HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Par Pharmaceutical, Inc.

INN (nume internaţional):

HYDROCODONE BITARTRATE

Compoziție:

HYDROCODONE BITARTRATE 5 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 [see WARNINGS ] - Hypersensitivity to hydrocodone or acetaminop

Rezumat produs:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied as follows: Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/300 mg are supplied as white to off-white, capsule shaped tablets containing 5 mg hydrocodone bitartrate (WARNING: May be habit-forming ) and 300 mg acetaminophen. Tablets are debossed "BP" bisect "648" on one side and "5" on the other side, and are supplied in bottles of 100 tablets, NDC 64376-648-01 and 500 tablets, NDC 64376-648-05. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/300 mg are supplied as white to off-white, capsule shaped tablets containing 7.5 mg hydrocodone bitartrate (WARNING: May be habit-forming ) and 300 mg acetaminophen. Tablets are debossed "BP" bisect "649" on one side and "7.5" on the other side, and are supplied in bottles of 100 tablets, NDC 64376-649-01 and 500 tablets, NDC 64376-649-05. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/300 mg are supplied as white to off-white, capsule shaped tablets containing 10 mg hydrocodone bitartrate (WARNING: May be habit-forming ) and 300 mg acetaminophen. Tablets are debossed "BP" bisect "643" on one side and "10" on the other side, and are supplied in bottles of 100 tablets, NDC 64376-643-01 and 500 tablets, NDC 64376-643-05. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Store hydrocodone bitartrate and acetaminophen tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients ].

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

ACETAMINOPHEN TABLET
Par Pharmaceutical, Inc.
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Medication Guide
Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate)
and Acetaminophen (a seet” a min’ oh fen) Tablets CII
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 is 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 the stomach or intestines.
•
known hypersensitivity to hy

Caracteristicilor produsului

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
PAR PHARMACEUTICAL, INC.
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HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
5 MG/300 MG, 7.5 MG/300 MG, 10 MG/300 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
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS EXPOSE 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 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
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS. MONITOR FOR
RESPIRATORY DEPRESS