Fentanyl Cit 600mcg Oral Transmcsl
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.This drug is not for mild pain or pain that only lasts a short time (like headaches, toothaches, or pain after surgery).This drug is only for use by people who have been taking pain drugs (opioids) and are used to their effects. Talk with the doctor.
Drug Class
Opioid analgesic
Pharmacologic Class
Opioid agonist
Pregnancy Category
Category C
FDA Approved
Sep 1998
DEA Schedule
Schedule II
Overview
What is this medicine?
Fentanyl lozenge is a very strong pain medicine used only for breakthrough cancer pain in patients who are already taking other opioid pain medicines around the clock for their cancer pain. It is not for other types of pain. It works quickly to relieve sudden, severe pain episodes. Because it is very strong, it must be used exactly as prescribed and kept out of reach of children and pets, as even a small amount can be fatal if accidentally ingested.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication properly, follow your doctor's instructions and read all the information provided. Place the lozenge in your mouth between your cheek and lower gum, and gently move it from side to side using the handle. Suck on the oral lozenge without chewing, breaking, or crushing it, and do not swallow it whole. After taking a dose, dispose of the handle in the trash, out of reach of children and pets. If any medication remains on the handle, rinse it with hot water before discarding to ensure the drug is fully dissolved.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding bathrooms. Keep it in a secure location where children cannot see or access it, and where others cannot reach it. Consider using a locked box or area to safeguard the medication. Keep all medications away from pets. Dispose of unused or expired medications by throwing them away. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
To use this medication properly, follow your doctor's instructions and read all the information provided. Place the lozenge in your mouth between your cheek and lower gum, and gently move it from side to side using the handle. Suck on the oral lozenge without chewing, breaking, or crushing it, and do not swallow it whole. After taking a dose, dispose of the handle in the trash, out of reach of children and pets. If any medication remains on the handle, rinse it with hot water before discarding to ensure the drug is fully dissolved.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding bathrooms. Keep it in a secure location where children cannot see or access it, and where others cannot reach it. Consider using a locked box or area to safeguard the medication. Keep all medications away from pets. Dispose of unused or expired medications by throwing them away. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Do not drive or operate heavy machinery until you know how this medicine affects you, as it can cause drowsiness and dizziness.
- Avoid alcohol and other medications that cause drowsiness (e.g., benzodiazepines, other opioids) unless specifically instructed by your doctor, as this can lead to dangerous breathing problems.
- Store this medicine securely in its original child-resistant container, out of sight and reach of children and pets. Accidental ingestion can be fatal.
- Dispose of any unused or expired units immediately by flushing them down the toilet, as instructed by the medication guide. Do not throw them in the trash.
- Inform all healthcare providers that you are taking fentanyl lozenge, especially before any surgery or dental procedures.
- Do not share this medication with anyone else.
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 titration for breakthrough cancer pain in opioid-tolerant patients. Initial dose is typically 200 mcg. Patients should be maintained on around-the-clock opioid therapy. One unit should be consumed over 15 minutes. If pain relief is not achieved after 15 minutes, a second unit of the same strength may be administered. No more than two units should be used for a single episode of breakthrough pain. Subsequent doses for new episodes should be titrated upwards in increments (e.g., 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, 1600 mcg) until an effective dose is found. A maximum of 4 units per day is generally recommended during titration, and no more than 4 units per day once a stable dose is achieved.
Dose Range:
200 - 1600 mg
Condition-Specific Dosing:
opioid_tolerant:
Patients must be opioid tolerant, defined as taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, or an equianalgesic dose of another opioid for a week or longer.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for increased opioid effects.
Moderate:
Use with caution; monitor for increased opioid effects. Consider dose reduction.
Severe:
Use with caution; monitor for increased opioid effects. Consider dose reduction.
Dialysis:
Fentanyl is not dialyzable. Use with extreme caution; monitor closely for prolonged respiratory depression and sedation.
Hepatic Impairment:
Mild:
Use with caution; monitor for increased opioid effects.
Moderate:
Use with caution; monitor for increased opioid effects. Consider dose reduction.
