Oxycodone Hydrochloride 5 mg/5mL Solution
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...
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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 XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII FV3431923Z
A natural flavoring derived from berry fruits. Added to medicines to improve taste and make them more pleasant to take.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
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UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
8 inactive ingredients listed in the exact product block matched to this NDC.
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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
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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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.047 | $22.33 / 473 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.1243 | $58.79 / 473 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.1116 | $52.79 / 473 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Oxycodone Hydrochloride 5 mg/5mL 62559-0151-16 | ANI | 1 bottle | $0.047 | AA | Availability likely | — |
| Oxycodone Hydrochloride 5 mg/5mLthis 71930-0022-43 | Eywa | 1 bottle | $0.047 | AA | Availability likely | — |
| Oxycodone Hydrochloride 5 mg/5mL 00406-8556-05 | SpecGx | 1 bottle | $0.074 | AA | Availability likely | +57% |
| Oxycodone Hydrochloride 5 mg/5mL 00904-6678-40 | MAJOR | 1 bottle | $0.074 | AA | Availability likely | +57% |
| oxycodone hydrochloride 5 mg/5mL 00054-0390-41 | Hikma | 15 ml | — | AA | Discontinued | — |
| Oxycodone Hydrochloride 5 mg/5mL 00121-0827-04 | PAI | 118 ml | — | AA | FDA listed | — |
| Oxycodone Hydrochloride 5 mg/5mL 00121-4827-40 | PAI | 10 cups | — | AA | FDA listed | — |
| Oxycodone Hydrochloride 5 mg/5mL 00904-6828-92 | MAJOR | 10 cups | — | AA | FDA listed | — |
| Oxycodone Hydrochloride 5 mg/5mL 10702-0183-50 | KVK-Tech, | 1 bottle | — | AA | FDA listed | — |
| Oxycodone Hydrochloride Oral Solution 5 mg/5mL 13107-0261-58 | Aurolife | 1 bottle | — | — | FDA listed | — |
| Oxycodone Hydrochloride 5 mg/5mL 43602-0190-31 | Ascent | 30 ml | — | AA | FDA listed | — |
| Oxycodone Hydrochloride 5 mg/5mL 60687-0406-67 | American | 10 cups | — | AA | FDA listed | — |
| Oxycodone Hydrochloride 5 mg/5mL 63629-1174-01 | Bryant | 1 bottle | — | AA | FDA listed | — |
| Oxycodone Hydrochloride 5 mg/5mL 63629-2104-01 | Bryant | 473 ml | — | AA | FDA listed | — |
| Oxycodone Hydrochloride 5 mg/5mL 64950-0354-10 | Genus | 1 bottle | — | AA | FDA listed | — |
| Oxycodone Hydrochloride 5 mg/5mL 67296-2167-06 | Redpharm | 1 bottle | — | AA | FDA listed | — |
| Oxycodone Hydrochloride 5 mg/5mL 70752-0136-10 | QUAGEN | 1 bottle | — | AA | FDA listed | — |
| Oxycodone Hydrochloride 5 mg/5mL 72162-1749-02 | Bryant | 1 bottle | — | AA | 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.
Where does this data come from?
🗺️ Medicaid utilization & spend
🔬 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 |
|---|---|---|---|
| 71930-0022-43 You're viewing this | 1 BOTTLE in 1 CARTON (71930-022-43) / 473 mL in 1 BOTTLE | 2019-03-01 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HYDROCHLORIDE ORAL SOLUTION Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering Oxycodone hydrochloride oral solution. Dosing errors due to confusion between mg and mL, and other Oxycodone hydrochloride oral solutions of different concentrations can result in accidental overdose and death [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) ]. Addiction, Abuse, and Misuse Because the use of Oxycodone hydrochloride oral solution 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 and Precautions (5.2) ].
Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Oxycodone hydrochloride oral solution, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Oxycodone Hydrochloride Oral Solution are essential [see Warnings and Precautions (5.3) ]. Accidental ingestion Accidental ingestion of even one dose of Oxycodone hydrochloride oral solution, especially by children, can result in a fatal overdose of oxycodone [see Warnings and Precautions (5.3) ].
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 hydrochloride oral Solution and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.4) , Drug Interactions (7) ]. Neonatal Opioid Withdrawal Syndrome (NOWS) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated.
Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.5) ]. 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 and Precautions (5.6) ]. Cytochrome P450 3A4 Interaction The concomitant use of Oxycodone hydrochloride oral solution 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 P4503A4 inducer may result in an increase in oxycodone plasma concentration. Regularly evaluate patients receiving Oxycodone hydrochloride oral solution and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.7) , Drug Interactions (7) , Clinical Pharmacology (12.3) ]. WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HYDROCHLORIDE SOLUTION See full prescribing information for complete boxed warning.
Ensure accuracy when prescribing, dispensing, and administering Oxycodone hydrochloride oral solution. Dosing errors due to confusion between mg and mL, and other Oxycodone hydrochloride oral solutions of different concentrations can result in accidental overdose and death. ( 2.1 , 5.1 ) Oxycodone hydrochloride oral solution exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death.
Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions. ( 5.2 ) Serious, life-threatening, or…
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Oxycodone hydrochloride oral solution is indicated in adults 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 and Precautions (5.2 )], reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Oxycodone hydrochloride oral solution is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid-analgesic and for which alternative treatments are inadequate. ( 1 ) 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, reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
( 1 , 5.2 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Oxycodone hydrochloride oral solution should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of Oxycodone hydrochloride oral solution 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.
( 2.1 , 5 ) 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. ( 2.1 ) 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.
( 2.1 , 5.2 ) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Oxycodone hydrochloride oral solution. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.3 ) Initiate dosing with a range of 5 to 15 mg every 4 to 6 hours as needed for pain, and 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 hydrochloride oral solution. ( 2.3 , 2.4 ) Periodically reassess patients receiving oxycodone hydrochloride to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse or misuse. ( 2.4 ) Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with Oxycodone hydrochloride oral solution, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose.
( 2.2 , 5.2 , 5.3 , 5.4 ) Do not rapidly reduce or abruptly discontinue oxycodone hydrochloride in a physically dependent patient because rapid reduction or abrupt discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. ( 2.5 , 5.15 )
2.1Important Dosage and Administration Instructions Ensure accuracy when prescribing, dispensing, and administering Oxycodone hydrochloride oral solution to avoid dosing errors due to confusion between mg and mL, and with other oxycodone hydrochloride solutions of different concentrations, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume.
Instruct patients and caregivers on how to accurately measure and take or administer the correct dose of Oxycodone hydrochloride oral solution. Strongly advise patients and caregivers to always use the enclosed graduated measuring cup when administering Oxycodone hydrochloride oral solution 5 mg/5 mL (1 mg/mL) to ensure that the dose is measured and administered accurately. Instruct patients and caregivers to never use household teaspoons or tablespoons to measure Oxycodone hydrochloride oral solution.
Oxycodone hydrochloride oral solution 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 and Precautions (5) ]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of Oxycodone hydrochloride oral solution for pa…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 5 mg per 5 mL (1 mg/mL) Strength Oral Solution: Each 5 mL of red Oxycodone hydrochloride oral solution, USP contains oxycodone hydrochloride 5 mg Oral Solution 5 mg per 5 mL (1 mg/mL) ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Oxycodone hydrochloride oral solution 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 [see Warnings and Precautions (5.9) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.13) ] Hypersensitivity to oxycodone (e.g., angioedema) [ Adverse Reactions (6) ] • 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 Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation. ( 5.8 ) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic or Debilitated Patients: Regularly evaluate, particularly during initiation and titration.
( 5.9 ) Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.10 ) Severe Hypotension: Regularly evaluate during dosage initiation and titration. Avoid use of Oxycodone hydrochloride oral solution in patients with circulatory shock.
( 5.11 ) 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 oral solution in patients with impaired consciousness or coma. ( 5.12 )
5.1Risk of Accidental Overdose and Death Due to Medication Errors Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg and mL and confusion with oxycodone hydrochloride solutions of different concentrations, when prescribing, dispensing, and administering Oxycodone hydrochloride oral solution. Ensure that the dose is communicated clearly and dispensed accurately.
Instruct patients and caregivers on how to measure and take or administer the correct dose of Oxycodone hydrochloride oral solution and to use extreme caution when measuring the dose. Instruct patients and caregivers to always use the enclosed graduated measuring cup when administering Oxycodone hydrochloride oral solution to ensure the dose is measured and administered accurately. Instruct them to never use a teaspoon or a tablespoon to measure a dose because household teaspoons or tablespoons are not adequate measuring devices.
