OXYCODONE AND ACETAMINOPHEN- oxycodone hydrochloride and acetaminophen tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Oxycodone Hydrochloride (UNII: C1ENJ2TE6C) (Oxycodone - UNII:CD35PMG570), Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)

Disponível em:

Mayne Pharma Inc.

DCI (Denominação Comum Internacional):

Oxycodone Hydrochloride

Composição:

Oxycodone Hydrochloride 2.5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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. 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 component of the product (e.g., anaphylaxis) [see WARN

Resumo do produto:

Oxycodone and Acetaminophen Tablets, USP are supplied as follows: The 2.5 mg/325 mg tablets are white, oval, flat-faced, beveled edge, unscored tablets debossed with 103 on one side of the tablet and blank on the other side. They are available as follows: NDC 68308-840-01 bottles of 100 tablets The 5 mg/325 mg tablets are white, round, flat-faced, beveled edge, scored tablets debossed with 104 above the score on one side of the tablet and blank on the other side. They are available as follows: NDC 68308-841-01 bottles of 100 tablets NDC 68308-405-47 100 (10×10) Unit Dose Tablets The 7.5 mg/325 mg tablets are white, caplet-shaped, flat-faced, beveled edge, unscored tablets debossed with 105 on one side of the tablet and blank on the other side. They are available as follows: NDC 68308-842-01 bottles of 100 tablets NDC 68308-475-47 100 (10×10) Unit Dose Tablets The 10 mg/325 mg tablets are white, round, flat-faced, beveled edge, unscored tablets debossed with 106 on one side of the tablet and blank on the other side. They are available as follows: NDC 68308-843-01 bottles of 100 tablets NDC 68308-480-47 100 (10×10) Unit Dose Tablets Store Oxycodone and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients]. 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.

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

Mayne Pharma Inc.
Reference Label Set Id: 7c7fdf76-4562-4267-9ba3-8a6eb85a4388
----------
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 problems.
•
A bowel blockage or have narrowing of the stomach

Características técnicas

OXYCODONE AND ACETAMINOPHEN- OXYCODONE HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
MAYNE PHARMA INC.
REFERENCE LABEL SET ID: 7C7FDF76-4562-4267-9BA3-8A6EB85A4388
----------
OXYCODONE AND ACETAMINOPHEN TABLETS, USP CII
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
ANALGESIC 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 FOLLO