Fentanyl Cit 0.05mg/ml Inj, 50ml
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 that belongs to a group of drugs called opioids. It is given by injection, usually in a hospital or clinic setting, to help manage severe pain, especially during and after surgery, or as part of anesthesia. It works by changing how your brain and nervous system respond to pain.
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.
For proper storage and disposal of this medication, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store it at home.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
For proper storage and disposal of this medication, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store it at home.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Avoid alcohol and other sedatives while receiving fentanyl, as this can dangerously increase drowsiness and slow breathing.
- Do not drive or operate heavy machinery after receiving fentanyl until you know how it affects you and you are no longer feeling drowsy or dizzy.
- Report any difficulty breathing, extreme drowsiness, or confusion to your healthcare provider immediately.
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:
Individualized based on patient status and procedure. For IV anesthesia: 2-20 mcg/kg, often followed by maintenance doses of 1-2 mcg/kg.
Dose Range:
0.002 - 0.02 mg
Condition-Specific Dosing:
premedication:
50-100 mcg IV/IM 30-60 minutes prior to surgery
induction_and_maintenance:
2-20 mcg/kg IV, followed by 1-2 mcg/kg IV as needed
adjunct_to_general_anesthesia:
2-50 mcg/kg IV, depending on desired effect and duration
Pediatric Dosing
Neonatal:
Not established for routine use; extreme caution and reduced doses if used for specific procedures (e.g., cardiac surgery).
Infant:
1-2 mcg/kg IV for induction/maintenance of anesthesia. Titrate carefully.
Child:
1-2 mcg/kg IV for induction/maintenance of anesthesia. Titrate carefully.
Adolescent:
Similar to adult dosing, 1-2 mcg/kg IV for induction/maintenance of anesthesia. Titrate carefully.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment, but monitor for increased effects.
Moderate:
Use with caution; consider reduced initial dose and slower titration due to potential for prolonged effects.
Severe:
Use with caution; consider reduced initial dose and slower titration due to potential for prolonged effects.
Dialysis:
Fentanyl is not significantly removed by dialysis. Monitor for prolonged effects.
Hepatic Impairment:
Mild:
No specific dose adjustment, but monitor for increased effects.
Moderate:
Use with caution; consider reduced initial dose and slower titration due to potential for prolonged effects.
Severe:
Use with caution; consider reduced initial dose and slower titration due to potential for prolonged effects.
Pharmacology
Mechanism of Action
Fentanyl is a potent, synthetic opioid agonist that primarily interacts with the mu-opioid receptors in the central nervous system (CNS). These receptors are coupled to G-proteins and their activation leads to inhibition of adenylyl cyclase, decreased intracellular cAMP, and modulation of ion channel activity (e.g., opening of potassium channels, closing of calcium channels). This results in hyperpolarization of neurons and inhibition of neurotransmitter release, leading to analgesia, sedation, and respiratory depression.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV)
Tmax:
Rapid (IV, within minutes)
FoodEffect:
Not applicable (IV)
Distribution:
Vd:
4 L/kg (initial), 4-6 L/kg (steady state)
ProteinBinding:
80-85% (primarily to alpha-1-acid glycoprotein)
CnssPenetration:
Yes
Elimination:
HalfLife:
3-7 hours (terminal elimination half-life)
Clearance:
0.8-1.2 L/kg/hr
ExcretionRoute:
Primarily renal (75% as metabolites, <10% as unchanged drug), fecal (9% as metabolites)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Immediate (IV)
PeakEffect:
1-5 minutes (IV)
DurationOfAction:
30-60 minutes (single IV dose)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE: Fentanyl Injection 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 Fentanyl Injection, 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 of Fentanyl Injection or following a dose increase.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of Fentanyl Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
CYP3A4 INTERACTION: The concomitant use of Fentanyl Injection with all CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used CYP3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving Fentanyl Injection and any CYP3A4 inhibitor or inducer.
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. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of Fentanyl Injection or following a dose increase.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of Fentanyl Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
CYP3A4 INTERACTION: The concomitant use of Fentanyl Injection with all CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used CYP3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving Fentanyl Injection and any CYP3A4 inhibitor or inducer.
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. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
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 Rare but Serious Condition
If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a potentially life-threatening condition. Seek medical help immediately if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or slow)
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. Seek medical help immediately if you experience:
Extreme fatigue or weakness
Fainting
Severe dizziness
Upset stomach
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 contact your doctor or seek medical help if you notice any of the following:
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
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 Rare but Serious Condition
If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a potentially life-threatening condition. Seek medical help immediately if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or slow)
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. Seek medical help immediately if you experience:
Extreme fatigue or weakness
Fainting
Severe dizziness
Upset stomach
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 contact your doctor or seek medical help if you notice any of the following:
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
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
- Confusion
- Bluish lips or fingernails
- Pinpoint pupils
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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without first 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.
