Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
oxycodone hydrochloride (UNII: C1ENJ2TE6C) (oxycodone - UNII:CD35PMG570)
Ethex Corporation
oxycodone hydrochloride
oxycodone hydrochloride 10 mg
ORAL
PRESCRIPTION DRUG
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 n
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: 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: 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: 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: Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Dispense in tight, light-resistant container.
New Drug Application Authorized Generic
OXYCODONE HYDROCHLORIDE CONTROLLED-RELEASE - OXYCODONE HYDROCHLORIDE TABLET, EXTENDED RELEASE ETHEX CORPORATION ---------- OXYCODONE HCL CONTROLLED-RELEASE TABLETS 10 MG, 20 MG, 40 MG, 80 MG* CII *80 mg and 160 mg is for use in opioid-tolerant patients only WARNING: OXYCODONE HCL CONTROLLED-RELEASE TABLETS ARE AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE. Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Oxycodone HCl Controlled-Release Tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. 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. OXYCODONE HCL CONTROLLED-RELEASE 80 MG AND 160 MG TABLETS, OR A SINGLE DOSE GREATER THAN 40 MG, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A SINGLE DOSE GREATER THAN 40 MG, OR TOTAL DAILY DOSES GREATER THAN 80 MG, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. OXYCODONE HCL CONTROLLED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCODONE HCL CONTROLLED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE. DESCRIPTION Oxycodone HCl Controlled-Release Tablets are an opioid analgesic supplied in 10 mg, 20 mg, 40 mg, and 80 mg tablet strengths for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows: The chemical formula is 4, 5α-epoxy-14-hydrox Lire le document complet