OXYCODONE AND ACETAMINOPHEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxycodone and Acetaminophen Tablets is indicated for the relief of moderate to moderately severe pain. Oxycodone and Acetaminophen Tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product. Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone is contraindicated in the setting of suspected or known paralytic ileus. Oxycodone and Acetaminophen Tablets are a Schedule II controlled substance. Oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. Oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion. Drug addiction is defined as an abnormal, compulsive use, use for non-medical purposes of a substance despite physical, psyc

Product summary:

Oxycodone and Acetaminophen Tablets are supplied as follows: 5 mg/325 mg Blue, round tablet, debossed with "ALV" and "196", separated by a bisect, on one side, and plain on the other side. Repackaged By Aidarex Pharmaceuticals, LLC Corona, CA 92880 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 (as required).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
AIDAREX PHARMACEUTICALS LLC
----------
OXYCODONE AND ACETAMINOPHEN TABLETS, USP
RX ONLY
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 4000 milligrams per day, and often
involve more than one
acetaminophen-containing product.
DESCRIPTION
Each tablet, for oral administration, contains oxycodone hydrochloride
and acetaminophen in the
following strengths:
Oxycodone Hydrochloride, USP 5 mg*
Acetaminophen, USP 325 mg
*5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.
Oxycodone Hydrochloride, USP 7.5mg*
Acetaminophen, USP 325 mg
*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.
Oxycodone Hydrochloride, USP 10 mg*
Acetaminophen, USP 325 mg
*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.
All strengths of Oxycodone and Acetaminophen Tablets also contain the
following inactive ingredients:
Pregelatinized cornstarch, povidone, lactose monohydrate,
crospovidone, and stearic acid. In addition,
the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The
7.5 mg/325 mg strength
contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength
contains D&C Yellow No.
10 Aluminum Lake.
Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid
analgesic which occurs as a
white, odorless, crystalline powder having a saline, bitter taste. The
molecular formula for oxycodone
hydrochloride is C
H NO •HCl and the molecular weight 351.82. It is derived from the
opium
alkaloid thebaine, and may be represented by the following structural
formula:
18
21
4
Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate
analgesic and antipyretic which
occurs as a white, odorless, crystalline powder, possessing a slightly
bitter taste. The molecular
formula for acetaminophen is C H NO and the molecular weight is
151.17. It may