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SUBSYS (FENTANYL)
- Breakthrough cancer pain in opioid-tolerant patient
1,200 mcg (600 mcg/spray X2) sublingual spray
- Spray 2 sprays (1,200 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ;May repeat in 30 minutes
1,600 mcg (800 mcg/spray X2) sublingual spray
- Spray 2 sprays (1,600 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ;May repeat in 30 minutes
100 mcg/spray sublingual spray
- Spray 1 spray (100 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ;May repeat in 30 minutes
200 mcg/spray sublingual spray
- Spray 1 spray (200 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ;May repeat in 30 minutes
400 mcg/spray sublingual spray
- Spray 1 spray (400 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ;May repeat in 30 minutes
600 mcg/spray sublingual spray
- Spray 1 spray (600 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ;May repeat in 30 minutes
800 mcg/spray sublingual spray
- Spray 1 spray (800 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ;May repeat in 30 minutes
Breakthrough cancer pain in opioid-tolerant patient
- Spray 2 sprays (1,200 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ; may repeat once in 30 minutes; not to exceed 2 doses per episode
- Spray 2 sprays (1,200 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ;May repeat in 30 minutes
- Spray 2 sprays (1,600 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ; may repeat once in 30 minutes; not to exceed 2 doses per episode
- Spray 2 sprays (1,600 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ;May repeat in 30 minutes
- Spray 1 spray (100 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ;May repeat in 30 minutes
- Spray 1 spray (100 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ; may repeat once in 30 minutes; not to exceed 2 doses per episode
- Spray 1 spray (200 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ; may repeat once in 30 minutes; not to exceed 2 doses per episode
- Spray 1 spray (200 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ;May repeat in 30 minutes
- Spray 1 spray (400 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ;May repeat in 30 minutes
- Spray 1 spray (400 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ; may repeat once in 30 minutes; not to exceed 2 doses per episode
- Spray 1 spray (600 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ; may repeat once in 30 minutes; not to exceed 2 doses per episode
- Spray 1 spray (600 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ;May repeat in 30 minutes
- Spray 1 spray (800 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ; may repeat once in 30 minutes; not to exceed 2 doses per episode
- Spray 1 spray (800 mcg) under the tongue by sublingual route 4 times per day as needed for breakthrough pain ;May repeat in 30 minutes
- Azilect
- Depade
- Eldepryl
- isocarboxazid
- linezolid
- Marplan
- Matulane
- methylene blue (antidote)
- naltrexone
- naltrexone microspheres
- Nardil
- Parnate
- phenelzine
- procarbazine
- rasagiline
- Revia
- selegiline HCl
- tranylcypromine
- Vivitrol
- Zelapar
- Zyvox
Contraindicated
- amiodarone
- amiodarone in dextrose,iso-osm
- amoxicil-clarithromy-lansopraz
- Biaxin
- Biaxin Xl
- Biaxin Xl Pak
- boceprevir
- Buprenex
- buprenorphine
- buprenorphine-naloxone
- butorphanol tartrate
- Butrans
- clarithromycin
- conivaptan in 5 % dextrose
- Cordarone
- Crixivan
- Diflucan
- elvitegr-cobicist-emtric-tenof
- enzalutamide
- Erythrocin
- erythromycin
- erythromycin-sulfisoxazole
- fluconazole
- fluconazole in dextrose(iso-o)
- fluconazole in NaCl (iso-osm)
- Incivek
- indinavir
- Invirase
- itraconazole
- Kaletra
- Ketek
- ketoconazole
- lopinavir-ritonavir
- nalbuphine
- nefazodone
- nelfinavir
- Nexterone
- Norvir
- Norvir Soft Gelatin
- Noxafil
- Omeclamox-pak
- omeprazole-clarith-amoxicillin
- Onmel
- Pacerone
- posaconazole
- Prevpac
- ritonavir
- saquinavir mesylate
- sodium oxybate
- Sporanox
- Sporanox Pulsepak
- Stribild
- Suboxone
- telaprevir
- telithromycin
- Vaprisol
- Vfend
- Vfend Iv
- Victrelis
- Viracept
- voriconazole
- Xtandi
- Xyrem
- Zubsolv
Severe
Moderate
- Acid Reducer (cimetidine)
- Acid Relief (cimetidine)
- Anafranil
- aprepitant
- atazanavir
- Brintellix
- Brisdelle
- Calan
- Calan Sr
- Cardizem
- Cardizem Cd
- Cardizem La
- Cartia Xt
- Celexa
- cimetidine
- Cipro
- Cipro In D5W
- Cipro Xr
- ciprofloxacin
- ciprofloxacin (mixture)
- ciprofloxacin in D5W
- citalopram
- clomipramine
- Cymbalta
- darunavir
- desvenlafaxine
- desvenlafaxine fumarate
- desvenlafaxine succinate
- Dilacor Xr
- Dilt-xr
- diltiazem HCl
- Diprivan
- dronedarone
- duloxetine
- Effexor Xr
- Emend
- escitalopram oxalate
- Fanatrex
- Fetzima
- fluoxetine
- fluvoxamine
- fosamprenavir
- fosaprepitant
- gabapentin
- gabapentin enacarbil
- Gleevec
- Gralise
- Gralise 30-day Starter Pack
- Heartburn Relief
- Horizant
- imatinib
- isoniazid-rifamp-pyrazinamide
- Khedezla
- levomilnacipran
- Lexapro
- Lexiva
- Luvox Cr
- Matzim La
- milnacipran
- Multaq
- Neurontin
- olanzapine-fluoxetine
- paroxetine HCl
- paroxetine mesylate
- Paxil
- Paxil Cr
- Pexeva
- Prezista
- Pristiq
- propofol
- Prozac
- Prozac Weekly
- Reyataz
