OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Elite Laboratories, Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични 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, even at recommended doses [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 is contraindicated in patients with:      •  Significant respiratory depression [see WARNINGS]      •  Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS]      •  Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS]     •  Hypersensitivity to oxycodone, acetaminophen, or any other

Каталог на резюме:

Oxycodone and Acetaminophen Tablets, USP are supplied as follows: 5 mg/325 mg White to off white capsule shaped tablet debossed on one side with “EO” and “XA” on either side of the bisect and “5/325” on the other side. Bottles of 30s              NDC 64850-621-30 Bottles of 60s              NDC 64850-621-60 Bottles of 90s              NDC 64850-621-90 7.5 mg/325 mg White to off white capsule shaped tablet debossed on one side with “EOXA” and “7.5/325” on the other side. Bottles of 30s              NDC 64850-622-30 Bottles of 60s              NDC 64850-622-60 Bottles of 90s              NDC 64850-622-90 10 mg/325 mg White to off white capsule shaped tablet debossed on one side with “EOXA” and “10/325” on the other side. Bottles of 30s              NDC 64850-623-30 Bottles of 60s              NDC 64850-623-60 Bottles of 90s              NDC 64850-623-90 Store Oxycodone and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients]. Storage 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. DEA Order Form Required. Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647    IN0516 Revised: September 2019

Статус Оторизация:

Abbreviated New Drug Application

Листовка

OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN - OXYCODONE HYDROCHLORIDE
AND
ACETAMINOPHEN TABLET
Elite Laboratories, Inc.
----------
SPL MEDGUIDE
Revised: 09/2019
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 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. 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 are 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 problems.
•
A bowel blockage or have narrowing of the stomach or intestines
•
Known hypersensitivity to oxycodone

Данни за продукта

OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN - OXYCODONE HYDROCHLORIDE
AND
ACETAMINOPHEN TABLET
ELITE LABORATORIES, INC.
----------
CII
RX ONLY
REVISED: 09/2019
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL
SYNDROME, CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY, AND
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE
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 OXYCODONE AND ACETAMINOPHEN
TABLETS, AND MONITOR ALL
PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS AND
CONDITIONS [SEE WARNINGS].
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS):
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE, AND
MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A REMS FOR
THESE PRODUCTS
[SEE WARNINGS]. UNDER THE REQUIREMENTS OF THE REMS, DRUG COMPANIES
WITH APPROVED
OPIOID ANALGESICS PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION PROGRAMS
AVAILABLE TO
HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO
COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM,
COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON
SAFE USE, SERIOUS
RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS,
EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING
THE MEDICATION
GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST, AND
CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY
SAFETY.
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF OXYCODONE
AND ACETAMINOPHEN TABLETS. MONITOR FOR RESPIRATORY DEPRESSION,
ESPECIALLY DURING
INITIATION OF OXYCODONE AND ACETAMINOPHEN TABLETS OR FOLLOWING A DOSE
INCREASE [SEE
WARNINGS].
ACCIDENTAL ING