Long-term or high-dose use of this medication can lead to tolerance, where the drug becomes less effective, and higher doses may be needed to achieve the same pain relief. If you notice that the medication is not working as well as it previously did, contact your doctor. Do not exceed the prescribed dose, as this can increase the risk of severe side effects.
Prolonged or regular use of opioid medications like this one can cause dependence. If you need to reduce the dose or stop taking the medication, consult your doctor first, as suddenly lowering the dose or stopping the medication can lead to withdrawal symptoms or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Adhere to your doctor's prescribed dose, frequency, and duration of treatment. Taking more than the recommended dose, taking it more frequently, or using it for an extended period can increase the risk of severe side effects.
Before taking this medication with other strong pain relievers or using a pain patch, consult your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain, contact your doctor immediately. Do not exceed the prescribed dose.
If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor, as it may interact with the medication. Avoid using this medication with alcohol or products containing alcohol, as this can lead to unsafe and potentially life-threatening effects.
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Long-term use of opioid medications can lead to decreased sex hormone levels. If you experience a decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
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 can pass into breast milk and potentially harm your baby. Monitor your baby for excessive sleepiness, limpness, or breathing difficulties, and seek medical attention immediately if you notice any of these symptoms.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.
Long-term or high-dose use of this medication can lead to tolerance, where the drug becomes less effective, and higher doses may be needed to achieve the same pain relief. If you notice that the medication is not working as well as it previously did, contact your doctor. Do not exceed the prescribed dose, as this can increase the risk of severe side effects.
Prolonged or regular use of opioid medications like this one can cause dependence. If you need to reduce the dose or stop taking the medication, consult your doctor first, as suddenly lowering the dose or stopping the medication can lead to withdrawal symptoms or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Adhere to your doctor's prescribed dose, frequency, and duration of treatment. Taking more than the recommended dose, taking it more frequently, or using it for an extended period can increase the risk of severe side effects.
Before taking this medication with other strong pain relievers or using a pain patch, consult your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain, contact your doctor immediately. Do not exceed the prescribed dose.
If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor, as it may interact with the medication. Avoid using this medication with alcohol or products containing alcohol, as this can lead to unsafe and potentially life-threatening effects.
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Long-term use of opioid medications can lead to decreased sex hormone levels. If you experience a decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
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 can pass into breast milk and potentially harm your baby. Monitor your baby for excessive sleepiness, limpness, or breathing difficulties, and seek medical attention immediately if you notice any of these symptoms.
Overdose Information
Overdose Symptoms:
- Severe respiratory depression (slowed or stopped breathing)
- Extreme somnolence progressing to stupor or coma
- Skeletal muscle flaccidity
- Cold, clammy skin
- Pinpoint pupils (miosis)
- Bradycardia
- Hypotension
- Circulatory collapse
- Cardiac arrest
- Death
What to Do:
Seek immediate emergency medical attention. Administer naloxone (Narcan) if available and trained. Call 911 or 1-800-222-1222 (Poison Control) immediately.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of serotonin syndrome or severe CNS depression)
- Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nelfinavir, cobicistat) - relative contraindication, extreme caution and dose reduction if unavoidable
Major Interactions
- Other CNS depressants (e.g., benzodiazepines, other opioids, sedatives/hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, alcohol) - increased risk of profound sedation, respiratory depression, coma, and death.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol) - risk of serotonin syndrome.
- Mixed agonist/antagonist opioids (e.g., buprenorphine, nalbuphine, butorphanol) - may reduce fentanyl's analgesic effect and/or precipitate withdrawal symptoms.
Moderate Interactions
Minor Interactions
- Anticholinergics - increased risk of urinary retention and/or severe constipation.
Monitoring
Baseline Monitoring
Respiratory rate and depth
Rationale: To assess for respiratory depression, the most serious adverse effect.
Timing: Pre-administration
Oxygen saturation (SpO2)
Rationale: To monitor for hypoxemia.
Timing: Pre-administration
Blood pressure and heart rate
Rationale: To assess for cardiovascular effects (e.g., bradycardia, hypotension).
Timing: Pre-administration
Level of consciousness/sedation score
Rationale: To assess baseline neurological status and risk of over-sedation.
Timing: Pre-administration
Pain level (if applicable)
Rationale: To establish baseline for efficacy assessment.
Timing: Pre-administration
Routine Monitoring
Respiratory rate and depth
Frequency: Continuously during and immediately after administration, then every 5-15 minutes until stable, then as clinically indicated.
