OXYCODONE AND ACETAMINOPHEN tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Alvogen, Inc.

INN (Kansainvälinen yleisnimi):

OXYCODONE HYDROCHLORIDE

Koostumus:

OXYCODONE HYDROCHLORIDE 7.5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Oxycodone and Acetaminophen Tablets is 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, psyc

Tuoteyhteenveto:

Oxycodone and Acetaminophen Tablets are supplied as follows: 7.5 mg/325 mg Orange to yellow, round tablet, debossed with “229” on one side and “”on the other side. Bottles of 100                                                                     NDC 47781-229-01 Bottles of 500                                                                     NDC 47781-229-05 10 mg/325 mg Yellow, round tablet, debossed with “230” on one side and “” on the other side. Bottles of 100                                                                     NDC 47781-230-01 Bottles of 500                                                                     NDC 47781-230-05 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 (as required). DEA Order Form Required. To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by: Norwich Pharmaceuticals, Inc. 6826 State Highway 12 Norwich, NY 13815 U.S.A. Manufactured for: Alvogen, Inc. Pine Brook, NJ  07058  U.S.A. PKG01398 Rev: 01/2012-01

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

OXYCODONE AND ACETAMINOPHEN - OXYCODONE AND ACETAMINOPHEN TABLET
ALVOGEN, INC.
----------
UNKNOWN TITLE
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
RX ONLY
Each tablet, for oral administration, contains oxycodone hydrochloride
and acetaminophen in the
following strengths:
Oxycodone Hydrochloride, USP 7.5mg*
Acetaminophen, USP 325 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.
All strengths of Oxycodone and Acetaminophen Tablets also contain the
following inactive ingredients:
Pregelatinized cornstarch, povidone, lactose monohydrate,
crospovidone, and stearic acid. The 7.5
mg/325 mg contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg
contains D&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 agonist whose principal
therapeutic action is analgesia.
Other pharmacological effects of oxycodone include