HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Sun Pharmaceutical Industries, Inc.

INN (Международно Name):

ACETAMINOPHEN

Композиция:

ACETAMINOPHEN 325 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the management of moderate to moderately severe 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, USP for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): Hydrocodone Bitartrate and Acetaminophen Tablets, USP are contraindicated in patients with:

Каталог на резюме:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg are available as white to off-white round, uncoated tablets, debossed with “RX” above the bisect and “497” below the bisect on one side and plain on the other side. They are supplied as: Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA

Статус Оторизация:

Abbreviated New Drug Application

Листовка

ACETAMINOPHEN TABLET
Sun Pharmaceutical Industries, 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, USP 10 mg/325 mg, CII
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 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, USP:
•
Get emergency help right away if you take too much Hydrocodone
Bitartrate and Acetaminophen
Tablets, USP (overdose). When you first start taking Hydrocodone
Bitartrate and Acetaminophen
Tablets, USP, 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, USP 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, USP. They
could die from taking it. Store Hydrocodone Bitartrate and
Acetaminophen Tablets, USP away
from children and in a safe place to prevent stealing or abuse.
Selling or giving away Hydrocodone
Bitartrate and Acetaminophen Tablets, USP is against the law.
Do not take Hydrocodone Bitartrate and Acetaminophen Tablets, USP if
you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
•
known hyp

Данни за продукта

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII
RX ONLY
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL
SYNDROME; AND 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, USP, 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, USP, 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
•
•
•
•
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP. MONITOR FOR
RESPIRATORY
DEPRESSION, ESPECIALLY DURING INITIATION OF HYDROCODONE BITARTRATE AND
ACETAMINOPHEN
TABLETS, USP OR FOLLOWING A DOSE INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF HYDROCODONE BITARTRATE AND ACETAMINOPHEN
TABLETS, USP,
ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF HYDROCODONE
BITARTRATE AND
ACETAMINOPHEN TABLETS, USP [SEE WARNINGS].
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED