OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)
Available from:
RedPharm Drug, Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Oxycodone hydrochloride tablets are 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 use in 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 expected to provide adequate analgesia. Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve oxycodone hydrochloride tablets for use in patien
Product summary:
Oxycodone Hydrochloride Tablet USP are available as follows: Each Oxycodone Hydrochloride Tablet USP 5 mg is available as a white round convex tablet with a  on one side and “0552” with a vertical bisect between the fives on the other. Bottles of 100............................. NDC 0406-0552-01 Unit Dose (10 x 10)................... NDC 0406-0552-62 Each Oxycodone Hydrochloride Tablet USP 15 mg is available as a light green round convex tablet with a  on one side and “15” above a bisect on the other. Bottles of 100............................. NDC 0406-8515-01 Unit Dose (10 x 10)................... NDC 0406-8515-62 Each Oxycodone Hydrochloride Tablet USP 30 mg is available as a light blue round convex tablet with a  on one side and “30” above a bisect on the other. Bottles of 100............................. NDC 0406-8530-01 Unit Dose (10 x 10)................... NDC 0406-8530-62 Dispense in a tight, light-resistant container with child-resistant closure. Protect from moisture. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Authorization status:
Abbreviated New Drug Application
Authorization number:
67296-0425-1, 67296-0425-4

OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride tablet

RedPharm Drug, Inc.

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Medication Guide

Oxycodone Hydrochloride Tablets USP, CII

(ox" i koe' done hye" droe klor' ide)

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 right away if you take too many 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.

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.

Store oxycodone hydrochloride tablets away from children and in a safe place to prevent

stealing or abuse. Selling or giving away oxycodone hydrochloride tablets is against the law.

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, 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 pass into breast milk and may harm your

baby.

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.

After you stop taking oxycodone hydrochloride tablets, flush any unused tablets down the

toilet.

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 are:

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 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

Manufactured by: SpecGx LLC, Webster Groves, MO 63119 USA, www.Mallinckrodt.com or call

1-800-778-7898

MG20O14

Mallinckrodt TM

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 07/2017

Revised: 1/2019

Document Id: 92614a3a-331e-16ad-e053-2a95a90a47cc

34391-3

Set id: 92614a3a-331d-16ad-e053-2a95a90a47cc

Version: 12

Effective Time: 20190101

RedPharm Drug, Inc.

OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride tablet

RedPharm Drug, Inc.

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Oxycodone 5mg

Oxycodone 5mg

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

See full prescribing information for complete boxed warning.

Oxycodone hydrochloride tablets expose users to risks of addiction, abuse, and misuse, which

can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for

these behaviors and conditions. ( 5.1)

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. ( 5.2)

Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially

upon initiation or following a dose increase. ( 5.3)

Accidental ingestion of oxycodone hydrochloride tablets, especially by children, can result in a

fatal overdose of oxycodone. ( 5.3)

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. If prolonged

opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid

withdrawal syndrome and ensure that appropriate treatment will be available. ( 5.4)

Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a

fatal overdose of oxycodone from oxycodone hydrochloride tablets. ( 5.5, 7, 12.3)

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 for use in patients for whom alternative treatment options

are inadequate; limit dosages and durations to the minimum required; and follow patients for signs

and symptoms of respiratory depression and sedation. ( 5.6, 7)

Addiction, Abuse, and Misuse

Oxycodone hydrochloride tablets expose 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 dose 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)

depressants, 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 or other CNS depressants for use in patients for whom alternative

treatment options are inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation.

1 INDICATIONS AND USAGE

Oxycodone hydrochloride tablets are 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 use in 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 expected to provide adequate analgesia.

Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an

opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see

Warnings and Precautions (5.1)] , 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.

2 DOSAGE AND ADMINISTRATION

Dosage and Administation:

2.1 Important 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)] .

2.2 Initial Dosage

Use of Oxycodone Hydrochloride Tablets as the First Opioid Analgesic

Initiate treatment with oxycodone hydrochloride tablets in a dosing range of 5 to 15 mg every 4 to 6

hours as needed for pain. Titrate the dose based upon the individual patient’s response to their initial

dose of oxycodone hydrochloride tablets. Patients with chronic pain should have their dosage given on

an around-the-clock basis to prevent the reoccurrence of pain rather than treating the pain after it has

occurred. This dose can then be adjusted to an acceptable level of analgesia taking into account side

effects experienced by the patient.

For control of severe chronic pain, oxycodone hydrochloride tablets should be administered on a

regularly scheduled basis, every 4 to 6 hours, at the lowest dosage level that will achieve adequate

analgesia.

