Oxymorphone HCl (Opana) for the Relief: PAIN MANAGEMENT

Posted by James

Available options for the treatment of moderate-to-severe pain include non-opioid and opioid analgesics. Non-opioid analgesics approved for moderate-to-severe pain are ketorolac (Toradol, Roche) and indomethacin (Indometha-cin ER, Sandoz). They work by preventing the formation of prostaglandins produced in response to noxious stimuli, thereby decreasing the number of pain impulses received by the central nervous system (CNS).

Opioids are the most potent analgesics available and are well established for the treatment of acute and chronic pain. Opioid analgesics consist of (1) opiate agonists, (2) opiate antagonists, and (3) mixed agonists/antagonists.
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Opiate agonists are the most common types. They bind to the opioid receptors in the CNS, leading to analgesia.

Examples include hydrocodone (Lortab, UCB Pharma); oxycodone (OxyContin, Purdue); codeine compounds; hydro-morphone (Dilaudid, Abbott); metha-done; morphine (DepoDur, Endo); levor-phanol; meperidine (Demerol, Sanofi-Synthelabo); tramadol (Ultram, PriCara/ Ortho McNeil); fentanyl (Duragesic, PriCara/Ortho-McNeil); and oxymor-phone (Opana, Endo).

Examples of opioid antagonists include naloxone (e.g., Suboxone, Reckitt Benc-kiser; Talwin NX, Sanofi-Synthelabo) and generic naltrexone (Vivitrol, Alkermes/Ceph-alon; ReVia drug, DuPont/Merck).

Mixed agonists/antagonists include nalbuphine (Nubain, Endo); butorphanol (Stadol, Apothecon); pentazocine (Tal-win, Talacen, Sanofi-Synthelabo); and buprenorphine (Suboxone, Subutex, Reckitt Benckiser).

Pure opioid antagonists act by binding competitively to opioid receptors without producing an analgesic or opioid response. They are therefore used most often to reverse the toxic effects of agonist and agonist-antagonist opioids.

Agonist-antagonists stimulate the analgesic portion of the opioid receptors and at the same time minimize the effect on the toxicity portion. They produce analgesia and have a ceiling effect on respiratory depression.

OXYMORPHONE HCl

Oxymorphone HCl immediate-release (IR) tablets (Opana IR, Endo) and extended-release oxymorphone tablets (Opana ER) were approved by the U.S. Food and Drug Administration (FDA) on June 22, 2006 for the relief of moderate-to-severe pain.

Opana ER is indicated for the relief of moderate-to-severe pain in patients requiring continuous opioid treatment for an extended period of time, but it is not intended to be used on an as-needed basis. Opana ER tablets come in 5-mg, 10-mg, 20-mg, and 40-mg strengths.

Opana IR tablets are indicated for the relief of moderate-to-severe acute pain when the use of an opioid is appropriate. They are available in 5-mg and 10-mg strengths.

The Opana products are the only available oral formulations of oxymorphone, which previously was available only in an injectable form (Numorphan, Endo).

Current data indicate that oral oxy­morphone does not inhibit or induce the cytochrome P450 (CYP 450) metabolic pathways, and it is not significantly metabolized by CYP 450 enzymes.