OXYCODONE AND ACETAMINOPHEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, which can occur at any dosage or duration [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 should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. 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 high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see WARNINGS ]. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of Oxycodone and Acetaminophen Tablets increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. The risk is increased with concurrent abuse of Oxycodone and Acetaminophen Tablets with alcohol and other CNS depressants. Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction. All patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Patients at high risk of Oxycodone and Acetaminophen Tablets abuse include those with a history of prolonged use of any opioid, including products containing oxycodone, those with a history of drug or alcohol abuse, or those who use Oxycodone and Acetaminophen Tablets in combination with other abused drugs. “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 healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. Oxycodone and Acetaminophen Tablets, like other opioids, can be diverted for nonmedical 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 reevaluation 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 Abuse of Oxycodone and Acetaminophen Tablets poses a risk of overdose and death. The risk is increased with concurrent use of Oxycodone and Acetaminophen Tablets with alcohol and/or other CNS 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 use of opioid therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), 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 use. 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 an extended period of time 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, and WARNINGS ]. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Pregnancy ].

Product summary:

Oxycodone and Acetaminophen Tablets, USP, 7.5 mg/325 mg are supplied as white to off-white, capsule-shaped, biconvex tablets, debossed “IP207” on obverse and plain on reverse. They are available as follows: Bottles of 30:                           NDC 65162-207-03 Bottles of 100:                         NDC 65162-207-10 Bottles of 500:                         NDC 65162-207-50 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. Store Oxycodone and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients /Caregivers ]. Manufactured by: Amneal Pharmaceuticals of NY, LLC Brookhaven, NY 11719 Rev. 03-2024-14 Dispense with Medication Guide available at: documents.amneal.com/mg/oxy-apap.pdf

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
AMNEAL PHARMACEUTICALS LLC
----------
OXYCODONE AND ACETAMINOPHEN TABLETS, USP CII
(7.5 MG / 325 MG)
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF
OXYCODONE AND ACETAMINOPHEN TABLETS
ADDICTION, ABUSE, AND MISUSE
BECAUSE THE USE OF 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 AND REASSESS ALL PATIENTS REGULARLY FOR THE
DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS [SEE WARNINGS].
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH
USE OF OXYCODONE AND ACETAMINOPHEN TABLETS, ESPECIALLY DURING
INITIATION OR FOLLOWING A DOSAGE INCREASE. TO REDUCE THE RISK OF
RESPIRATORY DEPRESSION, PROPER DOSING AND TITRATION OF OXYCODONE AND
ACETAMINOPHEN TABLETS ARE ESSENTIAL [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF EVEN ONE DOSE OF OXYCODONE AND ACETAMINOPHEN
TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF
OXYCODONE [SEE WARNINGS].
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING OF OXYCODONE AND ACETAMINOPHEN TABLETS AND
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS FOR USE IN PATIENTS FOR WHOM
ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE [SEE WARNINGS;
PRECAUTIONS; DRUG INTERACTIONS].
NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS)
IF OPIOID USE IS REQUIRED FOR AN EXTENDED PERIOD OF TIME IN A PREGNANT
WOMAN, ADVISE THE PATIENT OF THE RISK OF NOWS, WHICH MAY BE LIFE-
THREATENING IF NOT RECOGNIZED AND TREATED. ENSURE THAT MANAGEMENT BY
NEONATOLOGY EXPERTS WILL BE AVAILABLE AT DELIVERY [SEE WARNINGS].
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS)