OXYCODONE AND ACETAMINOPHEN tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Quality Care Products, LLC

INN (Tên quốc tế):

OXYCODONE HYDROCHLORIDE

Thành phần:

OXYCODONE HYDROCHLORIDE 7.5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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

Tóm tắt sản phẩm:

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. 35356-802-15 Bottles of 15 35356-802-30 Bottles of 30 35356-802-40 Bottles of 40 35356-802-60 Bottles of 60 35356-802-90 Bottles of 90 35356-802-01 Bottles of 120 10 mg/325 mg Yellow, round tablet, debossed with “230” on one side and “” on the other side. 35356-801-30 Bottles of 30 35356-801-60 Bottles of 60 35356-801-90 Bottles of 90 35356-801-01 Bottles of 120 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

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
QUALITY CARE PRODUCTS, LLC
----------
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:
18
21
4
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:
CLINICAL PHARMACOLOGY
CENTRAL NERVOUS SYSTEM
Oxycodone is a semisynthetic pure opioid agonist whose principal
therapeutic action is
analgesia. Other pharmacological effects of oxycodone in