The chemical name is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride.
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 0.7).
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 400, polyethylene oxide, magnesium stearate, titanium dioxide.
The 10 mg tablets also contain: hydroxypropyl cellulose.
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.
The 80 mg tablets also contain: hydroxypropyl cellulose, yellow iron oxide and FD&C Blue #2/Indigo Carmine Aluminum Lake.