IMPORTANT SAFETY INFORMATION

Fentanyl Citrate Injection, USP

WARNING: RISK OF ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Dilaudid^® (HYDROmorphone HCl) Injection, USP

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Morphine Sulfate Injection, USP

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Please see complete Important Safety Information including Boxed Warning.

Indications and usage

Fentanyl Citrate Injection, for intravenous or intramuscular use, is indicated for:

Analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance and in the immediate postoperative period (recovery room) as the need arises.
Use as an opioid analgesic supplement in general or regional anesthesia.
Administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
Use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.

Fentanyl Citrate Injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids. Ensure that an opioid antagonist, resuscitative and intubation equipment, and oxygen are readily available.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

See full prescribing information for complete boxed warning.

Fentanyl Citrate Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.
Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl.
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Fentanyl Citrate Injection is contraindicated in patients with a hypersensitivity to fentanyl.

Risks of Skeletal Muscle Rigidity and Skeletal Muscle Movement: Manage with neuromuscular blocking agent. See full prescribing information for more detail on managing these risks.

Severe Cardiovascular Depression: Monitor during dosage initiation and titration.

Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue Fentanyl Citrate Injection if serotonin syndrome is suspected.

Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.

Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, or Head Injury: Monitor for sedation and respiratory depression.

The most common serious adverse reactions were respiratory depression, apnea, rigidity, and bradycardia.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Concomitant Use of CNS Depressants: May decrease pulmonary arterial pressure and may cause hypotension. See full prescribing information for management instructions. For post-operative pain, start with the lowest effective dosage and monitor for potentiation of CNS depressant effects.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Fentanyl Citrate Injection because they may reduce the analgesic effect of Fentanyl Citrate Injection or precipitate withdrawal symptoms.

Pregnancy: May cause fetal harm.

Lactation: Infants exposed to Fentanyl Citrate Injection through breast milk should be monitored for excess sedation and respiratory depression.

Geriatric Patients: Titrate slowly and monitor for CNS and respiratory depression.

This Important Safety Information does not include all the information needed to use FENTANYL CITRATE safely and effectively. Please see full prescribing information, including BOXED WARNING, for FENTANYL CITRATE INJECTION.

Indications and usage

DILAUDID INJECTION is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve DILAUDID INJECTION for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

Have not been tolerated, are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

See full prescribing information for complete boxed warning.

DILAUDID INJECTION exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.
Prolonged use of DILAUDID INJECTION during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

DILAUDID INJECTION is contraindicated in patients with:

Significant respiratory depression.
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.
Known or suspected gastrointestinal obstruction, including paralytic ileus.
Known hypersensitivity to hydromorphone, hydromorphone salts, sulfite-containing medications, or any other components of the product.

Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.

Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.

Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of DILAUDID INJECTION in patients with circulatory shock.

Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of DILAUDID INJECTION in patients with impaired consciousness or coma.

DILAUDID INJECTION contains sodium metabisulfite. There is a risk of anaphylactic symptoms and life-threatening asthmatic episodes in susceptible people.

Most common adverse reactions are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Serotenergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue DILAUDID INJECTION if serotonin syndrome is suspected.

Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of hydromorphone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping treatment with an MAOI.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with DILAUDID INJECTION because they may reduce analgesic effect of DILAUDID INJECTION or precipitate withdrawal symptoms.

Pregnancy: May cause fetal harm.

Overdosage: Acute overdose with DILAUDID INJECTION can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis, rather than miosis, may be seen with hypoxia in overdose situations.

This Important Safety Information does not include all the information needed to use DILAUDID safely and effectively. Please see full prescribing information, including BOXED WARNING, for Dilaudid Injection.

Indications and usage

Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

Have not been tolerated, are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

See full prescribing information for complete boxed warning.

Morphine Sulfate Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.
Prolonged use of Morphine Sulfate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Morphine Sulfate Injection is contraindicated in patients with:

Significant respiratory depression.
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days.
Known or suspected gastrointestinal obstruction, including paralytic ileus.
Hypersensitivity to morphine.

Cardiovascular Instability: High doses are excitatory. Have Naloxone Injection and resuscitative equipment immediately available.

Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.

Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.

Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Injection in patients with circulatory shock.

Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Morphine Sulfate Injection in patients with impaired consciousness or coma.

The most serious adverse reactions encountered are respiratory depression, apnea, circulatory depression, respiratory arrest, shock and cardiac arrest. Common frequently observed adverse reactions include: sedation, lightheadedness, dizziness, nausea, vomiting, constipation and diaphoresis.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC, at 1-800-551-7176 option 5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue Morphine Sulfate Injection if serotonin syndrome is suspected.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Morphine Sulfate Injection because they may reduce analgesic effect of Morphine Sulfate Injection or precipitate withdrawal symptoms.

Pregnancy: May cause fetal harm.

Overdosage: Acute overdose with Morphine Sulfate Injection can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose.

This important safety information does not include all the information needed to use MORPHINE SULFATE INJECTION safely and effectively. Please see full prescribing information, including BOXED WARNING, for Morphine Sulfate Injection.

As healthcare costs continue to rise, it is essential to limit medication waste and workforce time waste whenever and wherever possible.¹

Less waste means fewer opportunities for diversion

Our comprehensve narcotic portfolio of Simplist^® ready-to-administer prefilled syringes help minimize risk by reducing waste potential and the opportunity for diversion.

Fentanyl 50 mcg per 1 mL Simplist prefilled syringe

Dilaudid 0.2 mg per 1 mL Simplist prefilled syringe

Dilaudid 0.5 mg per 0.5 mL Simplist prefilled syringe

Morphine 2 mg per 1 mL Simplist prefilled syringe

Hover over syringes for more product information

Tap syringes for more product information.

Simplist prefilled syringe presentations that more closely align with commonly ordered doses help reduce the need to waste excess medication.¹

Simplist less waste product optimization illustration

Average potential reduction in waste events^*

52%

Fentanyl Citrate Injection, USP

69%

Hydromorphone HCl Injection, USP

50%

Morphine Sulfate Injection, USP

^*Data on file provided by real clients (Fentanyl Citrate Injection, USP N = 36, Hydromorphone HCl Injection, USP N = 37, Morphine Sulfate Injection, USP N = 24).

Fresenius Kabi provides no guarantee of the likelihood that you will achieve similar results if you use our products.

Based on hospitals analyzed, we found institutions benefited in these areas^*:

Let's reduce narcotic waste together

We can help identify the necessary waste data from your automated dispensing systems and calculate how much narcotic waste is costing your institution. Schedule a call with our Pharmacy Analytics team for a custom analysis.

As healthcare costs continue to rise, it is essential to limit medication waste and workforce time waste whenever and wherever possible.1

Less waste means fewer opportunities for diversion

Simplist prefilled syringe presentations that more closely align with commonly ordered doses help reduce the need to waste excess medication.1

Average potential reduction in waste events*

52%

Fentanyl Citrate Injection, USP

69%

Hydromorphone HCl Injection, USP

50%

Morphine Sulfate Injection, USP

Based on hospitals analyzed, we found institutions benefited in these areas*:

Fentanyl

(n = 37)

52%

52%

52%

Hydromorphone

(n = 36)

52%

52%

52%

Morphine

(n = 24)

52%

52%

52%

Let's reduce narcotic waste together

As healthcare costs continue to rise, it is essential to limit medication waste and workforce time waste whenever and wherever possible.¹

Simplist prefilled syringe presentations that more closely align with commonly ordered doses help reduce the need to waste excess medication.¹

Average potential reduction in waste events^*

Based on hospitals analyzed, we found institutions benefited in these areas^*: