Complete SPL Sections#
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
BOXED WARNING SECTION
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Oxycodone hydrochloride tablets are 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) ].
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
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) ]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
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 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. 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) ]. Examples: 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. Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.3) ]. Intervention: The use of oxycodone hydrochloride tablets is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. Examples: phenelzine, tranylcypromine, linezolid Mixed Agonist/Antagonist Opioid Analgesics Clinical Impact: May reduce the analgesic effect of oxycodone hydrochloride tablets and/or may precipitate withdrawal symptoms. Intervention: Avoid concomitant use Examples: Butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of oxycodone hydrochloride tablets and/or the muscle relaxant as necessary. Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration (2.2) , Warnings and Precautions (5.3 , 5.6) ]. Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Intervention: Monitor patients for signs of dismissed diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed. Anticholinergic Drugs Clinical Impact: The concomitant risk of anticholinergic drugs may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Intervention: Monitor patients for signs of urinary retention or reduced gastric motility when oxycodone hydrochloride tablets are used concurrently with anticholinergic drugs.
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
9 DRUG ABUSE AND DEPENDENCE
DRUG ABUSE AND DEPENDENCE SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
11 DESCRIPTION
DESCRIPTION SECTION
Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 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: The Oxycodone Hydrochloride Tablets, USP contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Oxycodone Hydrochloride Tablets, USP are available as follows: 5 mg – white to off-white, round, flat faced, beveled edged tablets debossed with "R" above bisect and "P" below on one side and "5" on the other side NDC 42858-001-01: Bottles of 100 tablets NDC 42858-001-10: Unit Dose Packages of 100, 10 per Card, 10 cards per shipper 10 mg – white to off-white, round, biconvex tablets debossed with "R" above bisect and "P" below on one side and "10" on the other side NDC 42858-002-01 Bottles of 100 tablets NDC 42858-002-10: Unit Dose Packages of 100, 10 per Card, 10 cards per shipper 15 mg – white to off-white, oval tablets with "R" and "P" (with a center score) on one side and "15" on the other side NDC 42858-003-01: Bottles of 100 tablets 20 mg – white to off-white, round, biconvex tablets debossed with "R" above bisect and "P" below on one side and "20" on the other side NDC 42858-004-01: Bottles of 100 tablets 30 mg – white to off-white, round, biconvex tablets debossed with "R" above bisect and "P" below on one side and "30" on the other side NDC 42858-005-01: Bottles of 100 tablets
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Marketed by: Rhodes Pharmaceuticals L.P. Coventry, RI 02816 Manufactured by: Purdue Pharma L.P. Stamford, CT 06901 304469-0D & 304494-0D Revised 03/2021
Medication Guide Oxycodone Hydrochloride (ox" i koe' done hye" droe klor' ide) Tablets, USP CII
SPL MEDGUIDE SECTION
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 03/2021 Oxycodone hydrochloride tablets are: 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 them. 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 problems urinating abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems liver, kidney, thyroid problems pancreas or gallbladder 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 pass into breast milk and may harm your baby. 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. 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 hydrochloride tablets DO NOT: Drive or operate heavy machinery, until you know how oxycodone hydrochloride tablets affect you. Oxycodone hydrochloride tablets can make you sleepy, dizzy, or lightheaded. Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with oxycodone hydrochloride tablets may cause you to overdose and die. The possible side effects of oxycodone hydrochloride tablets: Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe. Get emergency medical help or call 911 right away if you have: Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion. These are not all the possible side effects of oxycodone hydrochloride tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information, go to dailymed.nlm.nih.gov Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816 US, http://rhodespharma.com or call 1-888-827-0616 Manufactured by: Purdue Pharma L.P., Stamford, CT 06901
PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 42858- 001 -01 CII Oxycodone Hydrochloride Tablets, USP 5 mg R x Only Dispense the accompanying Medication Guide to each patient. Rhodes 100 Tablets Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816 Manufactured by: Purdue Pharma L.P., Stamford, CT 06901
PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 42858- 002 -01 CII Oxycodone Hydrochloride Tablets, USP 10 mg R x Only Dispense the accompanying Medication Guide to each patient. Rhodes 100 Tablets Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816 Manufactured by: Purdue Pharma L.P., Stamford, CT 06901
PRINCIPAL DISPLAY PANEL - 15 mg Tablet Bottle Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 42858- 003 -01 CII Oxycodone Hydrochloride Tablets, USP 15 mg R x Only Dispense the accompanying Medication Guide to each patient. Rhodes 100 Tablets Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816 Manufactured by: Purdue Pharma L.P., Stamford, CT 06901
PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 42858- 004 -01 CII Oxycodone Hydrochloride Tablets, USP 20 mg R x Only Dispense the accompanying Medication Guide to each patient. Rhodes 100 Tablets Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816 Manufactured by: Purdue Pharma L.P., Stamford, CT 06901
PRINCIPAL DISPLAY PANEL - 30 mg Tablet Bottle Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 42858- 005 -01 CII Oxycodone Hydrochloride Tablets, USP 30 mg R x Only Dispense the accompanying Medication Guide to each patient. Rhodes 100 Tablets Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816 Manufactured by: Purdue Pharma L.P., Stamford, CT 06901
