OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

STAT Rx USA LLC

SNN (starptautisko nepatentēto nosaukumu):

OXYCODONE HYDROCHLORIDE

Kompozīcija:

OXYCODONE HYDROCHLORIDE 5 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

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 28:     NDC 42549-618-28 Bottles of 30:     NDC 42549-618-30 Bottles of 40:     NDC 42549-618-40 Bottles of 60:     NDC 42549-618-60 Bottles of 84:     NDC 42549-618-84 Bottles of 90:     NDC 42549-618-90 Bottles of 112:   NDC 42549-618-02 Bottles of 120:   NDC 42549-618-12 Oxycodone and Acetaminophen Tablets USP, 10 mg / 325 mg are supplied as white to off-white, capsule-shaped, biconvex tablets, debossed 'IP204' on obverse and plain on reverse. They are available as follows: Bottles of 28:     NDC 42549-640-28 Bottles of 30:     NDC 42549-640-30 Bottles of 40:     NDC 42549-640-40 Bottles of 60:     NDC 42549-640-60 Bottles of 84:     NDC 42549-640-84 Bottles of 90:     NDC 42549-640-90 Bottles of 112:   NDC 42549-640-02 Bottles of 120:   NDC 42549-640-12 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

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN - OXYCODONE HYDROCHLORIDE
AND
ACETAMINOPHEN TABLET
STAT RX USA LLC
----------
5/325 MG 10/325 MG
CII
RX ONLY
DESCRIPTION
Each tablet for oral administration contains:
Oxycodone Hydrochloride, USP .................... 5 mg*
Acetaminophen ............................................ 325 mg
* 5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.
Each tablet for oral administration contains:
Oxycodone Hydrochloride, USP .................... 10 mg*
Acetaminophen ............................................ 325 mg
* 10 mg oxycodone HCl is equivalent to 8.9637 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 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:
C
H NO •HCl MW 351.82
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
18
21
4
18
21
4
formula for acetaminophen is C H NO and the molecular weight is
151.16. It may be represented by
the following structural formula:
C H NO MW 151.17
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
d