ROXICODONE (oxycodone hydrochloride) ® tablets have been evaluated in open label clinical trials in
patients with cancer and nonmalignant pain. ROXICODONE (oxycodone hydrochloride) ® tablets are associated
with adverse experiences similar to those seen with other opioids.
Serious adverse reactions that may be associated with ROXICODONE (oxycodone hydrochloride) ® therapy
in clinical use are those observed with other opioid analgesics and include:
respiratory depression, respiratory arrest, circulatory depression, cardiac
arrest, hypotension, and/or shock (see OVERDOSE, WARNINGS).
The less severe adverse events seen on initiation of therapy with ROXICODONE (oxycodone hydrochloride) ®
are also typical opioid side effects. These events are dose dependent, and their
frequency depends on the clinical setting, the patient's level of opioid tolerance,
and host factors specific to the individual. They should be expected and managed
as a part of opioid analgesia. The most frequent of these include nausea, constipation,
vomiting, headache, and pruritus.
In many cases the frequency of adverse events during initiation of opioid therapy
may be minimized by careful individualization of starting dosage, slow titration
and the avoidance of large rapid swings in plasma concentration of the opioid.
Many of these adverse events will abate as therapy is continued and some degree
of tolerance is developed, but others may be expected to remain throughout therapy.
In all patients for whom dosing information was available (n=191) from the
open-label and double-blind studies involving ROXICODONE (oxycodone hydrochloride) ®, the following
adverse events were recorded in ROXICODONE (oxycodone hydrochloride) ® treated patients with an incidence
≥ 3%. In descending order of frequency they were: nausea, constipation, vomiting,
headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
The following adverse experiences occurred in less than 3% of patients involved
in clinical trials with oxycodone:
Body as a Whole: abdominal pain, accidental injury, allergic reaction,
back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain,
photosensitivity reaction, and sepsis.
Cardiovascular: deep thrombophlebitis, heart failure, hemorrhage, hypotension,
migraine, palpitation, and tachycardia.
Digestive: anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis,
and nausea and vomiting.
Hemic and Lymphatic: anemia and leukopenia.
Metabolic and Nutritional: edema, gout, hyperglycemia, iron deficiency
anemia and peripheral edema.
Musculoskeletal: arthralgia, arthritis, bone pain, myalgia and pathological
Nervous: agitation, anxiety, confusion, dry mouth, hypertonia, hypesthesia,
nervousness, neuralgia, personality disorder, tremor, and vasodilation.
Respiratory: bronchitis, cough increased, dyspnea, epistaxis, laryngismus,
lung disorder, pharyngitis, rhinitis, and sinusitis.
Skin and Appendages: herpes simplex, rash, sweating, and urticaria.
Special Senses: amblyopia.
Urogenital: urinary tract infection
Drug Abuse And Dependence
Controlled Substance Roxicodone (oxycodone hydrochloride) contains oxycodone, a mu-agonist opioid of
the morphine type and is a Schedule II controlled substance. Roxicodone (oxycodone hydrochloride) , like
other opioids used in analgesia, can be abused and is subject to criminal diversion.
Drug addiction is characterized by compulsive use, use for non-medical purposes,
and continued use despite harm or risk of harm. Drug addiction is a treatable
disease, utilizing a multi-disciplinary approach, but relapse is common.
“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 addiction.
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 addition, abuse
of opioids can occur in the absence of true addiction and is characterized by
misuse for nonmedical purposes, often in combination with other psychoactive
substances. Careful record-keeping of prescribing information, including quantity,
frequency, and renewal requests is strongly advised.
Roxicodone (oxycodone hydrochloride) is intended for oral use only. Abuse of Roxicodone (oxycodone hydrochloride) poses a risk
of overdose and death. The risk is increased with concurrent abuse of alcohol
and other substances. Parenteral drug abuse is commonly associated with transmission
of infectious diseases such as hepatitis and HIV.
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.
Infants born to mothers physically dependent on opioids will also be physically
dependent and may exhibit respiratory difficulties and withdrawal symptoms.
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). Physical dependence is manifested by withdrawal symptoms after abrupt
discontinuation of a drug or upon administration of an antagonist. Physical
dependence and tolerance are not unusual during chronic opioid therapy.
The opioid abstinence or withdrawal syndrome is characterized by some or all
of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration,
chills, myalgia, and mydriasis. Other 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. In general, opioids should not be abruptly discontinued.