PROLATE- oxycodone and acetaminophen tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

זמין מ:

Forte Bio-Pharma LLC

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 ] Oxycodone and acetaminophen tablets contain oxycodone, a Schedule II controlled substance. Oxycodone and acetaminophen tablets contain 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. 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 is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting 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. Do not abruptly discontinue oxycodone and acetaminophen tablets in a patient physically dependent on opioids. Rapid tapering of oxycodone and acetaminophen tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. When discontinuing oxycodone and acetaminophen tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of oxycodone and acetaminophen tablets the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see DOSAGE AND ADMINISTRATION , WARNINGS ]. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see PRECAUTIONS; Pregnancy ].

leaflet_short:

PROLATE ® (Oxycodone and Acetaminophen Tablets, USP) is supplied as: 5 mg/300 mg Yellow, capsule-shaped, convex face tablets, debossed "A” score "P" on one side and “681” on the other side, in bottles of 30 tablets NDC 72245-681-03 and 100 tablets NDC 72245-681-10. 7.5 mg/300 mg Red, capsule-shaped, flat face, beveled edge tablets, debossed “AP” on one side and “682” on the other side, in bottles of 30 tablets NDC 72245-682-03 and 100 tablets NDC 72245-682-10. 10 mg/300 mg Orange, oval-shaped, convex face tablets, debossed “AP” on one side and “683” on the other side, in bottles of 30 tablets NDC 72245-683-03 and 100 tablets NDC 72245-683-10. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required). Store oxycodone and acetaminophen tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients/Caregivers ]. Distributed by: Forte Bio-Pharma LLC Las Vegas, NV 89113 Rev. 06/2021 Code 1143C00

מצב אישור:

Abbreviated New Drug Application

עלון מידע

PROLATE- OXYCODONE AND ACETAMINOPHEN TABLET
Forte Bio-Pharma LLC
----------
MEDICATION GUIDE
MEDICATION GUIDE
PROLATE ®
(Oxycodone and Acetaminophen Tablets), CII
PROLATE ® is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain,
severe enough to require an opioid analgesic and for which alternative
treatments are inadequate
and 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 PROLATE ®:
•
Get emergency help or call 911 right away if you take too much PROLATE
® (overdose). When
you first start taking, PROLATE ® 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 you healthcare provider about naloxone, a medicine for the
emergency treatment of an opioid
overdose.
•
Taking PROLATE ® 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 PROLATE ® . They could die from taking
it. Selling or giving away
PROLATE ® is against the law.
•
Store PROLATE ® securely, out of sight and reach of children, and in
a location not accessible
by others, including visitors to the home.
Do not take PROLATE ® 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 PROLATE ®
Before taking PROLATE ® , tell your healthcare provider if you have a
history of:
•
Head injury, seizures
•
Liver, kidney, thyroid problems
•

מאפייני מוצר

PROLATE- OXYCODONE AND ACETAMINOPHEN TABLET
FORTE BIO-PHARMA LLC
----------
PROLATE
(OXYCODONE AND ACETAMINOPHEN TABLETS, USP)
®
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; HEPATOTOXICITY;
AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER
CNS DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE
OXYCODONE AND ACETAMINOPHEN TABLETS EXPOSE 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 AND CONDITIONS [SEE
WARNINGS].
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS)
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 REMS FOR THESE PRODUCTS [SEE WARNINGS]. UNDER THE
REQUIREMENTS OF THE REMS, DRUG COMPANIES WITH APPROVED OPIOID
ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION PROGRAMS
AVAILABLE TO HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY
ENCOURAGED TO
COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM,
COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON
SAFE USE, SERIOUS RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS,
EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING
THE MEDICATION GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST,
AND
CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY
SAFETY.
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH
USE OF OXYCODONE AND ACETAMINOPHEN TABLETS. MONITOR FOR RESPIRATORY
DEPRESSION, ESPECIALLY DURING INITIATION OF OXYCODONE AND
ACETAMINOPHEN
TABLETS OR FOLLOWING A DOSE INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF