OXYCODONE AND ACETAMINOPHEN tablet

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Mikart, LLC

INN (International Name):

OXYCODONE HYDROCHLORIDE

রচনা:

OXYCODONE HYDROCHLORIDE 2.5 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Oxycodone and acetaminophen tablets are 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 are 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 oxycodo

পণ্য সারাংশ:

Oxycodone and Acetaminophen Tablets, USP are supplied as: 2.5 mg/300 mg Light blue, round-shaped, convex face tablets, debossed “MIA” on one side and “250” on the other side, in bottles of 30 tablets NDC 46672-193-03, 100 tablets NDC 46672-193-10 and 500 tablets NDC 46672-193-50. 5 mg/300 mg Yellow, capsule-shaped, convex face tablets, debossed “MIA” on the scored side and “500” on the other side, in bottles of 30 tablets NDC 46672-194-03, 100 tablets NDC 46672-194-10 and 500 tablets NDC 46672-194-50. 7.5 mg/300 mg Red, capsule-shaped, flat face, beveled edge tablets, debossed “MIA” on one side and “750” on the other side, in bottles of 30 tablets NDC 46672-195-03, 100 tablets NDC 46672-195-10 and 500 tablets NDC 46672-195-50. 10 mg/300 mg Orange, oval-shaped, convex face tablets, debossed “MIA” on one side and “1000” on the other side, in bottles of 30 tablets NDC 46672-196-03, 100 tablets NDC 46672-196-10 and 500 tablets NDC 46672-196-50. 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 with a child-resistant closure (as required). Store oxycodone and acetaminophen tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients/Caregivers ]. Manufactured by: MIKART, LLC Atlanta, GA 30318 Rev. 07/2020 Code 991Z00

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
Mikart, LLC
----------
MEDICATION GUIDE
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

পণ্য বৈশিষ্ট্য

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
MIKART, LLC
----------
OXYCODONE AND ACETAMINOPHEN TABLETS 2.5 MG/300 5 MG/300 7.5 MG/300 10
MG/300 MG
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 EXPOSE 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 FOLLOWING A DOSE INCREASE
[SEE WARNINGS].
ACCIDENT