HYDROCODONE /APAP tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Direct_Rx

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

Hydrocodone Bitartrate and Acetaminophen Tablets USP are available in the following strengths: Hydrocodone Bitartrate and Acetaminophen Tablet USP, 5 mg/325 mg is available as white to off-white, round tablets, debossed with “U01” on one side and break-line on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. Bottles of 30 Bottles of 100 Bottles of 500 Bottles of 1000 Hydrocodone Bitartrate and Acetaminophen Tablet USP, 7.5 mg/325 mg is available as white to off-white, capsule shaped tablets, debossed with “U02” on one side and break-line on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. Bottles of 30 Bottles of 100 Bottles of 500 Bottles of 1000 Hydrocodone Bitartrate and Acetaminophen Tablet USP, 10 mg/325 mg is available as white to off-white, oval shaped tablets, debossed with “U03” on one side and break-line on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. Bottles of 30 Bottles of 100 Bottles of 500 Bottles of 1000 Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store Hydrocodone Bitartrate and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Keep this and all medication out of the reach of children. A Schedule C-II controlled drug substance. Dispense with Medication Guide available at www.aurobindousa.com/product-medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised: 04/2019

授权状态:

Abbreviated New Drug Application

资料单张

HYDROCODONE /APAP- HYDROCODONE /APAP TABLET
Direct_Rx
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Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
HIGH-droe-KOE-dohn by-TAR-trate/ass-eet-ah-MEE-noe-fen
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 are 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 hydrocodone or acetaminophen ,or any
ingredient in hydrocod

产品特点

HYDROCODONE /APAP- HYDROCODONE /APAP TABLET
DIRECT_RX
----------
HYDROCODONE/APAP
Hydrocodone bitartrate and acetaminophen is supplied in tablet form
for oral
administration.
Hydrocodone bitartrate is an opioid analgesic and antitussive 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:
[chemical structure]
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:
[Chemical Structure]
Hydrocodone bitartrate and acetaminophen tablets USP, for oral
administration, are
available in a variety of strengths as described in the following
table.
Each hydrocodone bitartrate and acetaminophen tablet contains:
Strength
Hydrocodone Bitartrate
Acetaminophen
5 mg/325 mg
7.5 mg/325 mg
10 mg/325 mg
5 mg
7.5 mg
10 mg
325 mg
325 mg
325 mg
In addition each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, crospovidone, magnesium stearate,
microcrystalline cellulose,
povidone, pregelatinized starch and stearic acid.
Meets USP Dissolution Test 1.
Mechanism of Action
Hydrocodone is 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
effect