HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

Aurolife Pharma, LLC

INN (International Name):

HYDROCODONE BITARTRATE

Composition:

HYDROCODONE BITARTRATE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocodone bitartrate 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 hydrocodone bitartrate 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 Hydrocodone bitartrate 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 hydrocodone or ac

Product summary:

Hydrocodone Bitartrate and Acetaminophen Tablets USP are available in the following strengths: Hydrocodone Bitartrate and Acetaminophen Tablet USP, 5 mg/325 mg is available as white to off-white, round tablets, debossed with “U01” on one side and break-line on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen.          Bottles of 30                 NDC 13107-019-30          Bottles of 100               NDC 13107-019-01          Bottles of 500               NDC 13107-019-05          Bottles of 1000             NDC 13107-019-99 Hydrocodone Bitartrate and Acetaminophen Tablet USP, 7.5 mg/325 mg is available as white to off-white, capsule shaped tablets, debossed with “U02” on one side and break-line on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen.          Bottles of 30                 NDC 13107-020-30          Bottles of 100               NDC 13107-020-01          Bottles of 500               NDC 13107-020-05          Bottles of 1000             NDC 13107-020-99 Hydrocodone Bitartrate and Acetaminophen Tablet USP, 10 mg/325 mg is available as white to off-white, oval shaped tablets, debossed with “U03” on one side and break-line on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen.          Bottles of 30                 NDC 13107-021-30          Bottles of 100               NDC 13107-021-01          Bottles of 500               NDC 13107-021-05          Bottles of 1000             NDC 13107-021-99 Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]  Store Hydrocodone Bitartrate and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients ]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Keep this and all medication out of the reach of children. A Schedule C-II controlled drug substance. Dispense with Medication Guide available at https://www.aurobindousa.com/medication-guides/ Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised: 08/2020

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ACETAMINOPHEN TABLET
Aurolife Pharma, LLC
----------
MEDICATION GUIDE
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
HIGH-droe-KOE-dohn by-TAR-trate/ass-eet-ah-MEE-noe-fen
Hydrocodone Bitartrate 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 pain medicine, 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 hydrocodone bitartrate and acetaminophen
tablets:
• Get emergency help or call 911 right away if you take too much
hydrocodone bitartrate and
acetaminophen tablets (overdose). When you first start taking
hydrocodone bitartrate 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 hydrocodone bitartrate 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 Hydrocodone Bitartrate and
Acetaminophen Tablets. They could die from
taking it. Selling or giving away Hydrocodone Bitartrate and
Acetaminophen Tablets are against the law.
• Store Hydrocodone Bitartrate 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 hydrocodone bitartrate and acetaminophen tablets if you
have:
• Severe asthma, trouble breathing, or other lung pr

Summary of Product characteristics

HYDROCODONE BITARTRATE AND ACETAMINOPHEN - HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
AUROLIFE PHARMA, LLC
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
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
HYDROCODONE BITARTRATE 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 HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLETS,
AND MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE
BEHAVIORS OR 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
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS. MONITOR FOR
RESPIRATORY DEPRESSION,
ESPECIALLY DURING INITIATION OF HYDROCODONE BITARTRATE AND
ACETAMINOPHE