Medication Guide

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

Addiction, Abuse, and Misuse

Inform patients that the use of Morphine Sulfate Extended-release tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death. Instruct patients not to share Morphine Sulfate Extended-release tablets with others and to take steps to protect Morphine Sulfate Extended-release 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 Morphine Sulfate Extended-release tablets or when the dosage is increased, and that it can occur even at recommended doses . 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. Instruct patients to take steps to store Morphine Sulfate Extended-release tablets securely and to dispose of unused Morphine Sulfate Extended-release tablets by flushing the tablets down the toilet.

Interactions with Benzodiazepines and Other CNS Depressants

Inform patients and caregivers that potentially fatal additive effects may occur if Morphine Sulfate Extended-release tablets is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider.

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 physicians if they are taking, or plan to take serotonergic medications.

MAOI Interaction

Inform patients not to take Morphine Sulfate Extended-release tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Morphine Sulfate Extended-release tablets.

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.

Important Administration Instructions

Instruct patients how to properly take Morphine Sulfate Extended-release tablets, including the following:

Swallow Morphine Sulfate Extended-release tablets whole [see Dosage and Administration

Do not crush, chew, or dissolve the tablets [see Dosage and Administration

Use Morphine Sulfate Extended-release tablets exactly as prescribed to reduce the risk of life-threatening adverse reactions (e.g., respiratory depression)
Do not discontinue Morphine Sulfate Extended-release tablets without first discussing the need for a tapering regimen with the prescriber.

Hypotension

Inform patients that Morphine Sulfate Extended-release 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).

Anaphylaxis

Inform patients that anaphylaxis has been reported with ingredients contained in Morphine Sulfate Extended-release tablets. Advise patients how to recognize such a reaction and when to seek medical attention.

Pregnancy

Neonatal Opioid Withdrawal Syndrome

Inform female patients of reproductive potential that prolonged use of Morphine Sulfate Extended-release tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.

Embryo-Fetal Toxicity

Inform female patients of reproductive potential that Morphine Sulfate Extended-release tablets can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy.

Lactation

Advise patients that breastfeeding is not recommended during treatment with Morphine Sulfate Extended-release tablets.

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 Morphine Sulfate Extended-release 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.

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention.

Disposal of Unused Morphine Sulfate Extended-release tablets

Advise patients to flush the unused tablets down the toilet when Morphine Sulfate Extended-release tablets are no longer needed.