Severe:
Use with caution; monitor for increased opioid effects. Consider dose reduction.
Pharmacology
Mechanism of Action
Fentanyl is a potent, synthetic opioid analgesic that acts primarily as an agonist at the mu-opioid receptors in the central nervous system (CNS). Its primary therapeutic action is analgesia. Other effects include respiratory depression, euphoria, miosis, and physical dependence.
Pharmacokinetics
Absorption:
Bioavailability:
25-50% (transmucosal, variable)
Tmax:
20-40 minutes (for transmucosal absorption)
FoodEffect:
Not directly applicable for transmucosal administration, but oral intake of food/liquid can affect dissolution and absorption.
Distribution:
Vd:
3-6 L/kg
ProteinBinding:
80-85%
CnssPenetration:
Yes
Elimination:
HalfLife:
3-12 hours (terminal half-life, highly variable)
Clearance:
0.5-1.5 L/hr/kg
ExcretionRoute:
Mainly renal (metabolites), small amount in feces
Unchanged:
<10% (urine)
Pharmacodynamics
OnsetOfAction:
5-15 minutes
PeakEffect:
20-40 minutes
DurationOfAction:
1-2 hours (for breakthrough pain relief)
Safety & Warnings
BLACK BOX WARNING
RISK OF MEDICATION ERRORS, ADDICTION, ABUSE, AND MISUSE, RESPIRATORY DEPRESSION, ACCIDENTAL INGESTION, CYTOCHROME P450 3A4 INTERACTION, NEONATAL OPIOID WITHDRAWAL SYNDROME, and RISK EVALUATION AND MITIGATION STRATEGY (REMS).
Fentanyl lozenge contains fentanyl, an opioid agonist, and is a Schedule II controlled substance. Fentanyl lozenge 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 lozenge, and monitor all patients regularly for the development of these behaviors and conditions.
Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of Fentanyl lozenge or following a dose increase.
Accidental ingestion of Fentanyl lozenge, especially by children, can result in a fatal overdose of fentanyl.
Concomitant use of Fentanyl lozenge with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving Fentanyl lozenge and any CYP3A4 inhibitor or inducer.
Prolonged use of Fentanyl lozenge 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.
Because of the risk of addiction, abuse, and misuse, and respiratory depression, Fentanyl lozenge is available only through a restricted program called the TIRF REMS Program.
Fentanyl lozenge contains fentanyl, an opioid agonist, and is a Schedule II controlled substance. Fentanyl lozenge 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 lozenge, and monitor all patients regularly for the development of these behaviors and conditions.
Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of Fentanyl lozenge or following a dose increase.
Accidental ingestion of Fentanyl lozenge, especially by children, can result in a fatal overdose of fentanyl.
Concomitant use of Fentanyl lozenge with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving Fentanyl lozenge and any CYP3A4 inhibitor or inducer.
Prolonged use of Fentanyl lozenge 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.
Because of the risk of addiction, abuse, and misuse, and respiratory depression, Fentanyl lozenge is available only through a restricted program called the TIRF REMS Program.
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
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Feeling confused
Severe constipation or stomach pain, which may indicate 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 Rare but Serious Condition
If you take this medication with certain other drugs, you may be at risk of developing 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
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 tiredness 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 do not experience any side effects or only minor ones, it is essential to report any concerns to your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention:
Feeling dizzy, sleepy, tired, or weak
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Headache
Feeling cold
Trouble sleeping
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
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Feeling confused
Severe constipation or stomach pain, which may indicate 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 Rare but Serious Condition
If you take this medication with certain other drugs, you may be at risk of developing 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
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 tiredness 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 do not experience any side effects or only minor ones, it is essential to report any concerns to your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention:
Feeling dizzy, sleepy, tired, or weak
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Headache
Feeling cold
Trouble sleeping
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, shallow, or difficult breathing
- Extreme drowsiness or inability to wake up
- Dizziness or lightheadedness when standing up
- Confusion
- Bluish lips or skin
- Severe constipation
- Signs of allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
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 obstruction 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
Presence of mouth sores, which may require discussion with your doctor
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without consulting your doctor first.
