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:

Camber Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocodone bitartrate and acetaminophen tablets, USP 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, USP 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 ace

Product summary:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied as 2.5 mg/325 mg containing 2.5 mg hydrocodone bitartrate and 325 mg acetaminophen. Off white/white capsule shaped tablet debossed ‘T 256’ on one side and plain on other side. NDC 31722-940-01, Bottles of 100 Tablets 5 mg/325 mg containing 5 mg hydrocodone bitartrate and 325 mg acetaminophen. Off white, with orange specks, capsule shaped tablet debossed ‘T 257’ on one side and plain on other side with bisect line. NDC 31722-941-01, Bottles of 100 Tablets NDC 31722-941-05, Bottles of 500 Tablets 7.5 mg/325 mg containing 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. Off white/white capsule shaped tablet debossed ‘T 258’ on one side and plain on other side with bisect line. NDC 31722-942-01, Bottles of 100 Tablets NDC 31722-942-05, Bottles of 500 Tablets 10 mg/325 mg containing 10 mg hydrocodone bitartrate and 325 mg acetaminophen. Light yellow to yellow color capsule shaped tablet debossed ‘T 259’ on one side and plain on other side with bisect line. NDC 31722-943-01, Bottles of 100 Tablets NDC 31722-943-05, Bottles of 500 Tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Store hydrocodone bitartrate and acetaminophen tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients ]. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Revised: 05/21

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

acetaminophen tablet
Camber Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Hydrocodone Bitartrate (hye" droe koe' done bye tar’ trate) and
Acetaminophen (a seet"a min' oh fen)
Tablets USP, CII
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 is 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

Summary of Product characteristics

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE
AND ACETAMINOPHEN TABLET
CAMBER PHARMACEUTICALS, INC.
----------
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: RISK EVALUATION AND MITIGATION
STRATEGY (REMS)
HYDROCODONE BITARTRATE 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 HYDROCODONE BITARTRATE 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 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS. MONITOR FOR
RESPIRATORY DEPRESSION ESPECIALLY DURING INITIATION OF HYDROCODONE
BITARTRATE AND ACETAMINOPHE