Oxycodone and Acetaminophen 7.5 mg; 325 mg Tablet, 100-count — NDC 47781-229-01 (Billing 47781-0229-01)
This is a package of 100 tablets of Oxycodone and Acetaminophen 7.5 mg; 325 mg Tablet from Alvogen, Inc., marketed since Jan 2012 and currently FDA-listed; retail pharmacies pay about $0.1825 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 048976
- GCN: 14965
- GPI-14 (Medi-Span): 65990002200327
- HICL (First Databank): 001741
- AHFS class code: 28:08.08.00
- RxCUI (RxNorm): 1049214
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Anilides class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.183 | $18.25 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2486 | $24.86 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.2090 | $20.90 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 47781-0229-01 You're viewing this Main listing | 100 TABLET in 1 BOTTLE | $0.1825 / ea | $18.25 | 2012-01-17 | — | Active |
| 47781-0229-05 47781-229-05 | 500 TABLET in 1 BOTTLE | $0.1825 / ea | $91.26 | 2012-01-17 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1825 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 60% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 47781-0229-05?
What NDC number is used to bill for this package of Oxycodone and Acetaminophen 7.5 mg; 325 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 42806-0115-01 | Epic | 100 tablets | $0.127 | AA | FDA listed | save 30% |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 00406-0522-01 | SpecGx | 100 tablets | $0.183 | AA | Availability likely | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 00904-7094-61 | Major | 100 tablets | $0.183 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 10702-0186-01 | KVK-Tech, | 100 tablets | $0.183 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 13107-0045-01 | Aurolife | 100 tablets | $0.183 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 31722-0193-01 | Camber | 100 tablets | $0.183 | AA | Availability likely | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 31722-0950-01 | Camber | 100 tablets | $0.183 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 42858-0103-01 | Rhodes | 100 tablets | $0.183 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mgthis 47781-0229-01 | Alvogen, | 100 tablets | $0.183 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 50268-0645-15 | AvPAK | 50 tablets | $0.183 | AA | Availability likely | — |
| Endocet 7.5 mg/1; 325 mg 60951-0700-70 | Par | 100 tablets | $0.183 | AA | Availability likely | — |
| Oxycodone Hydrochloride and Acetaminophen 7.5 mg/1; 325 mg 64850-0622-01 | Elite | 100 tablets | $0.183 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 68084-0699-01 | American | 100 tablets | $0.183 | AA | Availability likely | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 70010-0669-01 | Granules | 100 tablets | $0.183 | AA | Availability likely | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 71930-0046-12 | Eywa | 100 tablets | $0.183 | AA | Availability likely | — |
| Percocet 7.5 mg/1; 325 mg 63481-0628-70 | SpecGx | 100 tablets | $31.605 | AA | Availability likely | +17217% |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 60760-0898-30 | St. | 30 tablets | — | AA | FDA listed | — |
| Oxycodone Hydrochloride and Acetaminophen 7.5 mg/1; 325 mg 60760-0964-30 | St. | 30 tablets | — | AA | FDA listed | — |
| Endocet 7.5 mg/1; 325 mg 63629-2190-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 65162-0207-03 | Amneal | 30 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 71335-0316-00 | Bryant | 84 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 71335-1472-00 | Bryant | 84 tablets | — | AA | Discontinued | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 71335-1909-01 | Bryant | 21 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 71335-1953-00 | Bryant | 84 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 71335-1959-01 | Bryant | 21 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 71335-9675-01 | Bryant | 21 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 72162-1338-03 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 325 mg/1; 7.5 mg 72189-0256-30 | DIRECT | 30 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 72189-0368-30 | Direct_Rx | 30 tablets | — | AA | FDA listed | — |
| Oxycodone/APAP 7.5 mg/1; 325 mg 72189-0375-30 | Direct_Rx | 30 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 72865-0115-01 | XLCare | 100 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 76420-0322-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
| Oxycodone And Acetaminophen 7.5 mg/1; 325 mg 87063-0033-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
| Oxycodone and Acetaminophen 7.5 mg/1; 325 mg 43386-0492-01 | Lupin | 100 tablets | — | AA | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE AND ACETAMINOPHEN TABLETS Addiction, Abuse, and Misuse Because the use of oxycodone and acetaminophen tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see WARNINGS ] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of oxycodone and acetaminophen tablets, especially during initiation or following a dosage increase.