Although it is not possible to list every condition that is important to the selection of the initial dose of

oxycodone hydrochloride tablets, attention should be given to: 1) the daily dose, potency, and

characteristics of a pure 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 needed, 3) the

degree of opioid tolerance, 4) the general condition and medical status of the patient, and 5) the balance

between pain control and adverse experiences.

Conversion from Other Opioids to Oxycodone Hydrochloride Tablets

There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a

conservative approach is advised when determining the total daily dosage of oxycodone hydrochloride

tablets. It is safer to underestimate a patient’s 24-hour oxycodone hydrochloride tablets dosage than to

overestimate the 24-hour oxycodone hydrochloride tablets dosage and manage an adverse reaction due

to overdose. If a patient has been receiving opioid-containing medications prior to taking oxycodone

hydrochloride tablets, the potency of the prior opioid relative to oxycodone should be factored into the

selection of the total daily dose (TDD) of oxycodone.

In converting patients from other opioids to oxycodone hydrochloride tablets close observation and

adjustment of dosage based upon the patient’s response to oxycodone hydrochloride tablets is

imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of

the total daily dose of oxycodone hydrochloride tablets may be necessary, especially in patients who

have disease states that are changing rapidly.

Conversion from Fixed-Ratio Opioid/Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal

Combination Drugs

When converting patients from fixed ratio opioid/non-opioid drug regimens a decision should be made

whether or not to continue the non-opioid analgesic. If a decision is made to discontinue the use of non-

opioid analgesic, it may be necessary to titrate the dose of oxycodone hydrochloride tablets in response

to the level of analgesia and adverse effects afforded by the dosing regimen. If the non-opioid regimen

is continued as a separate single entity agent, the starting dose oxycodone hydrochloride tablets should

be based upon the most recent dose of opioid as a baseline for further titration of oxycodone.

Incremental increases should be gauged according to side effects to an acceptable level of analgesia.

Conversion from Oxycodone Hydrochloride Tablets to Extended-Release Oxycodone

The relative bioavailability of oxycodone hydrochloride tablets compared to extended-release

oxycodone is unknown, so conversion to extended-release tablets must be accompanied by close

observation for signs of excessive sedation and respiratory depression.

2.3 Titration and Maintenance of Therapy

Individually titrate oxycodone hydrochloride tablets to a dose that provides adequate analgesia and

minimizes adverse reactions. Continually reevaluate patients receiving oxycodone hydrochloride tablets

to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as

monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)].

Frequent communication is important among the prescriber, other members of the healthcare team, the

patient, and the caregiver/family during periods of changing analgesic requirements, including initial

titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain

before increasing the oxycodone hydrochloride tablets dosage. If unacceptable opioid-related adverse

reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate

balance between management of pain and opioid-related adverse reactions.

2.4 Discontinuation of Oxycodone Hydrochloride Tablets

When a patient who has been taking oxycodone hydrochloride tablets regularly and may be physically

dependent no longer requires therapy with oxycodone hydrochloride tablets, taper the dose gradually,

by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If

the patient develops these signs or symptoms, raise the dose to the previous level and taper more

slowly, either by increasing the interval between decreases, decreasing the amount of change in dose,

or both. Do not abruptly discontinue oxycodone hydrochloride tablets in a physically-dependent patient

[see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.3)] .

3 DOSAGE FORMS AND STRENGTHS

Oxycodone Hydrochloride Tablets USP:

5 mg is available as a white round convex tablet with a

on one side and “0552” with a vertical bisect

between the fives on the other.

15 mg is available as a light green round convex tablet with a

on one side and “15” above a bisect on

the other.

30 mg is available as a light blue round convex tablet with a

on one side and “30” above a bisect on

the other.

4 CONTRAINDICATIONS

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:

5.1 Addiction, Abuse, and Misuse

Oxycodone hydrochloride tablets contain oxycodone, a Schedule II controlled substance. As an opioid,

oxycodone hydrochloride tablets expose 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.

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.

5.2 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 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.

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. 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 Medication Guide that they

will receive from their pharmacist every time an opioid analgesic is dispensed to them.Emphasize to

patients and their caregivers the importance of reading the Medication Guide that they will receive

from their pharmacist every time an opioid analgesic is dispensed to them.

Consider using other tools to improve patient, household, and community safety, such as patient-

prescriber agreements that reinforce patient-prescriber responsibilities.Consider using other tools

to improve patient, household, and community safety, such as patient-prescriber agreements that

reinforce patient-prescriber responsibilities.

