Percodan (aspirin/oxycodone) Painkiller Side Effects & Warnings

Generic drug: aspirin and oxycodone hydrochloride

Brand name: Percodan

What is Percodan (aspirin and oxycodone hydrochloride), and how does it work?

Percodan (aspirin and oxycodone hydrochloride) is a prescription medicine used to treat the symptoms of Moderate to Moderately Severe Pain. Percodan may be used alone or with other medications.

Percodan belongs to a class of drugs called Analgesics, NSAID/Opioid Combos.

It is not known if Percodan is safe and effective in children.

What are the side effects of Percodan?

Percodan may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• slowed breathing with long pauses,
• blue colored lips,
• difficult to wake up,
• severe stomach pain,
• constipation,
• vomiting,
• fast or slow heartbeats,
• weak or shallow breathing,
• breathing that stops during sleep,
• confusion,
• unusual thoughts or behavior,
• lightheadedness,
• decreased hearing,
• ringing in the ears,
• seizures,
• bloody or tarry stools,
• coughing up blood,
• vomit that looks like coffee grounds,
• nausea,
• vomiting,
• loss of appetite,
• dizziness,
• worsening tiredness,
• weakness,
• agitation,
• hallucination,
• fever,
• sweating,
• shivering,
• fast heart rate,
• muscle stiffness,
• twitching,
• loss of coordination, and
• diarrhea

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Percodan include:

• headache,
• dizziness,
• drowsiness,
• constipation,
• heartburn,
• upset stomach,
• bloating,
• gas,
• diarrhea, and
• dry mouth

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Percodan. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Does Percodan cause addiction or withdrawal symptoms?

Drug Abuse And Dependence

Controlled Substance

Percodan contain oxycodone, a Schedule II controlled substance.

Abuse

• Percodan contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol.
  Percodan can be abused and is subject to misuse, addiction, and criminal
  diversion.
• All patients treated with opioids require careful monitoring for signs of abuse and addiction, since 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 health care 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. Health care 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.
• Percodan 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 Percodan

• Percodan is for oral use only. Abuse of Percodan poses a risk of overdose and death. The risk is increased with concurrent use of
  Percodan with alcohol and other central nervous system depressants.
• Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

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 is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting 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.
• Do not abruptly discontinue Percodan in a patient physically dependent on opioids. Rapid tapering of
  Percodan in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse.
• When discontinuing Percodan, gradually taper the dosage using a patient-specific plan that considers the following: the dose of
  Percodan the patient has been taking, the duration of treatment, and the
  physical and psychological attributes of the patient. To improve the
  likelihood of a successful taper and minimize withdrawal symptoms, it is
  important that the opioid tapering schedule is agreed upon by the patient.
  In patients taking opioids for a long duration at high doses, ensure that a
  multimodal approach to pain management, including mental health support (if
  needed), is in place prior to initiating an opioid analgesic taper.
• Infants born to mothers physically dependent on opioids will also be
  physically dependent and may exhibit respiratory difficulties and withdrawal
  signs.

Medically speaking, the term “myalgia” refers to what type of pain?
See Answer

What is the dosage for Percodan?

Important Dosage And Administration Instructions

• Use the lowest effective dosage for the shortest duration consistent
  with individual patient treatment goals.
• 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.
• Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with
  Percodan tablets and adjust the dosage accordingly.

Patient Access To Naloxone For The Emergency Treatment Of Opioid Overdose

• Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with
  Percodan.
• Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing regulations (e.g., by prescription, directly from a pharmacist, or as part of a community-based program).
• Consider prescribing naloxone, based on the patient’s risk factors for
  overdose, such as concomitant use of CNS depressants, a history of opioid
  use disorder, or prior opioid overdose. The presence of risk factors for
  overdose should not prevent the proper management of pain in any given
  patient.
• Consider prescribing naloxone when the patient has household members (including children) or other close contacts at risk for accidental ingestion or overdose.

Initial Dosage

Initiating Treatment With Percodan

Initiate treatment with one tablet every 6 hours as needed for pain. The maximum daily dose of aspirin should not exceed 4 grams or 12 tablets.

Titration And Maintenance Of Therapy

• Individually titrate Percodan to a dose that provides adequate analgesia and minimizes adverse reactions.
• Continually reevaluate patients receiving Percodan 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.
• 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
  Percodan 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.

Safe Reduction Or Discontinuation Of Percodan Tablets

• Do not abruptly discontinue Percodan in patients who may be physically dependent on opioids. Rapid discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.
• Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.
• When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking
  Percodan, there are a variety of factors that should be considered, including the dose of
  Percodan the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.
• It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic. When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder. Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder. Complex patients with comorbid pain and substance use disorders may benefit from referral to a specialist.
• There are no standard opioid tapering schedules that are suitable for all patients. Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually. For patients on
  Percodan who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., no greater than 10% to 25% of the total daily dose) to avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2 to 4 weeks. Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper.
• It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper. Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge.
• Common withdrawal symptoms include
  • 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. If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper. In addition, monitor patients for any changes in mood, emergence of suicidal thoughts, or use of other substances.
• When managing patients taking opioid analgesics, particularly those who
  have been treated for a long duration and/or with high doses for chronic
  pain, ensure that a multimodal approach to pain management, including mental
  health support (if needed), is in place prior to initiating an opioid
  analgesic taper. A multimodal approach to pain management may optimize the
  treatment of chronic pain, as well as assist with the successful tapering of
  the opioid analgesic.

