OXYCODONE AND ACETAMINOPHEN (Page 4 of 10)

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

The use of oxycodone and acetaminophen 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 and acetaminophen 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 and acetaminophen tablets ( see WARNINGS, Life-Threatening Respiratory Depression).

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, Life-Threatening Respiratory Depression).

Regularly evaluate patients, particularly when initiating and titrating oxycodone and acetaminophen tablets and when oxycodone and acetaminophen tablets are given concomitantly with other drugs that depress respiration ( see WARNINGS, Life-Threatening Respiratory Depression). Alternatively, consider the use of non-opioid analgesics in these patients.

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

Oxycodone and acetaminophen 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 PRECAUTIONS, Drug Interactions). Regularly evaluate these patients for signs of hypotension after initiating or titrating the dosage of oxycodone and acetaminophen tablets. In patients with circulatory shock oxycodone and acetaminophen tablets may cause vasodilatation that can further reduce cardiac output and blood pressure. Avoid the use of oxycodone and acetaminophen tablets with circulatory shock.

Serious Skin Reactions

Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Hypersensitivity/Anaphylaxis

There have been postmarketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue oxycodone and acetaminophen tablets immediately and seek medical care if they experience these symptoms. Do not prescribe oxycodone and acetaminophen tablets for patients with acetaminophen allergy ( see PRECAUTIONS, Information for Patients/Caregivers).

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 2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), oxycodone and acetaminophen tablets may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with oxycodone and acetaminophen tablets.

Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of oxycodone and acetaminophen tablets in patients with impaired consciousness or coma.

Risks of Use in Patients with Gastrointestinal Conditions

Oxycodone and acetaminophen tablets are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.

The administration of oxycodone and acetaminophen tablets, or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

The oxycodone in oxycodone and acetaminophen tablets may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Regularly evaluate patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

Increased Risk of Seizures in Patients with Seizure Disorders

The oxycodone in oxycodone and acetaminophen tablets may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occuring in other clinical settings associated with seizures. Regularly evaluate patients with a history of seizure disorders for worsened seizure control during oxycodone and acetaminophen tablets therapy.

Withdrawal

Do not abruptly discontinue oxycodone and acetaminophen tablets in a patient physically dependent on opioids. When discontinuing oxycodone and acetaminophen tablets in a physically dependent patient, gradually taper the dosage. Rapid tapering of oxycodone and acetaminophen tablets in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain ( see DOSAGE AND ADMINISTRATION, DRUG ABUSE AND DEPENDENCE).

Additionally, 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 and acetaminophen tablets. In these patients, mixed agonist/antagonist and partial analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms ( see PRECAUTIONS, Drug Interactions).

Risks of Driving and Operating Machinery

Oxycodone and acetaminophen 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 and acetaminophen tablets and know how they will react to the medication ( see PRECAUTIONS, Information for Patients/Caregivers).

PRECAUTIONS

Information for Patients/Caregivers

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

Storage and Disposal
Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store oxycodone and acetaminophen tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving oxycodone and acetaminophen tablets unsecured can pose a deadly risk to others in the home ( see WARNINGS, DRUG ABUSE AND DEPENDENCE).

Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused oxycodone and acetaminophen tablets should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.

Addiction, Abuse, and Misuse
Inform patients that the use of oxycodone and acetaminophen tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death ( see WARNINGS). Instruct patients not to share oxycodone and acetaminophen tablets with others and to take steps to protect oxycodone and acetaminophen tablets from theft or misuse.

Life-Threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting oxycodone and acetaminophen tablets or when the dosage is increased, and that it can occur even at recommended dosages.

Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose ( see WARNINGS, Life-Threatening Respiratory Depression).

Accidental Ingestion
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death ( see WARNINGS).

Interactions with Benzodiazepines and Other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if oxycodone and acetaminophen tablets are used with benzodiazepines and other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider ( see WARNINGS and PRECAUTIONS, Drug Interactions).

Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose
Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with oxycodone and acetaminophen tablets. Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program) ( see WARNINGS, Life-Threatening Respiratory Depression; DOSAGE AND ADMINISTRATION).

Educate patients and caregivers on how to recognize the signs and symptoms of an overdose.

Explain to patients and caregivers that naloxone’s effects are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered ( see OVERDOSAGE).

If naloxone is prescribed, also advise patients and caregivers:

  • How to treat with naloxone in the event of an opioid overdose
  • To tell family and friends about their naloxone and to keep it in a place where family and friends can access it in an emergency
  • To read the Patient Information (or other educational material) that will come with their naloxone. Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do.

Hyperalgesia and Allodynia
Inform patients and caregivers not to increase opioid dosage without first consulting a clinician. Advise patients to seek medical attention if they experience symptoms of hyperalgesia, including worsening pain, increased sensitivity to pain, or new pain ( see WARNINGS; ADVERSE REACTIONS).

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 medications ( see PRECAUTIONS, Drug Interactions).

Monoamine Oxidase Inhibitor (MAOI) Interaction
Inform patients to avoid taking oxycodone and acetaminophen tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking oxycodone and acetaminophen tablets ( see PRECAUTIONS, Drug Interactions).

Important Administration Instructions
Instruct patients how to properly take oxycodone and acetaminophen tablets ( see DOSAGE AND ADMINISTRATION, WARNINGS). Advise patients not to adjust the dose of oxycodone and acetaminophen tablets without consulting with a physician or other healthcare professional. If patients have been receiving treatment with oxycodone and acetaminophen tablets for more than a few weeks and cessation of therapy is indicated, counsel them on the importance of safely tapering the dose as abrupt discontinuation of the medication could precipitate withdrawal symptoms. Provide a dose schedule to accomplish a gradual discontinuation of the medication ( see DOSAGE AND ADMINISTRATION).

Important Discontinuation Instructions
In order to avoid developing withdrawal symptoms, instruct patients not to discontinue oxycodone and acetaminophen tablets without first discussing a tapering plan with the prescriber ( see DOSAGE AND ADMINISTRATION).

Maximum Daily Dose of Acetaminophen
Inform patients to not take more than 4000 milligrams of acetaminophen per day. Advise patients to call their prescriber if they take more than the recommended dose.

Driving or Operating Heavy Machinery
Inform patients that oxycodone and acetaminophen tablets may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication ( see PRECAUTIONS).

Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention ( see ADVERSE REACTIONS and CLINICAL PHARMACOLOGY).

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).

Hypotension
Inform patients that oxycodone and acetaminophen 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 a sitting or lying position) ( see WARNINGS).

Anaphylaxis
Inform patients that anaphylaxis have been reported with ingredients contained in oxycodone and acetaminophen tablets. Advise patients how to recognize such a reaction and when to seek medical attention ( see CONTRAINDICATIONS and ADVERSE REACTIONS).

Pregnancy

Neonatal Opioid Withdrawal Syndrome

Inform female patients of reproductive potential that use of oxycodone and acetaminophen tablets for an extended period of time during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated ( see WARNINGS and PRECAUTIONS, Pregnancy).

Embryo-Fetal Toxicity

Inform female patients of reproductive potential that oxycodone and acetaminophen tablets can cause fetal harm and to inform the healthcare provider of a known or suspected pregnancy ( see PRECAUTIONS, Pregnancy).

Lactation
Advise breastfeeding women using oxycodone and acetaminophen tablets to carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct breastfeeding women to seek immediate medical care if they notice these signs ( see PRECAUTIONS, Nursing Mothers).

Infertility
Inform patients that use of opioids for an extended period of time may cause reduced fertility. It is not known whether these effects on fertility are reversible ( see ADVERSE REACTIONS).

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