HYDROCODONE BITARTRATE AND ACETAMINOPHEN 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:

Proficient Rx LP

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Hydrocodone bitartrate and acetaminophen tablets USP are, indicated for the relief of moderate to moderately severe pain. This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a Schedule II controlled substance. Hydrocodone bitartrate and acetaminophen tablets, and other opioids used in analgesia can be abused and are subject to criminal diversion. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary appro

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 12               NDC 63187-375-12          Bottles of 15               NDC 63187-375-15          Bottles of 20               NDC 63187-375-20          Bottles of 30               NDC 63187-375-30          Bottles of 600             NDC 63187-375-60 Storage: 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. Keep this and all medication out of the reach of children. A Schedule C-II controlled drug substance. Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810  Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810  Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320  Revised: 09/2014

授权状态:

Abbreviated New Drug Application

产品特点

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE
AND ACETAMINOPHEN TABLET
PROFICIENT RX LP
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
WARNING
HEPATOTOXICITY
ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE,
AT
TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF
LIVER
INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT DOSES THAT
EXCEED 4,000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE
ACETAMINOPHEN-CONTAINING PRODUCT (SEE WARNINGS).
DESCRIPTION
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:
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:
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.
CLINICAL PHARMACOLOGY
Hydrocodone is a semisynthetic narcotic analgesic and antitussive with
multiple actions
qualitatively similar to those of codeine. Most of these involve the
central nervous
system and smooth muscle. The precise mechanism of action of
hydrocodone and
other opiates is not known, although it is believed to rela