Fentanyl Cit 0.05mg/ml Inj, 5ml
WARNING: This is an opioid drug. Opioid drugs can put you at risk for drug use disorder. These can lead to overdose and death. You will be watched closely while taking this drug.Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing. Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life-threatening if not treated. @ COMMON USES: It is used to manage pain.
Drug Class
Opioid analgesic
Pharmacologic Class
Opioid agonist
Pregnancy Category
Category C
FDA Approved
Jun 1968
DEA Schedule
Schedule II
Overview
What is this medicine?
Fentanyl is a very strong pain medicine, part of a group called opioids. It works by changing how your brain and nervous system respond to pain. It is often used in hospitals for severe pain or during surgery.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This medication is administered via injection.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Avoid alcohol and other sedatives while taking this medication, as they can increase the risk of serious side effects like severe drowsiness and breathing problems.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
- Inform your healthcare provider about all other medications you are taking, especially other pain medications, sedatives, or antidepressants.
- Keep this medication out of reach of children and pets, as even a small amount can be fatal if accidentally ingested.
Available Forms & Alternatives
Available Strengths:
- Fentanyl 25mcg/hr Patch
- Fentanyl 50mcg/hr Patch
- Fentanyl 75mcg/hr Patch
- Fentanyl 100mcg/hr Patch
- Fentanyl Cit 0.05mg/ml Inj, 20ml
- Fentanyl Cit 0.05mg/ml Inj, 2ml
- Fentanyl Cit 0.05mg/ml Inj, 50ml
- Fentanyl Cit 0.05mg/ml Inj, 5ml
- Fentanyl Cit 800mcg Oral Transmcsl
- Fentanyl Cit 1200mcg Oral Transmcsl
- Fentanyl Cit 600mcg Oral Transmcsl
- Fentanyl Cit 1600mcg Oral Transmcsl
- Fentanyl Cit 400mcg Oral Transmcsl
- Fentanyl Cit 200mcg Oral Transmcsl
- Fentanyl 62.5mcg/hr Patch
- Fentanyl 87.5mcg/hr Patch
- Fentanyl Cit 600mcg Oraltransmcsl
- Fentanyl Cit 800mcg Oral Transmcsl
- Fentanyl Cit 1600mcg Oral Transmcsl
- Fentanyl Cit 100mcg Tablets
- Fentanyl Cit 200mcg Tablets
- Fentanyl 37.5mcg/hr Patch
- Fentanyl 62.5mcg/hr Patch
- Fentanyl Cit 50mcg/ml Pf Inj, 1ml
- Fentanyl 12mcg/hr Patch
- Fentanyl Cit 50mcg/1ml Inj, 10ml
- Fentanyl Cit 100mcg/2ml Pf Inj, 2ml
- Fentanyl Cit 25mcg/0.5ml Pf Inj
Dosing & Administration
Adult Dosing
Standard Dose:
For analgesia: 50-100 mcg (1-2 mL) IV/IM, repeated every 1-2 hours as needed. For anesthesia adjunct: 2-20 mcg/kg (0.04-0.4 mL/kg) IV, depending on procedure and desired effect.
Dose Range:
25 - 200 mg
Condition-Specific Dosing:
premedication:
50-100 mcg (1-2 mL) IM 30-60 minutes prior to surgery.
anesthesia_induction:
2-20 mcg/kg (0.04-0.4 mL/kg) IV.
anesthesia_maintenance:
2-20 mcg/kg (0.04-0.4 mL/kg) IV, or 25-100 mcg (0.5-2 mL) IV as needed.
postoperative_pain:
50-100 mcg (1-2 mL) IM/IV every 1-2 hours as needed.
Pediatric Dosing
Neonatal:
Not established for routine use; extreme caution and reduced doses if used (e.g., 0.5-1 mcg/kg IV).
Infant:
1-2 mcg/kg (0.02-0.04 mL/kg) IV for anesthesia adjunct, repeated as needed. Max single dose 50 mcg.