To obtain further information on the opioid analgesic REMS and for a list of accredited REMS

CME/CE, call 1-800-503-0784, or log on to www.opioidanalgesicrems.com. The FDA Blueprint can

be found at www.fda.gov/OpioidAnalgesicREMSBlueprint.

5.3 Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids,

even when used as recommended. Respiratory depression, if not immediately recognized and treated,

may lead to respiratory arrest and death. Management of respiratory depression may include close

observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical

status [see Overdosage (10)] . Carbon dioxide (CO

) retention from opioid-induced respiratory

depression can exacerbate the sedating effects of opioids.

While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of

oxycodone hydrochloride tablets, the risk is greatest during the initiation of therapy or following a

dosage increase. Monitor patients closely for respiratory depression, especially within the first 24 to

72 hours of initiating therapy with and following dosage increases of oxycodone hydrochloride tablets.

To reduce the risk of respiratory depression, proper dosing and titration of oxycodone hydrochloride

tablets are essential [see Dosage and Administration (2)] . Overestimating the oxycodone hydrochloride

tablets dosage when converting patients from another opioid product can result in fatal overdose with

the first dose.

Accidental ingestion of even one dose of oxycodone hydrochloride tablets, especially by children, can

result in respiratory depression and death due to an overdose of oxycodone.

5.4 Neonatal Opioid Withdrawal Syndrome

Prolonged use of oxycodone hydrochloride tablets during pregnancy can result in withdrawal in the

neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be

life-threatening if not recognized and treated, and requires management according to protocols

developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal

syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the

risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see

Use in Specific Populations (8.1), Patient Counseling Information (17)] .

5.5 Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and

Inducers

Concomitant use of oxycodone hydrochloride tablets with a CYP3A4 inhibitor, such as macrolide

antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors

(e.g., ritonavir), may increase plasma concentrations of oxycodone and prolong opioid adverse

reactions, which may cause potentially fatal respiratory depression [see Warnings and Precautions (5.3)]

, particularly when an inhibitor is added after a stable dose of oxycodone hydrochloride tablets is

achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and

phenytoin, in oxycodone hydrochloride tablets-treated patients may increase oxycodone plasma

concentrations and prolong opioid adverse reactions. When using oxycodone hydrochloride tablets

with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in oxycodone hydrochloride tablets-treated

patients, monitor patients closely at frequent intervals and consider dosage reduction of oxycodone

hydrochloride tablets until stable drugs effects are achieved [see Drug Interactions (7)] .

Concomitant use of oxycodone hydrochloride tablets with CYP3A4 inducers or discontinuation of an

CYP3A4 inhibitor could decrease oxycodone plasma concentrations, decrease opioid efficacy or,

possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to

oxycodone. When using oxycodone hydrochloride tablets with CYP3A4 inducers or discontinuing

CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing the opioid

dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur [see Drug

Interactions (7)] .

5.6 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Profound sedation, respiratory depression, coma, and death may result from the concomitant use of

oxycodone hydrochloride tablets with benzodiazepines or other CNS depressants (e.g., non-

benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics,

antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of

these drugs for use in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines

increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of

similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of

other CNS depressant drugs with opioid analgesics [see Drug Interactions (7)] .

If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an

opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In

patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or

other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response.

If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant,

prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow

patients closely for signs and symptoms of respiratory depression and sedation.

Advise both patients and caregivers about the risks of respiratory depression and sedation when

oxycodone hydrochloride tablets are used with benzodiazepines or other CNS depressants (including

alcohol and illicit drugs). Advise patients not to drive or operate dangerous machinery until the effects

of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen

patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the

risk for overdose and death associated with the use of additional CNS depressants including alcohol

and illicit drugs [see Drug Interactions (7), Patient Counseling Information (17)] .

5.7 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or

in Elderly, Cachectic, or Debilitated Patients

The use of oxycodone hydrochloride tablets in patients with acute or severe bronchial asthma in an

unmonitored setting or in the absence of resuscitative equipment is contraindicated.

Patients with Chronic Pulmonary Disease: Oxycodone hydrochloride tablets-treated patients with

significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially

decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at

increased risk of decreased respiratory drive including apnea, even at recommended dosages of

oxycodone hydrochloride tablets [see Warnings and Precautions (5.3)] .

Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to

occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or

altered clearance compared to younger, healthier patients [see Warnings and Precautions (5.3)] .