To reduce the risk of respiratory depression, proper dosing and titration of oxycodone and acetaminophen tablets are essential [see WARNINGS ] . Accidental Ingestion Accidental ingestion of even one dose of oxycodone and acetaminophen tablets, especially by children, can result in a fatal overdose of oxycodone [see WARNINGS ] . Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Reserve concomitant prescribing of oxycodone and acetaminophen tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see WARNINGS , PRECAUTIONS , DRUG INTERACTIONS ] . Neonatal Opioid Withdrawal Syndro me (N OWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome , which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see WARNINGS ] .
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see WARNINGS ] . Cytochrome P450 3A4 Interaction The concomitant use of oxycodone and acetaminophen tablets with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression.
In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving oxycodone and acetaminophen tablets and any CYP3A4 inhibitor or inducer [see CLINICAL PHARMACOLOGY , WARNINGS , PRECAUTIONS , DRUG INTERACTIONS ] . Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.
Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg per day, and often involve more than one acetaminophen-containing product.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS ] , reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients forwhom alternative treatmentoptions are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Oxycodone and acetaminophen tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see WARNINGS ]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of oxycodone and acetaminophen tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.
Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors.
Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction,abuse, and misuse [see WARNINGS ] . Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with oxycodone and acetaminophen tablets. Consider this risk when selecting an initial dose and when making dose adjustments [see WARNINGS ] .
Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.
The presence of risk factors for overdose should not prevent the management of pain in any patient [ see WARNINGS; Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants ] . Discuss the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program). There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics.
Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent. Initial Dosage Use of Oxycodone and Acetaminophen Tablets as the First Opioid Analgesic Initiate treatment with oxycodone and acetaminophen tablets using oxycodone and acetaminophen tablets 2.5 mg/325 mg tablets in a dosing range of 1 to 2 tablets every 6 hours as needed for pain, at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of oxycodone and acetaminophen tablets.
The total daily dose of acetaminophen should not exceed 4 grams. Strength Usual Adult Dosage Maximal Daily Dose Oxycodone and Acetaminophen Tablets 5 mg/325 mg 1 tablet every 6 hours as needed for pain 12 Tablets Oxycodone and Acetaminophen Tablets 7.5 mg/325 mg 1 tablet every 6 hours as needed for pain 8 Tablets Oxycodone and Acetaminophen Tablets 10 mg/325 mg 1 tablet every 6 hours as needed for pain 6 Tablets Conversion from Oxycodone and Acetaminophen Tablets to Extended-Release Oxycodone The relative bioavailability of oxycodone and acetaminophen tablets compared to extended-release oxycodon… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Oxycodone and acetaminophen tablets are contraindicated in patients with: Significant respiratory depression [see WARNINGS ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] Hypersensitivity to oxycodone, acetaminophen, or any other component of the product (e.g., anaphylaxis) [see WARNINGS, ADVERSE REACTIONS ]
⚠️ Warnings ▾
WARNINGS Addiction, Abuse, and Misuse Oxycodone and acetaminophen tablets contain oxycodone, a Schedule II controlled substance. As an opioid, oxycodone and acetaminophen tablets exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE ] . Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed oxycodone and acetaminophen tablets.
Addiction can occur at recommended dosages and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [ see ADVERSE REACTIONS ] .
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing oxycodone and acetaminophen tablets, and reassess all patients receiving oxycodone and acetaminophen tablets for the development of these behaviors and conditions. 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.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient.
Patients at increased risk may be prescribed opioids such as oxycodone and acetaminophen tablets, but use in such patients necessitates intensive counseling about the risks and proper use of oxycodone and acetaminophen tablets along with frequent reevaluation for signs of addiction, abuse, and misuse. Consider recommending or prescribing an opioid overdose reversal agent [see WARNINGS , DOSAGE AND ADMINISTRATION ] . Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use.
