OXYCODONE AND ACETAMINOPHEN- oxycodone hydrochloride and acetaminophen tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Major Pharmaceuticals

INN (Tên quốc tế):

OXYCODONE HYDROCHLORIDE

Thành phần:

OXYCODONE HYDROCHLORIDE 5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Oxycodone Hydrochloride 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, even at recommended doses [see WARNINGS ], reserve Oxycodone Hydrochloride and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] Oxycodone Hydrochloride and Acetaminophen Tablets is contraindicated in patients with: Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, a Schedule II controlled substance. Oxycodone Hydrochloride 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 Hydrochloride and Acetaminophen Tablets can be abused and is subject to misuse, addiction, and criminal diversion [s

Tóm tắt sản phẩm:

Oxycodone Hydrochloride and Acetaminophen Tablets, USP, 5 mg/325 mg, supplied as a white round tablet, with one face, scored debossed 4839 and V, and the other plain, are available as follows: 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. DEA Order Form Required. Store Oxycodone Hydrochloride and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients ].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

Major Pharmaceuticals
----------
Medication Guide
Oxycodone Hydrochloride (ox" i koe' done hye" droe klor' ide) and
Acetaminophen (a seet" a min' oh
fen) Tablets, CII
Oxycodone Hydrochloride 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 Hydrochloride and Acetaminophen
Tablets:
•
Get emergency help right away if you take too much Oxycodone
Hydrochloride and
Acetaminophen Tablets (overdose). When you first start taking
Oxycodone Hydrochloride 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
Hydrochloride 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 Hydrochloride and Acetaminophen
Tablets. They could
die from taking it. Selling or giving away Oxycodone Hydrochloride and
Acetaminophen Tablets is
against the law.
•
Store Oxycodone Hydrochloride 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 Hydrochloride 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
•
kno

Đặc tính sản phẩm

OXYCODONE AND ACETAMINOPHEN- OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
TABLET
MAJOR PHARMACEUTICALS
----------
OXYCODONE AND ACETAMINOPHEN TABLETS, USP
5 MG/325 MG
CII
RX ONLY
Revised: AUGUST 2019
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 HYDROCHLORIDE 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
HYDROCHLORIDE 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
•
•
•
•
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF OXYCODONE
HYDROCHLORIDE AND ACETAMINOPHEN TABLETS. MONITOR FOR RESPIRATORY
DEPRESSION, ESPECIALLY
DURING INITIATION OF OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS
OR FOLLOWING A
DOSE INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
TABLETS, ESPECIALLY
BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF OXYCODONE HYDROCHLORIDE
AND ACETAMINOPHEN
TABLETS [SEE WARNINGS].
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF OXYCODONE HYDROCHLORIDE AND