Oxycodone Hydrochloride 5 mg Tablet, 30-count
Other active recalls for Oxycodone Hydrochloride (different manufacturers) — 2 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Opioid Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Oxycodone is used to relieve severe pain. Oxycodone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
Read the full MedlinePlus article ↗- Extended-release oxycodone is designed for pain that's severe enough to need steady, around-the-clock control — not just occasional flare-ups. The tablet releases slowly over 12 ho...
- Why has my doctor prescribed an extended-release opioid instead of regular pain pills?
- No — and this is really important. Crushing, breaking, chewing, or dissolving the tablet destroys the controlled-release mechanism. The entire dose, meant to be released slowly ove...
- Is it okay to crush or break the tablet to make it easier to swallow?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Oxycodone Hydrochloride — tap one for details:
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💊 What it looks like
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🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1678 | $5.03 / 30 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Oxycodone Hydrochloride 5 mg 00406-0552-01 | SpecGx | 100 tablets | $0.087 | AB | Availability likely | — |
| Oxycodone Hydrochloride 5 mg 00904-6966-61 | Major | 100 tablets | $0.087 | AB | Availability likely | — |
| Oxycodone Hydrochloride 5 mg 10702-0018-01 | KVK-TECH,INC | 100 tablets | $0.087 | AB | Availability likely | — |
| Oxycodone Hydrochloride 5 mg 13107-0055-01 | Aurolife | 100 tablets | $0.087 | AB | Availability likely | — |
| Oxycodone Hydrochloride 5 mg 31722-0484-01 | Camber | 100 tablets | $0.087 | AB | Availability likely | — |
| Oxycodone Hydrochloride 5 mg 42806-0005-01 | Epic | 100 tablets | $0.087 | AB | Availability likely | — |
| Oxycodone hydrochloride 5 mg 47781-0263-01 | Alvogen, | 100 tablets | $0.087 | AB | Availability likely | — |
| Oxycodone Hydrochloride 5 mg 64380-0259-01 | Strides | 100 tablets | $0.087 | AB | Availability likely | — |
| Oxycodone Hydrochloride 5 mg 68084-0354-01 | American | 100 tablets | $0.087 | AB | Availability likely | — |
| Oxycodone Hydrochloride 5 mg 42858-0001-01 | Rhodes | 100 tablets | $0.098 | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 43386-0432-01 | Lupin | 100 tablets | $0.098 | — | FDA listed | — |
| Oxycodone Hydchloride 5 mg 49999-0899-15 | Quality | 15 tablets | — | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 60760-0954-30 | St. | 30 tablets | — | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 65162-0047-03 | Amneal | 30 tablets | — | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 67296-0425-02 | RedPharm | 6 tablets | — | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 67296-2188-01 | Redpharm | 12 tablets | — | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 67296-2233-02 | Redpharm | 4 tablets | — | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 68071-2368-06 | NuCare | 6 tablets | — | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 68071-2899-06 | NuCare | 6 tablets | — | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 68071-3600-04 | NuCare | 4 tablets | — | AB | FDA listed | — |
| Oxaydo 5 mg 69344-0113-11 | Zyla | 100 tablets | — | — | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 71335-0981-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mgthis 71335-1361-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 71335-1421-01 | Bryant | 30 tablets | — | AB | Discontinued | — |
| Oxycodone Hydrochloride 5 mg 72162-1334-02 | Bryant | 20 tablets | — | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 72162-1811-00 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 72189-0095-30 | DIRECT | 30 tablets | — | — | FDA listed | — |
| Oxycodone HCL 5 mg 72189-0611-30 | Direct_Rx | 30 tablets | — | AB | FDA listed | — |
| Oxycodone HCL 5 mg 72189-0618-30 | Direct_Rx | 30 tablets | — | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 76420-0362-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Oxycodone hydrochloride 5 mg 76420-0763-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Oxycodone Hydrochloride 5 mg 76420-0897-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| RoxyBond 5 mg 81140-0101-10 | Protega | 100 tablets | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71335-1361-01 You're viewing this | 30 TABLET in 1 BOTTLE (71335-1361-1) | 2019-11-19 | Active |
| 71335-1361-02 | 60 TABLET in 1 BOTTLE (71335-1361-2) | 2019-10-01 | Active |
| 71335-1361-03 | 90 TABLET in 1 BOTTLE (71335-1361-3) | 2019-10-01 | Active |
| 71335-1361-04 | 56 TABLET in 1 BOTTLE (71335-1361-4) | 2021-12-28 | Active |
| 71335-1361-05 | 100 TABLET in 1 BOTTLE (71335-1361-5) | 2021-12-28 | Active |
| 71335-1361-06 | 120 TABLET in 1 BOTTLE (71335-1361-6) | 2021-12-28 | Active |
| 71335-1361-07 | 50 TABLET in 1 BOTTLE (71335-1361-7) | 2021-12-28 | Active |
| 71335-1361-08 | 40 TABLET in 1 BOTTLE (71335-1361-8) | 2021-12-28 | Active |
| 71335-1361-09 | 20 TABLET in 1 BOTTLE (71335-1361-9) | 2019-10-18 | Active |
| 71335-1361-00 | 15 TABLET in 1 BOTTLE (71335-1361-0) | 2024-08-12 | Active |
You're viewing one of 10 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 71335-1361-01?