5.2Addiction, Abuse and Misuse Oxycodone hydrochloride oral solution contains oxycodone, a Schedule II controlled substance. As an opioid, Oxycodone hydrochloride oral solution 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 oral solution.
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 (6) ] .
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Oxycodone hydrochloride oral solution, and reassess all patients receiving Oxycodone hydrochloride oral solution 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 but use in such patients necessitates intensive counseling about the risks and proper use of oxycodone hydrochloride along with frequent reevaluation for signs of addiction, abuse, and misuse. Consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration (2.2) , Warnings and Precautions (5.3) ] . Opioids are sought for nonmedical use and are subject to diversion from legitimate pr…
🤒 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 (5.2) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.3) ] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.4) ] Neonatal Opioid Withdrawal Syndrome [ see Warnings and Precautions (5.5) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.8) ] Adrenal Insufficiency [see Warnings and Precautions (5.10) ] Severe Hypotension [see Warnings and Precautions (5.11) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.13) ] Seizures [see Warnings and Precautions (5.14)] Withdrawal [see Warnings and Precautions (5.15) ] The following adverse reactions associated with the use of oxycodone were identified in clinical studies or postmarketing reports.
Because some of these reactions were 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 associated with oxycodone 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 are dose-related and are typical opioid-related adverse reactions.
The most frequent adverse events include nausea, constipation, vomiting, headache, and pruritus. 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 another formulation of immediate-release oxycodone, the following adverse events were recorded in oxycodone treated patients with an incidence ≥ 3%.
In descending order of frequency, they were nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. The other less frequently observed adverse reactions from opioid analgesics, including Oxycodone hydrochloride oral solution included: Body as a Whole: abdominal pain, accidental injury, allergic reaction, back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain, photosensitivity reaction, and sepsis. Cardiovascular: deep thrombophlebitis, heart failure, hemorrhage, hypotension, migraine, palpitation, and tachycardia.
Digestive: anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis, and nausea and vomiting. Hemic and Lymphatic: anemia and leukopenia. Metabolic and Nutritional: edema, gout, hyperglycemia, iron deficiency anemia and peripheral edema.
Musculoskeletal: arthralgia, arthritis, bone pain, myalgia and pathological fracture. Nervous: agitation, anxiety, confusion, dry mouth, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, and vasodilation. Respiratory: bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, and sinusitis.
Skin and Appendages: herpes simplex, rash, sweating, and urticaria. Special Senses: amblyopia. Urogenital: urinary tract infection 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 hydrochloride oral solution. Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids for an extended time [see Clinical Pharmacology (12.2)].
Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been reported with o…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with Oxycodone hydrochloride oral solution. Table 1: Clinically Significant Drug Interactions with Oxycodone hydrochloride oral solution Inhibitors of CYP3A4 and CYP2D6 Clinical Impact: The concomitant use of Oxycodone hydrochloride oral solution 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 oral solution and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Oxycodone hydrochloride oral solution is achieved [see Warnings and Precautions (5.7) ].
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 oral solution until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation.
If a CYP3A4 inhibitor is discontinued, consider increasing the Oxycodone hydrochloride oral solution dosage until stable drug effects are achieved [see Dosage and Administration (2.3) ]. Evaluate 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 oral solution 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 (5.15) ] .
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 oral solution dosage until stable drug effects are achieved. Evaluate patients for signs of opioid withdrawal.
If a CYP3A4 inducer is discontinued, consider Oxycodone hydrochloride oral solution dosage reduction and evaluate patients at frequent intervals for signs of respiratory depression and sedation. Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and other Central Nervous System (CNS) Depressants 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. Inform patients and caregivers of this potential interaction and educate them on the signs and symptoms of respiratory depression (including sedation).
If concomitant use is warranted, consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration (2.3) , Warnings and Precautions (5.2 , 5.3 , 5.4) ]. Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), 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 Warnings and Precautions (5.10) ].
Interventi…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. ( 8.1 )
8.1Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5) ] . Available data with Oxycodone hydrochloride oral solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 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. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.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: 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 and Precautions (5.5) ] .
Labor or Delivery: Opioids cross the placenta and may produce respiratory depression and psycho- physiologic effects in neonates. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Oxycodone hydrochloride oral solution 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 oral solution, 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 hydrochloride administered during the period of organogenesis up to 16 mg/kg/day and up 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/m 2 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/m 2 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/m 2 basi…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5) ] . Available data with Oxycodone hydrochloride oral solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 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. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.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: 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 and Precautions (5.5) ] .