Consider these risks when prescribing or dispensing oxycodone and acetaminophen tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on careful storage of the drug during the course of treatment and proper disposal of unused drug. 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.
Life-Threatening Respiratory Depression 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. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists overdose reversal agents, depending on the patient’s clinical status [see OVERDOSAGE ] .
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 oxycodone and acetaminophen tablets, the risk is greatest during the initiation of therapy or following a dosage increase of oxycodone and acetaminophen tablets. To reduce the risk of respiratory depression, proper dosing and titration of oxycodone and acetaminophen tablets are essential [see DOSAGE AND ADMINISTRATION ] .
Overestimating the oxycodone and acetaminophen tablets dosage when converting patients from another opioid product can result in a fatal overdose with the first dose. Accidental ingestion of even one dose of oxycodone and acetaminophen tablets, especially by children, can result in a fatal overdose of oxycodone [see WARNINGS ] . Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see PRECAUTIONS ; Information for Patients and/or… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of oxycodone and acetaminophen tablets. 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. Serious adverse reactions that may be associated with oxycodone and acetaminophen use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock [see OVERDOSAGE ] .
The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or 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. Other adverse reactions include euphoria, dysphoria, constipation, and pruritus.
Hypersensitivity reactions may include: Skin eruptions, urticarial, erythematous skin reactions. Hematologic reactions may include: thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. Rare cases of agranulocytosis has likewise been associated with acetaminophen use.
In high doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycemic coma also may occur. Other adverse reactions obtained from postmarketing experiences with oxycodone and acetaminophen are listed by organ system and in decreasing order of severity and/or frequency as follows: Body as a Whole: Anaphylactoid reaction, allergic reaction, malaise, asthenia, fatigue, chest pain, fever, hypothermia, thirst, headache, increased sweating, accidental overdose, non-accidental overdose Cardiovascular: Hypotension, hypertension, tachycardia, orthostatic hypotension, bradycardia, palpitations, dysrhythmias Central and Peripheral Nervous System: Stupor, tremor, paraesthesia, hypoaesthesia, lethargy, seizures, anxiety, mental impairment, agitation, cerebral edema, confusion, dizziness Fluid and Electrolyte: Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis Gastrointestinal: Dyspepsia, taste disturbances, abdominal pain, abdominal distention, sweating increased, diarrhea, dry mouth, flatulence, gastrointestinal disorder, nausea, vomiting, pancreatitis, intestinal obstruction, ileus Hepatic: Transient elevations of hepatic enzymes, increase in bilirubin, hepatitis, hepatic failure, jaundice, hepatotoxicity, hepatic disorder Hearing and Vestibular: Hearing loss, tinnitus Hematologic: Thrombocytopenia Hypersensitivity: Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria, anaphylactoid reaction Metabolic and Nutritional: Hypoglycemia, hyperglycemia, acidosis, alkalosis Musculoskeletal: Myalgia, rhabdomyolysis Ocular: Miosis, visual disturbances, red eye Psychiatric: Drug dependence, drug abuse, insomnia, confusion, anxiety, agitation, depressed level of consciousness, nervousness, hallucination, somnolence, depression, suicide Respiratory System: Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, aspiration, hypoventilation, laryngeal edema Skin and Appendages: Erythema, urticaria, rash, flushing Urogenital: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, urinary retention 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. Anaphylaxis : Anaphylaxis has been reported with ingredients contained in oxycodone and acetaminophen tablets. Androgen deficiency : Cases of androgen deficiency have occurred with use of opioids for an extended period of time.
Hyperalgesia and Allodynia : Cases of hyperalgesia and allodynia have been rep… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Animal reproductive studies have not been conducted with oxycodone and acetaminophen tablets. It is also not known whether oxycodone and acetaminophen tablets can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Oxycodone and acetaminophen tablets should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards.
