Serious adverse reactions that may be associated with PERCOCET tablet use include
respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension,
and shock (see OVERDOSAGE).
The most frequently observed non-serious adverse reactions include lightheadedness,
dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem
to be more prominent in ambulatory than in nonambulatory patients, and some
of these adverse reactions may be alleviated if the patient lies down. Other
adverse reactions include euphoria, dysphoria, constipation, and pruritus.
Hypersensitivity reactions may include: Skin eruptions, urticarial, erythematous
skin reactions. Hematologic reactions may include: Thrombocytopenia, neutropenia,
pancytopenia, hemolytic anemia. Rare cases of agranulocytosis has likewise been
associated with acetaminophen use. In high doses, the most serious adverse effect
is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis
and hypoglycemic coma also may occur.
Other adverse reactions obtained from postmarketing experiences with PERCOCET
tablets are listed by organ system and in decreasing order of severity and/or
frequency as follows:
Body as a Whole
Anaphylactoid reaction, allergic reaction, malaise, asthenia, fatigue, chest
pain, fever, hypothermia, thirst, headache, increased sweating, accidental overdose,
non-accidental overdose
Cardiovascular
Hypotension, hypertension, tachycardia, orthostatic hypotension, bradycardia,
palpitations, dysrhythmias
Central and Peripheral Nervous System
Stupor, tremor, paraesthesia, hypoaesthesia, lethargy, seizures, anxiety, mental
impairment, agitation, cerebral edema, confusion, dizziness
Fluid and Electrolyte
Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis
Gastrointestinal
Dyspepsia, taste disturbances, abdominal pain, abdominal distention, sweating
increased, diarrhea, dry mouth, flatulence, gastro-intestinal disorder, nausea,
vomiting, pancreatitis, intestinal obstruction, ileus
Hepatic
Transient elevations of hepatic enzymes, increase in bilirubin, hepatitis,
hepatic failure, jaundice, hepatotoxicity, hepatic disorder
Hearing and Vestibular
Hearing loss, tinnitus
Hematologic
Thrombocytopenia
Hypersensitivity
Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria,
anaphylactoid reaction
Metabolic and Nutritional
Hypoglycemia, hyperglycemia, acidosis, alkalosis
Musculoskeletal
Myalgia, rhabdomyolysis
Ocular
Miosis, visual disturbances, red eye
Psychiatric
Drug dependence, drug abuse, insomnia, confusion, anxiety, agitation, depressed
level of consciousness, nervousness, hallucination, somnolence, depression,
suicide
Respiratory System
Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, aspiration, hypoventilation,
laryngeal edema
Skin and Appendages
Erythema, urticaria, rash, flushing
Urogenital
Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency
and failure, urinary retention
Drug Abuse and Dependence
PERCOCET tablets are a Schedule II controlled substance. Oxycodone is a mu-agonist
opioid with an abuse liability similar to morphine. Oxycodone, like morphine
and other opioids used in analgesia, can be abused and is subject to criminal
diversion.
Drug addiction is defined as an abnormal, compulsive use, use for non-medical
purposes of a substance despite physical, psychological, occupational or interpersonal
difficulties resulting from such use, and continued use despite harm or risk
of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary
approach, but relapse is common. Opioid addiction is relatively rare in patients
with chronic pain but may be more common in individuals who have a past history
of alcohol or substance abuse or dependence. Pseudoaddiction refers to pain
relief seeking behavior of patients whose pain is poorly managed. It is considered
an iatrogenic effect of ineffective pain management. The health care provider
must assess continuously the psychological and clinical condition of a pain
patient in order to distinguish addiction from pseudoaddiction and thus, be
able to treat the pain adequately.
Physical dependence on a prescribed medication does not signify addiction.
Physical dependence involves the occurrence of a withdrawal syndrome when there
is sudden reduction or cessation in drug use or if an opiate antagonist is administered.
Physical dependence can be detected after a few days of opioid therapy. However,
clinically significant physical dependence is only seen after several weeks
of relatively high dosage therapy. In this case, abrupt discontinuation of the
opioid may result in a withdrawal syndrome. If the discontinuation of opioids
is therapeutically indicated, gradual tapering of the drug over a 2-week period
will prevent withdrawal symptoms. The severity of the withdrawal syndrome depends
primarily on the daily dosage of the opioid, the duration of therapy and medical
status of the individual.
The withdrawal syndrome of oxycodone is similar to that of morphine. This syndrome
is characterized by yawning, anxiety, increased heart rate and blood pressure,
restlessness, nervousness, muscle aches, tremor, irritability, chills alternating
with hot flashes, salivation, anorexia, severe sneezing, lacrimation, rhinorrhea,
dilated pupils, diaphoresis, piloerection, nausea, vomiting, abdominal cramps,
diarrhea and insomnia, and pronounced weakness and depression.
“Drug-seeking” behavior is very common in addicts and drug abusers.
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 physician(s).
“Doctor Shopping” to obtain additional prescriptions is common among
drug abusers and people suffering from untreated infection.
Abuse and addiction are separate and distinct from physical dependence and
tolerance. Physicians 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 and
is characterized by misuse for non-medical purposes, often in combination with
other psychoactive substances. Oxycodone, like other opioids, has been diverted
for non-medical use. Careful record-keeping of prescribing information, including
quantity, frequency, and renewal requests 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.
Like other opioid medications, PERCOCET tablets are subject to the Federal
Controlled Substances Act. After chronic use, PERCOCET tablets should not be
discontinued abruptly when it is thought that the patient has become physically
dependent on oxycodone.
Interactions with Alcohol and Drugs of Abuse
Oxycodone may be expected to have additive effects when used in conjunction
with alcohol, other opioids, or illicit drugs that cause central nervous system
depression.