What is the difference between NDC 71335-1361-01 and NDC 71335-1361-00?
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE- THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Oxycodone Hydrochloride 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 Oxycodone Hydrochloride Tablets, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 )]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings and Precautions ( 5.2 )]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.
Healthcare providers are strongly encouraged to • complete a REMS-compliant education program, • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and • consider other tools to improve patient, household, and community safety. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Oxycodone Hydrochloride Tablets.
Monitor for respiratory depression, especially during initiation of Oxycodone Hydrochloride Tablets or following a dosage increase [see Warnings and Precautions ( 5.3 )]. Accidental Ingestion Accidental ingestion of even one dose of Oxycodone Hydrochloride Tablets, especially by children, can result in a fatal overdose of oxycodone [see Warnings and Precautions ( 5.3 )]. Neonatal Opioid Withdrawal Syndrome Prolonged use of Oxycodone Hydrochloride Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions ( 5.4 )]. Cytochrome P450 3A4 Interaction The concomitant use of Oxycodone Hydrochloride 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 Hydrochloride Tablets and any CYP3A4 inhibitor or inducer [see Warnings and Precautions ( 5.5 ), Drug Interactions ( 7 ), Clinical Pharmacology ( 12.3 )]. Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depresants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions ( 5.6 ), Drug Interactions ( 7 )]. • Reserve concomitant prescribing of Oxycodone Hydrochloride Tablets and benzodiazepines…
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Oxycodone Hydrochloride Tablets is 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, and misuse with opioids, which can occur at any dosage or duration , reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): • Have not been tolerated or are not expected to be tolerated, • Have not provided adequate analgesia or are not expected to provide adequate analgesia.
Oxycodone Hydrochloride Tabletsis an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Oxycodone Hydrochloride Tablets for usein patients for whom alternative treatment options (e.g., non-opioid analgesics or non-opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expectedto provide adequate analgesia.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ( 2.1 ) • Individualize dosing based on severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse and misuse. ( 2.1 ) • Discuss availability of naloxone with the patient and caregiver and assess each patient’s need for access to naloxone, both when initiating and renewing treatment with Oxycodone Hydrochloride Tablets.
Consider prescribing naloxone based on the patient’s risk factors for overdose. ( 2.2 , 5.1 , 5.3 , 5.6 ) • Initiate dosing with a range of 5 to 15 mg every 4 to 6 hours as needed for pain. (2.3) • For control of chronic pain, administer Oxycodone Hydrochloride Tablets on a regularly scheduled basis, at the lowest dosage level to achieve adequate analgesia.
( 2.3 ) • Individually titrate Oxycodone Hydrochloride Tablets to a dose that provides adequate analgesia and minimizes adverse reactions. ( 2.4 ) • Do not abruptly discontinue Oxycodone Hydrochloride Tablets in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. ( 2.5 )
2.1Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)]. Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with Oxycodone Hydrochloride Tablets and adjust the dosage accordingly [see Warnings and Precautions (5.3)].
2.2Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with Oxycodone Hydrochloride Tablets [see Warnings and Precautions (5.3), Patient Counseling Information ( 17 )]. Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program).
Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. The presence of risk factors for overdose should not prevent the proper management of pain in any given patient [see Warnings and Precautions ( 5.1 , 5.3 , 5.6 )]. Consider prescribing naloxone if the patient has household members (including children) or other close contacts at risk for accidental ingestion or overdose.
2.3Initial Dosage Although it is not possible to list every condition that is important to the selection of the initial dose of Oxycodone Hydrochloride Tablets, attention must be given to: 1. the daily dose, potency and characteristics of a full agonist or mixed agonist/antagonist the patient has been taking previously. 2. the reliability of the relative potency estimate to calculate the dose of oxycodone HCl needed. 3. the degree of opioid tolerance.
4. the general condition and medical status of the patient, including the patient's weight and age. 5. the balance between pain management and adverse reactions. 6. the type and severity of the patient's pain.
7. risk factors for abuse or addiction, including a prior history of abuse or addiction. Use of Oxycodone Hydrochloride Tablets as the First Opioid Analgesic Initiate treatment with Oxycodone Hydrochlori…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Oxycodone Hydrochloride Tablets, USP: 5 mg white to off white, round tablets, debossed with “U22” on one side and break line on the other side. 15 mg light green to green, round tablets, debossed with “U23” on one side and break line on the other side. 30 mg light blue to blue, round tablets, debossed with “U24” on one side and break line on the other side. Immediate-release tablets: 5 mg, 15 mg, 30 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Oxycodone Hydrochloride Tablets is contraindicated in patients with: • Significant respiratory depression [see Warnings and Precautions ( 5.3 )]. • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [see Warnings and Precautions ( 5.7 )]. • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.11 )]. • Known hypersensitivity (e.g., anaphylaxis) to oxycodone [see Adverse Reactions ( 6.2 )]. • Significant respiratory depression ( 4 ) • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment ( 4 ) • Known or suspected gastrointestinal obstruction, including paralytic ileus ( 4 ) • Hypersensitivity to oxycodone ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Monitor closely, particularly during initiation and titration. (5.7) Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.8) Severe Hypotension : Monitor during dosage initiation and titration.
Avoid use of Oxycodone Hydrochloride Tablets in patients with circulatory shock. (5.9) Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Oxycodone Hydrochloride Tablets in patients with impaired consciousness or coma.
(5.10)
5.1Addiction, Abuse, and Misuse Oxycodone Hydrochloride Tablets contains oxycodone, a Schedule II controlled substance. As an opioid, Oxycodone Hydrochloride Tablets exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence ( 9 )]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Oxycodone Hydrochloride Tablets.
Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing Oxycodone Hydrochloride Tablets, and monitor all patients receiving Oxycodone Hydrochloride 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 Hydrochloride Tablets, but use in such patients necessitates intensive counseling about the risks and proper use of Oxycodone Hydrochloride Tablets along with intensive monitoring for signs of addiction, abuse, and misuse. Consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.3 )].
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Oxycodone Hydrochloride Tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drugs [see Patient Counseling Information ( 17 )].
Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
5.2Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to do all of the following: • Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain. • Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed.
The Patient Counseling Guide (PCG) can be obtained at this link: www.fda.gov/OpioidAnalgesicREMSPCG . • Emphasize to patients and their caregivers the importance of reading the Me…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.1 )] • Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.3 )] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.4 )] • Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions ( 5.6 )] • Adrenal Insufficiency [see Warnings and Precautions ( 5.8 )] • Severe Hypotension [see Warnings and Precautions ( 5.9 )] • Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.11 )] • Seizures [see Warnings and Precautions ( 5.12 )] • Withdrawal [see Warnings and Precautions ( 5.13 )] Most common adverse reactions (≥3%) were nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials 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. Oxycodone Hydrochloride Tablets have been evaluated in open label clinical trials in patients with cancer and nonmalignant pain. Oxycodone Hydrochloride Tablets are associated with adverse experiences similar to those seen with other opioids.