Nonteratogenic Effects Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time 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 ] .
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness of oxycodone and acetaminophen tablets in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Elderly patients (aged 65 years or older) may have increased sensitivity oxycodone and acetaminophen tablets. In general, use caution when selecting a dosage 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 and acetaminophen tablets slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see WARNINGS ] . These drugs are 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 regularly evaluate renal function.
🆘 Overdosage ▾
OVERDOSAGE Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen. Clinical Presentation Oxycodone Acute overdosage with oxycodone 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, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [ see CLINCAL PHARMACOLOGY ] .
Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication. Acetaminophen Dose-dependent potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur.
Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Treatment of Overdose Oxycodone 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 measures. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene.
Because the duration of opioid reversal is expected to be less than the duration of action of oxycodone in oxycodone and acetaminophen tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist overdose reversal agent is suboptimal or only brief in nature, administer additional reversal agent 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 opioid overdose reversal agent 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 reversal agent administered. If a decision is made to treat serious respiratory depression in the physically-dependent patient, administration of the antagonist reversal agent should be initiated begin with care and by titration with smaller than usual doses of the antagonist reversal agent. Acetaminophen Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation.
Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with 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.
The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions. Pharmacodynamics 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 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.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations.
Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing. Effects on the 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 biliary and pancreatic secretions, spasm of sphincter of Oddi, transient elevations in serum amylase, and opioid-induced esophageal dysfunction (OIED). Effects on the Cardiovascular System Oxycodone produces peripheral vasodilation which may result in orthostatic hypotension or syncope.
Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see ADVERSE REACTIONS ] . They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon.
Use of opioids for an extended period of time 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 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 ] . Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system.
The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive. Concentration–Efficacy Relationships The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with opioid agonists.
The minimum effective analgesic concentration of oxycodone for any individual patient may increase over time due to an incre… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Oxycodone and Acetaminophen Tablets, USP are supplied as follows: Oxycodone and Acetaminophen Tablets, USP 5 mg/325 mg Blue, round tablet, debossed with "ALV" over "196", separated by a bisect, on one side, and plain on the other side. Bottles of 100 NDC 47781-196-01 Bottles of 250 NDC 47781-196-63 Bottles of 500 NDC 47781-196-05 Oxycodone and Acetaminophen Tablets, USP 7.5 mg/325 mg Orange to yellow, round tablet, debossed with “229” on one side and “ ”on the other side. Bottles of 100 NDC 47781-229-01 Bottles of 250 NDC 47781-229-63 Bottles of 500 NDC 47781-229-05 Oxycodone and Acetaminophen Tablets, USP 10 mg/325 mg Yellow, round tablet, debossed with “230” on one side and “ ” on the other side.
Bottles of 100 NDC 47781-230-01 Bottles of 250 NDC 47781-230-63 Bottles of 500 NDC 47781-230-05 Storage Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Store Oxycodone and Acetaminophen Tablets, USP securely and dispose of properly [see PRECAUTIONS ; I nformation for Patients and/or Caregivers ] .
📦 Storage and Handling ▾
Storage Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Store Oxycodone and Acetaminophen Tablets, USP securely and dispose of properly [see PRECAUTIONS ; I nformation for Patients and/or Caregivers ] .
📋 Description ▾
DESCRIPTION Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains: Oxycodone Hydrochloride, USP.................................... 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP....................................................
325 mg Oxycodone Hydrochloride, USP.................................... 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg Oxycodone Hydrochloride, USP....................................
10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg Inactive Ingredients All strengths of Oxycodone and Acetaminophen Tablets, USP contain the inactive ingredients crospovidone, lactose monohydrate, povidone, pregelatinized corn starch, and stearic acid. The 5 mg/325 mg tablets contain FD&C Blue No.
1 Aluminum Lake as a colorant. The 7.5 mg/325 mg tablets contain FD&C Yellow No. 6 Aluminum Lake as a colorant.
The 10 mg/325 mg tablets contain D&C Yellow No. 10 Aluminum Lake as a colorant. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder.