Monitor patients closely, particularly when initiating and titrating oxycodone hydrochloride tablets and

when oxycodone hydrochloride tablets are given concomitantly with other drugs that depress

respiration [see Warnings and Precautions (5.3)] . Alternatively, consider the use of non-opioid

analgesics in these patients.

5.8 Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than

one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs

including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal

insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal

insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the

patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until

adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid

without recurrence of adrenal insufficiency. The information available does not identify any particular

opioids as being more likely to be associated with adrenal insufficiency.

5.9 Severe Hypotension

Oxycodone hydrochloride tablets may cause severe hypotension including orthostatic hypotension and

syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood

pressure has already been compromised by a reduced blood volume or concurrent administration of

certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) [see Drug Interactions (7)] .

Monitor these patients for signs of hypotension after initiating or titrating the dosage of oxycodone

hydrochloride tablets. In patients with circulatory shock, use of oxycodone hydrochloride tablets may

cause vasodilation that can further reduce cardiac output and blood pressure. Avoid use of oxycodone

hydrochloride tablets in patients with circulatory shock.

5.10 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head

Injury, or Impaired Consciousness

In patients who may be susceptible to the intracranial effects of CO

retention (e.g., those with

evidence of increased intracranial pressure or brain tumors), oxycodone hydrochloride tablets may

reduce the respiratory drive, and the resultant CO

retention can further increase intracranial pressure.

Monitor such patients for signs of sedation and respiratory depression, particularly when initiating

therapy with oxycodone hydrochloride tablets.

Opioids may obscure the clinical course in a patient with a head injury. Avoid the use of oxycodone

hydrochloride tablets in patients with impaired consciousness or coma.

5.11 Risks of Use in Patients with Gastrointestinal Conditions

Oxycodone hydrochloride tablets are contraindicated in patients with gastrointestinal obstruction,

including paralytic ileus.

The oxycodone in oxycodone hydrochloride tablets may cause spasm of the sphincter of Oddi. Opioids

may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute

pancreatitis, for worsening symptoms.

5.12 Increased Risk of Seizures in Patients with Seizure Disorders

The oxycodone in oxycodone hydrochloride tablets may increase the frequency of seizures in patients

with seizure disorders, and may increase the risk of seizures occurring in other clinical settings

associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure

control during oxycodone hydrochloride tablets therapy.

5.13 Withdrawal

Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial

agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic,

including oxycodone hydrochloride tablets. In these patients, mixed agonist/antagonist and partial

agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms [see Drug

Interactions (7)] .

When discontinuing oxycodone hydrochloride tablets in a physically-dependent patient, gradually taper

the dosage [see Dosage and Administration (2.4)] . Do not abruptly discontinue oxycodone

hydrochloride tablets in these patients [see Drug Abuse and Dependence (9.3)] .

5.14 Risks of Driving and Operating Machinery

Oxycodone hydrochloride tablets may impair the mental or physical abilities needed to perform

potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive

or operate dangerous machinery unless they are tolerant to the effects of oxycodone hydrochloride

tablets and know how they will react to the medication [see Patient Counseling Information (17)] .

6 ADVERSE REACTIONS

Most common adverse reactions (≥3%) were nausea, constipation, vomiting, headache, pruritus,

insomnia, dizziness, asthenia, and somnolence. ( 6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt at 1-800-778-7898 or FDA at

1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical 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: thrombophlebitis, hemorrhage, hypotension, vasodilatation

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of oxycodone. Because

these reactions are reported voluntarily from a population of uncertain size, it is not always possible to

reliably estimate their frequency or establish a causal relationship to drug exposure.

General disorders and administrative site disorders: drug withdrawal syndrome neonatal [see Warnings

and Precautions (5.4)]

Respiratory, thoracic and mediastinal disorders: pharyngeal edema

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been

reported during concomitant use of opioids with serotonergic drugs [see Drug Interactions (7)] .

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often

following greater than one month of use [see Warnings and Precautions (5.8)] .

Anaphylaxis: Anaphylactic reaction has been reported with ingredients contained in oxycodone

hydrochloride tablets [see Contraindications (4)] .

Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see

Clinical Pharmacology (12.2)] .

7 DRUG INTERACTIONS

Table 1 includes clinically significant drug interactions with oxycodone hydrochloride tablets.

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)].

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), 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.

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

Pregnancy: May cause fetal harm. ( 8.1)

See 17 for Patient Counseling Information and Medication Guide

8.1 Pregnancy

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 are 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/m

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

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

basis).

