Acetaminophen and Codeine Phosphate (Page 3 of 9)

PRECAUTIONS

Risks of Driving and Operating Machinery

Acetaminophen and Codeine Phosphate Tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Acetaminophen and Codeine Phosphate Tablets and know how they will react to the medication [see PRECAUTIONS, Information for Patients/Caregivers ].

Information for Patients/Caregivers

Storage and Disposal:

Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store Acetaminophen and Codeine Phosphate Tablets, USP securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home [see WARNINGS, DRUG ABUSE AND DEPENDENCE ]. Inform patients that leaving Acetaminophen and Codeine Phosphate Tablets, USP unsecured can pose a deadly risk to others in the home.

Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Inform patients that medicine take-back options are the preferred way to safely dispose of most types of unneeded medicines. If no take back programs or DEA-registered collectors are available, instruct patients to dispose of Acetaminophen and Codeine Phosphate Tablets, USP by following these four steps:

Mix Acetaminophen and Codeine Phosphate Tablets, USP (do not crush) with an unpalatable substance such as dirt, cat litter, or used coffee grounds;
Place the mixture in a container such as a sealed plastic bag;
Throw the container in the household trash;
Delete all personal information on the prescription label of the empty bottle

Inform patients that they can visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Addiction, Abuse and Misuse

Inform patients that the use of Acetaminophen and Codeine Phosphate Tablets, USP, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS ]. Instruct patients not to share Acetaminophen and Codeine Phosphate Tablets with others and to take steps to protect Acetaminophen and Codeine Phosphate Tablets, USP from theft or misuse.

Life-Threatening Respiratory Depression

Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Acetaminophen and Codeine Phosphate Tablets, USP or when the dosage is increased, and that it can occur even at recommended dosages.

Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose (see WARNINGS, Life Threatening Respiratory Depression ).

Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose
Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with Acetaminophen and Codeine Phosphate Tablets, USP. Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program) (see WARNINGS, Life Threatening Respiratory Depression; DOSAGE AND ADMINISTRATION).

Educate patients and caregivers on how to recognize the signs and symptoms of an overdose.

Explain to patients and caregivers that naloxone’s effects are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered (see OVERDOSAGE).

If naloxone is prescribed, also advise patients and caregivers:

How to treat with naloxone in the event of an opioid overdose
To tell family and friends about their naloxone and to keep it in a place where family and friends can access it in an emergency
To read the Patient Information (or other educational material) that will come with their naloxone. Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do.

Accidental Ingestion

Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS ].

Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-threatening

Respiratory Depression in Children

Advise caregivers that acetaminophen and codeine phosphate tablets are contraindicated in all children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Advise caregivers of children 12 to 18 years of age receiving acetaminophen and codeine to monitor for signs of respiratory depression [see WARNINGS].

Interactions with Benzodiazepines and Other CNS Depressants

Inform patients and caregivers that potentially fatal additive effects may occur if Acetaminophen and Codeine Phosphate Tablets, USP is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these drugs concomitantly unless supervised by a healthcare provider [see WARNINGS, PRECAUTIONS; Drug Interactions ].

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms and signs of serotonin syndrome and to seek medical attention right away if symptoms develop.

Instruct patients to inform their healthcare provider if they are taking, or plan to take serotonergic medications [see PRECAUTIONS; Drug Interactions ].

MAOI Interaction

Inform patients not to take Acetaminophen and Codeine Phosphate Tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Acetaminophen and Codeine Phosphate Tablets, USP [see WARNINGS , Drug Interactions ].

Adrenal Insufficiency

Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see WARNINGS ].

Important Administration Instructions

Instruct patients how to properly take Acetaminophen and Codeine Phosphate Tablets [see DOSAGE and ADMINISTRATION ].

Advise patients not to adjust the dose of acetaminophen and codeine phosphate tablets without consulting a physician or other healthcare professional.

Important Discontinuation Instructions

In order to avoid developing withdrawal symptoms, instruct patients not to discontinue Acetaminophen and Codeine Phosphate Tablets without first discussing a tapering plan with the prescriber [see DOSAGE AND ADMINISTRATION ]

Maximum Daily Dose of Acetaminophen

Inform patients not to take more than 4,000 milligrams of acetaminophen per day. Advise patients to call their healthcare provider if they have taken more than the recommended dose.

Hypotension

Inform patients that Acetaminophen and Codeine Phosphate Tablets may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see WARNINGS; Hypotension ].

Anaphylaxis

Inform patients that anaphylaxis has been reported with ingredients contained in Acetaminophen and Codeine Phosphate Tablets. Advise patients how to recognize such a reaction, and if they develop signs of allergy such as a rash or difficulty breathing to stop taking Acetaminophen and Codeine Phosphate Tablets and seek medical attention. [see Contraindications, Adverse Reactions ].

Pregnancy

Neonatal Opioid Withdrawal Syndrome

Inform female patients of reproductive potential that prolonged use of Acetaminophen and Codeine Phosphate Tablets, USP during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see WARNINGS, Pregnancy ].

Embryo-Fetal Toxicity

Inform female patients of reproductive potential that Acetaminophen and Codeine Phosphate Tablets, USP can cause fetal harm and to inform the prescriber of a known or suspected pregnancy [see PRECAUTIONS; Pregnancy ].

Lactation

Advise women that breastfeeding is not recommended during treatment with acetaminophen and codeine phosphate tablets [see PRECAUTIONS; Nursing Mothers ].

Infertility

Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible.

Driving or Operating Heavy Machinery

Inform patients that Acetaminophen and Codeine Phosphate Tablets may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery and to avoid such tasks while taking this product, until they know how they will react to the medication.

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see ADVERSE REACTIONS, CLINICAL PHARMACOLOGY].

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.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.