fentanyl citrate injection, USP VIAL , AMPULE 17 PATIENT COUNSELING INFORMATION

17 PATIENT COUNSELING INFORMATION

Addiction, Abuse, and Misuse ‎

Inform patients that the use of Fentanyl Citrate Injection, even when taken as recommended, can result in ‎addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1)]. ‎

Life-Threatening Respiratory Depression

Inform patients of the risk of life-threatening respiratory depression, including information that the risk is ‎greatest when starting Fentanyl Citrate Injection or when the dosage is increased, and that it can occur ‎even at recommended dosages ‎[see Warnings and Precautions (5.2)]‎.

Hyperalgesia and Allodynia

Advise ‎patients to inform their healthcare provider if they ‎experience symptoms of hyperalgesia, including worsening ‎pain, increased ‎sensitivity to pain, or new pain [see Warnings and Precautions (5.7), ‎Adverse Reactions (6)].‎

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening condition called serotonin syndrome 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 after discharge from the hospital.‎ Instruct patients to inform their healthcare provider if they are taking, or plan to take serotonergic medications [see Warnings and Precautions (5.8), Drug Interactions (7)].

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Clinical Pharmacology (12.2)].

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Medication Guide

Health Professional Information

17 PATIENT COUNSELING INFORMATION

17 PATIENT COUNSELING INFORMATION

Addiction, Abuse, and Misuse ‎

Inform patients that the use of Fentanyl Citrate Injection, even when taken as recommended, can result in ‎addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1)]. ‎

Life-Threatening Respiratory Depression

Inform patients of the risk of life-threatening respiratory depression, including information that the risk is ‎greatest when starting Fentanyl Citrate Injection or when the dosage is increased, and that it can occur ‎even at recommended dosages ‎[see Warnings and Precautions (5.2)]‎.

Hyperalgesia and Allodynia

Advise ‎patients to inform their healthcare provider if they ‎experience symptoms of hyperalgesia, including worsening ‎pain, increased ‎sensitivity to pain, or new pain [see Warnings and Precautions (5.7), ‎Adverse Reactions (6)].‎

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening condition called serotonin syndrome 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 after discharge from the hospital.‎ Instruct patients to inform their healthcare provider if they are taking, or plan to take serotonergic medications [see Warnings and Precautions (5.8), Drug Interactions (7)].

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Clinical Pharmacology (12.2)].

Prescribing Information
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Health Professional Information

17 PATIENT COUNSELING INFORMATION

17 PATIENT COUNSELING INFORMATION

Addiction, Abuse, and Misuse ‎

Inform patients that the use of Fentanyl Citrate Injection, even when taken as recommended, can result in ‎addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1)]. ‎

Life-Threatening Respiratory Depression

Inform patients of the risk of life-threatening respiratory depression, including information that the risk is ‎greatest when starting Fentanyl Citrate Injection or when the dosage is increased, and that it can occur ‎even at recommended dosages ‎[see Warnings and Precautions (5.2)]‎.

Hyperalgesia and Allodynia

Advise ‎patients to inform their healthcare provider if they ‎experience symptoms of hyperalgesia, including worsening ‎pain, increased ‎sensitivity to pain, or new pain [see Warnings and Precautions (5.7), ‎Adverse Reactions (6)].‎

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening condition called serotonin syndrome 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 after discharge from the hospital.‎ Instruct patients to inform their healthcare provider if they are taking, or plan to take serotonergic medications [see Warnings and Precautions (5.8), Drug Interactions (7)].

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Clinical Pharmacology (12.2)].

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