Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)
Teva Pharmaceuticals USA, Inc.
OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
OXYCODONE HCl EXTENDED-RELEASE TABLETS are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in: - Adults; and - Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. Limitations of Use - Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve OXYCODONE HCl EXTENDED-RELEASE TABLETS for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - OXYCODONE HCl EXTENDED-RELEASE TABLETS are not indicated as an as-needed (prn) ana
OXYCODONE HCl EXTENDED-RELEASE TABLETS 10 mg are film-coated, round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0093-5731-01 ). OXYCODONE HCl EXTENDED-RELEASE TABLETS 20 mg are film-coated, round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0093-5732-01 ). OXYCODONE HCl EXTENDED-RELEASE TABLETS 40 mg are film-coated, round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0093-5733-01 ). OXYCODONE HCl EXTENDED-RELEASE TABLETS 80 mg are film-coated, round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0093-5734-01 ). Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Store OXYCODONE HCl EXTENDED-RELEASE TABLETS securely and dispose of properly [see Patient Counseling Information (17)] . Dispense in tight, light-resistant container.
New Drug Application Authorized Generic
OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride tablet, film coated, extended release Teva Pharmaceuticals USA, Inc. ---------- MEDICATION GUIDE OXYCODONE (OX-ee-KOH-dohn) HCl EXTENDED-RELEASE TABLETS , CII OXYCODONE HCl EXTENDED-RELEASE TABLETS are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them. • A long-acting (extended-release) 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. • Not for use to treat pain that is not around-the-clock. • Not for use in children less than 11 years of age and who are not already using opioid pain medicines regularly to manage pain severe enough to require daily around-the-clock long-term treatment of pain with an opioid. Important information about OXYCODONE HCl EXTENDED-RELEASE TABLETS: • Get emergency help or call 911 right away if you take too much OXYCODONE HCl EXTENDED- RELEASE TABLETS (overdose). When you first start taking OXYCODONE HCl EXTENDED- RELEASE 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 HCl EXTENDED-RELEASE 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 HCl EXTENDED-RELEASE TABLETS. They could die from taking it. Selling or giving away OXYCODONE HCl EXTENDED-REL Lees het volledige document
OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE TEVA PHARMACEUTICALS USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OXYCODONE HCL EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXYCODONE HCL EXTENDED-RELEASE TABLETS. OXYCODONE HCL EXTENDED-RELEASE 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 HCL EXTENDED-RELEASE TABLETS EXPOSES 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. INSTRUCT PATIENTS TO SWALLOW OXYCODONE HCL EXTENDED-RELEASE TABLETS WHOLE TO AVOID EXPOSURE TO A POTENTIALLY FATAL DOSE OF OXYCODONE. (5.3) ACCIDENTAL INGESTION OF OXYCODONE HCL EXTENDED-RELEASE TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF OXYCODONE. (5.3) PROLONGED USE OF OXYCODONE HCL EXTENDED-RELEASE 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 APPROPRI Lees het volledige document