OXYCODONE AND ACETAMINOPHEN solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

KVK-Tech, Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Oxycodone Hydrochloride and Acetaminophen Oral Solution 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 hydrochloride and acetaminophen oral solution 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 hydrochloride and acetaminophen oral solution 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 hydrochloride and acetaminophen oral solution 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 ] Controlled Substance Oxycodone hydrochloride and acetaminophen oral solution contains oxycodone, a Schedule II controlled substance. Abuse Oxycodone hydrochloride and acetaminophen oral solution contains 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 hydrochloride and acetaminophen oral solution 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 hydrochloride and acetaminophen oral solution 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 hydrochloride and acetaminophen oral solution 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 hydrochloride and acetaminophen oral solution 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 hydrochloride and acetaminophen oral solution, 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 Hydrochloride and Acetaminophen Oral Solution Abuse of Oxycodone hydrochloride and acetaminophen oral solution poses a risk of overdose and death. The risk is increased with concurrent use of Oxycodone hydrochloride and acetaminophen oral solution 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. Dependence 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 hydrochloride and acetaminophen oral solution in a patient physically dependent on opioids. Rapid tapering of oxycodone hydrochloride and acetaminophen oral solution 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 hydrochloride and acetaminophen oral solution, gradually taper the dosage using a patient specific plan that considers the following: the dose of oxycodone hydrochloride and acetaminophen oral solution 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 samenvatting:

Oxycodone hydrochloride and acetaminophen oral solution is a clear red, berry-flavored solution containing oxycodone hydrochloride 5 mg (equivalent to 4.4815 mg oxycodone) and acetaminophen 325 mg per 5 mL. Bottles of 500 mL……………………………….NDC 10702-238-50 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store oxycodone hydrochloride and acetaminophen oral solution securely and dispose of properly [see Precautions, Information for Patients ]. Dispense in a tight, light-resistant container with a child-resistant closure. DEA Order Form Required. Manufactured by: KVK-Tech, Inc. 110 Terry Drive Newtown, PA 18940 Item ID #: 6352/10 Rev.: 03/2024 Manufacturer's code: 10702

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

KVK-Tech, Inc.
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MEDICATION GUIDE
Oxycodone Hydrochloride (ox" i koe' done hye" droe klor' ide) and
Acetaminophen (a seet" a min' oh
fen) Oral Solution, CII
Oxycodone hydrochloride and acetaminophen oral solution 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 oxycodone hydrochloride and acetaminophen
oral solution:
•
Get emergency help or call 911 right away if you take too much
oxycodone hydrochloride and
acetaminophen oral solution (overdose). When you first start taking
oxycodone hydrochloride and
acetaminophen oral solution, 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 hydrochloride and acetaminophen oral solution 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 hydrochloride and acetaminophen
oral solution. They
could die from taking it. Selling or giving away oxycodone
hydrochloride and acetaminophen oral
solution is against the law.
•
Store oxycodone hydrochloride and acetaminophen oral solution
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 hydrochloride and

Productkenmerken

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN SOLUTION
KVK-TECH, INC.
----------
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ORAL SOLUTION, CII
RX ONLY
REVISED MARCH 2024
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ORAL SOLUTION
RISK OF MEDICATION ERRORS
Ensure accuracy when prescribing, dispensing, and administering
oxycodone
hydrochloride and acetaminophen oral solution 5mg/325mg per 5mL.
Dosing
errors due to confusion between mg and mL, and other oxycodone
hydrochloride
and acetaminophen oral solution of different concentrations can result
in accidental
overdose and death _[see DOSAGE AND ADMINISTRATION, WARNINGS]._
ADDICTION‚ ABUSE‚ AND MISUSE
Because the use of Oxycodone hydrochloride and acetaminophen oral
solution
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
_S_erious, life-threatening, or fatal respiratory depression may occur
with use of
oxycodone hydrochloride and acetaminophen oral solution,especially
during
initiation or following a dosage increase. To reduce the risk of
respiratory
depression, proper dosing and titration of oxycodone hydrochloride and
acetaminophen oral solution are essential _[see WARNINGS]._
ACCIDENTAL INGESTION
Accidental ingestion of even one dose of oxycodone hydrochloride and
acetaminophen oral solution, 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
hydrochloride and acetaminophen oral solution an