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What drugs interact with Percodan?

Table 1: Clinically Significant Drug Interactions with Percodan

Inhibitors of CYP3A4 and CYP2D6

Clinical Impact:
The concomitant use of Percodan 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 Percodan and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Percodan is achieved.

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease, 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 Percodan 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 Percodan 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 Percodan and CYP3A4 inducers can decrease the plasma concentration of oxycodone, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oxycodone.

After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase, 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 Percodan dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Percodan 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, increases the risk of 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. If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose.

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 Percodan 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 effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Monoamine Oxidase Inhibitors (MAOIs)

Clinical Impact:
MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma).

Intervention:
The use of Percodan 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 and Partial Agonist Opioid Analgesics

Clinical Impact:
May reduce the analgesic effect of Percodan and/or 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 Percodan and/or the muscle relaxant as necessary. Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, consider prescribing naloxone for the emergency treatment of opioid overdose.

Diuretics

Clinical Impact:
Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.

Intervention:
Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.

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 Percodan is used concomitantly with anticholinergic drugs.

Analgesics

Clinical Impact:
Analgesics may reduce the analgesic effect of oxycodone or may precipitate withdrawal symptoms

Intervention:
Should be administered with caution to a patient who has received or is receiving a full opioid agonist such as oxycodone.

Examples:
Pentazocine, nalbuphine, naltrexone, and butorphanol

Angiotensin Converting Enzyme (ACE) Inhibitors

• The hyponatremic and hypotensive effects of ACE inhibitors may be diminished by the concomitant administration of aspirin due to its indirect effect on the renin-angiotensin conversion pathway.

Acetazolamide

• Concurrent use of aspirin and acetazolamide can lead to high serum concentrations of acetazolamide (and toxicity) due to competition at the renal tubule for secretion.

Anticoagulant Therapy (Heparin And Warfarin)

• Patients on anticoagulation therapy are at increased risk for bleeding because of drug-drug interactions and the effect on platelets.
• Aspirin can displace warfarin from protein binding sites, leading to prolongation of both the prothrombin time and the bleeding time. Aspirin can increase the anticoagulant activity of heparin, increasing bleeding risk.

Anticonvulsants

• Salicylate can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic acid levels.

Beta Blockers

• The hypotensive effects of beta blockers may be diminished by the concomitant administration of aspirin due to inhibition of renal prostaglandins, leading to decreased renal blood flow, and salt and fluid retention.

Diuretics

• The effectiveness of diuretics in patients with underlying renal or cardiovascular disease may be diminished by the concomitant administration of aspirin due to inhibition of renal prostaglandins, leading to decreased renal blood flow and salt and fluid retention.

Methotrexate

• Aspirin may enhance the serious side and toxicity of methotrexate due to displacement from its plasma protein binding sites and/or reduced renal clearance.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

• The concurrent use of aspirin with other NSAIDs should be avoided because this may increase bleeding or lead to decreased renal function. Aspirin may enhance the serious side effects and toxicity of ketorolac, due to displacement from its plasma protein binding sites and/or reduced renal clearance.

Oral Hypoglycemics Agents

• Aspirin may increase the serum glucose-lowering action of insulin and sulfonylureas leading to hypoglycemia.

Uricosuric Agents

• Salicylates antagonize the uricosuric action of probenecid or sulfinpyrazone.

Drug Abuse And Dependence

Controlled Substance

Percodan contain oxycodone, a Schedule II controlled substance.

Abuse

• Percodan contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. Percodan can be abused and is subject to misuse, addiction, and criminal diversion.
• All patients treated with opioids require careful monitoring for signs of abuse and addiction, since 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 health care 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. Health care 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.
• Percodan 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 Percodan

• Percodan is for oral use only. Abuse of Percodan poses a risk of overdose and death. The risk is increased with concurrent use of Percodan with alcohol and other central nervous system depressants.
• Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

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 is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting 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.
• Do not abruptly discontinue Percodan in a patient physically dependent on opioids. Rapid tapering of Percodan in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse.
• When discontinuing Percodan, gradually taper the dosage using a patient-specific plan that considers the following: the dose of Percodan the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper.
• Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs.

Is Percodan safe to use while pregnant or breastfeeding?

• Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome.
• Use of NSAIDs, including aspirin, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
• Because of these risks, limit dose and duration of Percodan use between about 20 and 30 weeks of gestation, and avoid
  Percodan use at about 30 weeks of gestation and later in pregnancy.
• 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 extended-release oxycodone, including
  Percodan, and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production.
• Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with
  Percodan.