Child:
1-2 mcg/kg (0.02-0.04 mL/kg) IV for anesthesia adjunct, repeated as needed. Max single dose 50 mcg.
Adolescent:
Similar to adult dosing, 1-2 mcg/kg (0.02-0.04 mL/kg) IV for anesthesia adjunct, or 50-100 mcg (1-2 mL) IV/IM for analgesia.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required, but monitor for increased effects.
Moderate:
Monitor closely for increased effects; consider lower initial doses and longer dosing intervals.
Severe:
Monitor closely for increased effects; consider lower initial doses and longer dosing intervals. Active metabolites may accumulate.
Dialysis:
Fentanyl is not significantly dialyzable. Monitor closely for prolonged effects.
Hepatic Impairment:
Mild:
No specific dose adjustment generally required, but monitor for increased effects.
Moderate:
Monitor closely for increased effects; consider lower initial doses and longer dosing intervals due to reduced clearance.
Severe:
Monitor closely for increased effects; consider lower initial doses and longer dosing intervals due to significantly reduced clearance.
Pharmacology
Mechanism of Action
Fentanyl is a potent, synthetic opioid analgesic that acts primarily as an agonist at mu-opioid receptors in the central nervous system (CNS). Its principal therapeutic actions are analgesia and sedation. It produces its effects by binding to stereospecific opioid receptors at various sites within the CNS, altering the perception of and response to pain.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV)
Tmax:
Immediate (IV)
FoodEffect:
Not applicable for IV injection
Distribution:
Vd:
4 L/kg (initial), 4-6 L/kg (steady state)
ProteinBinding:
80-85%
CnssPenetration:
Yes
Elimination:
HalfLife:
3-12 hours (terminal elimination half-life, highly variable)
Clearance:
0.5-1.5 L/kg/hr
ExcretionRoute:
Urine (75% as metabolites, <10% unchanged), Feces (9% as metabolites)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Within 1-2 minutes (IV)
PeakEffect:
3-5 minutes (IV)
DurationOfAction:
30-60 minutes (IV, single dose)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE: Fentanyl exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors and conditions.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.
ACCIDENTAL EXPOSURE: Accidental exposure to fentanyl, especially in children, can result in a fatal overdose.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.
CYP3A4 INTERACTION: Concomitant use with CYP3A4 inhibitors can increase fentanyl plasma concentrations, leading to increased or prolonged opioid effects and potentially fatal respiratory depression. Concomitant use with CYP3A4 inducers may decrease fentanyl plasma concentrations, leading to reduced efficacy or withdrawal symptoms.
RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.
ACCIDENTAL EXPOSURE: Accidental exposure to fentanyl, especially in children, can result in a fatal overdose.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.
CYP3A4 INTERACTION: Concomitant use with CYP3A4 inhibitors can increase fentanyl plasma concentrations, leading to increased or prolonged opioid effects and potentially fatal respiratory depression. Concomitant use with CYP3A4 inducers may decrease fentanyl plasma concentrations, leading to reduced efficacy or withdrawal symptoms.
RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Confusion
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Chest pain
Abnormal heartbeat (fast or slow)
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Changes in eyesight
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach or vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor right away if you experience:
Extreme fatigue or weakness
Fainting
Severe dizziness
Upset stomach or vomiting
Decreased appetite
Other Possible Side Effects
Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical attention:
Dizziness
Drowsiness
Fatigue or weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach or vomiting
Decreased appetite
Headache
Feeling cold
Sleep disturbances
Excessive sweating
Irritation at the site of administration
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Confusion
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Chest pain
Abnormal heartbeat (fast or slow)
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Changes in eyesight
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach or vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor right away if you experience:
Extreme fatigue or weakness
Fainting
Severe dizziness
Upset stomach or vomiting
Decreased appetite
Other Possible Side Effects
Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical attention:
Dizziness
Drowsiness
Fatigue or weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach or vomiting
Decreased appetite
Headache
Feeling cold
Sleep disturbances
Excessive sweating
Irritation at the site of administration
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Slow or shallow breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion
- Pinpoint pupils
- Cold, clammy skin
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
Kidney or liver disease
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
* Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing health conditions and medications. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
Kidney or liver disease
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
* Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing health conditions and medications. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is crucial to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the drug becomes less effective, and higher doses may be needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.
