tended-Release Tablets
MedDRA Preferred Term
Oxymorphone Hydrochloride Extended-Release Tablets (N=1259)
Placebo (N=461)
Nausea
33%
13%
Constipation
28%
13%
Dizziness (Excl Vertigo)
18%
8%
Somnolence
17%
2%
Vomiting
16%
4%
Pruritus
15%
8%
Headache
12%
6%
Sweating increased
9%
9%
Dry mouth
6%
<1%
Sedation
6%
8%
Diarrhea
4%
6%
Insomnia
4%
2%
Fatigue
4%
1%
Appetite decreased
3%
<1%
Abdominal pain
3%
2%
The common (≥1% to <10%) adverse drug reactions reported at least once by patients treated with oxymorphone hydrochloride extended-release tablets in the clinical trials organized by MedDRA’s (Medical Dictionary for Regulatory Activities) System Organ Class and not represented in Table 1 were:
Eye disorders: vision blurred
ntestinal disorders: diarrhea, abdominal pain, dyspepsia
General disorders and administration site conditions: dry mouth, appetite decreased, fatigue, lethargy, weakness, pyrexia, dehydration, weight decreased, edema
Nervous system disorders: insomnia
Psychiatricdisorders: anxiety, confusion, disorientation, restlessness, nervousness, depression
Respiratory, thoracic and mediastinal disorders: dyspnea
Vascular disorders: flushing and hypertension
Other less common adverse reactions known with opioid treatment that were seen <1% in the oxymorphone hydrochloride extended-release tablets trials include the following: Bradycardia, palpitation, syncope, tachycardia, postural hypotension, miosis, abdominal distention, ileus, hot flashes, allergic reactions, hypersensitivity, urticaria, oxygen saturation decreased, central nervous system depression, depressed level of consciousness, agitation, dysphoria, euphoric mood, hallucination, mental status changes, difficult micturition, urinary retention, hypoxia, respiratory depression, respiratory distress, clamminess, dermatitis, hypotension.
6.2 Post-marketing Experience
The following adverse reactions have been identified during post approval use of OPANA ER. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nervous system disorder: amnesia, convulsion, memory impairment
7 DRUG INTERACTIONS
7.1 Alcohol
Concomitant use of alcohol with OPANA ER can result in an increase of oxymorphone plasma levels and potentially fatal overdose of oxymorphone. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products containing alcohol while on OPANA ER therapy [see Clinical Pharmacology (12.3)].
7.2 CNS Depressants
Concurrent use of OPANA ER and other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol can increase the risk of respiratory depression, hypotension, profound sedation, or coma. Monitor patients receiving CNS depressants and OPANA ER for signs of respiratory depression and hypotension. When such combined therapy is contemplated, reduce the initial dose of one or both agents.
7.3 Mixed Agonist/Antagonist Opioid Analgesics
Mixed agonist/antagonist analgesics (i.e., pentazocine |