The molecular formula for oxycodone hydrochloride is C 18 H 21 NO 4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula: Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8 H 9 NO 2 and the molecular weight is 151.17.
It may be represented by the following structural formula:
💬 Information for Patients ▾
Information for Patients and/or Caregivers Advise the patient to read the FDA-approved patient labeling (Medication Guide). Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store oxycodone and acetaminophen tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving oxycodone and acetaminophen tablets unsecured can pose a deadly risk to others in the home [see WARNINGS , D RUG ABUSE AND DEPENDENCE ] .
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused oxycodone and acetaminophen tablets should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.
Addiction, Abuse, and Misuse Inform patients that the use of oxycodone and acetaminophen tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS ] . Instruct patients not to share oxycodone and acetaminophen tablets with others and to take steps to protect oxycodone and acetaminophen tablets from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting oxycodone and acetaminophen tablets or when the dosage is increased, and that it can occur even at recommended dosages.
Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see WARNINGS ; Life Threatening Respiratory Depression ] . Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS ] . Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if oxycodone and acetaminophen tabletsare used with benzodiazepines and other CNS depressants, includingalcohol, (e.g., non-benzodiazepine sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids), and not to use these concomitantly unless supervised by a healthcare provider [see WARNINGS , PRECAUTIONS, DRUG INTERACTIONS ] .
Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.
Discuss with the patient the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program) [ see WARNINGS , DOSAGE AND ADMINISTRATION ] . Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to patients and caregivers that effects of opiod overdose reversal agents like naloxone and nalmefene are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if an opioid overdose reversal agent is administered [see OVERDOSAGE ] .
Advise patients and caregivers: how to treat with… [Excerpted — this section continues on DailyMed.]
💬 Medication Guide ▾
Medication Guide Oxycodone (ox" i koe' done) and Acetaminophen (a seet" a min' oh fen) Tablets, CII Oxycodone and Acetaminophen Tablets are: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate and when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. An opioid pain medicine that can put you at risk for overdose and death.
Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Important information about Oxycodone and Acetaminophen Tablets : Get emergency help or call 911 right away if you take too much oxycodone and acetaminophen tablets (overdose). When you first start taking oxycodone and acetaminophen tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose. Taking oxycodone and acetaminophen tablets with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabline), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Never give anyone else your oxycodone and acetaminophen tablets.
They could die from taking it. Selling or giving away oxycodone and acetaminophen tablets is against the law. Store oxycodone and acetaminophen tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Do not take Oxycodone and Acetaminophen Tablets if you have : Severe asthma, trouble breathing, or other lung problems. A bowel blockage or have narrowing of the stomach or intestines known hypersensitivity to oxycodone, acetaminophen, or any ingredient in oxycodone and acetaminophen tablets Before taking Oxycodone and Acetaminophen Tablets, tell your healthcare provider if you have a history of : Head injury, seizures Liver, kidney, thyroid problems Problems urinating Pancreas or gallbladder problems Abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems Tell your healthcare provider if you are: Noticing your pain getting worse.
If your pain gets worse after you take oxycodone and acetaminophen tablets, do not take more of oxycodone and acetaminophen tablets without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking oxycodone and acetaminophen tablets. Are pregnant or planning to become pregnant.
Use of oxycodone and acetaminophen tablets for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Breastfeeding. Oxycodone and acetaminophen passes into breast milk and may harm your baby.
Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs. Living in a household where there are small children or someone who has abused street or prescription drugs.
Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking oxycodone and acetaminophen tablets with certain other medicines can cause serious side effects that could lead to death. When taking Oxycodone and Acetaminophen Tablets : Do not change your dose.
Take oxycodone and acetaminophen tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed. For acute (short-term) pain, you may only need to take oxycodone and aceta… [Excerpted — this section continues on DailyMed.]
⚠️ Precautions ▾
PRECAUTIONS Information for Patients and/or Caregivers Advise the patient to read the FDA-approved patient labeling (Medication Guide). Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store oxycodone and acetaminophen tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving oxycodone and acetaminophen tablets unsecured can pose a deadly risk to others in the home [see WARNINGS , D RUG ABUSE AND DEPENDENCE ] .
