ACETAMINOPHEN AND CODEINE PHOSPHATE solution

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:

PAI Holdings, LLC

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 120 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acetaminophen and codeine phosphate oral solution is indicated for the management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve acetaminophen and codeine phosphate oral solution 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 Acetaminophen and codeine phosphate oral solution is 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 oral solution is 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] . - Patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ]. - Patients with hypersensitivity to codeine, acetaminophen, or any of the formulation excipients (e.g., anaphylaxis) [see WARNINGS ]. Acetaminophen and codeine phosphate oral solution contains codeine, a Schedule II controlled substance. Acetaminophen and codeine phosphate oral solution contains codeine, a substance with a high potential for abuse similar to other opioids including, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Acetaminophen and codeine phosphate oral solution 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. Acetaminophen and codeine phosphate oral solution, 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. Acetaminophen and codeine phosphate oral solution is for oral use only. Abuse of acetaminophen and codeine phosphate oral solution poses a risk of overdose and death. The risk is increased with concurrent use of acetaminophen and codeine phosphate oral solution with alcohol and other central nervous system depressants. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. 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 oral solution in a patient physically dependent on opioids. Rapid tapering of acetaminophen and codeine phosphate oral solution 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 oral solution, gradually taper the dosage using a patient-specific plan that considers the following: the dose of acetaminophen and codeine phosphate oral solution 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:

Acetaminophen and Codeine Phosphate Oral Solution USP (orange-yellow color, cherry flavor) is supplied in the following oral dosage forms: NDC 0121-0504-04: 4 fl oz (118 mL) bottle NDC 0121-0504-16: 16 fl oz (473 mL) bottle NDC 0121-0504-05:  5 mL unit dose cup.  Case contains 100 unit-dose cups of 5 mL (NDC 0121-0504-00), packaged in 10 trays of 10 unit-dose cups each. NDC 0121-1008-12:  12.5 mL unit dose cup.  Case contains 100 unit-dose cups of 12.5 mL (NDC 0121-1008-00), packaged in 10 trays of 10 unit-dose cups each. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Store acetaminophen and codeine phosphate oral solution securely and dispose of properly [see PRECAUTIONS, Information for Patients ].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PAI Holdings, LLC
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MEDICATION GUIDE
Acetaminophen and Codeine Phosphate (a seet' a min' oh fen and koe'
deen fos'fate) Oral Solution, CV
Acetaminophen and Codeine Phosphate Oral Solution is:
•
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
Oral Solution:
•
Get emergency help right away if you take too much
acetaminophen and codeine phosphate oral solution
(overdose). When you first start taking acetaminophen and
codeine phosphate oral solution, 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 acetaminophen and codeine phosphate oral solution
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 oral solution. They could die from taking it. Selling
or giving away acetaminophen and codeine phosphate oral
solution is against the law.
•
Store acetaminophen and codeine phosphate oral solution
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 oral
solution to a child younger than 12 years of age.
•
Do not give acetaminophen and codeine phosphate oral
solution to a child younger than 18 years of age after surgery to
remove the tonsils and/or a

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE
PHOSPHATE SOLUTION
PAI HOLDINGS, LLC
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ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION USP CV
WARNING: RISK OF MEDICATION ERRORS; 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; DEATH RELATED TO ULTRA-RAPID
METABOLISM OF CODEINE TO MORPHINE; INTERACTIONS WITH DRUGS
AFFECTING CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; AND
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER
CNS DEPRESSANTS
RISK OF MEDICATION ERRORS
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION. DOSING ERRORS DUE
TO CONFUSION BETWEEN MG AND ML, AND OTHER CODEINE CONTAINING ORAL
PRODUCTS OF DIFFERENT CONCENTRATIONS CAN RESULT IN ACCIDENTAL OVERDOSE
AND DEATH [SEE WARNINGS, DOSAGE AND ADMINISTRATION].
ADDICTION, ABUSE, AND MISUSE
ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION 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 ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION, 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 P