HYDROCODONE /APAP tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Direct_Rx

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS]. Follow patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with hydrocodone bitartrate and acetaminophen tablets and adjust the dosage accordingly [see WARNINGS]. Initial Dosage Initiating Treatment with Hydrocodone Bitartrate and Acetaminophen Tablets 5 mg/325 mg The usual adult dosage is one or two tablets every four to six hours as needed for pain.The total daily dosage should not exceed 8 tablets. 7.5 mg/325 mg The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets. 10 mg/325 mg The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets. Conversion from Other Opioids to Hydrocodone Bitartrate and Acetaminophen Tablets There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of Hydrocodone Bitartrate and Acetaminophen Tablets. It is safer to underestimate a patient’s 24-hour Hydrocodone Bitartrate and Acetaminophen Tablets dosage than to overestimate the 24-hour Hydrocodone Bitartrate and Acetaminophen Tablets dosage and manage an adverse reaction due to overdose. Conversion from Hydrocodone Bitartrate and Acetaminophen Tablets to Extended-Release Hydrocodone The relative bioavailability of hydrocodone from Hydrocodone Bitartrate and Acetaminophen Tablets compared to extended-release hydrocodone products is unknown, so conversion to extended-release products must be accompanied by close observation for signs of excessive sedation and respiratory depression. Titration and Maintenance of Therapy Individually titrate hydrocodone bitartrate and acetaminophen tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving hydrocodone bitartrate and acetaminophen tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the hydrocodone bitartrate and acetaminophen tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions. Safe Reduction or Discontinuation of Hydrocodone Bitartrate and Acetaminophen Tablets Do not abruptly discontinue hydrocodone bitartrate and acetaminophen tablets in patients who may be physically dependent on opioids. Rapid discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in 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. Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances. When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking hydrocodone bitartrate and acetaminophen tablets, there are a variety of factors that should be considered, including the dose of hydrocodone bitartrate and acetaminophen tablets the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic. When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder. Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder. Complex patients with co-morbid pain and substance use disorders may benefit from referral to a specialist. There are no standard opioid tapering schedules that are suitable for all patients. Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually. For patients on hydrocodone bitartrate and acetaminophen tablets who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., no greater than 10% to 25% of the total daily dose) to avoid withdrawal symptoms, and proceed with dose lowering at an interval of every 2 to 4 weeks. Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper. It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper. Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge. Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper. In addition, monitor patients for any changes in mood, emergence of suicidal thoughts, or use of other substances. When managing patients taking opioid analgesics, particularly those who have been treated for a long duration and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see WARNINGS/ Withdrawal, DRUG ABUSE AND DEPENDENCE].

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

HYDROCODONE /APAP- HYDROCODONE /APAP TABLET
Direct_Rx
----------
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 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.
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 problems.
a bowel blockage or have narrowing of the stomach or intestines.
known hypersensitivity to hydrocodone or acetaminophen ,or any
ingredient in hydrocod

خصائص المنتج

HYDROCODONE /APAP- HYDROCODONE /APAP TABLET
DIRECT_RX
----------
HYDROCODONE/APAP
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
acetaminophen tablets or following a dose increase [seeWARNINGS].
Accidental Ingestion
Accidental ingestion