PERCOCET- oxycodone hydrochloride and acetaminophen tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

STAT RX USA LLC

INN (Internationale Bezeichnung):

OXYCODONE HYDROCHLORIDE

Zusammensetzung:

OXYCODONE HYDROCHLORIDE 10 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

PERCOCET is indicated for the relief of moderate to moderately severe pain. PERCOCET 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. PERCOCET 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, psychological, occupational or interpersonal difficulties resulting f

Produktbesonderheiten:

PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows: 2.5 mg/325 mg Pink, oval, tablet debossed with “PERCOCET” on one side and “2.5” on the other. Bottles of 100                                  NDC 63481-627-70 5 mg/325 mg Blue, round, tablet, debossed with “PERCOCET” and “5” on one side and bisect on the other. Bottles of 100    NDC 63481-623-70 Bottles of 500    NDC 63481-623-85 Unit dose package of 100 tablets      NDC 63481-623-75 7.5 mg/325 mg Peach, oval-shaped, tablet debossed with “PERCOCET” on one side and “7.5/325” on the other. Bottles of 100                                  NDC 63481-628-70 7.5 mg/500 mg Peach, capsule-shaped, tablet debossed with “PERCOCET” on one side and “7.5” on the other. Bottles of 100                                  NDC 63481-621-70 10 mg/325 mg Yellow, capsule-shaped, tablet debossed with “PERCOCET” on one side and “10/325” on the other. Bottles of 100                                  NDC 63481-629-70 10 mg/650 mg Yellow, oval, tablet debossed with “PERCOCET” on one side and “10” on the other. Bottles of 100                                  NDC 63481-622-70 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). DEA Order Form Required. Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317 PERCOCET® is a Registered Trademark of Endo Pharmaceuticals Inc.                                   Copyright © Endo Pharmaceuticals Inc. 2006 Printed in U.S.A.                                                                                  2000055/November, 2006

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

PERCOCET - OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET
STAT RX USA LLC
----------
PERCOCET®
(OXYCODONE AND ACETAMINOPHEN TABLETS, USP) CII
RX ONLY
DESCRIPTION
Each tablet, for oral administration, contains oxycodone hydrochloride
and acetaminophen in the
following strengths:
Oxycodone Hydrochloride, USP 2.5 mg*
Acetaminophen, USP 325 mg
*2.5 mg oxycodone HCl is equivalent to 2.2409 mg of oxycodone.
Oxycodone Hydrochloride, USP 5 mg*
Acetaminophen, USP 325 mg
*5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.
Oxycodone Hydrochloride, USP 7.5 mg*
Acetaminophen, USP 325 mg
*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.
Oxycodone Hydrochloride, USP 7.5 mg*
Acetaminophen, USP 500 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.
Oxycodone Hydrochloride, USP 10 mg*
Acetaminophen, USP 650 mg
*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.
All strengths of PERCOCET also contain the following inactive
ingredients: Colloidal silicon dioxide,
croscarmellose sodium, crospovidone, microcrystalline cellulose,
povidone, pregelatinized cornstarch,
and stearic acid. In addition, the 2.5 mg/325 mg strength contains
FD&C Red No. 40 Aluminum Lake and
the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The
7.5 mg/325 mg and the 7.5
mg/500 mg strengths contain FD&C Yellow No. 6 Aluminum Lake. The 10
mg/325 mg and the 10
mg/650 mg strengths contain 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 351.83. 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 antipy