HYDROCODONE BITARTRATE AND IBUPROFEN tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Доступно од:

Aurolife Pharma, LLC

INN (Међународно име):

HYDROCODONE BITARTRATE

Састав:

HYDROCODONE BITARTRATE 7.5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Hydrocodone Bitartrate and Ibuprofen Tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Carefully consider the potential benefits and risks of Hydrocodone Bitartrate and Ibuprofen Tablets and other treatment options before deciding to use Hydrocodone Bitartrate and Ibuprofen Tablets Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation ). Do not use Hydrocodone Bitartrate and Ibuprofen Tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (seeWARNINGS: Addiction, Abuse, and Misuse ), reserve Hydrocodone Bitartrate and Ibuprofen Tablets for use in patients for whom alternative treatment opti

Резиме производа:

Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg are white to off-white, round, film coated tablets, debossed with “U13” on one side and plain on the other side. Bottles of 10                  NDC 13107-004-11 Bottles of 100                NDC 13107-004-01 Bottles of 500                NDC 13107-004-05 Bottles of 1,000             NDC 13107-004-99 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Keep this and all medication out of the reach of children. A Schedule II Controlled Drug Substance. Store Hydrocodone Bitartrate and Ibuprofen Tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients ].   Dispense with Medication Guide available at https://www.aurobindousa.com/medication-guides/ Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised: 03/2021

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

coated
Aurolife Pharma, LLC
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MEDICATION GUIDE
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS CII
Hydrocodone Bitartrate and ibuprofen Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
and a non-steroidal anti-
inflammatory drug (NSAID), that is used to manage short-term (acute)
pain, 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 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.
•
NSAIDs are used to treat pain, redness, swelling, and inflammation.
Important information about Hydrocodone Bitartrate And Ibuprofen
Tablets:
•
Get emergency help or call 911 right away if you take too much
Hydrocodone Bitartrate And
Ibuprofen Tablets (overdose). When you first start taking Hydrocodone
Bitartrate and Ibuprofen
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. Talk to your
healthcare provider about
naloxone, a medicine for the emergency treatment of an opioid
overdose.
•
Taking Hydrocodone Bitartrate and Ibuprofen 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 Ibuprofen
Tablets. They could die from
taking it. Selling or giving away Hydrocodone Bitartrate and Ibuprofen
Tablets are against the law.
•
Store Hydrocodone Bitartrate and Ibuprofen Tablets securely, out of
sight and reach of children,
and in a location not accessible by others, including visitors to the
home.
Hydrocodone Bitartrate And Ibuprofen Tablets contains an NSAID. NSAIDs
can cause serious side effects,
including:
•
Increased risk of a heart atta

Карактеристике производа

HYDROCODONE BITARTRATE AND IBUPROFEN - HYDROCODONE BITARTRATE AND
IBUPROFEN TABLET, FILM COATED
AUROLIFE PHARMA, LLC
----------
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS C-II
7.5 MG/200 MG
WARNING: ADDICTION, ABUSE, AND MISUSE:RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL
SYNDROME; CYTOCHROME P4503A4 INTERACTION; RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
ADDICTION, ABUSE, AND MISUSE
HYDROCODONE BITARTRATE AND IBUPROFEN 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 IBUPROFEN TABLETS, AND MONITOR
ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS AND
CONDITIONS (SEE WARNINGS: ADDICTION, ABUSE, AND MISUSE).
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 IBUPROFEN TABLETS. MONITOR FOR
RESPIRATORY