Drug Information for OXYCONTIN (OXYCODONE HCl CONTROLLED-RELEASE) TABLETS CII10 mg 15 mg 20 mg 30 mg 40 mg 60 mg* 80 mg* 160 mg* (Purdue Pharma LP): ADVERSE REACTIONS

Ads
  • The safety of OxyContin® was evaluated in double-blind clinical trials involving 713 patients with moderate to severe pain of various etiologies. In open-label studies of cancer pain, 187 patients received OxyContin in total daily doses ranging from 20 mg to 640 mg per day. The average total daily dose was approximately 105 mg per day.

    Serious adverse reactions which may be associated with OxyContin Tablet therapy in clinical use are those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, and (to an even lesser degree) circulatory depression, hypotension, or shock (see OVERDOSAGE).

    The non-serious adverse events seen on initiation of therapy with OxyContin are typical opioid side effects. These events are dose-dependent, and their frequency depends upon the dose, 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 (>5%) include: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, sweating, and asthenia.

    In many cases the frequency of these events during initiation of therapy may be minimized by careful individualization of starting dosage, slow titration, and the avoidance of large swings in the plasma concentrations of the opioid. Many of these adverse events will cease or decrease in intensity as OxyContin therapy is continued and some degree of tolerance is developed.

    Clinical trials comparing OxyContin with immediate-release oxycodone and placebo revealed a similar adverse event profile between OxyContin and immediate-release oxycodone. The most common adverse events (>5%) reported by patients at least once during therapy were:

    TABLE 3
    OxyContin(n=227)Immediate-Release(n=225)Placebo(n=45)
    (%)(%)(%)
    Constipation(23)(26)(7)
    Nausea(23)(27)(11)
    Somnolence(23)(24)(4)
    Dizziness(13)(16)(9)
    Pruritus(13)(12)(2)
    Vomiting(12)(14)(7)
    Headache(7)(8)(7)
    Dry Mouth(6)(7)(2)
    Asthenia(6)(7)-
    Sweating(5)(6)(2)

    The following adverse experiences were reported in OxyContin®-treated patients with an incidence between 1% and 5%. In descending order of frequency they were anorexia, nervousness, insomnia, fever, confusion, diarrhea, abdominal pain, dyspepsia, rash, anxiety, euphoria, dyspnea, postural hypotension, chills, twitching, gastritis, abnormal dreams, thought abnormalities, and hiccups.

    The following adverse reactions occurred in less than 1% of patients involved in clinical trials or were reported in postmarketing experience.

    Blood and lymphatic system disorders: lymphadenopathy

    Cardiac disorders: palpitations (in the context of withdrawal)

    Ear and labyrinth disorders: tinnitus

    Endocrine disorders: syndrome of inappropriate antidiuretic hormone secretion (SIADH)

    Eye disorders: abnormal vision

    Gastrointestinal disorders: dysphagia, eructation, flatulence, gastrointestinal disorder, ileus, increased appetite, stomatitis

    General disorders and administration site conditions: chest pain, edema, facial edema, malaise, pain, peripheral edema, thirst, withdrawal syndrome (with and without seizures)

    Immune system disorders: anaphylactic or anaphylactoid reaction (symptoms of)

    Infections and infestations: pharyngitis

    Injury, poisoning and procedural complications: accidental injury

    Investigations: hyponatremia, increased hepatic enzymes, ST depression

    Metabolism and nutrition disorders: dehydration

    Musculoskeletal and connective tissue disorders: neck pain

    Nervous system disorders: abnormal gait, amnesia, hyperkinesia, hypertonia (muscular), hypesthesia, hypotonia, migraine, paresthesia, seizures, speech disorder, stupor, syncope, taste perversion, tremor, vertigo

    Psychiatric disorders: agitation, depersonalization, depression, emotional lability, hallucination

    Renal and urinary disorders: dysuria, hematuria, polyuria, urinary retention, urination impaired

    Reproductive system and breast disorders: amenorrhea,decreased libido, impotence

    Respiratory, thoracic and mediastinal disorders: cough increased, voice alteration

    Skin and subcutaneous tissue disorders: dry skin, exfoliative dermatitis, urticaria

    Vascular disorders: vasodilation

  • Drug Information Provided by National Library of Medicine (NLM).
Ads