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused oxycodone and acetaminophen tablets should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.
Addiction, Abuse, and Misuse Inform patients that the use of oxycodone and acetaminophen tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS ] . Instruct patients not to share oxycodone and acetaminophen tablets with others and to take steps to protect oxycodone and acetaminophen tablets from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting oxycodone and acetaminophen tablets or when the dosage is increased, and that it can occur even at recommended dosages.
Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see WARNINGS ; Life Threatening Respiratory Depression ] . Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS ] . Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if oxycodone and acetaminophen tabletsare used with benzodiazepines and other CNS depressants, includingalcohol, (e.g., non-benzodiazepine sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids), and not to use these concomitantly unless supervised by a healthcare provider [see WARNINGS , PRECAUTIONS, DRUG INTERACTIONS ] .
Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.
Discuss with the patient the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program) [ see WARNINGS , DOSAGE AND ADMINISTRATION ] . Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to patients and caregivers that effects of opiod overdose reversal agents like naloxone and nalmefene are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if an opioid overdose reversal agent is administered [see OVERDOSAGE ] .
Advise patients and caregivers: how t… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers Available data from lactation studies indicate that oxycodone is present in breastmilk and that doses of less than 60 mg/day of the immediate-release formulation are unlikely to result in clinically relevant exposures in breastfed infants. A pharmacokinetics study utilizing opportunistic sampling of 76 lactating women receiving oxycodone immediate-release products for postpartum pain management showed that oxycodone concentrates in breastmilk with an average milk to plasma ratio of 3.2. The relative infant dose was low, approximately 1.3% of a weight-adjusted maternal dose (see Data ) .
In the same study, among the 70 infants exposed to oxycodone in breastmilk, no adverse events were attributed to oxycodone. However, based on known adverse effects in adults, infants should be monitored for signs of excess sedation and respiratory depression. There are no data on the effects of the oxycodone on milk production.
Acetaminophen is also excreted in breast milk in low concentrations. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for oxycodone and acetaminophen tablets and any potential adverse effects on the breastfed infant from oxycodone and acetaminophen tablets or from the underlying maternal condition. Infants exposed to oxycodone and acetaminophen through breast milk should be monitored 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.
Data Oxycodone concentration data from 76 lactating women receiving immediate-release oxycodone products for postpartum pain management, and 28 infants exposed to oxycodone in breastmilk showed that following a median (range) dose of oxycodone in mothers of 9.2 (5-10) mg/dose or 33.0 (5.4-59.3) mg/day, oxycodone concentrated in breastmilk with a median (range) milk to plasma ratio of 3.2 (1.2-5.3). However, when using maternal breastmilk data to estimate the daily and relative infant dose, the infant dose was 0.006 mg/kg/day, which is 1.3% of a weight-adjusted maternal dose of 10 mg every 6 hours.
These estimates based on maternal breastmilk concentrations were corroborated by the observed infant concentrations, of which over 75% (19/25) were below the limit of quantification. Among the 6 infants with quantifiable concentration, the median (range) concentration was 0.2 ng/mL (0.1-0.7). These concentrations are 100 to 1000 times lower than concentrations observed in other studies after infants received oxycodone at 0.1 mg/kg/dose (~20-200 ng/mL).
🔒 Drug Abuse and Dependence ▾
DRUG ABUSE AND DEPENDENCE Abuse Oxycodone and acetaminophen tablet contains oxycodone, a substance with a high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see WARNINGS ] . Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects.
Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.q., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of oxycodone and acetaminophen tablets increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death.
The risk is increased with concurrent abuse of oxycodone and acetaminophen tablets with alcohol and other CNS depressants. Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction.
All patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Patients at high risk of oxycodone and acetaminophen tablets abuse include those with a history of prolonged use of any opioid, including products containing oxycodone, those with a history of drug or alcohol abuse, or those who use oxycodone and acetaminophen tablets in combination with other abused drugs. “Drug-seeking” behavior is very common in persons with substance use disorders.
