OXYCODONE AND ACETAMINOPHEN tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Apotheca, Inc

INN (Nome Internazionale):

OXYCODONE HYDROCHLORIDE

Composizione:

OXYCODONE HYDROCHLORIDE 5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

  Oxycodone and Acetaminophen Tablets 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, p

Dettagli prodotto:

Oxycodone Hydrochloride and Acetaminophen Tablets, USP, 5 mg/325 mg, supplied as a white round tablet, with one face, scored debossed 4839 and V, and the other plain, are available: NDC: 12634-942-80 BOTTLE OF 20 NDC: 12634-942-71 BOTTLE OF 30 NDC: 12634-942-40 BOTTLE OF 40 NDC: 12634-942-60 BOTTLE OF 60 Store at 20° to 25°C (68° to 77°F). DISPENSE in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
APOTHECA, INC
----------
OXYCODONE AND ACETAMINOPHEN CII
5/325MG
BOXED WARNING
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.
DESCRIPTION
Each tablet, for oral administration, contains:
Oxycodone hydrochloride, USP
................................................................. 5 mg
(equivalent to 4.4815 mg of Oxycodone)
Acetaminophen, USP
..............................................................................
325 mg
In addition each tablet contains the following inactive ingredients:
crospovidone, magnesium stearate,
microcrystalline cellulose, povidone, pregelatinized corn starch,
sodium starch glycolate 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
151.17. It may be represented by
the following structural formula:
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 κ) in the
central nervous system for endogenous
opioid-like com