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 obstruction 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
Presence of mouth sores, which may require discussion with your doctor
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Safety Precautions
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When rising from a sitting or lying position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs.
Long-Term Use and Dependence
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means the medication may not work as effectively. In this case, you may require higher doses to achieve the same effect. If you notice the medication is no longer working well, contact your doctor. Do not take more than the prescribed dose.
Long-term or regular use of opioid medications like this one can lead to dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as suddenly stopping or lowering the dose can increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, suicidal thoughts, or other concerns.
Dosage and Administration
Do not exceed the prescribed dose or take the medication more frequently or for a longer duration than recommended. Doing so may increase the risk of severe side effects.
Interactions and Contraindications
Before taking this medication with other strong pain medications 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 take more than the prescribed dose.
If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor. Avoid taking this medication with alcohol or products containing alcohol, as this can lead to unsafe and potentially deadly 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 can lead to lower sex hormone levels. If you experience decreased libido, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
Dental Care
Maintain good oral hygiene and visit your dentist regularly.
Diabetes
If you have high blood sugar (diabetes), consult your doctor, as some products may contain sugar.
Geriatric Use
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.
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Safety Precautions
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When rising from a sitting or lying position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs.
Long-Term Use and Dependence
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means the medication may not work as effectively. In this case, you may require higher doses to achieve the same effect. If you notice the medication is no longer working well, contact your doctor. Do not take more than the prescribed dose.
Long-term or regular use of opioid medications like this one can lead to dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as suddenly stopping or lowering the dose can increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, suicidal thoughts, or other concerns.
Dosage and Administration
Do not exceed the prescribed dose or take the medication more frequently or for a longer duration than recommended. Doing so may increase the risk of severe side effects.
Interactions and Contraindications
Before taking this medication with other strong pain medications 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 take more than the prescribed dose.
If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor. Avoid taking this medication with alcohol or products containing alcohol, as this can lead to unsafe and potentially deadly 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 can lead to lower sex hormone levels. If you experience decreased libido, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
Dental Care
Maintain good oral hygiene and visit your dentist regularly.
Diabetes
If you have high blood sugar (diabetes), consult your doctor, as some products may contain sugar.
Geriatric Use
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:
- Slowed or stopped breathing (respiratory depression)
- Extreme drowsiness or sedation
- Pinpoint pupils (miosis)
- Cold, clammy skin
- Limp muscles
- Low blood pressure
- Slowed heart rate
- Coma
- Death
What to Do:
Seek immediate emergency medical attention. Call 911 or your local emergency number. If naloxone (Narcan) is available and you are trained to use it, administer it immediately. Continue to monitor breathing and be prepared to administer additional doses of naloxone if needed. Provide rescue breathing if the person is not breathing. Call 1-800-222-1222 (Poison Control Center) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of severe, unpredictable reactions)
- Patients who are not opioid tolerant
- Management of acute or post-operative pain (not for opioid-naïve patients)
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected gastrointestinal obstruction, including paralytic ileus
Major Interactions
- CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, grapefruit juice) - increased fentanyl plasma concentrations, leading to potentially fatal respiratory depression.
- CNS depressants (e.g., benzodiazepines, other opioids, sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, alcohol) - additive CNS depression, profound sedation, respiratory depression, coma, and death.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, linezolid) - risk of serotonin syndrome.
- Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol) - may reduce fentanyl's analgesic effect and/or precipitate withdrawal symptoms.
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) - decreased fentanyl plasma concentrations, leading to reduced efficacy or withdrawal.
- Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants) - increased risk of urinary retention and/or severe constipation.
Minor Interactions
- Not many specific minor interactions are typically highlighted for fentanyl due to its potency and critical safety profile.
Monitoring
Baseline Monitoring
Opioid tolerance status
Rationale: Fentanyl lozenge is only for opioid-tolerant patients to prevent fatal respiratory depression.
Timing: Prior to initiation
Pain assessment (type, severity, frequency of breakthrough pain)
Rationale: To determine appropriate dosing and assess treatment efficacy.