Additionally, regular use of opioid medications like this one can cause dependence. If you need to lower your dose or stop taking this medication, consult your doctor first, as sudden changes may increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Safe Use Guidelines
Do not exceed the prescribed dose, frequency, or duration of treatment, as this may increase the risk of severe side effects. Avoid taking this medication with other strong pain medications or using a pain patch without consulting your doctor first.
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Interactions and Contraindications
If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor. Do not take this medication with alcohol or products containing alcohol, as this may lead to unsafe and potentially fatal effects.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Hormonal Effects
Long-term use of opioid medications like this one may lead to decreased sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, inform your doctor, as this medication passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
It is crucial to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the drug becomes less effective, and higher doses may be needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.
Additionally, regular use of opioid medications like this one can cause dependence. If you need to lower your dose or stop taking this medication, consult your doctor first, as sudden changes may increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Safe Use Guidelines
Do not exceed the prescribed dose, frequency, or duration of treatment, as this may increase the risk of severe side effects. Avoid taking this medication with other strong pain medications or using a pain patch without consulting your doctor first.
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Interactions and Contraindications
If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor. Do not take this medication with alcohol or products containing alcohol, as this may lead to unsafe and potentially fatal effects.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Hormonal Effects
Long-term use of opioid medications like this one may lead to decreased sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, inform your doctor, as this medication passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
Overdose Information
Overdose Symptoms:
- Severe respiratory depression (very slow, shallow, or stopped breathing)
- Extreme drowsiness, inability to wake up
- Pinpoint pupils
- Limp muscles
- Cold, clammy skin
- Blue lips or fingernails
- Loss of consciousness
What to Do:
Seek immediate emergency medical attention. Call 911 or your local emergency number. If available, administer naloxone (Narcan) if the person is unresponsive or has severe breathing problems, and continue to monitor until emergency help arrives. Stay with the person and try to keep them awake and breathing.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of severe, unpredictable reactions)
Major Interactions
- CNS Depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants): Increased risk of respiratory depression, profound sedation, coma, and death.
- CYP3A4 Inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, erythromycin, verapamil, diltiazem, grapefruit juice): Increased fentanyl plasma concentrations, leading to prolonged opioid effects and increased risk of respiratory depression.
- Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, linezolid): Risk of serotonin syndrome.
- Opioid Agonist/Antagonists (e.g., buprenorphine, nalbuphine, pentazocine): May precipitate withdrawal symptoms or reduce analgesic effect.
Moderate Interactions
- CYP3A4 Inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Decreased fentanyl plasma concentrations, leading to reduced efficacy or withdrawal symptoms.
- Anticholinergic Drugs: Increased risk of urinary retention and severe constipation.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Respiratory rate and depth
Rationale: To assess baseline respiratory function and risk of respiratory depression.
Timing: Prior to administration
Level of consciousness/sedation
Rationale: To establish baseline mental status and assess risk of excessive sedation.
Timing: Prior to administration
Pain score
Rationale: To establish baseline pain level for efficacy assessment.
Timing: Prior to administration
Vital signs (heart rate, blood pressure)
Rationale: To assess cardiovascular stability.
