ENDOCET- oxycodone and acetaminophen tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

STAT RX USA LLC

Designación común internacional (DCI):

OXYCODONE HYDROCHLORIDE

Composición:

OXYCODONE HYDROCHLORIDE 10 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

ENDOCET is indicated for the relief of moderate to moderately severe pain. ENDOCET 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. ENDOCET 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, psychological, occupational or interpersonal difficulties re

Resumen del producto:

ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows: 5 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100                                            NDC 60951-602-70 Bottles of 500                                            NDC 60951-602-85 Unit dose package of 100 tablets           NDC 60951-602-75 7.5 mg/325 mg Peach oval-shaped, tablet debossed with “E700” on one side and “7.5/325” on the other. Bottles of 100                                            NDC 60951-700-70 7.5 mg/500 mg Peach, capsule-shaped, tablet debossed with “E796” on one side and “7.5” on the other. Bottles of 100                                            NDC 60951-796-70 10 mg/325 mg Yellow, capsule-shaped, tablet debossed with “E712” on one side and “10/325” on the other. Bottles of 100                                            NDC 60951-712-70 10 mg/650 mg Yellow, oval, tablet debossed with “E797” on one side and “10” on the other. Bottles of 100                                            NDC 60951-797-70 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. Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317 ENDOCET® is a Registered Trademark of Endo Pharmaceuticals Inc. Copyright © Endo Pharmaceuticals Inc. 2007 Printed in U.S.A.                                                                                                                                    2002274/February, 2007

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ENDOCET - OXYCODONE AND ACETAMINOPHEN TABLET
STAT RX USA LLC
----------
DESCRIPTION
Each tablet, for oral administration, contains oxycodone hydrochloride
and acetaminophen in the
following strengths:
Oxycodone Hydrochloride, USP 5 mg*
Acetaminophen, USP 325 mg
*5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.
Oxycodone Hydrochloride, USP 7.5 mg*
Acetaminophen, USP 325 mg
*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.
Oxycodone Hydrochloride, USP 7.5 mg*
Acetaminophen, USP 500 mg
*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.
Oxycodone Hydrochloride, USP 10 mg*
Acetaminophen, USP 325 mg
*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.
Oxycodone Hydrochloride, USP 10 mg*
Acetaminophen, USP 650 mg
*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.
All strengths of ENDOCET also contain the following inactive
ingredients: Colloidal silicon dioxide,
croscarmellose sodium, crospovidone, microcrystalline cellulose,
povidone, pregelatinized cornstarch,
and stearic acid. In addition, the 7.5 mg/325 mg and the 7.5 mg/500 mg
strengths contain FD and C
Yellow No. 6 Aluminum Lake. The 10 mg/325 mg and the 10 mg/650 mg
strengths contain D and C
Yellow No. 10 Aluminum Lake.
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 351.83. 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 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
CLINICAL PHARMACOLOGY
CENTRAL NERVOUS SYSTEM
Oxycodone is a semisynthetic pure opioid a