ACETAMINOPHEN AND CODEINE PHOSPHATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain,where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] •Have not provided adequate analgesia, or are not expected to provide adequate analgesia •Have not been tolerated, or are not expected to be tolerated Acetaminophen and codeine phosphate tablets are contraindicated for: - All children younger than 12 years of age (see WARNINGS ). - Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see WARNINGS ).  Acetaminophen and codeine phosphate 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 ]. - concurrent  use  of  monoamine  oxidase  inhibitors  (MAOIs)  or  use  of  MAOIs within the last 14 days [see WARNINGS ]. - known or suspected  gastrointestinal obstruction, including paralytic ileus [see WARNINGS ]. - Hypersensitivity to codeine, acetaminophen, or any of the formulation excipients (e.g., anaphylaxis) [see WARNINGS ]. Controlled Substance Acetaminophen and codeine phosphate tablets contain codeine. Codeine in combination with acetaminophen, is a Schedule III controlled substance. Abuse Acetaminophen and codeine phosphate tablets contain codeine, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Acetaminophen and codeine phosphate tablets 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, or potentially 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 health care providers.  '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. Acetaminophen and codeine phosphate 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 Acetaminophen and Codeine Phosphate Tablets Acetaminophen and Codeine Phosphate Tablets are for oral use only. Abuse of Acetaminophen and Codeine Phosphate Tablets poses a risk of overdose and death. The risk is increased with concurrent use of Acetaminophen and Codeine Phosphate 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 acetaminophen and codeine phosphate tablets in a patient physically dependent on opioids. Rapid tapering of acetaminophen and codeine phosphate 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 acetaminophen and codeine phosphate tablets, gradually taper the dosage using a patient specific plan that considers the following: the dose of acetaminophen and codeine phosphate 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 ].

Product summary:

300 mg/30 mg White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U36” on one side and plain on the other side. NDC: 70518-2989-00 PACKAGING: 30 in 1 BLISTER PACK Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store acetaminophen and codeine phosphate tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients]. Keep this and all medication out of the reach of children. Protect from moisture. Dispense in a tight, light-resistant container as described in the USP. PROTECT FROM LIGHT Dispense with Medication Guide available at https://www.aurobindousa.com/medication-guides/ Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

REMEDYREPACK INC.
----------
MEDICATION GUIDE
MEDICATION GUIDE
Acetaminophen and Codeine Phosphate Tablets(ass-cet-ah-MEE-noe-fen
with KOE-deen FOSS-fate),
USP CIII
Acetaminophen and Codeine Phosphate Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage mild
to moderate pain, 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 Acetaminophen and Codeine Phosphate
Tablets:
•
Get emergency help or call 911 right away if you take too much
acetaminophen and codeine
phosphate tablets (overdose). When you first start taking
acetaminophen and codeine 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 acetaminophen and codeine 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 acetaminophen and codeine phosphate
tablets. They could die from
taking it. Selling or giving away acetaminophen and codeine phosphate
tablets are against the law.
•
Store acetaminophen and codeine phosphate tablets securely, out of
sight and reach of children,
and in a location not accessible by others, including visitors to the
home.
Important Information Guiding Use in Pediatric Patients:
•
Do not give acetaminophen and codeine phosphate tablets to a child
younger than 12 years of age.
•
Do not give acetaminophen and codeine phosphate tablets to a child
younger than

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE TABLET
REMEDYREPACK INC.
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ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII
WARNING: ADDICTION, ABUSE, AND MISUSE: RISK EVALUATION AND
MITIGATION STRATEGY (REMS), LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF
CODEINE AND OTHER RISK FACTORS FOR LIFE- THREATENING
RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID
WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING
CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; AND RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
ADDICTION, ABUSE AND MISUSE
ACETAMINOPHEN AND CODEINE PHOSPHATE 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 ACETAMINOPHEN AND CODEINE PHOSPHATE 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 ACETAMINOPHEN AND CODEI