Timing: Prior to administration
Routine Monitoring
Respiratory rate and depth
Frequency: Every 5-15 minutes initially, then as clinically indicated (e.g., every 30-60 minutes) during and after administration
Target: Typically >10-12 breaths/min (adults)
Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation (e.g., cyanosis, decreased SpO2)
Oxygen saturation (SpO2)
Frequency: Continuous or frequent monitoring during and after administration
Target: >92-95%
Action Threshold: <90% or significant drop from baseline
Level of consciousness/sedation (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Every 5-15 minutes initially, then as clinically indicated
Target: Alert to mildly drowsy (S1-S2)
Action Threshold: Difficult to arouse (S3) or unarousable (S4)
Pain score
Frequency: Every 30-60 minutes or as needed based on patient response
Target: Patient-specific goal (e.g., 0-3/10)
Action Threshold: Uncontrolled pain or adverse effects
Pupil size
Frequency: As clinically indicated
Target: Normal to pinpoint
Action Threshold: Pinpoint pupils (miosis) can indicate opioid effect
Symptom Monitoring
- Respiratory depression (slow, shallow breathing, cyanosis)
- Excessive sedation/drowsiness
- Dizziness/lightheadedness
- Nausea and vomiting
- Constipation
- Pruritus (itching)
- Urinary retention
- Muscle rigidity (especially with rapid IV administration or high doses)
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended unless the potential benefits outweigh the risks. Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening if not recognized and treated.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure.
Second Trimester:
Risk of neonatal opioid withdrawal syndrome increases with prolonged use.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome if used chronically. Risk of respiratory depression in the neonate if administered close to delivery.
Lactation
Fentanyl is excreted into breast milk. It is generally not recommended for use by breastfeeding mothers due to the potential for serious adverse reactions in the infant, including sedation, respiratory depression, and withdrawal symptoms.
Infant Risk:
High (L3 - Moderately Safe, but with significant caution; L4 - Potentially Hazardous, depending on dose and duration). Monitor infants for increased sedation, difficulty feeding, and respiratory depression. If used, consider pumping and discarding milk for a period after administration.
Pediatric Use
Use with extreme caution, especially in infants and young children, due to increased sensitivity to respiratory depressant effects. Dosing must be carefully calculated based on weight and age. Not recommended for routine use in neonates.
Geriatric Use
Elderly patients may be more sensitive to the effects of fentanyl, particularly respiratory depression. Lower initial doses and slower titration are recommended. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Fentanyl is extremely potent; even small errors in dosing can be fatal. Always double-check calculations.
- Rapid IV administration can cause chest wall rigidity, making ventilation difficult. Administer slowly.
- Naloxone should always be readily available when administering fentanyl.
- Due to its short duration of action, fentanyl is often preferred for short procedures or for rapid titration of analgesia.
- Tolerance and physical dependence can develop with repeated use, even over short periods.
- Patients receiving fentanyl should be continuously monitored for respiratory depression and sedation.
Alternative Therapies
- Other opioid analgesics (e.g., morphine, hydromorphone, sufentanil, remifentanil)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts
- Regional anesthesia techniques
- Local anesthetics
Cost & Coverage
Average Cost:
Not available (highly variable by supplier, contract, and volume) per 5mL vial
Generic Available:
Yes
Insurance Coverage:
Tier 2-3 (often covered for inpatient/surgical use)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
When disposing of unused doses, follow the instructions provided with the medication. If you have questions or concerns about disposal, consult your pharmacist for guidance. Additionally, some medications may come with a separate patient information leaflet; check with your pharmacist to see if this applies to your medication. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat the overdose. Consult your doctor or pharmacist about obtaining and using naloxone. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide information about the overdose, including the substance taken, the amount, and the time it occurred. You can also contact your local poison control center or seek emergency medical care right away, providing the same detailed information about the overdose.
When disposing of unused doses, follow the instructions provided with the medication. If you have questions or concerns about disposal, consult your pharmacist for guidance. Additionally, some medications may come with a separate patient information leaflet; check with your pharmacist to see if this applies to your medication. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat the overdose. Consult your doctor or pharmacist about obtaining and using naloxone. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide information about the overdose, including the substance taken, the amount, and the time it occurred. You can also contact your local poison control center or seek emergency medical care right away, providing the same detailed information about the overdose.