OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN - oxycodone hydrochloride and acetaminophen tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

St. Mary's Medical Park Pharmacy

INN (International Name):

OXYCODONE HYDROCHLORIDE

Sammensetning:

OXYCODONE HYDROCHLORIDE 5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 physical

Produkt oppsummering:

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: NDC 60760-200-30 BOTTLES OF 30 60760-200-40 BOTTLES OF 40 60760-200-60 BOTTLES OF 60 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 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 08-2008

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN - OXYCODONE HYDROCHLORIDE
AND
ACETAMINOPHEN TABLET
ST. MARY'S MEDICAL PARK PHARMACY
----------
CLINICAL PHARMACOLOGY
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
antipyretic effect of acetaminophen is
accomplished through the inhibition of endogenous pyrogen action on
the hypothalamic heat-regulating
centers.
GASTROINTESTINAL TRACT AND OTHER SMOOTH MUSCLE
Oxycodone reduces motility by increasing smooth muscle tone in the
stomach and duodenum. In the
small intestine, digestion of food is delayed by decreases in
propulsive contractions. Other opioid
effects include contraction of biliary tract smooth muscle, spasm of
the Sphincter of Oddi, increased
ureteral and bladder sphincter tone, and a reduction in uterine tone.
CARDIOVASCULAR SYSTEM
Oxycodone may produce a release of histamine and may be associated
with orthostatic hypotension, and
other symptoms, such as pruritus, flushing, red eyes, and sweating.
PHARMACOKINETICS
Absorption and Distribution
The mean absolute oral bioavailability of oxycodone in cancer patients
was reported to be about 87%.
Oxycodone has been shown to be 45% bound to human plasma proteins _in
vitro_. The volume of
distribution after intravenous administration is 211.9 ±186.6 L.
Absorption of acetaminophen is rapid and almost complete from the GI
tract after oral administr