LORCET- hydrocodone bitartrate and acetaminophen tablet LORCET PLUS- hydrocodone bitartrate and acetaminophen tablet LORCET

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Mayne Pharma Inc.

INN (الاسم الدولي):

HYDROCODONE BITARTRATE

تركيب:

HYDROCODONE BITARTRATE 5 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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): Hydrocodone Bitartrate and Acetaminophen Tablets are contraindicated in patients with: Hydrocodone Bitartrate and Acetaminophen Tablets contain hydrocodone, a Schedule II controlled substance. Hydrocodone Bitartrate and Acetaminophen Tablets contain hydrocodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS ]. All patients treated with op

ملخص المنتج:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied as: 5 mg/325 mg : White to off-white, capsule-shaped, biconvex, uncoated tablets debossed with ‘126’ on one side and scored on the other side. Each tablet contains 5 mg of hydrocodone bitartrate, USP and 325 mg of acetaminophen, USP. They are supplied as follows: 7.5 mg/325 mg: Yellow colored, oval-shaped, biconvex, uncoated tablets debossed with ‘170’ on one side and scored on the other side. Each tablet contains 7.5 mg of hydrocodone bitartrate, USP and 325 mg of acetaminophen, USP. They are supplied as follows: 10 mg/325 mg : White to off-white, oval-shaped, biconvex, uncoated tablets debossed with ‘176’ on one side and scored on the other side. Each tablet contains 10 mg of hydrocodone bitartrate, USP and 325 mg of acetaminophen, USP. They are supplied as follows: Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Store at 20° - 25°C (68° - 77°F). (See USP for Controlled Room Temperature). A Schedule CII Controlled Drug Substance. DEA ORDER FORM REQUIRED Distributed by : Mayne Pharma Manufactured by : Sun Pharmaceutical Industries, Inc. 5186939 Rev. 07/2018

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

LORCET PLUS- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
LORCET HD- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Mayne Pharma Inc.
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Medication Guide
LORCET®LORCET® PLUS LORCET® HD
Hydrocodone Bitartrate and Acetaminophen (HIGH-droe-KOE-dohn
by-TAR-trate/ass-eet-ah-MEE-noe-
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. Store Hydrocodone Bitartrate and Acetaminophen Tablets
away from children and
in a safe place to prevent stealing or abuse. Selling or giving away
Hydrocodone Bitartrate and
Acetaminophen Tablets is against the law.
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 th

خصائص المنتج

LORCET- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
LORCET PLUS- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
LORCET HD- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
MAYNE PHARMA INC.
----------
LORCET LORCET PLUS LORCET HD
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII
RX ONLY
®
®
®
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATIONSTRATEGY (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
•
•
•
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
ACETAMINOPHEN TABLETS OR
FOLLOWING A DOSE INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF HYDROCODONE BITARTRATE AND ACETAMINOPHEN
TABLETS, ESPECIALLY BY
CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF HYDROCODONE BITARTRATE AND
ACETAMINOPHEN
TABLETS