Do not abruptly discontinue acetaminophen and codeine phosphate 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 acetaminophen and codeine phosphate tablets, there are a variety of factors that should be considered, including the dose of acetaminophen and codeine phosphate 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 acetaminophen and codeine phosphate 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).
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg are white, round, flat, beveled edged tablets debossed “IP 33” on obverse and “3” on reverse.
They are available as follows:
Bottles of 100: NDC 65162-033-10
Bottles of 500: NDC 65162-033-50
Bottles of 1000: NDC 65162-033-11
Store Acetaminophen and Codeine Phosphate Tablets, USP 300 mg/30 mg between 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight, light-resistant container as defined in the USP.
Amneal Pharmaceuticals of NY, LLC
Brookhaven, NY 11719
Acetaminophen and Codeine Phosphate (a seet’ a min’ oh fen and koe’ deen fos’ fate) Tablets CIII
Acetaminophen and Codeine Phosphate Tablets are:
Important information about Acetaminophen and Codeine Phosphate Tablets:
Important Information Guiding Use in Pediatric Patients:
Do not take Acetaminophen and Codeine Phosphate Tablets if you have:
Before taking Acetaminophen and Codeine Phosphate Tablets, tell your healthcare provider if you have a history of:
Tell your healthcare provider if you are:
When taking Acetaminophen and Codeine Phosphate Tablets:
While taking Acetaminophen and Codeine Phosphate Tablets DO NOT:
The possible side effects of Acetaminophen and Codeine Phosphate Tablets:
Get emergency medical help or call 911 right away if you have:
These are not all the possible side effects of acetaminophen and codeine phosphate tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.