Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)
NuCare Pharmaceuticals,Inc,
ORAL
PRESCRIPTION DRUG
Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.1)] , reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): - Have not been tolerated or are not expected to be tolerated, - Have not provided adequate analgesia or are not expected to provide adequate analgesia. Oxycodone hydrochloride tablets are contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions ( 5.3)]. - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [see Warnings and Precautio
Oxycodone hydrochloride tablets, USP are available as follows: 5 mg tablets: white, round, biconvex tablets debossed “ALG 263” on one side and score line on the other side. NDC 68071-2536-6 BOTTLES OF 6 Store at 25°C (77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Store oxycodone hydrochloride tablets securely and dispose of properly [see Patient Counseling Information ( 17)] .
Abbreviated New Drug Application
OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET NuCare Pharmaceuticals,Inc, ---------- MEDICATION GUIDE Oxycodone Hydrochloride (ox" i koe' done hye" droe klor' ide) Tablets USP, CII Oxycodone hydrochloride tablets are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Important information about oxycodone hydrochloride tablets: • Get emergency help or call 911 right away if you take too many oxycodone hydrochloride tablets (overdose). When you first start taking oxycodone hydrochloride tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. • Taking oxycodone hydrochloride tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. • Never give anyone else your oxycodone hydrochloride tablets. They could die from taking them. Selling or giving away oxycodone hydrochloride tablets is against the law. • Store oxycodone hydrochloride tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not take oxycodone hydrochloride tablets if you have: • severe asthma, trouble breathing, or other lung problems. • a bowel blockage or have narrowing of the stomach or intestines. • allergy to oxycodone. Before taking oxycodone hydrochloride tab Baca dokumen lengkapnya
OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET NUCARE PHARMACEUTICALS,INC, ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OXYCODONE HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXYCODONE HYDROCHLORIDE TABLETS. OXYCODONE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII INITIAL U.S. APPROVAL: 1950 WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ OXYCODONE HYDROCHLORIDE TABLETS EXPOSE USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE PRESCRIBING AND MONITOR REGULARLY FOR THESE BEHAVIORS AND CONDITIONS. ( 5.1) TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF ADDICTION, ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A RISK EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. ( 5.2) SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR. MONITOR CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. ( 5.3) ACCIDENTAL INGESTION OF OXYCODONE HYDROCHLORIDE TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF OXYCODONE. ( 5.3) PROLONGED USE OF OXYCODONE HYDROCHLORIDE TABLETS DURING PREGNANCY CAN RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE- THREATENING IF NOT RECOGNIZED AND TREATED. IF PROLONGED OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE AVAILABLE. ( 5.4) CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4 INDUCERS) CAN RESULT IN A FATAL OVERDOSE OF OXYCODONE FROM OXYCODONE HYDROCHLORIDE TABLETS. ( 5.5, Baca dokumen lengkapnya