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). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control.
Oxycodone and acetaminophen tablets, like other opioids, can be diverted for nonmedical 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 reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
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. Risks Specific to Abuse of Oxycodone and Acetaminophen Tablets Abuse of oxycodone and acetaminophen tablets poses a risk of overdose and death. The risk is increased with concurrent use of oxycodone and acetaminophen tablets with alcohol and/or other CNS depressants.
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Dependence Both tolerance and physical dependence can develop during use of opioid therapy.
Tolerance is a physiological state characterized by a reduced response to a… [Excerpted — this section continues on DailyMed.]
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies to evaluate the carcinogenic potential of the combination of oxycodone hydrochloride and acetaminophen have not been conducted. Long-term studies in mice and rats have been completed by the National Toxicology Program to evaluate the carcinogenic potential of acetaminophen. In 2-year feeding studies, F344/N rats and B6C3F1 mice were fed a diet containing acetaminophen up to 6000 ppm.
Female rats demonstrated equivocal evidence of carcinogenic activity based on increased incidences of mononuclear cell leukemia at 0.8 times the maximum human daily dose (MHDD) of 4 grams/day, based on a body surface area comparison. In contrast, there was no evidence of carcinogenic activity in male rats that received up to 0.7 times or mice at up to 1.2-1.4 times the MHDD, based on a body surface area comparison. Mutagenesis The combination of oxycodone hydrochloride and acetaminophen has not been evaluated for mutagenicity.
Oxycodone alone was negative in a bacterial reverse mutation assay (Ames), an in vitro chromosome aberration assay with human lymphocytes without metabolic activation and an in vivo mouse micronucleus assay. Oxycodone was clastogenic in the human lymphocyte chromosomal assay in the presence of metabolic activation and in the mouse lymphoma assay with or without metabolic activation. In the published literature, acetaminophen has been reported to be clastogenic when administered at 1500 mg/kg/day to the rat model (3.6-times the MHDD, based on a body surface area comparison).
In contrast, no clastogenicity was noted at a dose of 750 mg/kg/day (1.8-times the MHDD, based on a body surface area comparison), suggesting a threshold effect. Impairment of Fertility In studies conducted by the National Toxicology Program, fertility assessments with acetaminophen have been completed in Swiss CD-1 mice via a continuous breeding study. There were no effects on fertility parameters in mice consuming up to 1.7 times the MHDD of acetaminophen, based on a body surface area comparison.
Although there was no effect on sperm motility or sperm density in the epididymis, there was a significant increase in the percentage of abnormal sperm in mice consuming 1.78 times the MHDD (based on a body surface comparison) and there was a reduction in the number of mating pairs producing a fifth litter at this dose, suggesting the potential for cumulative toxicity with chronic administration of acetaminophen near the upper limit of daily dosing. Published studies in rodents report that oral acetaminophen treatment of male animals at doses that are 1.2 times the MHDD and greater (based on a body surface comparison) result in decreased testicular weights, reduced spermatogenesis, reduced fertility, and reduced implantation sites in females given the same doses.
These effects appear to increase with the duration of treatment. The clinical significance of these findings is not known. Infertility Use of opioids for an extended period of time 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 ] .
📄 Package Label / Principal Display Panel ▾
NDC 47781- 196 -01 Oxycodone and Acetaminophen Tablets, USP CII 5 mg/325 mg Multiple strengths: Do not dispense unless strength is stated. PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 100 Tablets
NDC 47781- 229 -01 Oxycodone and Acetaminophen Tablets, USP CII 7.5 mg/325 mg Multiple strengths: Do not dispense unless strength is stated. PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 100 Tablets apap-structure alvogen-logo-1 alvogen-logo-2
NDC 47781- 230 -01 Oxycodone and Acetaminophen Tablets, USP CII 10 mg/325 mg Multiple strengths: Do not dispense unless strength is stated. PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 100 Tablets