Target: 12-20 breaths/min (adults), age-appropriate for pediatrics
Action Threshold: <10 breaths/min (adults), significant decrease from baseline, or irregular breathing pattern
Oxygen saturation (SpO2)
Frequency: Continuously during and immediately after administration, then every 5-15 minutes until stable, then as clinically indicated.
Target: >92-95%
Action Threshold: <90% or significant drop from baseline
Level of consciousness/sedation score
Frequency: Every 5-15 minutes during and after administration, then as clinically indicated.
Target: Alert to easily aroused
Action Threshold: Unarousable, excessive somnolence
Blood pressure and heart rate
Frequency: Every 5-15 minutes during and after administration, then as clinically indicated.
Target: Within patient's normal range
Action Threshold: Significant hypotension or bradycardia
Pain level
Frequency: As needed, based on patient's condition and procedure.
Target: Acceptable pain score for patient
Action Threshold: Uncontrolled pain
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation or somnolence
- Nausea and vomiting
- Constipation
- Pruritus (itching)
- Muscle rigidity (especially truncal rigidity with rapid IV administration)
- Bradycardia
- Hypotension
- Dizziness
- Confusion
Special Patient Groups
Pregnancy
Fentanyl crosses the placenta. Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening. Use during labor and delivery may cause respiratory depression in the neonate. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure. Risk of NOWS if prolonged use continues into later trimesters.
Second Trimester:
Risk of NOWS if prolonged use continues into later trimesters.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Risk of acute respiratory depression in the neonate if used close to delivery.
Lactation
Fentanyl is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., sedation, respiratory depression), breastfeeding is not recommended during treatment with fentanyl. If breastfeeding cannot be avoided, monitor the infant closely for signs of sedation and respiratory depression.
Infant Risk:
Moderate risk (L3) - potential for sedation, respiratory depression, and withdrawal symptoms in the infant.
Pediatric Use
Fentanyl injection is used in pediatric patients for anesthesia and analgesia, but dosing must be carefully individualized and titrated based on age, weight, and clinical condition. Neonates and very young infants may be more sensitive to respiratory depressant effects. Close monitoring is essential.
Geriatric Use
Elderly patients may be more sensitive to the effects of fentanyl, particularly respiratory depression. A reduced initial dose and slower titration are recommended. Monitor closely for adverse effects, especially respiratory and CNS depression.
Clinical Information
Clinical Pearls
- Always have naloxone readily available when administering fentanyl.
- Administer IV fentanyl slowly (over 1-2 minutes) to minimize the risk of muscle rigidity, especially truncal rigidity, which can impair ventilation.
- Fentanyl has a rapid onset and short duration of action for single IV boluses, making it suitable for acute pain management and anesthesia induction/maintenance.
- Be aware of the potential for delayed respiratory depression, especially after large or repeated doses, due to redistribution from peripheral tissues.
- Consider the patient's opioid tolerance when determining initial doses; opioid-naive patients require significantly lower doses.
- The 0.05 mg/ml (50 mcg/ml) concentration is commonly used for direct IV administration and titration.
Alternative Therapies
- Morphine (opioid analgesic)
- Hydromorphone (opioid analgesic)
- Sufentanil (another potent synthetic opioid)
- Remifentanil (ultra-short acting opioid)
- Alfentanil (short-acting opioid)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts
- Regional anesthesia/analgesia techniques
Cost & Coverage
Average Cost:
Varies significantly by manufacturer, volume, and purchasing contract. Typically ranges from $10-$50 per 50ml vial. per 50ml vial
Generic Available:
Yes
Insurance Coverage:
Typically covered under medical benefit for hospital/clinic administration. For outpatient, usually Tier 2 or 3 if applicable.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others, and never 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 this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. It is also crucial to be aware that an overdose of this medication can be treated with naloxone. Consult your doctor or pharmacist about obtaining and using naloxone, and remember that if an overdose is suspected, immediate medical attention is necessary, even if naloxone has been administered.
In the event of a suspected overdose, call your local poison control center or seek medical care immediately. Be prepared to provide information about the medication, including the amount taken and the time of ingestion, to ensure prompt and effective treatment.
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 this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. It is also crucial to be aware that an overdose of this medication can be treated with naloxone. Consult your doctor or pharmacist about obtaining and using naloxone, and remember that if an overdose is suspected, immediate medical attention is necessary, even if naloxone has been administered.
In the event of a suspected overdose, call your local poison control center or seek medical care immediately. Be prepared to provide information about the medication, including the amount taken and the time of ingestion, to ensure prompt and effective treatment.