Oxymorphone Tablets

Name: Oxymorphone Tablets

Uses of Oxymorphone Tablets

  • It is used to ease pain.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Dosage Forms and Strengths

The 5 mg dosage form is peach colored, round compressed tablets, debossed “cor” over “258” on one side and plain on the other side.

The 10 mg dosage form is light yellow to yellow, round compressed tablets debossed "cor" over "259" on one side and plain on the other side.

Warnings and Precautions

Addiction, Abuse, and Misuse

Oxymorphone Hydrochloride Tablets contain oxymorphone, a Schedule II controlled substance. As an opioid, Oxymorphone 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 Oxymorphone 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 Oxymorphone Hydrochloride Tablets, and monitor all patients receiving Oxymorphone 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 Oxymorphone Hydrochloride Tablets, but use in such patients necessitates intensive counseling about the risks and proper use of Oxymorphone 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 Oxymorphone 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 drug [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.

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 (CO2) 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 Oxymorphone 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 24-72 hours of initiating therapy with and following dosage increases of Oxymorphone Hydrochloride Tablets.

To reduce the risk of respiratory depression, proper dosing and titration of Oxymorphone Hydrochloride Tablets are essential [see Dosage and Administration (2)]. Overestimating the Oxymorphone Hydrochloride Tablets dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.

Accidental ingestion of even one dose of Oxymorphone Hydrochloride Tablets, especially by children, can result in respiratory depression and death due to an overdose of oxymorphone.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Oxymorphone 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)].

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Patients must not consume alcoholic beverages or prescription or non-prescription products containing alcohol while on Oxymorphone Hydrochloride Tablets therapy. The co-ingestion of alcohol with Oxymorphone Hydrochloride Tablets may result in increased plasma levels and a potentially fatal overdose of oxymorphone [see Clinical Pharmacology (12.3)].

Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Oxymorphone 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 Oxymorphone Hydrochloride Tablets are used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy 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)].

Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients

The use of Oxymorphone 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: Oxymorphone 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 Oxymorphone Hydrochloride Tablets [see Warnings and Precautions (5.2)].

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 (8.5)].

Monitor such patients closely, particularly when initiating and titrating Oxymorphone Hydrochloride Tablets and when Oxymorphone Hydrochloride Tablets are given concomitantly with other drugs that depress respiration [see Warnings and Precautions (5.2)]. Alternatively, consider the use of non-opioid analgesics in these patients.

Anaphylaxis, Angioedema, and Other Hypersensitivity Reactions

Potentially life-threatening hypersensitivity reactions, including anaphylaxis and angioedema, have occurred in patients treated with Oxymorphone Hydrochloride Tablets in the postmarket setting. The most commonly described clinical features in these reports were swelling of the face, eyes, mouth, lips, tongue, hands, and/or throat; dyspnea; hives, pruritus, and/or rash; and nausea/vomiting. If anaphylaxis or other hypersensitivity occurs, stop administration of Oxymorphone Hydrochloride Tablets immediately, discontinue Oxymorphone Hydrochloride Tablets permanently, and do not rechallenge with any formulation of oxymorphone.  Advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction [see Patient Counseling Information (17)].

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.

  Severe Hypotension

Oxymorphone 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 Warnings and Precautions (5.4) and Drug Interactions (7)]. Monitor these patients for signs of hypotension after initiating or titrating the dosage of Oxymorphone Hydrochloride Tablets. In patients with circulatory shock, Oxymorphone Hydrochloride Tablets may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of Oxymorphone Hydrochloride Tablets in patients with circulatory shock.

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 CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), Oxymorphone Hydrochloride Tablets may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with Oxymorphone Hydrochloride Tablets.

Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of Oxymorphone Hydrochloride Tablets in patients with impaired consciousness or coma.

Risks of Use in Patients with Gastrointestinal Conditions

Oxymorphone Hydrochloride Tablets are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.

The oxymorphone in Oxymorphone 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.

Increased Risk of Seizures in Patients with Seizure Disorders

The oxymorphone in Oxymorphone 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 Oxymorphone Hydrochloride Tablets therapy.

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 Oxymorphone Hydrochloride Tablets. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms [seeDrug Interactions (7)].

When discontinuing Oxymorphone Hydrochloride Tablets in a physically-dependent patient, gradually taper the dosage [see Dosage and Administration (2.8)]. Do not abruptly discontinue Oxymorphone Hydrochloride Tablets in these patients [see Drug Abuse and Dependence (9.3)].

Risks of Driving and Operating Machinery

Oxymorphone 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 Oxymorphone Hydrochloride Tablets and know how they will react to the medication.

Hepatic Impairment

A study of extended-release Oxymorphone Tablets in patients with hepatic disease indicated greater plasma concentrations than in those with normal hepatic function [see Clinical Pharmacology (12.3)]. Use Oxymorphone Hydrochloride Tablets with caution in patients with mild impairment, starting with the lowest dose and titrating slowly while carefully monitoring for side effects [see Dosage and Administration (2.2, 2.3)]. Oxymorphone Hydrochloride Tablets are contraindicated in patients with moderate or severe hepatic impairment.

Drug Interactions

Table 2 includes clinically significant drug interactions with Oxymorphone Hydrochloride Tablets.

Table 2: Clinically Significant Drug Interactions with Oxymorphone Hydrochloride Tablets

Alcohol

Clinical Impact:

The concomitant use of alcohol with Oxymorphone Hydrochloride Tablets can result in an increase of oxymorphone plasma levels and potentially fatal overdose of oxymorphone.

Intervention:

Instruct patients not to consume alcoholic beverages or use prescription or non- prescription products containing alcohol while on Oxymorphone Hydrochloride Tablets therapy [see Clinical Pharmacology 12.3)].

Benzodiazepines and Other Central Nervous System (CNS) Depressants

Clinical Impact:

Due to additive pharmacologic effect, the concomitant use of benzodiazepines and 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 [Warnings and Precautions (5.4)].

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.

Intervention:

If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Oxymorphone 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 (5.2)].

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.

Intervention:

The use of Oxymorphone Hydrochloride Tablets is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.

Examples:

phenelzine, tranylcypromine, linezolid

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics

Clinical Impact:

May reduce the analgesic effect of Oxymorphone Hydrochloride Tablets and/or precipitate withdrawal symptoms.

Intervention:

Avoid concomitant use.

Examples:

butorphanol, nalbuphine, pentazocine, buprenorphine,

Muscle Relaxants

Clinical Impact:

Oxymorphone 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 Oxymorphone 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 urinary retention or reduced gastric motility when Oxymorphone Hydrochloride Tablets are used concomitantly with anticholinergic drugs.

Anticholinergic Drugs

Clinical Impact:

The concomitant use of anticholinergic drugs may increase 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 Oxymorphone Hydrochloride Tablets are used concomitantly with anticholinergic drugs.

Cimetidine

Clinical Impact:

Cimetidine can potentiate opioid-induced respiratory depression.

Intervention:

Monitor patients for respiratory depression when Oxymorphone Hydrochloride Tablets and cimetidine are used concurrently.

Anticholinergic Drugs

Clinical Impact:

The concomitant use of anticholinergic drugs may increase 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 Oxymorphone Hydrochloride Tablets are used concomitantly with anticholinergic drugs.


Oxymorphone Tablets Description

Oxymorphone Hydrochloride Tablets are an opioid agonist available in 5 mg and 10 mg tablet strengths for oral administration. The chemical name for oxymorphone hydrochloride is 4, 5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 337.80. The molecular formula is C17H19NO4  . HCl and it has the following chemical structure.

Oxymorphone hydrochloride is white to off white odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water

The inactive ingredients in Oxymorphone Hydrochloride Tablets include: lactose monohydrate, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. In addition, the 5 mg tablets contain Iron Oxide Red. The 10 mg tablets contain D&C Yellow No. 10 Aluminum Lake.

PRINCIPAL DISPLAY PANEL - 5 mg

NDC 64720-258-10    100 tablets

                                                         

PRINCIPAL DISPLAY PANEL - 10 mg

NDC 64720-259-10    100 tablets

                                                  

OXYMORPHONE HYDROCHLORIDE 
oxymorphone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64720-258
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE) OXYMORPHONE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
STARCH, CORN  
SODIUM LAURYL SULFATE  
FERRIC OXIDE RED  
Product Characteristics
Color ORANGE ((Peach)) Score no score
Shape ROUND (Compressed) Size 9mm
Flavor Imprint Code cor;258
Contains     
Packaging
# Item Code Package Description
1 NDC:64720-258-10 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201187 01/17/2015 09/30/2017
OXYMORPHONE HYDROCHLORIDE 
oxymorphone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64720-259
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE) OXYMORPHONE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
STARCH, CORN  
SODIUM LAURYL SULFATE  
D&C YELLOW NO. 10  
Product Characteristics
Color YELLOW ((Light Yellow)) Score no score
Shape ROUND (Compressed) Size 9mm
Flavor Imprint Code cor;259
Contains     
Packaging
# Item Code Package Description
1 NDC:64720-259-10 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201187 01/17/2015 12/31/2017
Labeler - CorePharma, LLC (031192276)
Revised: 08/2017   CorePharma, LLC
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