OXYCODONE AND ACETAMINOPHEN tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

DIRECT RX

INN (Mezinárodní Name):

OXYCODONE HYDROCHLORIDE

Složení:

OXYCODONE HYDROCHLORIDE 5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Oxycodone and Acetaminophen Tablets, USP are 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 physi

Přehled produktů:

Oxycodone and Acetaminophen Tablets USP, 5 mg / 325 mg are supplied as white to off-white, round, flat-faced, beveled edged tablets, debossed “IP203” on obverse and bisect on reverse. They are available as follows: Bottles of 100: NDC 53746-203-01 Bottles of 500: NDC 53746-203-05 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. DEA Order Form Required

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
DIRECT RX
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OXYCODONE AND ACETAMINOPHEN
DESCRIPTION SECTION
Each tablet for oral administration contains:
Oxycodone Hydrochloride, USP……………. 5 mg*
Acetaminophen, USP………………………325 mg
*5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.
Oxycodone and Acetaminophen Tablets, USP also contain the following
inactive ingredients: colloidal
silicon dioxide, crospovidone, magnesium stearate, microcrystalline
cellulose, povidone,
pregelatinized 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 is C18H21NO4•HCl and the molecular weight 351.82. It
is derived from the opium
alkaloid thebaine, and may be represented by the following structural
formula:
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 C8H9NO2 and the molecular weight is
151.16. It may be represented by
the following structural formula:
CLINICAL PHARMACOLOGY SECTION
Central Nervous System
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 k)
in the central nervous system
for endogenous opioid-like compounds such as endorphins and
enkephalins. Oxycodone produces
respiratory depression through direct activity at respiratory centers
in the brain stem and depresses
the cough reflex by direct effect on the center of the medulla.
Acetaminophen is a non-opiate, non-salicylate analgesic and
antipyretic. The site and mechanism for
the analgesic effect of acetaminophen has not been determined. The
antipy