8.2 Lactation

Risk Summary

Oxycodone is present in breast milk. Published lactation studies report variable concentrations of

oxycodone in breast milk with administration of immediate-release oxycodone to nursing mothers in the

early postpartum period. The lactation studies did not assess breastfed infants for potential adverse

reactions. Lactation studies have not been conducted with oxycodone hydrochloride tablets, and no

information is available on the effects of the drug on the breastfed infant or the effects of the drug on

milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s

clinical need for oxycodone hydrochloride tablets and any potential adverse effects on the breastfed

infant from oxycodone hydrochloride tablets or from the underlying maternal condition.

Clinical Considerations

Infants exposed to oxycodone hydrochloride tablets through breast milk should be monitored for

excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when

maternal administration of an opioid analgesic is stopped or when breast-feeding is stopped.

8.3 Females and Males of Reproductive Potential

8.3 Females and Males of Reproductive Potential

Infertility

Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is

not known whether these effects on fertility are reversible [see Adverse Reactions (6.2), Clinical

Pharmacology (12.2)] .

8.4 Pediatric Use

The safety and efficacy of oxycodone hydrochloride tablets in pediatric patients have not been

evaluated.

8.5 Geriatric 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 monitor

renal function.

8.6 Hepatic Impairment

Because oxycodone is extensively metabolized in the liver, its clearance may decrease in patients with

hepatic impairment. Initiate therapy in these patients with a lower than usual dosage of oxycodone

hydrochloride tablets and titrate carefully. Monitor closely for adverse events such as respiratory

depression, sedation, and hypotension [see Clinical Pharmacology (12.3)] .

8.7 Renal Impairment

Because oxycodone is known to be substantially excreted by the kidney, its clearance may decrease in

patients with renal impairment. Initiate therapy with a lower than usual dosage of oxycodone

hydrochloride tablets and titrate carefully. Monitor closely for adverse events such as respiratory

depression, sedation, and hypotension [see Clinical Pharmacology (12.3)] .

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Oxycodone hydrochloride tablets contain oxycodone, a Schedule II controlled substance.

9.2 Abuse

Oxycodone hydrochloride tablets contain oxycodone, a substance with a high potential for abuse

similar to other opioids including fentanyl, hydrocodone hydromorphone, methadone, morphine,

oxymorphone, and tapentadol. Oxycodone hydrochloride tablets can be abused and is subject to misuse,

addiction, and criminal diversion [see Warnings and Precautions (5.1)] .

All patients treated with opioids require careful monitoring for signs of abuse and addiction, because

use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its

rewarding psychological or physiological effects.

Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after

repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use,

persisting in its use despite harmful consequences, a higher priority given to drug use than to other

activities and obligations, increased tolerance, and sometimes a physical withdrawal.

“Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking

tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate

examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions, and

reluctance to provide prior medical records or contact information for other treating healthcare

provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is

common among drug abusers and people suffering from untreated addiction. Preoccupation with

achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare

providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms

of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true

addiction.

Oxycodone hydrochloride tablets, like other opioids, can be diverted for non-medical use into illicit

channels of distribution. Careful record-keeping of prescribing information, including quantity,

frequency, and renewal requests, as required by state and federal law, is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and

proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Risks Specific to Abuse of Oxycodone Hydrochloride Tablets

Oxycodone hydrochloride tablets are for oral use only. Abuse of oxycodone hydrochloride tablets

poses a risk of overdose and death. The risk is increased with concurrent abuse of oxycodone

hydrochloride tablets with alcohol and other central nervous system depressants.

Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis

and HIV.

9.3 Dependence

Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the

need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of

disease progression or other external factors). Tolerance may occur to both the desired and undesired

effects of drugs, and may develop at different rates for different effects.

Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage

reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with

opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g.,

pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence

may not occur to a clinically significant degree until after several days to weeks of continued opioid

usage.

Oxycodone hydrochloride tablets should not be abruptly discontinued in a physically-dependent patient

[see Dosage and Administration (2.4)] . If oxycodone hydrochloride tablets are abruptly discontinued in a

physically-dependent patient, a withdrawal syndrome may occur. Some or all of the following can

characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia,

and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache,

joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased

blood pressure, respiratory rate, or heart rate.

Infants born to mothers physically dependent on opioids will also be physically dependent and may

exhibit respiratory difficulties and withdrawal signs [see Use in Specific Populations (8.1)] .

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.

