OXYCODONE 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:

EPM Packaging Inc

INN (Internationale Bezeichnung):

OXYCODONE HYDROCHLORIDE

Zusammensetzung:

OXYCODONE HYDROCHLORIDE 7.5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Oxycodone and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain. Oxycodone and acetaminophen tablets, USP should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, USP, 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 muagonist 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 fo

Produktbesonderheiten:

Oxycodone and acetaminophen tablets, USP, 7.5 mg/ 325 mg, are supplied as white to off-white, capsule shaped, biconvex tablets, debossed “IP207” on obverse and plain on the reverse. They are available as follows: Bottles of 30: NDC: 65162-207-03 Bottles of 100: NDC: 65162-207-10 Bottles of 500: NDC: 65162-207-50 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. MFG. ADDRESS Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Rev. 08-2015-02

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
EPM PACKAGING INC
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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.
Oxycodone and Acetaminophen Tablets , USP 7.5 mg / 325 mg CII
Each tablet, for oral administration, contains oxycodone
hydrochloride, USP and acetaminophen, USP in
the following strengths:
Oxycodone Hydrochloride, USP 7.5 mg*
Acetaminophen, USP 325 mg
*7.5 mg oxycodone HCl, USP is equivalent to 6.7228 mg of oxycodone.
All strengths of oxycodone and acetaminophen, USP also contain the
following inactive ingredients:
colloidal silicon dioxide, crospovidone, magnesium stearate,
microcrystalline cellulose, povidone,
pregelatinized corn starch and stearic acid.
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, USP 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:
Acetaminophen, USP, 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, USP is C H NO and the molecular weight is
151.17. It may be represented
by the following structural formula:
18 21 4
8 9 2
Central Nervous Sys tem
Oxycodone is a semisynthetic pure opioid agonist whose principal
therapeutic action is analgesia.
Other pharmacological effects of oxycodone include anxiolysis,
euphoria and feelings of relaxation.
These effects are mediated by receptors (notably µ and ?) in the
central nervous system for endogenous
opioid-like