OXYCODONE AND ACETAMINOPHEN tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Alvogen, Inc.

ИНН (Международная Имя):

OXYCODONE HYDROCHLORIDE

состав:

OXYCODONE HYDROCHLORIDE 7.5 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Oxycodone and acetaminophen tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse, with opioids, , which can occur at any dosage or duration [see WARNINGS ] , reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia Oxycodone and acetaminophen tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Oxycodone and acetaminophen tablets is contraindicated in patients with: - Significant respiratory depression [see WARNINGS ] - Acute or severe bronchial asthma in an unmonitor

Обзор продуктов:

Oxycodone and Acetaminophen Tablets, USP are supplied as follows: Oxycodone and Acetaminophen Tablets, USP 5 mg/325 mg Blue, round tablet, debossed with "ALV" over "196", separated by a bisect, on one side, and plain on the other side. Bottles of 100 NDC 47781-196-01 Bottles of 250 NDC 47781-196-63 Bottles of 500 NDC 47781-196-05 Oxycodone and Acetaminophen Tablets, USP 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 250 NDC 47781-229-63 Bottles of 500 NDC 47781-229-05 Oxycodone and Acetaminophen Tablets, USP 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 250 NDC 47781-230-63 Bottles of 500 NDC 47781-230-05 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Store Oxycodone and Acetaminophen Tablets, USP securely and dispose of properly [see PRECAUTIONS; Information for Patients and/or Caregivers ] .

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
Alvogen, Inc.
Reference Label Set Id: 94b95304-8d3b-496a-8d2c-22ae89688427
----------
Medication Guide
Oxycodone (ox" i koe' done) and Acetaminophen (a seet" a min' oh fen)
Tablets, CII
Oxycodone and Acetaminophen Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain,
severe enough to require an opioid analgesic and for which alternative
treatments are inadequate
and when other pain treatments such as non-opioid pain medicines do
not treat your pain well
enough or you cannot tolerate them.
•
An opioid pain medicine that can put you at risk for overdose and
death. Even if you take your
dose correctly as prescribed you are at risk for opioid addiction,
abuse, and misuse that can lead to
death.
Important information about Oxycodone and Acetaminophen Tablets :
•
Get emergency help or call 911 right away if you take too much
oxycodone and acetaminophen
tablets (overdose). When you first start taking oxycodone and
acetaminophen tablets, when your
dose is changed, or if you take too much (overdose), serious or
life-threatening breathing problems
that can lead to death may occur. Talk to your healthcare provider
about naloxone, a medicine for
the emergency treatment of an opioid overdose.
•
Taking oxycodone and acetaminophen tablets with other opioid
medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe
drowsiness, decreased awareness, breathing problems, coma, and death.
•
Never give anyone else your oxycodone and acetaminophen tablets. They
could die from taking it.
Selling or giving away oxycodone and acetaminophen tablets is against
the law.
•
Store oxycodone and acetaminophen tablets securely, out of sight and
reach of children, and in a
location not accessible by others, including visitors to the home.
Do not take Oxycodone and Acetaminophen Tablets if you have :
•
Severe asthma, trouble breathing, or other lung

Характеристики продукта

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
ALVOGEN, INC.
REFERENCE LABEL SET ID: 94B95304-8D3B-496A-8D2C-22AE89688427
----------
OXYCODONE AND ACETAMINOPHEN TABLETS, USP CII
RX ONLY
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF
OXYCODONE AND ACETAMINOPHEN TABLETS
ADDICTION, ABUSE, AND MISUSE
Because the use of oxycodone and acetaminophen tablets exposes
patients and
other users to the risks of opioid addiction, abuse, and misuse, which
can lead to
overdose and death, assess each patient’s risk prior to prescribing
and reassess all
patients regularly for the development of these behaviors and
conditions _[SEE_
_WARNINGS]_.
LIFE-THREATENING RESPIRATORY DEPRESSION
Serious, life-threatening, or fatal respiratory depression may occur
with use of
oxycodone and acetaminophen tablets, especially during initiation or
following a
dose increase. To reduce the risk of respiratory depression, proper
dosing and
titration of oxycodone and acetaminophen tablets are essential _[SEE
WARNINGS]_.
ACCIDENTAL INGESTION
Accidental ingestion of even one dose of oxycodone and acetaminophen
tablets,
especially by children, can result in a fatal overdose of oxycodone
and
acetaminophen _[SEE WARNINGS]_.
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
Concomitant use of opioids with benzodiazepines or other central
nervous system
(CNS) depressants, including alcohol, may result in profound sedation,
respiratory
depression, coma, and death. Reserve concomitant prescribing of
oxycodone and
acetaminophen tablets and benzodiazepines or other CNS depressants for
use in
patients for whom alternative treatment options are inadequate _[SEE
WARNINGS,_
_PRECAUTIONS, DRUG INTERACTIONS]_.
NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS)
If opioid use is required for an extended period of time in a pregnant
woman,
advise the patient of the risk of NOWS, which may be life-threatening
if not
recognized and treated. Ensure that management by neonatology experts
will be
available at delivery _[SEE WARNINGS]