The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression

resulting from opioid overdose. For clinically significant respiratory or circulatory depression

secondary to oxycodone overdose, administer an opioid antagonist. Opioid antagonists should not be

administered in the absence of clinically significant respiratory or circulatory depression secondary to

oxycodone overdose.

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.

11 DESCRIPTION

Oxycodone Hydrochloride Tablets USP contain 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:

The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate,

stearic acid, D&C Yellow No. 10 (15 mg tablet), and FD&C Blue No. 2 (15 mg and 30 mg tablets).

The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27.0 mg, respectively,

of oxycodone free base.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism 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.

12.2 Pharmacodynamics

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 agonist opioids. 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 reactions such as nausea, vomiting, CNS effects, and respiratory

depression. In opioid-tolerant patients, the situation may be altered by the development of tolerance to

opioid-related adverse reactions [see Dosage and Administration (2.1, 2.2, 2.3)] .

12.3 Pharmacokinetics

The activity of oxycodone hydrochloride tablets is primarily due to the parent drug oxycodone.

Oxycodone hydrochloride tablets are designed to provide immediate release of oxycodone.

Table 2:

Pharmacokinetic Parameters (Mean±SD)

Dose\Parameters

(ngxhr/mL)

Cmax

(ng/mL)

Tmax

(hr)

Cmin

(ng/mL)

Cavg

(ng/mL)

Half-

Life

(hr)

Single Dose

Pharmacokinetics

Oxycodone

Hydrochloride

Tablets

5 mg tabs x 3

133.2±33

22.3±8.2

1.8±1.8 n/a

3.73±0.9

Oxycodone

Hydrochloride

Tablets

15 mg tab

128.2±35.1 22.2±7.6

1.4±0.7 n/a

3.55±1.0

Oxycodone

Hydrochloride

Oral Concentrate

Solution

15 mg oral

solution

130.6±34.7 21.1±6.1

1.9±1.5 n/a

3.71±0.8

Oxycodone

Hydrochloride

268.2±60.739.3±14.0 2.6±3.0 n/a

3.85±1.3

Tablets

30 mg tab

268.2±60.739.3±14.0 2.6±3.0 n/a

3.85±1.3

Food-Effect,

Single Dose

Oxycodone

Hydrochloride

Oral Solution USP

10 mg/10 mL oral

sol’n (fasted)

105±6.2

19.0±3.7 1.25±0.5n/a

2.9±0.4

Oxycodone

Hydrochloride

Oral Solution USP

10 mg/10 mL oral

sol’n (fed)

133±25.2

17.7±3.0

2.54±1.2n/a

3.3±0.5

Multiple-Dos e

Studies

(72-84)

Oxycodone

Hydrochloride

Tablets

5 mg tabs

q6h x 14 doses

113.3±24.0 15.7±3.2

1.3±0.3 7.4±1.8 9.4±2.0 n/a

Oxycodone

Hydrochloride

Oral Solution USP

3.33 mg (3.33 mL)

oral sol’n.

q4h x 21 doses

99.0±24.8 12.9±3.1

1.0±0.3 7.2±2.3 9.7±2.6 n/a

Absorption

About 60% to 87% of an oral dose of oxycodone reaches the systemic circulation in comparison to a

parenteral dose. This high oral bioavailability (compared to other oral opioids) is due to lower

presystemic and/or first-pass metabolism of oxycodone. The relative oral bioavailability of oxycodone

hydrochloride tablets 15 mg and 30 mg tablets, compared to the 5 mg oxycodone hydrochloride tablets,

is 96% and 101% respectively. Oxycodone hydrochloride tablets 15 mg tablets and 30 mg tablets are

bioequivalent to the 5 mg oxycodone hydrochloride tablet ( see Table 2 for pharmacokinetic

parameters). Dose proportionality of oxycodone has been established using the oxycodone

hydrochloride tablets 5 mg tablets at doses of 5 mg, 15 mg (three 5 mg tablets) and 30 mg (six 5 mg

tablets) based on extent of absorption (AUC) ( see Figure 1). It takes approximately 18 to 24 hours to

reach steady-state plasma concentrations of oxycodone with oxycodone hydrochloride tablets.

Food Effect

A single-dose food effect study was conducted in normal volunteers using the 5 mg/5 mL solution. The

concurrent intake of a high fat meal was shown to enhance the extent (27% increase in AUC), but not the

rate of oxycodone absorption from the oral solution ( see Table 2). In addition, food caused a delay in T

(1.25 to 2.54 hour). Similar effects of food are expected with the 15 mg and 30 mg tablets.

Distribution

Following intravenous administration, the volume of distribution (V

) for oxycodone was 2.6 L/kg.

