Oxymorphone Hydrochloride

Oxymorphone Hydrochloride is used for: Moderate to severe pain, Maintain anesthesia

Preoperative Anesthesia/Analgesia Also effective for relief of anxiety in patients with dyspnea associated with pulmonary edema secondary to acute left ventricular dysfunction 1-1.5 mg IM/SC q4-6hr PRN Analgesia during labor: 0.5-1 mg IM IV: 0.5 mg, increased PRN Moderate-to-Severe Pain Acute pain Immediate-release tablets indicated for acute moderate-to-severe pain where opioid use is appropriate Opioid-naive patients (immediate-release): 10-20 mg PO q4-6 hr PRN initially, then titrated as warranted (may start with 5-mg increments) Conversion from IV oxymorphone to PO: The absolute bioavailability of PO is ~10%, therefore conversion from 1 mg IV q4-6hr is equipotent to 10 mg PO q4-6hr Elderly patients or those with renal or hepatic impairment: 5 mg PO q4-6hr initially Hepatic impairment: Mild: Give the lowest dose w/ careful titration to pain control. Moderate to severe: Contraindicated.

Not recommended

Renal impairment: Mild to moderate: Give the lowest dose w/ careful titration to pain control. Severe: Contraindicated.

Significant respiratory depression Acute or severe bronchial asthma or hypercarbia Known or suspected paralytic ileus Moderate and severe hepatic impairment Hypersensitivity (e.g. anaphylaxis) to oxymorphone

Do not stop abruptly; taper gradually to stop treatment. Use caution in patients with acute pancreatitis, Addison disease, benign prostatic hyperplasia, cardiac arrhythmias, central nervous system (CNS) depression, drug abuse or dependence, emotional lability, gallbladder disease, gastrointestinal (GI) disorder, pseudomembranous colitis, GI surgery, head injury, hypothyroidism or untreated myxedema, intracranial hypertension, brain tumor, toxic psychosis, urethral stricture, urinary tract surgery, seizures, acute alcoholism, delirium tremens, shock, cor pulmonale, chronic pulmonary disease, emphysema, kyphoscoliosis, severe obesity, renal or hepatic impairment, elderly or debilitated patients. Avoid alcohol. Reduce dosage if drug is coadministered with other CNS depressants. Thrombocytopenia purpura resulting in kidney failure or death has been reported when extended-release tablets are dissolved and injected IV. May obscure diagnosis of abdominal conditions. Addiction, abuse, and misuse Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death Assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions Life-threatening respiratory depression Serious, life-threatening, or fatal respiratory depression may occur Monitor for respiratory depression, especially during initiation or following a dose increase Lactation: Unknown whether drug is excreted in breast milk; use caution

Pregnancy Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome; there are no available data in pregnant women to inform a drug associated risk for major birth defects and miscarriage; published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth; the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of drug by newborn; observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly Observe newborns for symptoms of neonatal opioid withdrawal syndrome (eg, poor feeding, diarrhea, irritability, tremor, rigidity, and seizures), and manage accordingly Labor or delivery Opioids cross placenta and may produce respiratory depression and psycho-physiologic effects in neonates; an opioid antagonist, such as naloxone, must be available for reversal of opioid induced respiratory depression in neonate; drug is not recommended for use in women during and immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate; opioid analgesics can prolong labor through actions that temporarily reduce strength, duration, and frequency of uterine contractions; however, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor; monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression Infertility Due to effects of androgen deficiency, chronic use of opioids may cause reduced fertility in females and males of reproductive potential; it is not known whether effects on fertility are reversible Lactation Unknown if excreted in breast milk; many drugs, including some opioids, are excreted in human milk If opioid must be used; monitor infant closely for excess sedation and respiratory depression; withdrawal symptoms can occur when breastfeeding or maternal opioid is stopped

Side effects of Oxymorphone Hydrochloride : >10% Dizziness (7-18%), Headache (7-12%), Fever (1-14%), Somnolence (9-19%), Pruritus (8-15%), Nausea (19-33%), Vomiting (9-16%), Constipation (4-28%), Agitation, Angina pectoris, Anticholinergic effects (dry mouth, palpitation, tachycardia), Bradycardia, Cardiac arrest, Coma, Constipation 1-10% Hypotension (<10%), Flushing (<10%), Hypertension (<10%), Edema (<10%), Sedation (1-10%), Nervousness (<10%), Insomnia (<4%), Confusion (3%), Depression (<10%), Disorientation (<10%), Lethargy (<10%), Dehydration (<10%), Flatulence (1-10%), Dyspepsia (<10%), Diarrhea (<4%), Decreased appetite (<3%), Hypoxia (<10%), Dyspnea (<10%), Diaphoresis (1-10%) <1% Agitation, Dermatitis, Bronchospasm, Miosis, Oliguria, Bradycardia, Apnea, Micturition difficulty, Palpitation, Euphoric mood, Urethral spasm, Urinary retention, Physical and psychological dependence, Hot flashes

Opioid agonist; inhibits ascending pain pathways, thus altering response to pain; produces analgesia, respiratory depression, and sedation .