12 HR Oxycodone Hydrochloride 80 MG Extended Release Oral Tablet
INDICATIONS AND USAGE Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic. Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for Health Care Policy and Research), the Federation of State Medical Boards Model Guidelines, or the American Pain Society. Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. Oxycodone HCl Controlled-Release Tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)
Ethex Corporation
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HOW SUPPLIED Oxycodone HCl Controlled-Release Tablets 10 mg are round, unscored, white-colored, convex tablets imprinted with OC on one side and 10 on the other. They are supplied as follows: NDC 58177-677-04: child-resistant closure, opaque plastic bottles of 100 Oxycodone HCl Controlled-Release Tablets 20 mg are round, unscored, pink-colored, convex tablets imprinted with OC on one side and 20 on the other. They are supplied as follows: NDC 58177-679-04: child-resistant closure, opaque plastic bottles of 100 Oxycodone HCl Controlled-Release Tablets 40 mg are round, unscored, yellow-colored, convex tablets imprinted with OC on one side and 40 on the other. They are supplied as follows: NDC 58177-681-04: child-resistant closure, opaque plastic bottles of 100 Oxycodone HCl Controlled-Release Tablets 80 mg are round, unscored, green-colored, convex tablets imprinted with OC on one side and 80 on the other. They are supplied as follows: NDC 58177-683-04: child-resistant closure, opaque plastic bottles of 100 Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Dispense in tight, light-resistant container.
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