Plasma protein binding of oxycodone at 37°C and a pH of 7.4 was about 45%. Oxycodone has been

found in breast milk [see Special Populations (8.2)] .

Elimination

Metabolism

A high portion of oxycodone is N-dealkylated to noroxycodone during first-pass metabolism, and is

catalyzed by CYP3A4. Oxymorphone is formed by the O-demethylation of oxycodone. The metabolism

of oxycodone to oxymorphone is catalyzed by CYP2D6 [see Drug Interactions (7)] . Free and conjugated

noroxycodone, free and conjugated oxycodone, and oxymorphone are excreted in human urine

following a single oral dose of oxycodone. The major circulating metabolite is noroxycodone with an

AUC ratio of 0.6 relative to that of oxycodone. Oxymorphone is present in the plasma only in low

concentrations. The analgesic activity profile of other metabolites is not known at present.

Excretion

Oxycodone and its metabolites are excreted primarily via the kidney. The amounts measured in the urine

have been reported as follows: free oxycodone up to 19%; conjugated oxycodone up to 50%; free

oxymorphone 0%; conjugated oxymorphone ≤ 14%; both free and conjugated noroxycodone have been

found in the urine but not quantified. The total plasma clearance was 0.8 L/min for adults. Apparent

elimination half-life of oxycodone following the administration of oxycodone hydrochloride tablets

was 3.5 to 4 hours.

Specific Populations

Age: Geriatric Population

Population pharmacokinetic studies conducted with oxycodone hydrochloride tablets, indicated that the

plasma concentrations of oxycodone did not appear to be increased in patients over the age of 65.

Hepatic Impairment

In a clinical trial supporting the development of oxycodone hydrochloride tablets, too few patients with

decreased hepatic function were evaluated to study these potential differences. However, because

oxycodone is extensively metabolized in the liver, its clearance may decrease in hepatic impaired

patients [see Use in Specific Populations (8.6)] .

Renal Impairment

This drug 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 [see Use in Specific Populations (8.7)] .

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term studies have not been performed in animals to evaluate the carcinogenic potential of

oxycodone hydrochloride tablets or oxycodone.

Mutagenesis

Oxycodone hydrochloride was genotoxic in an in vitro mouse lymphoma assay in the presence of

metabolic activation. There was no evidence of genotoxic potential in an in vitro bacterial reverse

mutation assay ( Salmonella typhimurium and Escherichia coli) or in an assay for chromosomal aberrations

( in vivo mouse bone marrow micronucleus assay).

Impairment of Fertility

Studies in animals to evaluate the potential impact of oxycodone on fertility have not been conducted.

16 HOW SUPPLIED/STORAGE AND HANDLING

Oxycodone Hydrochloride Tablet USP are available as follows:

Each Oxycodone Hydrochloride Tablet USP 5 mg is available as a white round convex tablet with a

on one side and “0552” with a vertical bisect between the fives on the other.

Bottles of 100............................. NDC 0406-0552-01

Unit Dose (10 x 10)................... NDC 0406-0552-62

Each Oxycodone Hydrochloride Tablet USP 15 mg is available as a light green round convex tablet

with a

on one side and “15” above a bisect on the other.

Bottles of 100............................. NDC 0406-8515-01

Unit Dose (10 x 10)................... NDC 0406-8515-62

Each Oxycodone Hydrochloride Tablet USP 30 mg is available as a light blue round convex tablet with

on one side and “30” above a bisect on the other.

Bottles of 100............................. NDC 0406-8530-01

Unit Dose (10 x 10)................... NDC 0406-8530-62

Dispense in a tight, light-resistant container with child-resistant closure.

Protect from moisture.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

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 [see Warnings and Precautions (5.3)] . Advise patients how to

recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Accidental Ingestion

Inform patients that accidental ingestion, especially by children, may result in respiratory depression or

death [see Warnings and Precautions (5.3)] . Instruct patients to take steps to store oxycodone

hydrochloride tablets securely and to dispose of unused oxycodone hydrochloride tablets by flushing

the tablets down the toilet or disposing of in accordance with local state guidelines and/or regulations.

Interactions with Benzodiazepines and Other CNS Depressants

Inform patients and caregivers that potentially fatal additive effects may occur if oxycodone

hydrochloride tablets are 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

(5.6), Drug Interactions (7)] .

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from

concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome

and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare

providers if they are taking, or plan to take serotonergic medication [see Drug Interactions (7)] .

