Sublimaze

Generic name: Fentanyl
Drug class: Opioids (narcotic analgesics)

Usage of Sublimaze

Fentanyl injection is used to relieve severe pain during and after surgery. It is also used with other medicines just before or during an operation to help the anesthetic (numbing medicine) work better.

Fentanyl belongs to the group of medicines called narcotic analgesics (pain medicines). It acts in the central nervous system (CNS) or brain to relieve pain. Some of its side effects are also caused by actions in the CNS such as drowsiness or dizziness.

This medicine is to be given only by or under the immediate supervision of your doctor.

Sublimaze side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Chest pain or discomfort

difficult or troubled breathing

irregular, fast or slow, or shallow breathing

lightheadedness, dizziness, or fainting

pale or blue lips, fingernails, or skin

severe muscle stiffness

slow or irregular heartbeat

unusual tiredness

Incidence not known

Blurred vision

change in consciousness

chills

confusion

cough

difficulty with swallowing

fast heartbeat

feeling cold

headache

hives, itching, or skin rash

inability to move the eyes

inability to sit still

increased blinking or spasms of the eyelid

nervousness

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

restlessness

seeing, hearing, or feeling things that are not there

sticking out the tongue when not meaning to

sweating

tightness in the chest

uncontrolled twisting movements of the neck, trunk, arms, or legs

unusual facial expressions

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

increased sweating

redness of the skin

vomiting

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Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Sublimaze

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fentanyl injection in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fentanyl injection in the elderly. However, elderly patients are more likely to have age-related lung, kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving fentanyl injection.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Levoketoconazole

