Fentanyl Cit 50mcg/1ml Inj, 10ml
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, Anesthetic Adjuvant
Pharmacologic Class
Mu-opioid receptor 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 works in your brain to change how your body feels and responds to pain. It is given as an injection, usually in a hospital setting, for severe pain or during surgery. Because it is very powerful, it must be used with extreme care and under close medical supervision.
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 be sure to follow all instructions provided. This medication is administered via injection.
For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication 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, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication 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 drowsy.
- Report any difficulty breathing, extreme drowsiness, or confusion immediately to your healthcare provider.
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:
Varies significantly by indication and route. For IV analgesia: 50-100 mcg/dose, repeated as needed. For anesthesia induction: 2-20 mcg/kg IV.
Dose Range:
2 - 20 mg
Condition-Specific Dosing:
acute_pain_iv:
50-100 mcg IV over 1-2 minutes, may repeat in 1-2 hours as needed. Max initial dose 100 mcg.
anesthesia_induction_iv:
2-20 mcg/kg IV, depending on desired level of analgesia/anesthesia and concomitant agents.
postoperative_pain_iv:
25-100 mcg IV, repeated every 30-60 minutes as needed.
Pediatric Dosing
Neonatal:
Not established for routine use; extreme caution and reduced doses if used (e.g., 1-2 mcg/kg IV for analgesia, titrate slowly).
Infant:
1-2 mcg/kg IV for analgesia, titrate slowly. For anesthesia: 2-5 mcg/kg IV.
Child:
1-2 mcg/kg IV for analgesia, titrate slowly. For anesthesia: 2-5 mcg/kg IV.
Adolescent:
Similar to adult dosing, 1-2 mcg/kg IV for analgesia, titrate slowly. For anesthesia: 2-5 mcg/kg IV.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment, but monitor closely for increased effects.
Moderate:
Consider dose reduction (e.g., 25-50% of usual dose) and extend dosing interval. Monitor closely.
Severe:
Significant dose reduction (e.g., 50-75% of usual dose) and extended dosing interval. Monitor closely for respiratory depression and prolonged sedation.
Dialysis:
Fentanyl is not significantly removed by hemodialysis. Administer after dialysis. Monitor closely for prolonged effects.
Hepatic Impairment:
Mild:
No specific dose adjustment, but monitor closely.
Moderate:
Consider dose reduction (e.g., 25-50% of usual dose) and extend dosing interval. Monitor closely for increased effects.
Severe:
Significant dose reduction (e.g., 50-75% of usual dose) and extended dosing interval. Monitor closely for respiratory depression and prolonged sedation.
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 primary therapeutic effects 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:
Minutes (IV)
FoodEffect:
Not applicable for IV formulation
Distribution:
Vd:
4 L/kg (adults)
ProteinBinding:
80-85%
CnssPenetration:
Yes
Elimination:
HalfLife:
3-7 hours (terminal elimination half-life, varies with route and duration of infusion)
Clearance:
0.8-1.2 L/kg/hr
ExcretionRoute:
Primarily renal (75% as metabolites, <10% as unchanged drug), some fecal (9% as metabolites)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Immediate (IV)
PeakEffect:
3-5 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.
CONCOMITANT USE OF 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.
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.
ACCIDENTAL EXPOSURE: Accidental exposure to even one dose of Fentanyl Injection, especially in children, can result in a fatal overdose.
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.
CONCOMITANT USE OF 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.
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.
ACCIDENTAL EXPOSURE: Accidental exposure to even one dose of Fentanyl Injection, especially in children, can result in a fatal overdose.
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 experience 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
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Feeling confused
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Breathing problems during sleep (sleep apnea)
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 right away 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
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 immediately if you experience:
Extreme fatigue or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Other Possible Side Effects
Like all medications, this drug may cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you experience any of the following:
Dizziness
Sleepiness
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 experience 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
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Feeling confused
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Breathing problems during sleep (sleep apnea)
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 right away 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
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 immediately if you experience:
Extreme fatigue or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Other Possible Side Effects
Like all medications, this drug may cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you experience any of the following:
Dizziness
Sleepiness
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
- Pinpoint pupils
- Bluish lips or fingernails
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, such as asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Kidney or liver disease
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of severely high blood pressure
* Current use of certain medications, such as 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 problems 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 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, such as asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Kidney or liver disease
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of severely high blood pressure
* Current use of certain medications, such as 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 problems 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 consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down 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 medication becomes less effective, and you may need higher doses 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 lead to 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 experience increased sensitivity to pain, or you develop new pain, 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, 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.
Hormonal Effects
Long-term use of opioid medications like this one may 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.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
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 overly sleepy, limp, or has breathing difficulties.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down 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 medication becomes less effective, and you may need higher doses 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 lead to 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 experience increased sensitivity to pain, or you develop new pain, 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, 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.
Hormonal Effects
Long-term use of opioid medications like this one may 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.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
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 overly sleepy, limp, or has breathing difficulties.