MAOI Interaction

Inform patients to avoid taking oxycodone hydrochloride tablets while using any drugs that inhibit

monoamine oxidase. Patients should not start MAOIs while taking oxycodone hydrochloride tablets [see

Drug Interactions (7)] .

Adrenal Insufficiency

Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition.

Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting,

anorexia, fatigue, weakness, dizziness and low blood pressure. Advise patients to seek medical attention

if they experience a constellation of these symptoms [see Warnings and Precautions (5.8)] .

Important Administration Instructions

Instruct patients how to properly take oxycodone hydrochloride tablets. Patients should be advised not

to adjust the dose of oxycodone hydrochloride tablets without consulting the prescribing healthcare

provider [see Dosage and Administration (2), Warnings and Precautions (5.13)] .

Hypotension

Inform patients that oxycodone hydrochloride tablets may cause orthostatic hypotension and syncope.

Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of

serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from sitting or

lying position) [see Warnings and Precautions (5.9)] .

Anaphylaxis

Inform patients that anaphylaxis has been reported with ingredients contained in oxycodone

hydrochloride tablets. Advise patients how to recognize such a reaction and when to seek medical

attention [see Contraindications (4), Adverse Reactions (6.2)] .

Pregnancy

Neonatal Opioid Withdrawal Syndrome

Inform female patients of reproductive potential that 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 [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)] .

Embryo-Fetal Toxicity

Inform female patients of reproductive potential that oxycodone hydrochloride tablets can cause fetal

harm and to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific

Populations (8.1)] .

Lactation

Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing

difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these

signs [see Use in Specific Populations (8.2)] .

Infertility

Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these

effects on fertility are reversible [see Use in Specific Populations (8.3)] .

Driving or Operating Machinery

Inform patients that oxycodone hydrochloride tablets may impair the ability to perform potentially

hazardous activities such as driving a car or operating dangerous machinery. Advise patients not to

perform such tasks until they know how they will react to the medication [see Warnings and Precautions

(5.14)] .

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to

seek medical attention [see Adverse Reactions (6), Clinical Pharmacology (12.1)].

Disposal of Unused Oxycodone Hydrochloride Tablets

Advise patients to dispose of unused oxycodone hydrochloride tablets by flushing the tablets down the

toilet or disposing of in accordance with local state guidelines and/or regulations.

Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and M are trademarks of a

Mallinckrodt company.

© 2018 Mallinckrodt.

SpecGx LLC

Webster Groves, MO 63119 USA

To request medical information or to report suspected adverse reactions, contact Mallinckrodt at

1 800 778 7898.

Rev 09/2018

Mallinckrodt

Pharmaceuticals

An electronic copy of this medication guide can be obtained from

www.mallinckrodt.com/Medguide/MG20O14.pdf or by calling 1-800-778-7898 for alternate delivery

options.

Medication Guide

Oxycodone Hydrochloride Tablets USP, CII

(ox" i koe' done hye" droe klor' ide)

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 right away if you take too many 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.

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.

Store oxycodone hydrochloride tablets away from children and in a safe place to prevent

stealing or abuse. Selling or giving away oxycodone hydrochloride tablets is against the law.

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

TM

pancreas or gallbladder problems

abuse of street or prescription drugs, alcohol addiction, 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 pass into breast milk and may harm your

baby.

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.

After you stop taking oxycodone hydrochloride tablets, flush any unused tablets down the

to ilet.

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 are:

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 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

Manufactured by: SpecGx LLC, Webster Groves, MO 63119 USA, www.Mallinckrodt.com or

call 1-800-778-7898

MG20O14

Mallinckrodt

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued:

07/2017

TM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OXYCODONE HYDROCHLORIDE

oxycodone hydrochloride tablet

Product Information

Product T ype

HUMAN

PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 729 6 -

0 425(NDC:0 40 6 -0 552)

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O XYCO DO NE HYDRO CHLO RIDE (UNII: C1ENJ2TE6 C) (OXYCODONE -

UNII:CD35PMG570 )

OXYCODONE

HYDROCHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

RedPharm Drug, Inc.

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

white

S core

2 pieces

S hap e

ROUND

S iz e

6 mm

Flavor

Imprint Code

M;0 552

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 729 6 -0 425-1

20 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 19

2

NDC:6 729 6 -0 425-4

4 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 758

0 7/30 /20 0 9

Labeler -

RedPharm Drug, Inc. (828374897)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

RedPharm Drug, Inc.

8 28 3748 9 7

repack(6 729 6 -0 425) , relabel(6 729 6 -0 425)

Revised: 1/2019

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