Mifepristone

Nalmefene

Naltrexone

Safinamide

Samidorphan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir

Acepromazine

Adagrasib

Alefacept

Alfentanil

Almotriptan

Alprazolam

Amifampridine

Amineptine

Amiodarone

Amitriptyline

Amitriptylinoxide

Amobarbital

Amoxapine

Amphetamine

Amprenavir

Anileridine

Aprepitant

Aripiprazole

Armodafinil

Asciminib

Asenapine

Atazanavir

Avacopan

Baclofen

Belzutifan

Benperidol

Benzhydrocodone

Benzphetamine

Berotralstat

Boceprevir

Bosentan

Bromazepam

Bromopride

Brompheniramine

Buprenorphine

Bupropion

Buspirone

Butabarbital

Butorphanol

Calcium Oxybate

Cannabis

Carphenazine

Ceritinib

Cetirizine

Chloral Hydrate

Chlordiazepoxide

Chlorpheniramine

Chlorpromazine

Chlorzoxazone

Ciprofloxacin

Citalopram

Clarithromycin

Clobazam

Clomipramine

Clonazepam

Clopidogrel

Clorazepate

Clozapine

Cobicistat

Cocaine

Codeine

Conivaptan

Crizotinib

Cyclobenzaprine

Cyclosporine

Dabrafenib

Daridorexant

Darunavir

Delavirdine

Desipramine

Desmopressin

Desvenlafaxine

Dexamethasone

Dexmedetomidine

Dextroamphetamine

Dextromethorphan

Dezocine

Diazepam

Dibenzepin

Dichloralphenazone

Difenoxin

Dihydrocodeine

Diltiazem

Diphenhydramine

Diphenoxylate

Dolasetron

Donepezil

Doxepin

Dronedarone

Droperidol

Duloxetine

Efavirenz

Eletriptan

Eluxadoline

Enflurane

Enzalutamide

Erdafitinib

Erythromycin

Escitalopram

Esketamine

Eslicarbazepine Acetate

Estazolam

Eszopiclone

Ethchlorvynol

Ethopropazine

Ethylmorphine

Etravirine

Fedratinib

Fenfluramine

Fexinidazole

Flibanserin

Fluconazole

Fluoxetine

Fluphenazine

Flurazepam

Fluspirilene

Fluvoxamine

Fosamprenavir

Fosaprepitant

Fosnetupitant

Fosphenytoin

Fospropofol

Frovatriptan

Furazolidone

Gabapentin

Gabapentin Enacarbil

Gepirone

Granisetron

Halazepam

Haloperidol

Halothane

Hexobarbital

Hydrocodone

Hydromorphone

Hydroxyamphetamine

Hydroxytryptophan

Hydroxyzine

Idelalisib

Imatinib

Imipramine

Indinavir

Iproniazid

Isocarboxazid

Isoflurane

Itraconazole

Ivacaftor

Ketamine

Ketobemidone

Ketoconazole

Lacosamide

Lanreotide

Lasmiditan

Lefamulin

Lemborexant

Lenacapavir

Levocetirizine

Levomilnacipran

Levorphanol

Linezolid

Lisdexamfetamine

Lithium

Lofepramine

Lofexidine

Lomitapide

Lopinavir

Lorazepam

Lorcaserin

Lorlatinib

Loxapine

Lumacaftor

Magnesium Oxybate

Mavacamten

Meclizine

Melitracen

Melperone

Meperidine

Mephobarbital

Meprobamate

Meptazinol

Mesoridazine

Metaxalone

Methadone

Methamphetamine

Methdilazine

Methocarbamol

Methohexital

Methotrimeprazine

Methylene Blue

Metoclopramide

Mibefradil

Midazolam

Milnacipran

Mirtazapine

Mitotane

Mobocertinib

Moclobemide

Modafinil

Molindone

Moricizine

Morphine

Morphine Sulfate Liposome

Nafcillin

Nalbuphine

Naratriptan

Nefazodone

Nelfinavir

Netupitant

Nevirapine

Nialamide

Nicardipine

Nicomorphine

Nifedipine

Nilotinib

Nirmatrelvir

Nitrazepam

Nitrous Oxide

Nortriptyline

Octreotide

Olanzapine

Omaveloxolone

Ondansetron

Opipramol

Opium

Opium Alkaloids

Orphenadrine

Oxazepam

Oxcarbazepine

Oxycodone

Oxymorphone

Ozanimod

Palbociclib

Palonosetron

Papaveretum

Paregoric

Paroxetine

Pazopanib

Pentazocine

Pentobarbital

Perampanel

Perazine

Periciazine

Perphenazine

Phenelzine

Phenobarbital

Phenytoin

Pimozide

Piperacetazine

Pipotiazine

Piritramide

Pirtobrutinib

Posaconazole

Potassium Oxybate

Prazepam

Prednisone

Pregabalin

Primidone

Procarbazine

Prochlorperazine

Promazine

Promethazine

Propofol

Protriptyline

Quazepam

Quetiapine

Ramelteon

Ranitidine

Ranolazine

Rasagiline

Remifentanil

Remimazolam

Remoxipride

Ribociclib

Rifabutin

Rifampin

Rifapentine

Ritlecitinib

Ritonavir

Rizatriptan

Ropeginterferon Alfa-2b-njft

Saquinavir

Scopolamine

Secobarbital

Selegiline

Selpercatinib

Sertindole

Sertraline

Sibutramine

Sodium Oxybate

Sotorasib

St John's Wort

Sufentanil

Sulpiride

Sumatriptan

Suvorexant

Tacrolimus

Tapentadol

Taurursodiol

Telaprevir

Telithromycin

Temazepam

Thiethylperazine

Thiopental

Thiopropazate

Thioridazine

Tianeptine

Tilidine

Tizanidine

Tocilizumab

Tolonium Chloride

Topiramate

Tramadol

Tranylcypromine

Trazodone

Triazolam

Trifluoperazine

Trifluperidol

Triflupromazine

Trimeprazine

Trimipramine

Trofinetide

Tryptophan

Tucatinib

Venlafaxine

Verapamil

Vilazodone

Voriconazole

Vortioxetine

Voxelotor

Zaleplon

Ziprasidone

Zolmitriptan

Zolpidem

Zopiclone

Zotepine

Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Grapefruit Juice

Relate drugs

How to use Sublimaze

A doctor or other trained health professional will give you or your child this medicine in a hospital. This medicine is given as a shot into a muscle or vein.

Warnings

It is very important that your doctor check you closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Do not use too much of this medicine or use it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

Dizziness, lightheadedness, or fainting may occur with this medicine, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping pills, prescription pain medicine or narcotics, barbiturates or seizure medicines, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your medical doctor or dentist before taking any of the above while you or your child are receiving this medicine.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

This medicine may make you dizzy, drowsy, confused, or disoriented. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

This medicine may increase risk for muscle rigidity and movement. Tell your doctor if you or your child have stiff or rigid muscles after using this medicine.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

Using too much of this medicine may cause reduced infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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