HYDROCODONE BITARTRATE AND IBUPROFEN tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

American Health Packaging

INN (Tarptautinis Pavadinimas):

HYDROCODONE BITARTRATE

Sudėtis:

HYDROCODONE BITARTRATE 7.5 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 (see WARNINGS: Addiction, Abuse, and Misuse ), reserve hydrocodone bitartrate and ibuprofen tablets for use in patients for whom a

Produkto santrauka:

Hydrocodone bitartrate and ibuprofen tablets, 7.5 mg/200 mg , are supplied as white, round, film-coated, biconvex tablets, debossed with “IP” over “145” on one side and plain on the other side. They are available as follows: Unit dose packages of 100 (10 x 10) NDC 68084-841-01 Storage Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Store hydrocodone bitartrate and ibuprofen tablets securely and dispose of properly (see PRECAUTIONS: Information for Patients ). DEA Order Form Required. Dispense with Medication Guide To order more Medication Guides call American Health Packaging at 1‐800‐707‐4621.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

American Health Packaging
----------
MEDICATION GUIDE
Dispense with Medication Guide
To order more Medication Guides call American Health Packaging at
1‐800‐707‐4621.
8284109/0822F
Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and
Ibuprofen (eye” bue proe’ fen) 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 is against the law.
•
Store hydrocodone bitartrate and ibuprofen tablets securely, out of
sight and reach of children, and
in a location not acc

Prekės savybės

HYDROCODONE BITARTRATE AND IBUPROFEN- HYDROCODONE BITARTRATE AND
IBUPROFEN TABLET
AMERICAN HEALTH PACKAGING
----------
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS (CII)
RX ONLY
8284109/0822F
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; RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
ADDICTION, ABUSE, AND MISUSE
HYDROCODONE BITARTRATE AND IBUPROFEN 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, 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.
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. MONITOR FOR RESPIRATORY
DEPRESSION, ESPECIALLY DURING INITIA