- Rifadin
- Rifamate
- rifampin
- rifampin-isoniazid
- Rifater
- Sarafem
- Savella
- sertraline
- Symbyax
- Tagamet Hb
- Tarka
- Taztia Xt
- Tiazac
- trandolapril-verapamil
- venlafaxine
- verapamil
- Verelan
- Verelan Pm
- Viibryd
- vilazodone
- vortioxetine
- Zoloft
- Alcoholism
- Gastrointestinal obstruction
- Headache disorder
- Migraine
- Postoperative acute pain
- Respiratory depression
Contraindicated
- Asthma
- Chronic disease of respiratory system
- Chronic obstructive pulmonary disease
- Cor pulmonale
- Drug abuse
- History of opioid overdose
- Hypotension
- Inflammatory bowel disease
- Intracranial hypertension
Severe
Moderate
- Adrenal cortical insufficiency
- Biliary tract disorder
- Bradycardia
- Disease of liver
- Kidney disease with likely reduction in GFR
SUBSYS (FENTANYL)
- Breakthrough cancer pain in opioid-tolerant patient
- CNS depression
- Dyspnea
- Constipation
- Dizziness
- Drowsy
- Nausea
- Vomiting
More Frequent
Severe
Less Severe
- Acute confusion
- Circulatory depression
- False sense of well-being
- Hallucinations
- Hypotension
- Respiratory depression
- Urinary retention
- Cough
- Dehydration
- Depression
- General weakness
- Headache disorder
- Nervousness
- Symptoms of anxiety
- Xerostomia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Adrenal cortical insufficiency
- Anaphylaxis
- Deep venous thrombosis
- Gastrointestinal obstruction
- Hypertension
- Intracranial hypertension
- Myoclonus
- Serotonin syndrome
- Shock
- Sleep apnea
- Tonic clonic seizure
Less Severe
- Agitation
- Androgen deficiency
- Ataxia
- Dental caries
- Erectile dysfunction
- Gait abnormality
- Hyperhidrosis
- Hypertonia
- Infertility
- Insomnia
- Libido changes
- Nightmares
- Pruritus of skin
- Skin rash
- Tooth disorder
- Tremor
- Vasodilation of blood vessels
- Vertigo
- Visual changes
- Weight loss
Contraindicated
Fentanyl (Eff,Film,SL)
Risk of severe respiratory depression. Restricted to opioid tolerant patients. Dose form not indicated for pediatric use.
- 1 Day – 16 Years
- 1 Risk of severe respiratory depression. Restricted to opioid tolerant patients. Dose form not indicated for pediatric use.
Severe Precaution
Fentanyl (Loz,Eff,Film,SL)
Risk of severe respiratory depression. Restricted to opioid tolerant patient.
- 16 Years – 18 Years
- Risk of severe respiratory depression. Restricted to opioid tolerant patient.
Management or Monitoring Precaution
None
Fentanyl
- Severity Level:
2
- Additional Notes: Neonatal withdrawal/resp.depress. w/chronic or high dose
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Fentanyl
Insufficient data avail; low levels excreted with short term use
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Excreted | Not known; no or inclusive data | Insufficient data avail; low levels excreted with short term use |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- Fentanyl has a risk for abuse and addiction, which can lead to overdose and death. Fentanyl may also cause severe, possibly fatal, breathing problems. Do not use this product unless you have been regularly taking moderate to large amounts of opioid pain medication.<br /><br />Otherwise, it may cause overdose (even death). To lower your risk, your doctor should have you use the smallest dose of fentanyl that works, and use it for the shortest possible time. See also How to Use section for more information about addiction.<br /><br /> The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you use the wrong dose/strength. Using this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Be sure you know how to use fentanyl and what other drugs you should avoid using with it.<br /><br />See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up. Carefully follow the specific directions for using fentanyl sublingual spray.<br /><br />Different forms of fentanyl (including lozenges, buccal tablets, patches) do not have the same effects at equal strengths and should not be substituted for each other. Tell your doctor or pharmacist of all medications that you use, especially of drugs that might affect breathing or that can affect how fentanyl works. Do not start, stop, or change the dosage of any medicines you are using without your doctor's approval.<br /><br /> Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally uses or swallows this drug, get medical help right away. Because of the risk of misuse, abuse, and overdose, you will need to register with a special distribution program before receiving your prescription.<br /><br />Only doctors and pharmacies enrolled in this program may prescribe or dispense this medication. Ask your doctor or pharmacist for details. Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits.<br /><br />Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy.<br /><br />Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, use the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.
| Breakthrough cancer pain in opioid-tolerant patient | |
| G89.3 | Neoplasm related pain (acute) (chronic) |
| Z79.891 | Long term (current) use of opiate analgesic |
| 0-9 | A-Z |
|---|---|
| G89.3 | Neoplasm related pain (acute) (chronic) |
| Z79.891 | Long term (current) use of opiate analgesic |
Formulary Reference Tool