Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)
STAT Rx USA LLC
OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE 20 mg
ORAL
PRESCRIPTION DRUG
OxyContin is a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Limitations of Usage OxyContin is not intended for use on an as-needed basis. OxyContin is not indicated for the management of 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. OxyContin is indicated for postoperative use following the immediate post-operative period only 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). OxyContin is not indicated for pre-emptive analgesia (preoperative administration for the m
OxyContin (oxycodone hydrochloride controlled-release) Tablets 20 mg are round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other and are supplied in: Bottles of 30 NDC 42549-645-30 Dispense in tight, light-resistant container. Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA 30501
New Drug Application
OXYCONTIN - OXYCODONE HYDROCHLORIDE TABLET STAT Rx USA LLC ---------- MEDICATION GUIDE OXYCONTIN® (ox-e-KON-tin) CII (oxycodone hydrochloride controlled-release) Tablets Read this Medication Guide before you start taking OxyContin and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about OxyContin? • OxyContin can cause serious side effects, including addiction or death. • Do not cut, break, chew, crush, or dissolve OxyContin before swallowing. If OxyContin is taken in this way, the medicine in the tablets will be released too fast. This is dangerous. It may cause you to stop breathing, and may lead to death. • OxyContin is not for use to treat pain that you only have once in a while ("as needed"). • Do not take OxyContin 60 mg or 80 mg tablets unless you are "opioid tolerant." Opioid tolerant means that you regularly use OxyContin or another opioid medicine for your constant (around-the- clock) pain and your body is used to it. • Do not take more than 40 mg of OxyContin in one dose or more than 80 mg of OxyContin in one day unless you are "opioid tolerant." This may cause you to stop breathing and may lead to death. • OxyContin is a federally controlled substance (CII) because it is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs. • Prevent theft, misuse and abuse. Keep OxyContin in a safe place, to keep it from being stolen. OxyContin can be a target for people who misuse or abuse prescription medicines or street drugs. • Never give OxyContin to anyone else, even if they have the same symptoms you have. It may harm them and even cause death. • Before taking OxyContin, tell your doctor if you or a family member have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental illness. • Do not dri Soma hati kamili
OXYCONTIN - OXYCODONE HYDROCHLORIDE TABLET STAT RX USA LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OXYCONTIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXYCONTIN. OXYCO NTIN (OXYCODONE HYDROCHLORIDE CONTROLLED-RELEASE) TABLETS CII INITIAL U.S. APPROVAL: 1950 WARNING: IMPORTANCE OF PROPER PATIENT SELECTION AND POTENTIAL FOR ABUSE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_. OXYCONTIN CONTAINS OXYCODONE WHICH IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE. (9) OXYCONTIN IS INDICATED FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN WHEN A CONTINUOUS, AROUND- THE-CLOCK OPIOID ANALGESIC IS NEEDED FOR AN EXTENDED PERIOD OF TIME. (1) OXYCONTIN IS NOT INTENDED FOR USE ON AN AS-NEEDED BASIS. (1) OXYCONTIN 60 MG AND 80 MG TABLETS, A SINGLE DOSE GREATER THAN 40 MG, OR A TOTAL DAILY DOSE GREATER THAN 80 MG ARE ONLY FOR USE IN OPIOID-TOLERANT PATIENTS TO AVOID FATAL RESPIRATORY DEPRESSION. (2.7) PATIENTS SHOULD BE ASSESSED FOR THEIR CLINICAL RISKS FOR OPIOID ABUSE OR ADDICTION PRIOR TO BEING PRESCRIBED OPIOIDS. (2.2) OXYCONTIN TABLETS MUST BE SWALLOWED WHOLE AND MUST NOT BE CUT, BROKEN, CHEWED, CRUSHED, OR DISSOLVED WHICH CAN LEAD TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE. (2.1) THE CONCOMITANT USE WITH CYTOCHROME P450 3A4 INHIBITORS SUCH AS MACROLIDE ANTIBIOTICS AND PROTEASE INHIBITORS MAY RESULT IN AN INCREASE IN OXYCODONE PLASMA CONCENTRATIONS AND MAY CAUSE POTENTIALLY FATAL RESPIRATORY DEPRESSION. (7.2) RECENT MAJOR CHANGES Dosage and Administration (2.1) 11/2010 Warnings and Precautions (5.6) 10/2011 INDICATIONS AND USAGE OxyContin is an opioid agonist indicated for: Management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. (1) Not for use on an as-needed basis or in the immediate post-operative period. (1) DOSAGE AND ADMINISTRATION Use low initial doses Soma hati kamili