HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

可用日期:

NuCare Pharmaceuticals,Inc.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Hydrocodone bitartrate 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 hydrocodone bitartrate 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 Hydrocodone bitartrate 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 [se

產品總結:

Hydrocodone Bitartrate and Acetaminophen Tablet USP, 10 mg/325 mg is available as white to off-white, oval shaped tablets,debossed with U03 on one side and break-line on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. NDC 68071-4941-6 BOTTLES OF 6 Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store Hydrocodone Bitartrate and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients ]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Keep this and all medication out of the reach of children. A Schedule C-II controlled drug substance. Dispense with Medication Guide available at www.aurobindousa.com/product-medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised: 04/2019

授权状态:

Abbreviated New Drug Application

资料单张

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
HIGH-droe-KOE-dohn by-TAR-trate/ass-eet-ah-MEE-noe-fen
Hydrocodone Bitartrate 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 pain medicine, 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 Hydrocodone Bitartrate and Acetaminophen
Tablets:
•
Get emergency help right away if you take too much hydrocodone
bitartrate and acetaminophen
tablets (overdose). When you first start taking hydrocodone bitartrate
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 hydrocodone bitartrate 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 Hydrocodone Bitartrate and Acetaminophen
Tablets. They could die
from taking it. Selling or giving away Hydrocodone Bitartrate and
Acetaminophen Tablets are
against the law.
•
Store Hydrocodone Bitartrate 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 Hydrocodone Bitartrate and Acetaminophen Tablets if you
have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of

产品特点

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE
AND ACETAMINOPHEN TABLET
NUCARE PHARMACEUTICALS,INC.
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
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
HYDROCODONE BITARTRATE 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 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, AND
MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS
OR
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 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS. MONITOR FOR
RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF HYDROCODONE
BITARTRATE AND ACETAM