Oxycodone and Acetaminophen (Page 3 of 8)

PRECAUTIONS

Information for Patients/Caregivers

Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Storage and Disposal:
Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store Oxycodone and Acetaminophen Tablets 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 Oxycodone and Acetaminophen Tablets 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 Oxycodone and Acetaminophen Tablets by following these four steps:
• Mix Oxycodone and Acetaminophen Tablets (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.
Addiction, Abuse, and Misuse
Inform patients that the use of oxycodone and acetaminophen tablets, 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 oxycodone and acetaminophen tablets with others and to take steps to protect oxycodone and acetaminophen tablets 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 oxycodone and acetaminophen tablets or when the dosage is increased, and that it can occur even at recommended dosages [see WARNINGS]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Accidental Ingestion
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS]. Instruct patients to take steps to store oxycodone and acetaminophen tablets securely and to dispose of unused Oxycodone and Acetaminophen Tablets by flushing tablets down the toilet. In the case of accidental ingestions, emergency medical care should be sought immediately.
Interactions with Benzodiazepines and Other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if Oxycodone and acetaminophen tablets is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider [see WARNINGS and 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 of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see PRECAUTIONS;Drug Interactions].
Monoamine Oxidase Inhibitor (MAOI) Interaction
Inform patients to avoid taking Oxycodone and Acetaminophen Tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Oxycodone and Acetaminophen Tablets [see PRECAUTIONS; 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 Oxycodone and Acetaminophen Tablets (see DOSAGE AND ADMINISTRATION, WARNINGS).
Advise patients not to adjust the dose of Oxycodone and Acetaminophen Tablets without consulting with a physician or other healthcare professional.
If patients have been receiving treatment with Oxycodone and Acetaminophen Tablets for more than a few weeks and cessation of therapy is indicated , counsel them on the importance of safely tapering the dose as abrupt discontinuation of the medication could precipitate withdrawal symptoms. Provide a dose schedule to accomplish a gradual discontinuation of the medication [see DOSAGE AND ADMINISTRATION].
Important Discontinuation Instructions
In order to avoid developing withdrawal symptoms, instruct patients not to discontinue Oxycodone and Acetaminophen Tablets without first discussing a tapering plan with the prescriber [see DOSAGE AND ADMINISTRATION ]
Maximum Daily Dose of Acetaminophen
Inform patients to not take more than 4000 milligrams of acetaminophen per day. Advise patients to call their prescriber if they take more than the recommended dose.
Hypotension
Inform patients that Oxycodone and Acetaminophen 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].
Anaphylaxis
Inform patients that anaphylaxis have been reported with ingredients contained in Oxycodone Hydrochloride and Acetaminophen Tablets. Advise patients how to recognize such a reaction and when to seek medical attention [see CONTRAINDICATIONS, ADVERSE REACTIONS].
Pregnancy
Neonatal Opioid Withdrawal Syndrome
Inform female patients of reproductive potential that prolonged use of Oxycodone Hydrochloride and Acetaminophen Tablets during pregnancy can result in neonatal opioid withdrawal syndrome,which may be life-threatening if not recognized and treated[see WARNINGS, PRECAUTIONS; Pregnancy]
Embryo-Fetal Toxicity
Inform female patients of reproductive potential that oxycodone Hydrochloride and acetaminophen tablets can cause fetal harm and to inform the healthcare provider of a known or suspected pregnancy [see PRECAUTIONS; Pregnancy].
Lactation
Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs [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 [see ADVERSE REACTIONS].
Driving or Operating Heavy Machinery
Inform patients that Oxycodone and Acetaminophen Tablets may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication [see PRECAUTIONS].
ConstipationAdvise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see ADVERSE REACTIONS, CLINICAL PHARMACOLOGY].

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