OXYCODONE 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:

Direct_Rx

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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, 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 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., ana

Tóm tắt sản phẩm:

HOW SUPPLIED Oxycodone and Acetaminophen Tablets, USP: 2.5 mg/325 mg White to Off-white color capsule shaped tablets debossed with ‘T 191’ on one side and plain on other side. Bottles of 100 Bottles of 500 5 mg/325 mg White to off-white color round, biconvex tablets having break line on one side and debossed with ‘T 192’ on other side. Bottles of 100 Bottles of 500 7.5 mg/325 mg White to Off-white color capsule shaped tablets debossed with ‘T 193’ on one side and plain on other side. Bottles of 100 Bottles of 500 10 mg/325 mg White to off-white color capsule shaped tablets debossed with ‘T 194’ on one side plain and plain on other side. Bottles of 100 Bottles of 500 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. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Rev 02/19

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
Direct_Rx
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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 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
are 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 and
Acetaminophen Tablets
Before taking Oxycodone and Acetaminophen Tablets, tell your
healthcare pr

Đặc tính sản phẩm

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
DIRECT_RX
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OXYCODONE AND ACETAMINOPHEN
WARNING: ADDICTION, ABUSE, AND MISUSE; 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: RISK EVALUATION AND MITIGATION STRATEGY
(REMS)
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
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
complete a REMS-compliant education program,
counsel patients and/or their caregivers, with every prescription, on
safe use,
serious risks, storage, and disposal of these products,
emphasize to patients and their caregivers the importance of reading
the
Medication Guide every time it is provided by their pharmacist, and
consider other tools to improve patient, household, and community
safety.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of
Oxycodone and Acetaminophen Tablets. Monitor for respiratory
depression,
especially during initiation of Oxycodone and Acetaminophen Tablets or
following a
dose increase [see WARNINGS].
Accidental Ingestion
Accidental ingestion of Oxycodone and A