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:

Quality Care Products LLC

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 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, 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].

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
Quality Care Products LLC
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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

Summary of Product characteristics

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
QUALITY CARE PRODUCTS LLC
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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