Serious adverse reactions associated with Oxycodone Hydrochloride Tablets use included: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock. The common adverse reactions seen on initiation of therapy with Oxycodone Hydrochloride Tablets are dose related and are typical opioid-related adverse reactions. The most frequent of these included nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
The frequency of these reactions depended on several factors, including clinical setting, the patient's level of opioid tolerance, and host factors specific to the individual. In all patients for whom dosing information was available (n=191) from the open-label and double- blind studies involving Oxycodone Hydrochloride Tablets, the following adverse events were recorded in Oxycodone Hydrochloride Tablets treated patients with an incidence ≥ 3%. In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
Other less frequently observed adverse reactions from opioid analgesics, including Oxycodone Hydrochloride Tablets included: Blood and lymphatic system disorders : anemia, leukopenia Cardiac disorders: cardiac failure, palpitation, tachycardia Gastrointestinal disorders: abdominal pain, dry mouth, diarrhea, dyspepsia, dysphagia, glossitis, nausea, vomiting. General disorders and administration site conditions: chills, edema, edema peripheral, pain, pyrexia Immune system disorders: hypersensitivity Infections and infestations: bronchitis, gingivitis, infection, pharyngitis, rhinitis, sepsis, sinusitis, urinary tract infection Injury, poisoning and procedural complications: injury Metabolism and nutrition disorders : decreased appetite, gout, hyperglycemia Musculoskeletal and connective tissue disorders: arthralgia, arthritis, back pain, bone pain, myalgia, neck pain, pathological fracture Nervous system disorders : hypertonia, hypoesthesia, migraine, neuralgia, tremor, vasodilation Psychiatric disorders: agitation, anxiety, confusional state, nervousness, personality disorder Respiratory, thoracic and mediastinal disorders: cough, dyspnea, epistaxis, laryngospasm, lung disorder Skin and subcutaneous tissue disorders: photosensitivity reaction, rash, hyperhidrosis, urticaria Vascular disorders : thromboph…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with Oxycodone Hydrochloride Tablets Table 1: Clinically Significant Drug Interactions with OXYCODONE HYDROCHLORIDE TABLETS Inhibitors of CYP3A4 and CYP2D6 Clinical Impact: The concomitant use of Oxycodone Hydrochloride Tablets and CYP3A4 inhibitors can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Oxycodone Hydrochloride Tablets and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Oxycodone Hydrochloride Tablets is achieved [see Warnings and Precautions (5.5)].
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see Clinical Pharmacology (12.3)], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to oxycodone. Intervention: If concomitant use is necessary, consider dosage reduction of Oxycodone Hydrochloride Tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals.
If a CYP3A4 inhibitor is discontinued, consider increasing the Oxycodone Hydrochloride Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g.,ketoconazole), protease inhibitors (e.g., ritonavir).
CYP3A4 Inducers Clinical Impact: The concomitant use of Oxycodone Hydrochloride Tablets and CYP3A4 inducers can decrease the plasma concentration of oxycodone [see Clinical Pharmacology (12.3)], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oxycodone [see Warnings and Precautions (5.13)]. After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see Clinical Pharmacology (12.3)], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
Intervention: If concomitant use is necessary, consider increasing the Oxycodone Hydrochloride Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Oxycodone Hydrochloride Tablets dosage reduction and monitor for signs of respiratory depression.
Examples: Rifampin, carbamazepine, phenytoin B enzodi az epin es and O th er C en tr al N er v ous S y s t em (CN S) D e pr es s an ts Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.
Follow patients closely for signs of respiratory depression and sedation [see Warnings and Precautions (5.6)]. If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 , 5.3 , 5.6 )]. Example: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol.
Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome [see Adverse Reactions (6.2)]. Intervention: If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Oxycodone Hydrochloride Tablets if serotonin syndrome is suspected.
Example: Selectiv…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. ( 8.1 )
8.1Pregnancy Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions ( 5.4 )]. Available data with Oxycodone Hydrochloride Tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone HCl in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectively, the human dose of 60 mg/day did not reveal evidence of teratogenicity or embryo-fetal toxicity.
In several published studies, treatment of pregnant rats with oxycodone at clinically relevant doses and below, resulted in neurobehavioral effects in offspring [see Data]. Based on animal data, advise pregnant women of the potential risk to a fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents 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 use, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions ( 5.4 )]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.
An opioid antagonist such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Oxycodone Hydrochloride Tablets is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Oxycodone Hydrochloride Tablets, can prolong labor through actions which temporarily reduce the strength, duration and frequency of uterine contractions.
