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:

Lupin Pharmaceuticals,Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxycodone and Acetaminophen Tablets is 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 is 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 contains oxycodone, a substance with a 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 product 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 and 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. 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 ].

Product summary:

Oxycodone and Acetaminophen Tablets, USP is supplied as follows: 2.5 mg/325 mg White, round, flat face tablet debossed with "n" and "490" on one side and plain on the other side. Bottles of 100 NDC 43386-490-01 Bottles of 500 NDC 43386-490-05 Bottles of 1000 NDC 43386-490-10 5 mg/325 mg White, round, flat face tablet debossed with "n" and "491" on one side and bisect on the other side. Bottles of 100 NDC 43386-491-01 Bottles of 500 NDC 43386-491-05 Bottles of 1000 NDC 43386-491-10 7.5 mg/325 mg White, round, flat face tablet debossed with "n" and "492" on one side and plain on the other side. Bottles of 100 NDC 43386-492-01 Bottles of 500 NDC 43386-492-05 Bottles of 1000 NDC 43386-492-10 10 mg/325 mg White, round, flat face tablet debossed with "n" and "493" on one side and plain on the other side. Bottles of 100 NDC 43386-493-01 Bottles of 500 NDC 43386-493-05 Bottles of 1000 NDC 43386-493-10 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. Store Oxycodone and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients ]. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 SAP Code: 275236 Rev. 12/2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OXYCODONE AND ACETAMINOPHEN - OXYCODONE AND ACETAMINOPHEN TABLET
Lupin Pharmaceuticals,Inc.
----------
MEDICATION GUIDE
Oxycodone (ox" i koe' done ) and Acetaminophen (a seet" a min' oh fen)
Tablets, CII
Oxycodone and Acetaminophen Tablets are:
•
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 Oxycodone and Acetaminophen Tablets:
•
Get emergency help or call 911 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. Talk to your healthcare
provider about naloxone, a
medicine for the emergency treatment of an opioid overdose.
•
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. Selling or giving away Oxycodone and Acetaminophen Tablets is
against the law.
•
Store Oxycodone and Acetaminophen 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 and Acetaminophen Tablets if you have:
•
Severe asthma, trouble breathing, or other lung problems.
•
A bowel blockage or have narrowin

Summary of Product characteristics

OXYCODONE AND ACETAMINOPHEN - OXYCODONE AND ACETAMINOPHEN TABLET
LUPIN PHARMACEUTICALS,INC.
----------
OXYCODONE AND ACETAMINOPHEN TABLETS, USP CII
RX ONLY
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 DOSE 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 AND ACETAMINOPHEN _[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
LIFETHREATENING IF NOT RECOGNIZED AND TREATED. ENSURE THAT MANAGEMENT
BY NEONATOLOGY EXPERTS WILL BE AVAILABLE AT DELIVERY _[SEE WARNINGS]._
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STR