HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Redpharm Drug

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia 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 ) Significant respiratory depression ( see WARNINGS ) - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment ( 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 ) Known or suspected gastrointestinal obstruction, including paralytic ileus ( see WARNINGS ) - Hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) ( see WARNINGS  and ADVERSE REACTIONS ) Hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) ( see WARNINGS  and ADVERSE REACTIONS ) Controlled Substance Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a Schedule II controlled substance. Abuse Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol,  can be abused and is subject to misuse, addiction, and criminal diversion ( see WARNINGS ). All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction. Hydrocodone bitartrate and acetaminophen tablets, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Risks Specific to Abuse of Hydrocodone Bitartrate and Acetaminophen Tablets Hydrocodone bitartrate and acetaminophen tablets are for oral use only. Hydrocodone bitartrate and acetaminophen tablets pose a risk of overdose and death. The risk is increased with concurrent abuse of hydrocodone bitartrate and acetaminophen tablets with alcohol and other central nervous system depressants. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Dependence Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. Do not abruptly discontinue hydrocodone bitartrate and acetaminophen tablets in a patient physically dependent on opioids. Rapid tapering of hydrocodone bitartrate and acetaminophen tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. When discontinuing hydrocodone bitartrate and acetaminophen tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of hydrocodone bitartrate and acetaminophen tablets the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper ( see DOSAGE AND ADMINISTRATION, WARNINGS ). Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs ( see PRECAUTIONS, Pregnancy ).

Sommarju tal-prodott:

Hydrocodone Bitartrate and Acetaminophen Tablets USP are supplied as follows: Strength How Supplied Each tablet contains: Description of tablet Hydrocodone Bitartrate Acetaminophen 5 mg/325 mg Bottles of 20 …………..… NDC 0406-0123-20 Bottles of 30 …………..… NDC 0406-0123-30 Bottles of 60 …………..… NDC 0406-0123-60 Bottles of 90 …………..… NDC 0406-0123-90 Bottles of 100 …………… NDC 0406-0123-01 Bottles of 120 ..………..… NDC 0406-0123-12 Bottles of 500 …………… NDC 0406-0123-05 Bottles of 1000 ………..… NDC 0406-0123-10 Unit Dose (10 x 10) …….. NDC 0406-0123-62 5 mg 325 mg It is available as a capsule-shaped white tablet debossed with M365 on one side and bisected on the other side. 7.5 mg/325 mg Bottles of 20 …………..… NDC 0406-0124-20 Bottles of 30 …………..… NDC 0406-0124-30 Bottles of 60 …………..… NDC 0406-0124-60 Bottles of 90 …………..… NDC 0406-0124-90 Bottles of 100 …………… NDC 0406-0124-01 Bottles of 120 ..………..… NDC 0406-0124-12 Bottles of 500 …………… NDC 0406-0124-05 Bottles of 1000 ………..… NDC 0406-0124-10 Unit Dose (10 x 10) …….. NDC 0406-0124-62 7.5 mg 325 mg It is available as an unscored oval-shaped white tablet debossed with M366 on one side. 10 mg/325 mg Bottles of 20 …………..… NDC 0406-0125-20 Bottles of 30 …………..… NDC 0406-0125-30 Bottles of 60 …………..… NDC 0406-0125-60 Bottles of 90 …………..… NDC 0406-0125-90 Bottles of 100 …………… NDC 0406-0125-01 Bottles of 120 ..………..… NDC 0406-0125-12 Bottles of 500 …………… NDC 0406-0125-05 Bottles of 1000 ………..… NDC 0406-0125-10 Unit Dose (10 x 10) …….. NDC 0406-0125-62 10 mg 325 mg It is available as a capsule-shaped white tablet debossed with M367 on one side and bisected on the other side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container (as defined in USP) with a child-resistant closure. Store hydrocodone bitartrate and acetaminophen tablets securely and dispose of properly ( see PRECAUTIONS, Information for Patients ). Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2020 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Rev 08/2020 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/MG20H32.pdf or by calling 1-800-778-7898 for alternate delivery options.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

ACETAMINOPHEN TABLET
Redpharm Drug
----------
Medication Guide
Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and
Acetaminophen (a seet” a min’ oh fen)
Tablets 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 many
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
many (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 other lung

Karatteristiċi tal-prodott

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE
AND ACETAMINOPHEN TABLET
REDPHARM DRUG
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CII
5 MG/325 MG, 7.5 MG/325 MG AND 10 MG/325 MG
REVISED: AUGUST 2020
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 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, ESPEC