However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of oxycodone HCl administered during the period of organogenesis up to 16 mg/kg/day and up to 25 mg/kg/day, respectively.
These studies revealed no evidence of teratogenicity or embryo-fetal toxicity due to oxycodone. The highest doses tested in rats and rabbits were equivalent to approximately 2.6 and 8.1 times an adult human dose of 60 mg/day, respectively, on a mg/m2 basis. In published studies, offspring of pregnant rats administered oxycodone during gestation have been reported to exhibit neurobehavioral effects including altered stress responses, increased anxiety-like behavior (2 mg/kg/day IV from Gestation Day 8 to 21 and Postnatal Day 1, 3, and 5; 0.3 times an adult human dose of 60 mg/day, on a mg/m2 basis) and altered learning and memory (15 mg/kg/day orally from breeding through parturition; 2.4 times an adult human dose of 60 mg/day, on a mg/m2 basis).
8.2Lactation Risk Summary Oxycodone is present in breast milk. Published lactation studies report variable concentrations of oxycodone in breast milk with administration of immediate-release oxyc…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions ( 5.4 )]. Available data with Oxycodone Hydrochloride Tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone HCl in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectively, the human dose of 60 mg/day did not reveal evidence of teratogenicity or embryo-fetal toxicity.
In several published studies, treatment of pregnant rats with oxycodone at clinically relevant doses and below, resulted in neurobehavioral effects in offspring [see Data]. Based on animal data, advise pregnant women of the potential risk to a fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents 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 use, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions ( 5.4 )]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates.
An opioid antagonist such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Oxycodone Hydrochloride Tablets is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Oxycodone Hydrochloride Tablets, can prolong labor through actions which temporarily reduce the strength, duration and frequency of uterine contractions.
However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of oxycodone HCl administered during the period of organogenesis up to 16 mg/kg/day and up to 25 mg/kg/day, respectively.
These studies revealed no evidence of teratogenicity or embryo-fetal toxicity due to oxycodone. The highest doses tested in rats and rabbits were equivalent to approximately 2.6 and 8.1 times an adult human dose of 60 mg/day, respectively, on a mg/m2 basis. In published studies, offspring of pregnant rats administered oxycodone during gestation have been reported to exhibit neurobehavioral effects including altered stress responses, increased anxiety-like behavior (2 mg/kg/day IV from Gestation Day 8 to 21 and Postnatal Day 1, 3, and 5; 0.3 times an adult human dose of 60 mg/day, on a mg/m2 basis) and altered learning and memory (15 mg/kg/day orally from breeding through parturition; 2.4 times an adult human dose of 60 mg/day, on a mg/m2 basis).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of Oxycodone Hydrochloride Tablets in pediatric patients have not been evaluated..
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of subjects in clinical studies of Oxycodone Hydrochloride Tablets, 20.8% (112/538) were 65 and over, while 7.2% (39/538) were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients (aged 65 years or older) may have increased sensitivity to oxycodone.
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 Hydrochloride Tablets slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see Warnings and Precautions ( 5.7 )]. Oxycodone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function.
🆘 Overdosage ▾
10 OVERDOSAGE Clinical Presentation Acute overdose with Oxycodone Hydrochloride Tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology ( 12.2 )]. Treatment of Overdose In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed.
Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques. Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose.
For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid antagonist. Because the duration of opioid reversal is expected to be less than the duration of action of oxycodone in Oxycodone Hydrochloride Tablets, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product's prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Oxycodone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone.
Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
12.2Pharmacodynamics Effects on 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. Effects on 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, and transient elevations in serum amylase.
Effects on Cardiovascular System Oxycodone produces peripheral vasodilatation, which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilatation 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 ( 6.2 )].
They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see Adverse Reactions ( 6.2 )].
Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.
Concentration-Efficacy Relationships The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent opioid agonists. The minimum effective analgesic concentration of oxycodone for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome, and/or the development of analgesic tolerance [see Dosage and Administration ( 2.1 , 2.3 )]. Concentration-Adverse Reaction Relationships There is a relationship between increasing oxycodone plasma concentration and increasing frequency of dose-related opioid adverse rea…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Oxycodone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone.
Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Oxycodone hydrochloride tablets, USP are available as follows: 5 mg White to off white, round tablets, debossed with “U22” on one side and breakline on the other side. NDC: 71335-1361-1: 30 Tablets in a BOTTLE NDC: 71335-1361-2: 60 Tablets in a BOTTLE NDC: 71335-1361-3: 90 Tablets in a BOTTLE NDC: 71335-1361-4: 56 Tablets in a BOTTLE NDC: 71335-1361-5: 100 Tablets in a BOTTLE NDC: 71335-1361-6: 120 Tablets in a BOTTLE NDC: 71335-1361-7: 50 Tablets in a BOTTLE NDC: 71335-1361-8: 40 Tablets in a BOTTLE NDC: 71335-1361-9: 20 Tablets in a BOTTLE NDC: 71335-1361-0: 15 Tablets in a BOTTLE Dispense in a tight, light-resistant container.
Protect from moisture. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store Oxycodone Hydrochloride Tablets securely and dispose of properly [see Patient Counseling Information (17)]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc.
Burbank, CA 91504
📋 Description ▾
11 DESCRIPTION Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine.
Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula: C 18 H 21 NO 4 •HCl MW = 351.82 All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid.
In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No.
2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION 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 Hydrochloride 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 Hydrochloride Tablets unsecured can pose a deadly risk to others in the home [see Warnings and Precautions ( 5.1 , 5.3 ), Drug Abuse and Dependence ( 9.2 )].
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused Oxycodone Hydrochloride 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 Hydrochloride Tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions ( 5.1 )]. Instruct patients not to share Oxycodone Hydrochloride Tablets with others and to take steps to protect Oxycodone Hydrochloride Tablets from theft and 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 Hydrochloride 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 and Precautions (5.3)]. Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with Oxycodone Hydrochloride Tablets. Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program) [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.3 )].
Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to patients and caregivers that naloxone’s effects 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 naloxone is administered [see Overdosage ( 10 )]. If naloxone is prescribed, also advise patients and caregivers: • How to treat with naloxone in the event of an opioid overdose • To tell family and friends about their naloxone and to keep it in a place where family and friends can access it in an emergency • To read the Patient Information (or other educational material) that will come with their naloxone.
Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do. Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions ( 5.3 )]. Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if Oxycodone Hydrochloride Tablets is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions…
💬 Patient Medication Information ▾
MEDICATION GUIDE Medication Guide Oxycodone Hydrochloride (ox” i koe’ done hye” droe klor’ ide) Tablets USP, CII Oxycodone Hydrochloride Tablets is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, 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 Hydrochloride Tablets: • Get emergency help or call 911 right away if you take too much Oxycodone Hydrochloride Tablets (overdose). When you first start taking Oxycodone Hydrochloride 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. • Taking Oxycodone Hydrochloride Tablets with other opioid medicines, benzodiazepines, 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 Hydrochloride Tablets.
They could die from taking it. Selling or giving away Oxycodone Hydrochloride Tablets is against the law. • Store Oxycodone Hydrochloride 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 Hydrochloride Tablets if you have: • severe asthma, trouble breathing, or other lung problems. • a bowel blockage or have narrowing of the stomach or intestines. • allergy to oxycodone.
Before taking Oxycodone Hydrochloride 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: • pregnant or planning to become pregnant. Prolonged use of Oxycodone Hydrochloride Tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. • breastfeeding .
Oxycodone Hydrochloride Tablets 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 Hydrochloride Tablets with certain other medicines can cause serious side effects that could lead to death. When taking Oxycodone Hydrochloride Tablets: • Do not change your dose. Take Oxycodone Hydrochloride Tablets exactly as prescribed by your healthcare provider.
Use the lowest dose possible for the shortest time needed. • Take your prescribed dose every 4 to 6 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time. • Call your healthcare provider if the dose you are taking does not control your pain. • If you have been taking Oxycodone Hydrochloride Tablets regularly, do not stop taking Oxycodone Hydrochloride Tablets without talking to your healthcare provider. • Dispose of expired, unwanted, or unused Oxycodone Hydrochloride Tablets by promptly flushing down the toilet, if a drug take-back option is not readily available.
Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. While taking Oxycodone Hydro…