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
- Bradycardia
- Hypotension
- Circulatory collapse
- Death
What to Do:
Seek immediate emergency medical attention. Administer naloxone if available and trained. Call 911 or 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Concomitant use with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nefazodone) in patients not already receiving fentanyl, due to increased risk of respiratory depression.
- Patients with significant respiratory depression.
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., 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, MAOIs): Risk of serotonin syndrome.
- Mixed agonist/antagonist and partial agonist opioids (e.g., buprenorphine, nalbuphine, pentazocine): May reduce the analgesic effect of fentanyl and/or precipitate withdrawal symptoms.
- CYP3A4 inhibitors (moderate, e.g., fluconazole, diltiazem, erythromycin): Increased fentanyl plasma concentrations, leading to increased opioid effects.
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease fentanyl plasma concentrations, leading to reduced efficacy.
- Anticholinergics: Increased risk of urinary retention and/or 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
Oxygen saturation (SpO2)
Rationale: To assess baseline oxygenation.
Timing: Prior to administration
Level of consciousness/sedation score
Rationale: To assess baseline neurological status and risk of over-sedation.
Timing: Prior to administration
Pain level (using a validated scale)
Rationale: To establish baseline pain and evaluate treatment efficacy.
Timing: Prior to administration
Blood pressure and heart rate
Rationale: To assess baseline cardiovascular status; fentanyl can cause bradycardia and hypotension.
Timing: Prior to administration
Routine Monitoring
Respiratory rate and depth
Frequency: Every 5-15 minutes initially, then every 1-4 hours or as clinically indicated, especially after dose changes.
Target: 12-20 breaths/min (adults), age-appropriate for pediatric
Action Threshold: <10 breaths/min (adults) or significant decrease from baseline; shallow breathing; signs of hypoventilation.
Oxygen saturation (SpO2)
Frequency: Continuous or every 5-15 minutes initially, then every 1-4 hours or as clinically indicated.
Target: >92-95%
Action Threshold: <90% or significant drop from baseline.
Level of consciousness/sedation score (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Every 5-15 minutes initially, then every 1-4 hours or as clinically indicated.
Target: Alert to mildly drowsy (S1-S2)
Action Threshold: Difficult to arouse (S3) or unarousable (S4).
Pain level
Frequency: Every 1-4 hours or as clinically indicated.
Target: Patient-specific goal (e.g., <4/10)
Action Threshold: Uncontrolled pain despite adequate dosing.
Blood pressure and heart rate
Frequency: Every 5-15 minutes initially, then every 1-4 hours or as clinically indicated.
Target: Within patient's normal range
Action Threshold: Significant hypotension or bradycardia.
Symptom Monitoring
- Excessive sedation
- Respiratory depression (slow, shallow breathing)
- Pinpoint pupils
- Dizziness
- Nausea/vomiting
- Constipation
- Urinary retention
- Pruritus
- Muscle rigidity (especially with rapid IV administration or high doses)
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure. Risk generally considered low for short-term use.
Second Trimester:
Risk of neonatal opioid withdrawal syndrome increases with prolonged use.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome with prolonged use. Risk of respiratory depression in the neonate if administered 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 concern (L3) - potential for sedation, respiratory depression, and withdrawal symptoms in the infant.
Pediatric Use
Use with extreme caution, especially in neonates and infants, due to increased sensitivity to respiratory depression. Dosing must be carefully titrated based on weight and clinical response. Not recommended for routine use in neonates.
Geriatric Use
Elderly patients may be more sensitive to the effects of fentanyl, particularly respiratory depression. Start with lower doses and titrate slowly. Monitor closely for adverse effects, especially respiratory and CNS depression.
Clinical Information
Clinical Pearls
- Fentanyl is highly potent; even small errors in dosing can be fatal. Always double-check calculations and concentrations.
- Rapid IV administration can cause chest wall rigidity, making ventilation difficult. Administer slowly over 1-2 minutes.
- Tolerance and physical dependence can develop with prolonged use, even at therapeutic doses.
- Naloxone should be readily available when administering fentanyl, especially in non-anesthesia settings.
- Monitor for delayed respiratory depression, particularly after large or repeated doses, due to redistribution from peripheral tissues.
- The 50mcg/1ml concentration is commonly used for bolus dosing in acute pain or as an anesthetic adjunct. Ensure correct vial concentration (e.g., 50mcg/ml vs 50mcg/10ml) to prevent errors.
Alternative Therapies
- Other opioid analgesics (e.g., morphine, hydromorphone, oxycodone, sufentanil)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, regional anesthesia, local anesthetics)
- Adjuvant analgesics (e.g., gabapentin, pregabalin, ketamine)
Cost & Coverage
Average Cost:
Varies widely by supplier and contract per 10ml vial (500mcg total)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand) - often requires prior authorization due to opioid class and abuse potential.
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, 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.
In the event of a suspected overdose, 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 this medication, 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.
In the event of a suspected overdose, 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.