Timing: Prior to initiation
Respiratory status (rate, depth, rhythm)
Rationale: To identify baseline respiratory function and risk factors for respiratory depression.
Timing: Prior to initiation
Concomitant medications (especially CNS depressants, CYP3A4 inhibitors/inducers)
Rationale: To identify potential drug interactions that could lead to adverse effects or reduced efficacy.
Timing: Prior to initiation
Routine Monitoring
Pain relief and breakthrough pain episodes
Frequency: Daily, or as needed during titration
Target: Acceptable pain control with minimal side effects
Action Threshold: Inadequate pain relief or excessive side effects warrant dose adjustment or re-evaluation.
Signs of respiratory depression (decreased respiratory rate, shallow breathing, cyanosis)
Frequency: Regularly, especially during initiation and dose titration
Target: Normal respiratory rate and effort for the patient
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, somnolence, or cyanosis requires immediate intervention (e.g., naloxone, respiratory support).
Level of consciousness/sedation
Frequency: Regularly, especially during initiation and dose titration
Target: Alert and oriented, or usual baseline mental status
Action Threshold: Excessive sedation, somnolence, or unresponsiveness requires intervention.
Bowel function (constipation)
Frequency: Daily
Target: Regular bowel movements
Action Threshold: Severe constipation requires laxative regimen adjustment or other interventions.
Signs of abuse, misuse, or addiction
Frequency: Ongoing, at each visit
Target: Absence of aberrant drug-related behaviors
Action Threshold: Evidence of abuse or misuse requires re-evaluation of treatment plan and potential referral to addiction specialist.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/drowsiness
- Dizziness
- Nausea
- Vomiting
- Constipation
- Confusion
- Miosis (pinpoint pupils)
- Itching
- Dry mouth
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Prolonged use can lead to neonatal opioid withdrawal syndrome (NOWS).
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure.
Second Trimester:
Risk of NOWS if prolonged exposure occurs.
Third Trimester:
High risk of NOWS if prolonged exposure occurs. Risk of 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 lozenge. If breastfeeding cannot be avoided, monitor the infant closely for signs of sedation and respiratory depression.
Infant Risk:
Moderate to high risk (L3). Potential for sedation, respiratory depression, poor feeding, and withdrawal symptoms in the infant.
Pediatric Use
Fentanyl lozenge is not indicated for use in pediatric patients. Safety and efficacy have not been established in this population. Accidental ingestion by children can be fatal.
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 depression and sedation. Consider age-related decreases in renal and hepatic function.
Clinical Information
Clinical Pearls
- Fentanyl lozenge is part of a restricted distribution program (TIRF REMS Program) due to risks of addiction, abuse, misuse, and accidental ingestion. Prescribers, patients, and pharmacies must enroll.
- Strictly for opioid-tolerant patients with breakthrough cancer pain. NOT for opioid-naïve patients or for acute/post-operative pain.
- Dosing is individualized by titration. Patients should be instructed to suck on the lozenge, not chew, to maximize transmucosal absorption.
- Patients should be advised to dispose of partially used or completely used units immediately by flushing down the toilet to prevent accidental ingestion by children or pets.
- Concomitant use with CYP3A4 inhibitors can significantly increase fentanyl levels, leading to life-threatening respiratory depression. Avoid co-administration or reduce fentanyl dose and monitor closely.
- Educate patients and caregivers on signs of respiratory depression and the importance of naloxone availability.
- Monitor for signs of opioid-induced constipation and implement a bowel regimen as needed.
Alternative Therapies
- Other short-acting opioids for breakthrough pain (e.g., immediate-release oxycodone, hydromorphone, morphine)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for mild-moderate pain (often used in conjunction with opioids for cancer pain)
- Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic pain)
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to over a thousand USD per 30 units
Generic Available:
Yes
Insurance Coverage:
Tier 3 or Tier 4 (Specialty/Non-Preferred Brand), often requiring prior authorization and step therapy due to REMS program and high cost.
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 or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care immediately. When seeking help, be prepared to provide information about the substance involved, the quantity taken, and the time of the incident.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care immediately. When seeking help, be prepared to provide information about the substance involved, the quantity taken, and the time of the incident.