Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Quality Care Products LLC
OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Oxycodone and acetaminophen 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 ] , reserve Oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics ] - 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 and acetaminophen tablets are contraindicated in patients with: - Significant respiratory depression [see WARNINGS ] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] - Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] - Hypersensitivity to oxycodone, acetaminophen, or any other component of the product (e.g., anaphylaxis) [see WARNINGS , ADVERSE REACTIONS ] Controlled Substance Oxycodone and acetaminophen tablet contains oxycodone and acetaminophen, a Schedule CII controlled substance. Abuse Oxycodone and Acetaminophen Tablets contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. Oxycodone and Acetaminophen Tablets can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS ]. All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating health care provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Abuse and addiction are separate and distinct from physical dependence and tolerance. Health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction. Oxycodone and Acetaminophen Tablets, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs Risks Specific to Abuse of Oxycodone and Acetaminophen Tablets Oxycodone and Acetaminophen Tablets are for oral use only. Abuse of Oxycodone and Acetaminophen Tablets poses a risk of overdose and death. The risk is increased with concurrent abuse of Oxycodone and Acetaminophen Tablets with alcohol and other central nervous system depressants. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Dependence Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. Oxycodone and Acetaminophen Tablets should not be abruptly discontinued in a physically-dependent patient [see DOSAGE AND ADMINISTRATION ]. If Oxycodone and Acetaminophen Tablets is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see PRECAUTIONS ; Pregnancy].
Oxycodone and Acetaminophen Tablets, USP are supplied as follows: 2.5 mg/325 mg White to off-white, round tablets, debossed with “U14” on one side and plain on the other side. 5 mg/325 mg White to off-white, capsule-shaped tablets, debossed with “U15” on one side and break line on the other side. 55700-498-15 55700-498-20 55700-498-30 55700-498-40 55700-498-60 55700-498-90 55700-498-01 7.5 mg/325 mg White to off-white, oval-shaped tablets, debossed with “U16” on one side and plain on the other side. 55700-497-30 55700-497-60 55700-497-90 55700-497-01 10 mg/325 mg White to off-white, capsule-shaped tablets, debossed with “U17” on one side and plain on the other side. 55700-496-30 55700-496-60 55700-496-90 55700-496-01 Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Dispense with Medication Guide available at www.aurobindousa.com/product-medication-guides Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 Revised: 12/2016
Abbreviated New Drug Application
OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET Quality Care Products LLC ---------- SPL MEDGUIDE MEDICATION GUIDE Oxycodone and Acetaminophen Tablets, USP CII ok″se-ko´dōn and ass-eet-ah-MEE-noe-fen Oxycodone and acetaminophen tablets are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used for the management of relief of moderate to moderately severe pain, pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate or when 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 and acetaminophen tablets: • Get emergency help right away if you take too much oxycodone and acetaminophen tablets (overdose). When you first start taking oxycodone and acetaminophen 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. • Taking oxycodone and Acetaminophen 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 and acetaminophen tablets. They could die from taking it. Store oxycodone and acetaminophen tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away oxycodone and acetaminophen tablets is against the law. Do not take oxycodone and acetaminophen tablets if you have: • severe asthma, trouble breathing, or other lung problems. • a bowel blockage or have narrowing of the stomach or intestines. • known hypersensitivity to oxycodone, acetaminophen, or any ingredient in Oxycodone Hydrochloride and A Lesen Sie das vollständige Dokument
OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET QUALITY CARE PRODUCTS LLC ---------- OXYCODONE AND ACETAMINOPHEN TABLETS, USP CII BOXED WARNING WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION, HEPATOTOXICITY AND AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE, AND MISUSE OXYCODONE AND ACETAMINOPHEN TABLETS EXPOSES PATIENTS AND OTHER USERS TO THE RISKS OF OPIOID ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT’S RISK PRIOR TO PRESCRIBING OXYCODONE AND ACETAMINOPHEN TABLETS, AND MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS OR CONDITIONS[SEEWARNINGS]. LIFE-THREATENING RESPIRATORY DEPRESSION SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR WITH USE OF OXYCODONEAND ACETAMINOPHEN TABLETS. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF OXYCODONE AND ACETAMINOPHEN TABLETS OR FOLLOWING A DOSE INCREASE [SEEWARNINGS]. ACCIDENTAL INGESTION ACCIDENTAL INGESTION OF OXYCODONE AND ACETAMINOPHEN TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF OXYCODONE AND ACETAMINOPHEN TABLETS [SEEWARNINGS]. NEONATAL OPIOID WITHDRAWAL SYNDROME PROLONGED USE OF OXYCODONE AND ACETAMINOPHEN TABLETS DURING PREGNANCY CAN RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED, AND REQUIRES MANAGEMENT ACCORDING TO PROTOCOLS DEVELOPED BY NEONATOLOGY EXPERTS. IF OPIOID USE IS REQUIRED FOR A PROLONGED PERIOD IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE AVAILABLE [SEE WARNINGS]. CYTOCHROME P450 3A4 INTERACTION THE CONCOMITANT USE OF OXYCODONE TABLETS WITH ALL CYTOCHROME P450 3A4 INHIBITORS MAY RESULT IN AN INCREASE IN OXYCODONE PLASMA CONCENTRATIONS, WHICH COULD INCREASE OR PROLONG ADVERSE REACTIONS AND MAY CA Lesen Sie das vollständige Dokument