Labor or Delivery: Opioids cross the placenta and may produce respiratory depression and psycho- physiologic effects in neonates. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Oxycodone hydrochloride oral solution 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 oral solution, 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 hydrochloride administered during the period of organogenesis up to 16 mg/kg/day and up 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/m 2 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/m 2 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/m 2 basis).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of Oxycodone hydrochloride oral solution have not been established in pediatric patients. The safety and pharmacokinetics of a single-dose of Oxycodone hydrochloride oral solution were evaluated in an open-label clinical trial in 89 pediatric patients 2 years to less than 17 years of age with postoperative pain. However, definitive conclusions were not possible because of insufficient information.
🧓 Geriatric Use ▾
8.5Geriatric Use Elderly patients (aged 65 years or older) may have increased sensitivity to oxycodone. In general, use caution when selecting a dose for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.
Titrate the dosage of Oxycodone hydrochloride oral solution slowly in geriatric patients and frequently reevaluate the patient closely for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.4) ] . 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 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 Clinical Pharmacology (12.2) ] . Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication.
Treatment of Overdose 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 morphine 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 hydrochloride in Oxycodone hydrochloride oral solution, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid overdose reversal agent is suboptimal or only brief in nature, administer additional reversal agent as directed by the product’s prescribing information.
In an individual physically dependent on opioids, administration of the recommended dosage of the 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 reversal agent administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the reversal agent should begin with care and by titration with smaller than usual doses of the reversal agent.
🧬 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 (CNS) 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 to 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 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 and 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) ] . 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 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) ] .
Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in invitro 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 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 , 2.4 )] . Concentration-Adverse Reaction Relationships There is a relationship between increasing oxycodone plasm…
🧬 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 oral solution, USP, 5 mg per 5 mL (1 mg/mL) is available as follows: NDC# 71930-022-43: 16 fl. oz. (473 mL) bottle packaged with calibrated measuring cup Dispense in a tight, light-resistant container as defined in the USP/NF. Store at controlled room temperature 20°-25°C (68°- 77°F); excursions are permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature] Store Oxycodone hydrochloride oral solution securely and dispose of properly.
📋 Description ▾
11 DESCRIPTION Oxycodone hydrochloride oral solution is an opioid agonist, available as solution in 5 mg/5mL (1 mg/mL) strength for oral administration. Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6one hydrochloride and has the following structural formula: C 18 H 21 NO 4 •HCl MW 351.82 Oxycodone hydrochloride, USP is a white to off-white fine 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).
Oxycodone hydrochloride oral solution USP, 5 mg per 5 mL contains equivalent of 4.5 mg of oxycodone free base per 5 mL and contains the following inactive ingredients: sorbitol solution, saccharin sodium, anhydrous citric acid, sodium citrate dihydrate, sodium benzoate, FD&C red #40, mixed berry flavor, and purified water. oxycodone-struct
💬 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 oral solution 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 oral solution unsecured can pose a deadly risk to others in the home . [ see Warnings and Precautions (5.2 , 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 oral solution 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.
Medication Errors Instruct patients and caregivers how to measure and take or administer the correct dose of Oxycodone hydrochloride oral solution, and to always use the enclosed graduated measuring cup when measuring Oxycodone hydrochloride oral solution to correctly measure the prescribed amount of medication [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) ] . Advise patients and caregivers that Oxycodone hydrochloride oral solution, is available in multiple concentrations. Inform patients and caregivers about which concentration they have been prescribed and provide detailed instruction on how to measure and take or administer the correct dose of Oxycodone hydrochloride oral solution, and to always use the enclosed measuring device when administering Oxycodone hydrochloride oral solution to ensure the dose is measured and administered accurately [see Dosage and Administration (2.1), [see Warnings and Precautions (5.1) ].
If the prescribed concentration is changed, instruct patients and caregivers on how to correctly measure the new dose to avoid errors which could result in accidental overdose and death. Addiction, Abuse, and Misuse Inform patients that the use of Oxycodone hydrochloride oral solution, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.2) ] . Instruct patients not to share Oxycodone hydrochloride oral solution with others and to take steps to protect Oxycodone hydrochloride oral solution 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 hydrochloride oral solution 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) ].
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 oral solution is used with benzodiazepines or other CNS depressants, including alcohol (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 and Precautions (5.4 ), Drug Interactions (7 )] .
Patient Access t…