HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

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:

Direct Rx

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Hydrocodone bitartrate and acetaminophen tablets, USP 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, USP 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 Controlled Substance Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a Schedule II controlled substance. Abuse 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

ملخص المنتج:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied as 5 mg/325 mg containing 5 mg hydrocodone bitartrate and 325 mg acetaminophen. Off white/white capsule shaped tablet debossed ‘T 257’ on one side and plain on other side with bisect line. Bottles of 100 Tablets Bottles of 500 Tablets 10 mg/325 mg containing 10 mg hydrocodone bitartrate and 325 mg acetaminophen. Off white/white capsule shaped tablet debossed ‘T 259’ on one side and plain on other side with bisect line. Bottles of 100 Tablets Bottles of 500 Tablets 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]. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Revised: 05/21

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

ACETAMINOPHEN TABLET
Direct Rx
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View NDC Code(s)NEW!
NDC Code(s): 31722-996-01, 31722-996-05, 31722-997-01, 31722-997-05
Packager: Camber Pharmaceuticals, Inc.
Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: CII
Marketing Status: Abbreviated New Drug Application
DRUG LABEL INFORMATIONUpdated May 21, 2021
If you are a consumer or patient please visit this version.
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BOXED WARNING (WHAT IS THIS?)
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: RISK EVALUATION AND MITIGATION STRATEGY
(REMS)
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 pr

خصائص المنتج

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE
AND ACETAMINOPHEN TABLET
DIRECT RX
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HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Hydrocodone bitartrate and acetaminophen, USP is available in tablet
form for oral
administration.
Hydrocodone bitartrate is an opioid analgesic and occurs as fine,
white crystals or as a
crystalline powder. It is affected by light. The chemical name is
4,5α-epoxy-3-methoxy-
17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the
following structural
formula:
Hydrocodone Bitartrate- Struct
Acetaminophen, 4' -hydroxyacetanilide, a slightly bitter, white,
odorless, crystalline
powder, is a non-opiate, non-salicylate analgesic and antipyretic. It
has the following
structural formula:
Acetaminophen- Struct
Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains:
Strength Hydrocodone Bitartrate Acetaminophen
5 mg/325 mg 5 mg 325 mg
10 mg/325 mg 10 mg 325 mg
In addition, each tablet contains the following inactive ingredients:
microcrystalline
cellulose, corn starch, colloidal silicon dioxide, crospovidone,
pregelatinized starch,
povidone, and stearic acid.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP complies to USP
Dissolution
Test 1.
Mechanism of Action
Hydrocodone is a full opioid agonist with relative selectivity for the
mu-opioid (μ)
receptor, although it can interact with other opioid receptors at
higher doses. The
principal therapeutic action of hydrocodone is analgesia. Like all
full opioid agonists,
there is no ceiling effect for analgesia with hydrocodone. Clinically,
dosage is titrated to
provide adequate analgesia and may be limited by adverse reactions,
including
respiratory and CNS depression.
The precise mechanism of the analgesic action is unknown. However,
specific CNS
opioid receptors for endogenous compounds with opioid-like activity
have been identified
throughout the brain and spinal cord and are thought to play a role in
the analgesic
effects of this drug. The precise mechanism of the analgesic
properties of
acetami